Investigación

2025

• 
  A Multifaceted Digital Intervention for the Prevention of Type 2 Diabetes Mellitus in Primary Care (PREDIABETEXT): Cluster Randomized Trial. Mira-Martínez, Sofía; Malih, Narges; Angullo-Martínez, Escarlata; Zamanillo-Campos, Rocío; Yañez, Aina M; Bennasar-Veny, Miquel; Gómez-Juanes, Rocío; Konieczna, Jadwiga; Jiménez, Rafael; Serrano-Ripoll, Maria J; Fiol deRoque, Maria Antonia; Leiva, Alfonso; Galmes-Panades, Aina M; Miralles-Xamena, Jerónima; Vidal-Thomàs, Maria Clara; Gómez-Cobo, Cristina; Gervilla, Elena; Oña-Gil, José Iván; Ricci-Cabello, Ignacio (2025). 27 e70981-e70981.

  AbstractURLBibTeXEndNoteDOIBibSonomy

  BACKGROUND: The diabetes epidemic continues to surge worldwide, demanding urgent and innovative solutions. Digital health interventions, particularly those targeting behavior change, hold promise due to their affordability and scalability. However, research in this field remains in its early stages. OBJECTIVE: This study aimed to evaluate the effectiveness of PREDIABETEXT (Prediabetes Text Message Digital Intervention for the Prevention of Type 2 Diabetes Mellitus), a digital health intervention, in reducing glycated hemoglobin (HbA(1c)) and in improving secondary clinical, physiological, and behavioral outcomes. METHODS: We conducted a 6-month, 3-arm, pragmatic cluster randomized clinical trial. We recruited patients with prediabetes (HbA(1c) levels between 6% and 6.4% in the previous 3 months or 2 consecutive fasting plasma glucose measurements of 110-125 mg/dL) registered at primary care centers in the Balearic Islands, Spain. The PREDIABETEXT intervention consisted of 3 personalized SMS text messages per week aimed at supporting lifestyle behavior changes and online training for their primary health care professionals. A total of 58 professionals (clusters) from 16 centers participated in the study and were randomized (1:1:1) to intervention group A (patient SMS text messaging), intervention group B (patient SMS text messaging+health care professional web-based training), or the control group (usual care). Following the 6-month intervention period, we conducted individual qualitative interviews with 8 patients and 7 health care professionals to evaluate their experiences with the intervention in terms of utility, satisfaction, and implementation barriers. RESULTS: In total, 58 health care professionals (clusters) were included, allocated to the control group (n=20, 34%; 119/365, 32.6% patients), intervention group A (SMS text messaging only; n=18, 31%; 106/365, 29% patients), and intervention group B (SMS text messaging+training; n=20, 34%; 140/365, 38.4% patients). The mean age of the patients was 59.79 (SD 9.75) years, and 54.5% (199/365) were female. The results of the intention-to-treat analysis at the 6-month time point showed that intervention A led to a small, nonsignificant reduction in HbA(1c) levels compared to the control group (β=-0.05, 95% CI -0.21 to 0.10; P=.50), whereas intervention B showed a similar nonsignificant reduction (β=-0.04, 95% CI -0.12 to 0.10; P=.56). No substantial differences were observed in the remaining secondary outcomes. Interviews revealed positive feedback from patients, who appreciated the intervention's dietary messages and their frequency and practicality. Participants suggested enhancements such as increased personalization, links to recipes, and nursing follow-ups. Health care professionals valued the online training but highlighted time constraints, suggesting shorter or blended formats to improve accessibility. CONCLUSIONS: While PREDIABETEXT did not significantly improve HbA(1c) levels, it demonstrated potential benefits for patient engagement. Further studies involving more intensive interventions are warranted to confirm the clinical impact on diabetes prevention. TRIAL REGISTRATION: ClinicalTrials.gov NCT05110625; https://www.clinicaltrials.gov/study/NCT05110625. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.3390/ijerph192214706.

  @article{miramartinez2025multifaceted,
  abstract = {BACKGROUND: The diabetes epidemic continues to surge worldwide, demanding urgent and innovative solutions. Digital health interventions, particularly those targeting behavior change, hold promise due to their affordability and scalability. However, research in this field remains in its early stages. OBJECTIVE: This study aimed to evaluate the effectiveness of PREDIABETEXT (Prediabetes Text Message Digital Intervention for the Prevention of Type 2 Diabetes Mellitus), a digital health intervention, in reducing glycated hemoglobin (HbA(1c)) and in improving secondary clinical, physiological, and behavioral outcomes. METHODS: We conducted a 6-month, 3-arm, pragmatic cluster randomized clinical trial. We recruited patients with prediabetes (HbA(1c) levels between 6% and 6.4% in the previous 3 months or 2 consecutive fasting plasma glucose measurements of 110-125 mg/dL) registered at primary care centers in the Balearic Islands, Spain. The PREDIABETEXT intervention consisted of 3 personalized SMS text messages per week aimed at supporting lifestyle behavior changes and online training for their primary health care professionals. A total of 58 professionals (clusters) from 16 centers participated in the study and were randomized (1:1:1) to intervention group A (patient SMS text messaging), intervention group B (patient SMS text messaging+health care professional web-based training), or the control group (usual care). Following the 6-month intervention period, we conducted individual qualitative interviews with 8 patients and 7 health care professionals to evaluate their experiences with the intervention in terms of utility, satisfaction, and implementation barriers. RESULTS: In total, 58 health care professionals (clusters) were included, allocated to the control group (n=20, 34%; 119/365, 32.6% patients), intervention group A (SMS text messaging only; n=18, 31%; 106/365, 29% patients), and intervention group B (SMS text messaging+training; n=20, 34%; 140/365, 38.4% patients). The mean age of the patients was 59.79 (SD 9.75) years, and 54.5% (199/365) were female. The results of the intention-to-treat analysis at the 6-month time point showed that intervention A led to a small, nonsignificant reduction in HbA(1c) levels compared to the control group (β=-0.05, 95% CI -0.21 to 0.10; P=.50), whereas intervention B showed a similar nonsignificant reduction (β=-0.04, 95% CI -0.12 to 0.10; P=.56). No substantial differences were observed in the remaining secondary outcomes. Interviews revealed positive feedback from patients, who appreciated the intervention's dietary messages and their frequency and practicality. Participants suggested enhancements such as increased personalization, links to recipes, and nursing follow-ups. Health care professionals valued the online training but highlighted time constraints, suggesting shorter or blended formats to improve accessibility. CONCLUSIONS: While PREDIABETEXT did not significantly improve HbA(1c) levels, it demonstrated potential benefits for patient engagement. Further studies involving more intensive interventions are warranted to confirm the clinical impact on diabetes prevention. TRIAL REGISTRATION: ClinicalTrials.gov NCT05110625; https://www.clinicaltrials.gov/study/NCT05110625. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.3390/ijerph192214706.},
  address = {Canada},
  author = {Mira-Martínez, Sofía and Malih, Narges and Angullo-Martínez, Escarlata and Zamanillo-Campos, Rocío and Yañez, Aina M and Bennasar-Veny, Miquel and Gómez-Juanes, Rocío and Konieczna, Jadwiga and Jiménez, Rafael and Serrano-Ripoll, Maria J and Fiol deRoque, Maria Antonia and Leiva, Alfonso and Galmes-Panades, Aina M and Miralles-Xamena, Jerónima and Vidal-Thomàs, Maria Clara and Gómez-Cobo, Cristina and Gervilla, Elena and Oña-Gil, José Iván and Ricci-Cabello, Ignacio},
  journal = {Journal of medical Internet research},
  keywords = {evisap},
  month = {oct},
  pages = {e70981--e70981},
  title = {A Multifaceted Digital Intervention for the Prevention of Type 2 Diabetes Mellitus in Primary Care (PREDIABETEXT): Cluster Randomized Trial},
  volume = 27,
  year = 2025
  }
  

  %0 Journal Article
  %1 miramartinez2025multifaceted
  %A Mira-Martínez, Sofía
  %A Malih, Narges
  %A Angullo-Martínez, Escarlata
  %A Zamanillo-Campos, Rocío
  %A Yañez, Aina M
  %A Bennasar-Veny, Miquel
  %A Gómez-Juanes, Rocío
  %A Konieczna, Jadwiga
  %A Jiménez, Rafael
  %A Serrano-Ripoll, Maria J
  %A Fiol deRoque, Maria Antonia
  %A Leiva, Alfonso
  %A Galmes-Panades, Aina M
  %A Miralles-Xamena, Jerónima
  %A Vidal-Thomàs, Maria Clara
  %A Gómez-Cobo, Cristina
  %A Gervilla, Elena
  %A Oña-Gil, José Iván
  %A Ricci-Cabello, Ignacio
  %C Canada
  %D 2025
  %J Journal of medical Internet research
  %P e70981--e70981
  %R 10.2196/70981
  %T A Multifaceted Digital Intervention for the Prevention of Type 2 Diabetes Mellitus in Primary Care (PREDIABETEXT): Cluster Randomized Trial
  %U https://pubmed.ncbi.nlm.nih.gov/41067715
  %V 27
  %X BACKGROUND: The diabetes epidemic continues to surge worldwide, demanding urgent and innovative solutions. Digital health interventions, particularly those targeting behavior change, hold promise due to their affordability and scalability. However, research in this field remains in its early stages. OBJECTIVE: This study aimed to evaluate the effectiveness of PREDIABETEXT (Prediabetes Text Message Digital Intervention for the Prevention of Type 2 Diabetes Mellitus), a digital health intervention, in reducing glycated hemoglobin (HbA(1c)) and in improving secondary clinical, physiological, and behavioral outcomes. METHODS: We conducted a 6-month, 3-arm, pragmatic cluster randomized clinical trial. We recruited patients with prediabetes (HbA(1c) levels between 6% and 6.4% in the previous 3 months or 2 consecutive fasting plasma glucose measurements of 110-125 mg/dL) registered at primary care centers in the Balearic Islands, Spain. The PREDIABETEXT intervention consisted of 3 personalized SMS text messages per week aimed at supporting lifestyle behavior changes and online training for their primary health care professionals. A total of 58 professionals (clusters) from 16 centers participated in the study and were randomized (1:1:1) to intervention group A (patient SMS text messaging), intervention group B (patient SMS text messaging+health care professional web-based training), or the control group (usual care). Following the 6-month intervention period, we conducted individual qualitative interviews with 8 patients and 7 health care professionals to evaluate their experiences with the intervention in terms of utility, satisfaction, and implementation barriers. RESULTS: In total, 58 health care professionals (clusters) were included, allocated to the control group (n=20, 34%; 119/365, 32.6% patients), intervention group A (SMS text messaging only; n=18, 31%; 106/365, 29% patients), and intervention group B (SMS text messaging+training; n=20, 34%; 140/365, 38.4% patients). The mean age of the patients was 59.79 (SD 9.75) years, and 54.5% (199/365) were female. The results of the intention-to-treat analysis at the 6-month time point showed that intervention A led to a small, nonsignificant reduction in HbA(1c) levels compared to the control group (β=-0.05, 95% CI -0.21 to 0.10; P=.50), whereas intervention B showed a similar nonsignificant reduction (β=-0.04, 95% CI -0.12 to 0.10; P=.56). No substantial differences were observed in the remaining secondary outcomes. Interviews revealed positive feedback from patients, who appreciated the intervention's dietary messages and their frequency and practicality. Participants suggested enhancements such as increased personalization, links to recipes, and nursing follow-ups. Health care professionals valued the online training but highlighted time constraints, suggesting shorter or blended formats to improve accessibility. CONCLUSIONS: While PREDIABETEXT did not significantly improve HbA(1c) levels, it demonstrated potential benefits for patient engagement. Further studies involving more intensive interventions are warranted to confirm the clinical impact on diabetes prevention. TRIAL REGISTRATION: ClinicalTrials.gov NCT05110625; https://www.clinicaltrials.gov/study/NCT05110625. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.3390/ijerph192214706.
  

• 
  Validation and pilot feasibility study of a novel screener to assess diet, lifestyle and mental health in people living with and beyond cancer: Study protocols. Chaplin, Alice; Wordsworth, Janna; Prohens, Lara; Obrador-Hevia, Antònia; Guillot, Monica; Ricci-Cabello, Ignacio; Sesé, Albert; Romaguera, Dora (2025). 20(6) e0323671-e0323671.

  AbstractURLBibTeXEndNoteDOIBibSonomyDownload

  BACKGROUND AND AIM: Current clinical care may not address behavioural and psychosocial elements which can influence quality of life (QoL) and recurrence risk of people living with and beyond cancer (PLWBC). There is a lack of validated tools to assess diet, lifestyle and mental health in PLWBC. We have developed a screener to identify individuals who may need further support beyond cancer recurrence. The aim is two-fold: 1) validate the screener in PLWBC; and 2) carry out a pilot feasibility study (PFS) to explore the impact of a lifestyle complex intervention (diet, physical activity and mental health components) on the QoL of PLWBC. METHODS: The study will be carried out at the University Hospital Son Espases (Spain) in PLWBC. A face validity study (n = 15) will assess construct interpretation, completion time, and acquiescence of the screener. For construct validity and reproducibility analysis (n = 100), participants will answer the screener together with validated diet, lifestyle, and mental health questionnaires for comparison. Body composition, physical activity, strength and cortisol levels will be assessed using validated instruments. All participants will answer the screener 7-10 days later for reproducibility analysis. Participants will then be randomized (1:1) to the Low Intervention (LI) or the High Intervention (HI) for the PFS study. LI will receive general advice regarding diet, lifestyle and mental health, and HI will receive individual and group sessions with specialised health professionals. Participants will be followed for three months. Primary outcomes include: 1) validity and reproducibility of the screener; and 2) feasibility of a complex intervention to improve QoL of PLWBC. Secondary outcomes include changes in screener answers and body composition. DISCUSSION: A validated screener which detects PLWBC's needs could be used in follow-up care plans. The PFS will inform on the recruitment of participants and identify potential shortfalls of the design and efficacy. TRIAL REGISTRATION: ClinicalTrials.gov NCT06582498.

  @article{chaplin2025validation,
  abstract = {BACKGROUND AND AIM: Current clinical care may not address behavioural and psychosocial elements which can influence quality of life (QoL) and recurrence risk of people living with and beyond cancer (PLWBC). There is a lack of validated tools to assess diet, lifestyle and mental health in PLWBC. We have developed a screener to identify individuals who may need further support beyond cancer recurrence. The aim is two-fold: 1) validate the screener in PLWBC; and 2) carry out a pilot feasibility study (PFS) to explore the impact of a lifestyle complex intervention (diet, physical activity and mental health components) on the QoL of PLWBC. METHODS: The study will be carried out at the University Hospital Son Espases (Spain) in PLWBC. A face validity study (n = 15) will assess construct interpretation, completion time, and acquiescence of the screener. For construct validity and reproducibility analysis (n = 100), participants will answer the screener together with validated diet, lifestyle, and mental health questionnaires for comparison. Body composition, physical activity, strength and cortisol levels will be assessed using validated instruments. All participants will answer the screener 7-10 days later for reproducibility analysis. Participants will then be randomized (1:1) to the Low Intervention (LI) or the High Intervention (HI) for the PFS study. LI will receive general advice regarding diet, lifestyle and mental health, and HI will receive individual and group sessions with specialised health professionals. Participants will be followed for three months. Primary outcomes include: 1) validity and reproducibility of the screener; and 2) feasibility of a complex intervention to improve QoL of PLWBC. Secondary outcomes include changes in screener answers and body composition. DISCUSSION: A validated screener which detects PLWBC's needs could be used in follow-up care plans. The PFS will inform on the recruitment of participants and identify potential shortfalls of the design and efficacy. TRIAL REGISTRATION: ClinicalTrials.gov NCT06582498.},
  address = {United States},
  author = {Chaplin, Alice and Wordsworth, Janna and Prohens, Lara and Obrador-Hevia, Antònia and Guillot, Monica and Ricci-Cabello, Ignacio and Sesé, Albert and Romaguera, Dora},
  journal = {PloS one},
  keywords = {evisap},
  month = {jun},
  number = 6,
  pages = {e0323671--e0323671},
  title = {Validation and pilot feasibility study of a novel screener to assess diet, lifestyle and mental health in people living with and beyond cancer: Study protocols},
  volume = 20,
  year = 2025
  }
  

  %0 Journal Article
  %1 chaplin2025validation
  %A Chaplin, Alice
  %A Wordsworth, Janna
  %A Prohens, Lara
  %A Obrador-Hevia, Antònia
  %A Guillot, Monica
  %A Ricci-Cabello, Ignacio
  %A Sesé, Albert
  %A Romaguera, Dora
  %C United States
  %D 2025
  %J PloS one
  %N 6
  %P e0323671--e0323671
  %R 10.1371/journal.pone.0323671
  %T Validation and pilot feasibility study of a novel screener to assess diet, lifestyle and mental health in people living with and beyond cancer: Study protocols
  %U https://pubmed.ncbi.nlm.nih.gov/40472046
  %V 20
  %X BACKGROUND AND AIM: Current clinical care may not address behavioural and psychosocial elements which can influence quality of life (QoL) and recurrence risk of people living with and beyond cancer (PLWBC). There is a lack of validated tools to assess diet, lifestyle and mental health in PLWBC. We have developed a screener to identify individuals who may need further support beyond cancer recurrence. The aim is two-fold: 1) validate the screener in PLWBC; and 2) carry out a pilot feasibility study (PFS) to explore the impact of a lifestyle complex intervention (diet, physical activity and mental health components) on the QoL of PLWBC. METHODS: The study will be carried out at the University Hospital Son Espases (Spain) in PLWBC. A face validity study (n = 15) will assess construct interpretation, completion time, and acquiescence of the screener. For construct validity and reproducibility analysis (n = 100), participants will answer the screener together with validated diet, lifestyle, and mental health questionnaires for comparison. Body composition, physical activity, strength and cortisol levels will be assessed using validated instruments. All participants will answer the screener 7-10 days later for reproducibility analysis. Participants will then be randomized (1:1) to the Low Intervention (LI) or the High Intervention (HI) for the PFS study. LI will receive general advice regarding diet, lifestyle and mental health, and HI will receive individual and group sessions with specialised health professionals. Participants will be followed for three months. Primary outcomes include: 1) validity and reproducibility of the screener; and 2) feasibility of a complex intervention to improve QoL of PLWBC. Secondary outcomes include changes in screener answers and body composition. DISCUSSION: A validated screener which detects PLWBC's needs could be used in follow-up care plans. The PFS will inform on the recruitment of participants and identify potential shortfalls of the design and efficacy. TRIAL REGISTRATION: ClinicalTrials.gov NCT06582498.
  

• 
  Engaging Primary Care Professionals and People at Risk of Type 2 Diabetes in the Design of PREDIABETEXT, a Multifaceted Digital Intervention Aimed at Preventing Type 2 Diabetes: A Qualitative Study. Serrano-Ripoll, Maria J.; Zamanillo-Campos, Rocío; Mira Martínez, Sofía; Fiol deRoque, Maria A.; Malih, Narges; Angullo-Martínez, Escarlata; Ricci-Cabello, Ignacio (2025). 6

  AbstractBibTeXEndNoteBibSonomy

  Objectives: This study aims to explore perspectives and opinions from healthcare professionals and people at risk of type 2 diabetes mellitus (T2DM) to inform the design of PREDIABETEXT, a new digital multifaceted intervention to prevent T2DM. Methods: in this qualitative study, we purposefully recruited 15 healthcare professionals (doctors and nurses) working in primary healthcare centers in Mallorca (Spain), and 15 of their patients at risk of T2DM (HbA1c 6–6.4%, and/or fasting plasma glucose 110–125 mg/dL). We collected the data through semi-structured phone interviews, using an interview guide aimed at gathering participants’ views about the two PREDIABETEXT proposed co-interventions (educational intervention targeted at professionals and delivered as an online training course, and behavioral intervention targeted at individuals at risk of T2DM and delivered using SMS short text messages). The interviews were audio-recorded, verbatim transcribed, and analyzed using a thematic analysis approach. Results: Primary healthcare professionals valued a prediabetes training course for standardizing care and supporting diabetes prevention. They preferred a blended format with content on early detection, intervention, and monitoring. They perceived SMS reminders to their patients as potentially useful for reinforcing guidelines and improving care. Individuals at risk of T2DM, who faced challenges maintaining a healthy diet and exercise routine, viewed SMS as potentially motivational and informative, offering suggestions on content, format, and frequency to enhance its intended benefits. Conclusions: This qualitative study provided valuable insights from primary care professionals and people at risk of T2DM that will inform the user-centered design of the PREDIABETEXT intervention.

  @article{serranoripoll2025engaging,
  abstract = {Objectives: This study aims to explore perspectives and opinions from healthcare professionals and people at risk of type 2 diabetes mellitus (T2DM) to inform the design of PREDIABETEXT, a new digital multifaceted intervention to prevent T2DM. Methods: in this qualitative study, we purposefully recruited 15 healthcare professionals (doctors and nurses) working in primary healthcare centers in Mallorca (Spain), and 15 of their patients at risk of T2DM (HbA1c 6–6.4%, and/or fasting plasma glucose 110–125 mg/dL). We collected the data through semi-structured phone interviews, using an interview guide aimed at gathering participants’ views about the two PREDIABETEXT proposed co-interventions (educational intervention targeted at professionals and delivered as an online training course, and behavioral intervention targeted at individuals at risk of T2DM and delivered using SMS short text messages). The interviews were audio-recorded, verbatim transcribed, and analyzed using a thematic analysis approach. Results: Primary healthcare professionals valued a prediabetes training course for standardizing care and supporting diabetes prevention. They preferred a blended format with content on early detection, intervention, and monitoring. They perceived SMS reminders to their patients as potentially useful for reinforcing guidelines and improving care. Individuals at risk of T2DM, who faced challenges maintaining a healthy diet and exercise routine, viewed SMS as potentially motivational and informative, offering suggestions on content, format, and frequency to enhance its intended benefits. Conclusions: This qualitative study provided valuable insights from primary care professionals and people at risk of T2DM that will inform the user-centered design of the PREDIABETEXT intervention.},
  author = {Serrano-Ripoll, Maria J. and Zamanillo-Campos, Rocío and Mira Martínez, Sofía and Fiol deRoque, Maria A. and Malih, Narges and Angullo-Martínez, Escarlata and Ricci-Cabello, Ignacio},
  booktitle = {Diabetology},
  keywords = {evisap},
  series = 1,
  title = {Engaging Primary Care Professionals and People at Risk of Type 2 Diabetes in the Design of PREDIABETEXT, a Multifaceted Digital Intervention Aimed at Preventing Type 2 Diabetes: A Qualitative Study},
  volume = 6,
  year = 2025
  }
  

  %0 Journal Article
  %1 serranoripoll2025engaging
  %A Serrano-Ripoll, Maria J.
  %A Zamanillo-Campos, Rocío
  %A Mira Martínez, Sofía
  %A Fiol deRoque, Maria A.
  %A Malih, Narges
  %A Angullo-Martínez, Escarlata
  %A Ricci-Cabello, Ignacio
  %B Diabetology
  %D 2025
  %T Engaging Primary Care Professionals and People at Risk of Type 2 Diabetes in the Design of PREDIABETEXT, a Multifaceted Digital Intervention Aimed at Preventing Type 2 Diabetes: A Qualitative Study
  %V 6
  %X Objectives: This study aims to explore perspectives and opinions from healthcare professionals and people at risk of type 2 diabetes mellitus (T2DM) to inform the design of PREDIABETEXT, a new digital multifaceted intervention to prevent T2DM. Methods: in this qualitative study, we purposefully recruited 15 healthcare professionals (doctors and nurses) working in primary healthcare centers in Mallorca (Spain), and 15 of their patients at risk of T2DM (HbA1c 6–6.4%, and/or fasting plasma glucose 110–125 mg/dL). We collected the data through semi-structured phone interviews, using an interview guide aimed at gathering participants’ views about the two PREDIABETEXT proposed co-interventions (educational intervention targeted at professionals and delivered as an online training course, and behavioral intervention targeted at individuals at risk of T2DM and delivered using SMS short text messages). The interviews were audio-recorded, verbatim transcribed, and analyzed using a thematic analysis approach. Results: Primary healthcare professionals valued a prediabetes training course for standardizing care and supporting diabetes prevention. They preferred a blended format with content on early detection, intervention, and monitoring. They perceived SMS reminders to their patients as potentially useful for reinforcing guidelines and improving care. Individuals at risk of T2DM, who faced challenges maintaining a healthy diet and exercise routine, viewed SMS as potentially motivational and informative, offering suggestions on content, format, and frequency to enhance its intended benefits. Conclusions: This qualitative study provided valuable insights from primary care professionals and people at risk of T2DM that will inform the user-centered design of the PREDIABETEXT intervention.
  

• 
  Describing the initial results of a pragmatic, cluster randomized clinical trial to examine the impact of a multifaceted digital intervention for the prevention of type 2 diabetes mellitus in the primary care setting: intervention design, recruitment strategy and participants’ baseline characteristics of the PREDIABETEXT trial. Mira-Martínez, Sofía; Zamanillo-Campos, Rocío; Malih, Narges; Fiol deRoque, Maria Antonia; Angullo-Martínez, Escarlata; Jimenez, Rafael; Serrano-Ripoll, Maria Jesús; Leiva, Alfonso; Oña, José Iván; Galmes-Panades, Aina M; Bennasar-Veny, Miquel; Yañez, Aina Maria; Gómez-Juanes, Rocío; Konieczna, Jadwiga; Miralles, Jerónima; Romaguera, Dora; Vidal-Thomasa, María Clara; Llobera-Canaves, Joan; García-Toro, Mauro; Gervilla-García, Elena; Vicens, Catalina; Bulilete, Oana; Montaño, Juan José; Gili, Margalida; Roca, Miquel; Colom, Antoni; Ricci-Cabello, Ignacio (2025). 16 1524336–1524336.

  AbstractURLBibTeXEndNoteDOIBibSonomyDownload

  INTRODUCTION: i) to describe PREDIABETEXT, a novel digital intervention for the prevention of type 2 diabetes; ii) to examine the performance of a strategy for virtual recruitment of participants in a trial to assess its impact, and; iii) to determine the baseline characteristics of the enrolled participants. METHODS: We developed PREDIABETEXT in a multistage process involving systematic literature reviews and qualitative research with end users (primary care patients and professionals). We combined multiple virtual strategies (SMS, phone calls, promotional videos) to recruit healthcare professionals and their patients. We collected baseline data from patients (sociodemographic, behavioral and clinical) and healthcare professionals (sociodemographic and professional experience). RESULTS: The intervention consisted in delivering personalized short text messages supporting lifestyle behavior changes to people at risk of type 2 diabetes; and online training to their primary healthcare professionals. We recruited 58/133 (43.6%) professionals (30 doctors; 28 nurses) from 16 centers. Most professionals (83%) were women [mean (SD) age 49.69 (10.15)]. We recruited 365/976 (37.4%) patients (54.5% women, 59.82 (9.77) years old. Around half (55.3%) presented obesity (BMI ≥25), 65% hypertension, 43.3% hypercholesterolemia, and 14.8% hypertriglyceridemia. CONCLUSIONS: The PREDIABETEX trial successfully recruited a representative sample of patients at risk of type 2 diabetes and their healthcare providers.

  @article{miramartinez2025describing,
  abstract = {INTRODUCTION: i) to describe PREDIABETEXT, a novel digital intervention for the prevention of type 2 diabetes; ii) to examine the performance of a strategy for virtual recruitment of participants in a trial to assess its impact, and; iii) to determine the baseline characteristics of the enrolled participants. METHODS: We developed PREDIABETEXT in a multistage process involving systematic literature reviews and qualitative research with end users (primary care patients and professionals). We combined multiple virtual strategies (SMS, phone calls, promotional videos) to recruit healthcare professionals and their patients. We collected baseline data from patients (sociodemographic, behavioral and clinical) and healthcare professionals (sociodemographic and professional experience). RESULTS: The intervention consisted in delivering personalized short text messages supporting lifestyle behavior changes to people at risk of type 2 diabetes; and online training to their primary healthcare professionals. We recruited 58/133 (43.6%) professionals (30 doctors; 28 nurses) from 16 centers. Most professionals (83%) were women [mean (SD) age 49.69 (10.15)]. We recruited 365/976 (37.4%) patients (54.5% women, 59.82 (9.77) years old. Around half (55.3%) presented obesity (BMI ≥25), 65% hypertension, 43.3% hypercholesterolemia, and 14.8% hypertriglyceridemia. CONCLUSIONS: The PREDIABETEX trial successfully recruited a representative sample of patients at risk of type 2 diabetes and their healthcare providers.},
  address = {Switzerland},
  author = {Mira-Martínez, Sofía and Zamanillo-Campos, Rocío and Malih, Narges and Fiol deRoque, Maria Antonia and Angullo-Martínez, Escarlata and Jimenez, Rafael and Serrano-Ripoll, Maria Jesús and Leiva, Alfonso and Oña, José Iván and Galmes-Panades, Aina M and Bennasar-Veny, Miquel and Yañez, Aina Maria and Gómez-Juanes, Rocío and Konieczna, Jadwiga and Miralles, Jerónima and Romaguera, Dora and Vidal-Thomasa, María Clara and Llobera-Canaves, Joan and García-Toro, Mauro and Gervilla-García, Elena and Vicens, Catalina and Bulilete, Oana and Montaño, Juan José and Gili, Margalida and Roca, Miquel and Colom, Antoni and Ricci-Cabello, Ignacio},
  journal = {Frontiers in endocrinology},
  keywords = {evisap grapp-caib},
  month = {mar},
  pages = {1524336--1524336},
  title = {Describing the initial results of a pragmatic, cluster randomized clinical trial to examine the impact of a multifaceted digital intervention for the prevention of type 2 diabetes mellitus in the primary care setting: intervention design, recruitment strategy and participants' baseline characteristics of the PREDIABETEXT trial},
  volume = 16,
  year = 2025
  }
  

  %0 Journal Article
  %1 miramartinez2025describing
  %A Mira-Martínez, Sofía
  %A Zamanillo-Campos, Rocío
  %A Malih, Narges
  %A Fiol deRoque, Maria Antonia
  %A Angullo-Martínez, Escarlata
  %A Jimenez, Rafael
  %A Serrano-Ripoll, Maria Jesús
  %A Leiva, Alfonso
  %A Oña, José Iván
  %A Galmes-Panades, Aina M
  %A Bennasar-Veny, Miquel
  %A Yañez, Aina Maria
  %A Gómez-Juanes, Rocío
  %A Konieczna, Jadwiga
  %A Miralles, Jerónima
  %A Romaguera, Dora
  %A Vidal-Thomasa, María Clara
  %A Llobera-Canaves, Joan
  %A García-Toro, Mauro
  %A Gervilla-García, Elena
  %A Vicens, Catalina
  %A Bulilete, Oana
  %A Montaño, Juan José
  %A Gili, Margalida
  %A Roca, Miquel
  %A Colom, Antoni
  %A Ricci-Cabello, Ignacio
  %C Switzerland
  %D 2025
  %J Frontiers in endocrinology
  %P 1524336--1524336
  %R 10.3389/fendo.2025.1524336
  %T Describing the initial results of a pragmatic, cluster randomized clinical trial to examine the impact of a multifaceted digital intervention for the prevention of type 2 diabetes mellitus in the primary care setting: intervention design, recruitment strategy and participants' baseline characteristics of the PREDIABETEXT trial
  %U https://pubmed.ncbi.nlm.nih.gov/40230484
  %V 16
  %X INTRODUCTION: i) to describe PREDIABETEXT, a novel digital intervention for the prevention of type 2 diabetes; ii) to examine the performance of a strategy for virtual recruitment of participants in a trial to assess its impact, and; iii) to determine the baseline characteristics of the enrolled participants. METHODS: We developed PREDIABETEXT in a multistage process involving systematic literature reviews and qualitative research with end users (primary care patients and professionals). We combined multiple virtual strategies (SMS, phone calls, promotional videos) to recruit healthcare professionals and their patients. We collected baseline data from patients (sociodemographic, behavioral and clinical) and healthcare professionals (sociodemographic and professional experience). RESULTS: The intervention consisted in delivering personalized short text messages supporting lifestyle behavior changes to people at risk of type 2 diabetes; and online training to their primary healthcare professionals. We recruited 58/133 (43.6%) professionals (30 doctors; 28 nurses) from 16 centers. Most professionals (83%) were women [mean (SD) age 49.69 (10.15)]. We recruited 365/976 (37.4%) patients (54.5% women, 59.82 (9.77) years old. Around half (55.3%) presented obesity (BMI ≥25), 65% hypertension, 43.3% hypercholesterolemia, and 14.8% hypertriglyceridemia. CONCLUSIONS: The PREDIABETEX trial successfully recruited a representative sample of patients at risk of type 2 diabetes and their healthcare providers.
  

• 
  Evaluating SinergiAPS, an intervention based on patient feedback to improve patient safety in primary care: a cluster randomized trial. Fiol deRoque, Maria Antònia; Valderas, José María; Serrano-Ripoll, María Jesús; Gens-Barbarà, Montserrat; Martín-Luján, Francisco; Sánchez-Freire, Encarna; Montaño, Juan José; Mira-Martínez, Sofía; Pastor-Moreno, Guadalupe; Zamanillo-Campos, Rocío; Riera-Serra, Pau; Ricci-Cabello, Ignacio (2025). 23(1) 202–202.

  AbstractURLBibTeXEndNoteDOIBibSonomyDownload

  BACKGROUND: Patient safety, defined by the WHO as the absence of preventable harm, is a critical component of healthcare quality and poses a significant challenge globally. This study aimed to evaluate the effectiveness of SinergiAPS, a patient-centred audit and feedback intervention, in improving patient safety in primary healthcare (PHC) centres. METHODS: We conducted a 12-month cluster randomized controlled, multicentre trial. Fifty-nine PHC centres (1053 PHC professionals) in Spain were recruited and randomly allocated (1:1) to usual care or SinergiAPS intervention. The SinergiAPS intervention comprised: a bespoke feedback report with results from audits of patient safety based on the Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC) questionnaire, administered to 75 patients/centre; a set of educational materials, and a structured template to record safety improvement plans. The primary outcome (at the PHC professional level) was patient safety culture (Medical Office Survey on Patient Safety Culture (MOSPSC) questionnaire). Secondary outcomes (at the centre level) were patient-reported safety (six PREOS-PC scales), and rate of avoidable hospital admissions. After a 12-month follow-up, we conducted 15 semi-structured interviews with PHC professionals to explore their perceptions of the intervention. RESULTS: During the 12-month follow-up, 10 of the 30 centres in the intervention group held action plan team meetings and eight registered 57 safety improvement action plans. The plans aimed to improve patient activation, address treatment-related incidents, enhance communication between patients and providers, and strengthen patient safety culture. At 12 months, no significant differences were observed in MOSPSC mean score (intervention: 3.60 [95% CI 3.55 to 3.64] vs. control: 3.64 [3.60 to 3.68]). Similarly, no differences were observed in the secondary outcomes, with both groups experiencing a decline in patient-reported safety and avoidable hospital admissions. The qualitative interviews evidenced that the onset of the COVID-19 pandemic 6-9 weeks after initiating the follow-up period severely limited PHC's capacity of developing and implementing safety improvement action plans, despite high levels of acceptability and perceived utility of the SinergiAPS intervention. CONCLUSIONS: In the context of the health emergency caused by the COVID-19 pandemic, SinergiAPS did not improve patient safety in Spanish PHC centres. TRIAL REGISTRATION: ClinicalTrials.gov (NCT03837912).

  @article{fiolderoque2025evaluating,
  abstract = {BACKGROUND: Patient safety, defined by the WHO as the absence of preventable harm, is a critical component of healthcare quality and poses a significant challenge globally. This study aimed to evaluate the effectiveness of SinergiAPS, a patient-centred audit and feedback intervention, in improving patient safety in primary healthcare (PHC) centres. METHODS: We conducted a 12-month cluster randomized controlled, multicentre trial. Fifty-nine PHC centres (1053 PHC professionals) in Spain were recruited and randomly allocated (1:1) to usual care or SinergiAPS intervention. The SinergiAPS intervention comprised: a bespoke feedback report with results from audits of patient safety based on the Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC) questionnaire, administered to 75 patients/centre; a set of educational materials, and a structured template to record safety improvement plans. The primary outcome (at the PHC professional level) was patient safety culture (Medical Office Survey on Patient Safety Culture (MOSPSC) questionnaire). Secondary outcomes (at the centre level) were patient-reported safety (six PREOS-PC scales), and rate of avoidable hospital admissions. After a 12-month follow-up, we conducted 15 semi-structured interviews with PHC professionals to explore their perceptions of the intervention. RESULTS: During the 12-month follow-up, 10 of the 30 centres in the intervention group held action plan team meetings and eight registered 57 safety improvement action plans. The plans aimed to improve patient activation, address treatment-related incidents, enhance communication between patients and providers, and strengthen patient safety culture. At 12 months, no significant differences were observed in MOSPSC mean score (intervention: 3.60 [95% CI 3.55 to 3.64] vs. control: 3.64 [3.60 to 3.68]). Similarly, no differences were observed in the secondary outcomes, with both groups experiencing a decline in patient-reported safety and avoidable hospital admissions. The qualitative interviews evidenced that the onset of the COVID-19 pandemic 6-9 weeks after initiating the follow-up period severely limited PHC's capacity of developing and implementing safety improvement action plans, despite high levels of acceptability and perceived utility of the SinergiAPS intervention. CONCLUSIONS: In the context of the health emergency caused by the COVID-19 pandemic, SinergiAPS did not improve patient safety in Spanish PHC centres. TRIAL REGISTRATION: ClinicalTrials.gov (NCT03837912).},
  address = {England},
  author = {Fiol deRoque, Maria Antònia and Valderas, José María and Serrano-Ripoll, María Jesús and Gens-Barbarà, Montserrat and Martín-Luján, Francisco and Sánchez-Freire, Encarna and Montaño, Juan José and Mira-Martínez, Sofía and Pastor-Moreno, Guadalupe and Zamanillo-Campos, Rocío and Riera-Serra, Pau and Ricci-Cabello, Ignacio},
  journal = {BMC medicine},
  keywords = {evisap grapp-caib},
  month = {apr},
  number = 1,
  pages = {202--202},
  title = {Evaluating SinergiAPS, an intervention based on patient feedback to improve patient safety in primary care: a cluster randomized trial},
  volume = 23,
  year = 2025
  }
  

  %0 Journal Article
  %1 fiolderoque2025evaluating
  %A Fiol deRoque, Maria Antònia
  %A Valderas, José María
  %A Serrano-Ripoll, María Jesús
  %A Gens-Barbarà, Montserrat
  %A Martín-Luján, Francisco
  %A Sánchez-Freire, Encarna
  %A Montaño, Juan José
  %A Mira-Martínez, Sofía
  %A Pastor-Moreno, Guadalupe
  %A Zamanillo-Campos, Rocío
  %A Riera-Serra, Pau
  %A Ricci-Cabello, Ignacio
  %C England
  %D 2025
  %J BMC medicine
  %N 1
  %P 202--202
  %R 10.1186/s12916-025-04029-7
  %T Evaluating SinergiAPS, an intervention based on patient feedback to improve patient safety in primary care: a cluster randomized trial
  %U https://pubmed.ncbi.nlm.nih.gov/40189506
  %V 23
  %X BACKGROUND: Patient safety, defined by the WHO as the absence of preventable harm, is a critical component of healthcare quality and poses a significant challenge globally. This study aimed to evaluate the effectiveness of SinergiAPS, a patient-centred audit and feedback intervention, in improving patient safety in primary healthcare (PHC) centres. METHODS: We conducted a 12-month cluster randomized controlled, multicentre trial. Fifty-nine PHC centres (1053 PHC professionals) in Spain were recruited and randomly allocated (1:1) to usual care or SinergiAPS intervention. The SinergiAPS intervention comprised: a bespoke feedback report with results from audits of patient safety based on the Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC) questionnaire, administered to 75 patients/centre; a set of educational materials, and a structured template to record safety improvement plans. The primary outcome (at the PHC professional level) was patient safety culture (Medical Office Survey on Patient Safety Culture (MOSPSC) questionnaire). Secondary outcomes (at the centre level) were patient-reported safety (six PREOS-PC scales), and rate of avoidable hospital admissions. After a 12-month follow-up, we conducted 15 semi-structured interviews with PHC professionals to explore their perceptions of the intervention. RESULTS: During the 12-month follow-up, 10 of the 30 centres in the intervention group held action plan team meetings and eight registered 57 safety improvement action plans. The plans aimed to improve patient activation, address treatment-related incidents, enhance communication between patients and providers, and strengthen patient safety culture. At 12 months, no significant differences were observed in MOSPSC mean score (intervention: 3.60 [95% CI 3.55 to 3.64] vs. control: 3.64 [3.60 to 3.68]). Similarly, no differences were observed in the secondary outcomes, with both groups experiencing a decline in patient-reported safety and avoidable hospital admissions. The qualitative interviews evidenced that the onset of the COVID-19 pandemic 6-9 weeks after initiating the follow-up period severely limited PHC's capacity of developing and implementing safety improvement action plans, despite high levels of acceptability and perceived utility of the SinergiAPS intervention. CONCLUSIONS: In the context of the health emergency caused by the COVID-19 pandemic, SinergiAPS did not improve patient safety in Spanish PHC centres. TRIAL REGISTRATION: ClinicalTrials.gov (NCT03837912).
  

• 
  Comparison between two tools assessing the methodological quality of systematic reviews: ReMarQ and AMSTAR 2. Marques-Cruz, Manuel; Perestrelo, Paula; Chu, Alexandro W. L.; Gil-Mata, Sara; Riera-Serra, Pau; Sousa-Pinto, Bernardo (2025). 2(2) e70021.

  URLBibTeXEndNoteDOIBibSonomyDownload

  @article{RN64,
  author = {Marques-Cruz, Manuel and Perestrelo, Paula and Chu, Alexandro W. L. and Gil-Mata, Sara and Riera-Serra, Pau and Sousa-Pinto, Bernardo},
  journal = {Clinical and Public Health Guidelines},
  keywords = {evisap},
  number = 2,
  pages = {e70021},
  title = {Comparison between two tools assessing the methodological quality of systematic reviews: ReMarQ and AMSTAR 2},
  type = {Journal Article},
  volume = 2,
  year = 2025
  }
  

  %0 Journal Article
  %1 RN64
  %A Marques-Cruz, Manuel
  %A Perestrelo, Paula
  %A Chu, Alexandro W. L.
  %A Gil-Mata, Sara
  %A Riera-Serra, Pau
  %A Sousa-Pinto, Bernardo
  %D 2025
  %J Clinical and Public Health Guidelines
  %N 2
  %P e70021
  %R https://doi.org/10.1002/gin2.70021
  %T Comparison between two tools assessing the methodological quality of systematic reviews: ReMarQ and AMSTAR 2
  %U https://onlinelibrary.wiley.com/doi/abs/10.1002/gin2.70021
  %V 2
  

• 
  Patient and family engagement interventions in primary care patient safety: systematic review and meta-analysis of randomised controlled trials. Pang, Yan; Szuecs, Anna; Ricci-Cabello, Ignacio; Gangannagaripalli, Jaheeda; Goh, Lay Hoon; Leong, Foon Leng; Zhou, Li Fan; Valderas, Jose Maria (2025). BJGP.2024.0369-.

  AbstractURLBibTeXEndNoteDOIBibSonomyDownload

  BACKGROUND: Engaging patients and families have been promoted as a key strategy for improving patient safety of health systems. However, evidence remains scarce on the effectiveness of this approach in primary care. AIM: To assess the combined effectiveness of primary care interventions in randomised controlled trials (RCTs) promoting patient and family engagement in patient safety. DESIGN AND SETTING: Systematic review and meta-analysis. METHODS: The review followed PRISMA and Cochrane guidelines. Five electronic databases (MEDLINE, CINAHL, Embase, Web of Science, CENTRAL) were searched from inception to 18 September 2024 with keywords in four blocks (patient and family engagement; patient safety; primary care; randomised controlled trial). Patient and family engagement levels were appraised. Where feasible and advisable, results were combined into meta-analyses. RESULTS: Of the 19 included records, 12 reported on completed RCTs. Only one intervention integrated patients/families into overall care safety (high engagement); six aimed at enhancing skills and tools (intermediate), and 12 infirmed patients/families how to engage and prompted them to do it (low). RCTs primarily targeted medication safety, with meta-analyses showing no significant effects on reducing adverse drug events (OR=0.83, 95%CI [0.70,1.08]) or improving medication appropriateness measured categorically (OR=0.92, 95%CI [0.76,1.13]) or continuously (MD=0.71, 95%CI [-0.10,1.52]). Overall risk of bias was low and certainty of evidence very low to moderate. CONCLUSION: Existing randomised controlled evidence on patient and family engagement in primary care remains inconclusive and limited in scope. Future interventions should include higher levels of engagement and address more diverse patient safety outcomes relevant for primary care.

  @article{pang2025patient,
  abstract = {BACKGROUND: Engaging patients and families have been promoted as a key strategy for improving patient safety of health systems. However, evidence remains scarce on the effectiveness of this approach in primary care. AIM: To assess the combined effectiveness of primary care interventions in randomised controlled trials (RCTs) promoting patient and family engagement in patient safety. DESIGN AND SETTING: Systematic review and meta-analysis. METHODS: The review followed PRISMA and Cochrane guidelines. Five electronic databases (MEDLINE, CINAHL, Embase, Web of Science, CENTRAL) were searched from inception to 18 September 2024 with keywords in four blocks (patient and family engagement; patient safety; primary care; randomised controlled trial). Patient and family engagement levels were appraised. Where feasible and advisable, results were combined into meta-analyses. RESULTS: Of the 19 included records, 12 reported on completed RCTs. Only one intervention integrated patients/families into overall care safety (high engagement); six aimed at enhancing skills and tools (intermediate), and 12 infirmed patients/families how to engage and prompted them to do it (low). RCTs primarily targeted medication safety, with meta-analyses showing no significant effects on reducing adverse drug events (OR=0.83, 95%CI [0.70,1.08]) or improving medication appropriateness measured categorically (OR=0.92, 95%CI [0.76,1.13]) or continuously (MD=0.71, 95%CI [-0.10,1.52]). Overall risk of bias was low and certainty of evidence very low to moderate. CONCLUSION: Existing randomised controlled evidence on patient and family engagement in primary care remains inconclusive and limited in scope. Future interventions should include higher levels of engagement and address more diverse patient safety outcomes relevant for primary care.},
  address = {England},
  author = {Pang, Yan and Szuecs, Anna and Ricci-Cabello, Ignacio and Gangannagaripalli, Jaheeda and Goh, Lay Hoon and Leong, Foon Leng and Zhou, Li Fan and Valderas, Jose Maria},
  journal = {The British journal of general practice : the journal of the Royal College of General Practitioners},
  keywords = {evisap},
  month = {may},
  pages = {BJGP.2024.0369--},
  title = {Patient and family engagement interventions in primary care patient safety: systematic review and meta-analysis of randomised controlled trials},
  year = 2025
  }
  

  %0 Journal Article
  %1 pang2025patient
  %A Pang, Yan
  %A Szuecs, Anna
  %A Ricci-Cabello, Ignacio
  %A Gangannagaripalli, Jaheeda
  %A Goh, Lay Hoon
  %A Leong, Foon Leng
  %A Zhou, Li Fan
  %A Valderas, Jose Maria
  %C England
  %D 2025
  %J The British journal of general practice : the journal of the Royal College of General Practitioners
  %P BJGP.2024.0369--
  %R 10.3399/BJGP.2024.0369
  %T Patient and family engagement interventions in primary care patient safety: systematic review and meta-analysis of randomised controlled trials
  %U https://pubmed.ncbi.nlm.nih.gov/40355248
  %X BACKGROUND: Engaging patients and families have been promoted as a key strategy for improving patient safety of health systems. However, evidence remains scarce on the effectiveness of this approach in primary care. AIM: To assess the combined effectiveness of primary care interventions in randomised controlled trials (RCTs) promoting patient and family engagement in patient safety. DESIGN AND SETTING: Systematic review and meta-analysis. METHODS: The review followed PRISMA and Cochrane guidelines. Five electronic databases (MEDLINE, CINAHL, Embase, Web of Science, CENTRAL) were searched from inception to 18 September 2024 with keywords in four blocks (patient and family engagement; patient safety; primary care; randomised controlled trial). Patient and family engagement levels were appraised. Where feasible and advisable, results were combined into meta-analyses. RESULTS: Of the 19 included records, 12 reported on completed RCTs. Only one intervention integrated patients/families into overall care safety (high engagement); six aimed at enhancing skills and tools (intermediate), and 12 infirmed patients/families how to engage and prompted them to do it (low). RCTs primarily targeted medication safety, with meta-analyses showing no significant effects on reducing adverse drug events (OR=0.83, 95%CI [0.70,1.08]) or improving medication appropriateness measured categorically (OR=0.92, 95%CI [0.76,1.13]) or continuously (MD=0.71, 95%CI [-0.10,1.52]). Overall risk of bias was low and certainty of evidence very low to moderate. CONCLUSION: Existing randomised controlled evidence on patient and family engagement in primary care remains inconclusive and limited in scope. Future interventions should include higher levels of engagement and address more diverse patient safety outcomes relevant for primary care.
  

• 
  Associations between unhealthy lifestyle and depression: Cross-sectional results from the Spanish National Health Survey. Navarra-Ventura, Guillem; Coronado-Simsic, Victoria; Riera-Serra, Pau; Castro, Adoración; García-Toro, Mauro; Roca, Miquel; Gili, Margalida (2025). 18(3) 191–198.

  AbstractURLBibTeXEndNoteDOIBibSonomyDownload

  INTRODUCTION: Depression usually worsens lifestyle habits, but previous evidence also suggests that an unhealthy lifestyle (UL) increases the risk of depression. Many studies have analyzed the association between lifestyle and depression in several nationally representative samples, but none have done so in the Spanish adult population. Our aim was to examine the associations between UL habits and depression in Spain. MATERIALS AND METHODS: Analysis of cross-sectional data from the latest National Health Survey published in 2018 (N=23,089). Data on depression and 4 lifestyle factors (diet, physical exercise, smoking, and alcohol consumption) were used. These factors were combined into an UL index ranging from 0 (healthiest lifestyle) to 4 (unhealthiest lifestyle). The prevalence of depression at different levels of the UL index, and the association between depression and both the cumulative UL index and the 4 UL factors was analyzed using parametric and non-parametric tests. RESULTS: Sedentarism was the most prevalent UL factor, followed by unhealthy diet, smoking and high-risk alcohol consumption. Having ≥1 UL factors was associated with a higher prevalence of depression compared to having 0 UL factors (2.5% vs. ≥5.2%), regardless of the cumulative number UL factors (1, 2, 3 or 4). Being physically inactive (OR=1.6) and a smoker (OR=1.3) increased the likelihood of depression. Being a high-risk wine drinker (OR=0.26) decreased the likelihood of depression. Dietary intake was not significant. CONCLUSIONS: The prevalence of depression changes depending on several modifiable lifestyle factors. Policy makers should therefore spare no resources in promoting strategies to encourage healthy lifestyles and prevent the acquisition of UL habits.

  @article{navarraventura2025associations,
  abstract = {INTRODUCTION: Depression usually worsens lifestyle habits, but previous evidence also suggests that an unhealthy lifestyle (UL) increases the risk of depression. Many studies have analyzed the association between lifestyle and depression in several nationally representative samples, but none have done so in the Spanish adult population. Our aim was to examine the associations between UL habits and depression in Spain. MATERIALS AND METHODS: Analysis of cross-sectional data from the latest National Health Survey published in 2018 (N=23,089). Data on depression and 4 lifestyle factors (diet, physical exercise, smoking, and alcohol consumption) were used. These factors were combined into an UL index ranging from 0 (healthiest lifestyle) to 4 (unhealthiest lifestyle). The prevalence of depression at different levels of the UL index, and the association between depression and both the cumulative UL index and the 4 UL factors was analyzed using parametric and non-parametric tests. RESULTS: Sedentarism was the most prevalent UL factor, followed by unhealthy diet, smoking and high-risk alcohol consumption. Having ≥1 UL factors was associated with a higher prevalence of depression compared to having 0 UL factors (2.5% vs. ≥5.2%), regardless of the cumulative number UL factors (1, 2, 3 or 4). Being physically inactive (OR=1.6) and a smoker (OR=1.3) increased the likelihood of depression. Being a high-risk wine drinker (OR=0.26) decreased the likelihood of depression. Dietary intake was not significant. CONCLUSIONS: The prevalence of depression changes depending on several modifiable lifestyle factors. Policy makers should therefore spare no resources in promoting strategies to encourage healthy lifestyles and prevent the acquisition of UL habits.},
  address = {Spain},
  author = {Navarra-Ventura, Guillem and Coronado-Simsic, Victoria and Riera-Serra, Pau and Castro, Adoración and García-Toro, Mauro and Roca, Miquel and Gili, Margalida},
  journal = {Spanish journal of psychiatry and mental health},
  keywords = {evisap},
  number = 3,
  pages = {191--198},
  title = {Associations between unhealthy lifestyle and depression: Cross-sectional results from the Spanish National Health Survey},
  volume = 18,
  year = 2025
  }
  

  %0 Journal Article
  %1 navarraventura2025associations
  %A Navarra-Ventura, Guillem
  %A Coronado-Simsic, Victoria
  %A Riera-Serra, Pau
  %A Castro, Adoración
  %A García-Toro, Mauro
  %A Roca, Miquel
  %A Gili, Margalida
  %C Spain
  %D 2025
  %J Spanish journal of psychiatry and mental health
  %N 3
  %P 191--198
  %R 10.1016/j.sjpmh.2023.08.001
  %T Associations between unhealthy lifestyle and depression: Cross-sectional results from the Spanish National Health Survey
  %U https://pubmed.ncbi.nlm.nih.gov/38591831
  %V 18
  %X INTRODUCTION: Depression usually worsens lifestyle habits, but previous evidence also suggests that an unhealthy lifestyle (UL) increases the risk of depression. Many studies have analyzed the association between lifestyle and depression in several nationally representative samples, but none have done so in the Spanish adult population. Our aim was to examine the associations between UL habits and depression in Spain. MATERIALS AND METHODS: Analysis of cross-sectional data from the latest National Health Survey published in 2018 (N=23,089). Data on depression and 4 lifestyle factors (diet, physical exercise, smoking, and alcohol consumption) were used. These factors were combined into an UL index ranging from 0 (healthiest lifestyle) to 4 (unhealthiest lifestyle). The prevalence of depression at different levels of the UL index, and the association between depression and both the cumulative UL index and the 4 UL factors was analyzed using parametric and non-parametric tests. RESULTS: Sedentarism was the most prevalent UL factor, followed by unhealthy diet, smoking and high-risk alcohol consumption. Having ≥1 UL factors was associated with a higher prevalence of depression compared to having 0 UL factors (2.5% vs. ≥5.2%), regardless of the cumulative number UL factors (1, 2, 3 or 4). Being physically inactive (OR=1.6) and a smoker (OR=1.3) increased the likelihood of depression. Being a high-risk wine drinker (OR=0.26) decreased the likelihood of depression. Dietary intake was not significant. CONCLUSIONS: The prevalence of depression changes depending on several modifiable lifestyle factors. Policy makers should therefore spare no resources in promoting strategies to encourage healthy lifestyles and prevent the acquisition of UL habits.
  

• 
  Impact of an adapted diabetes prevention program in a spanish primary care setting: protocol for a type II hybrid effectiveness-implementation cluster-randomized trial (ALADIM). Bennasar-Veny, Miquel; Abbate, Manuela; Colom-Rosselló, Miquel; Capitán-Moyano, Laura; Hernández-Bermúdez, Ivonne C; Ricci-Cabello, Ignacio; Yañez, Aina M; Fernandez, Maria E; investigators, ALADIM (2025). 20(1) 27–27.

  AbstractURLBibTeXEndNoteDOIBibSonomyDownload

  BACKGROUND: Type 2 diabetes (T2D) is a global health concern affecting 10.5% of the adult population and is projected to rise significantly in the coming decades. Lifestyle modification programs, such as the Diabetes Prevention Program (DPP), can effectively reduce T2D risk among individuals with prediabetes. However, their implementation in real-world healthcare settings remains poor, particularly in Spain, where T2D prevalence is the highest in Europe. The ALADIM study aims to evaluate the effectiveness and implementation of an adapted DPP in Spanish Primary Care Centers (PCCs). The primary effectiveness outcome is weight, the co-primary implementation outcome is implementation fidelity. We will also assess the effect of DPP implementation on overall prediabetes management within the PCCs (spillover) by measuring the percentage of people with prediabetes receiving lifestyle advice. METHODS: The ALADIM trial is a hybrid type II effectiveness-implementation cluster-randomized controlled trial involving 10 PCCs of Mallorca (Balearic Islands, Spain). PCCs will be randomized to the intervention (5 PCCs) or control (5 PCCs) group in a 1:1 ratio. The intervention group will receive training and materials to implement and deliver the adapted DPP over 12 months. The control group will continue providing usual care. The DPP will be culturally adapted using the Intervention Mapping-ADAPT (IM-ADAPT) approach. The implementation strategy will be designed using Implementation Mapping. Measures of effectiveness will be assessed at the participant level at baseline, 6 and 12 months during the intervention period, and 18 months after baseline. Implementation outcomes will be assessed at the PCC level at multiple time-points throughout the study period. Spillover will be assessed at PCC level at months -1, 6 and 18. An intention-to-treat analysis will assess effectiveness and spillover effect using generalized estimating equations. Implementation outcomes will be evaluated using a mixed-methods approach. DISCUSSION: The ALADIM study has the potential to address the gap between research and practice by employing implementation science for evaluation, adaptation and implementation of an evidence-based diabetes intervention. The findings will contribute to the development of a sustainable and scalable implementation strategy for T2D prevention, with potential implications for policy and practice at regional and national levels. TRIAL REGISTRATION: ClinicalTrials.gov, NCT06871059. Registered 10 March 2025, https://clinicaltrials.gov/study/NCT06871059.

  @article{bennasarveny2025impact,
  abstract = {BACKGROUND: Type 2 diabetes (T2D) is a global health concern affecting 10.5% of the adult population and is projected to rise significantly in the coming decades. Lifestyle modification programs, such as the Diabetes Prevention Program (DPP), can effectively reduce T2D risk among individuals with prediabetes. However, their implementation in real-world healthcare settings remains poor, particularly in Spain, where T2D prevalence is the highest in Europe. The ALADIM study aims to evaluate the effectiveness and implementation of an adapted DPP in Spanish Primary Care Centers (PCCs). The primary effectiveness outcome is weight, the co-primary implementation outcome is implementation fidelity. We will also assess the effect of DPP implementation on overall prediabetes management within the PCCs (spillover) by measuring the percentage of people with prediabetes receiving lifestyle advice. METHODS: The ALADIM trial is a hybrid type II effectiveness-implementation cluster-randomized controlled trial involving 10 PCCs of Mallorca (Balearic Islands, Spain). PCCs will be randomized to the intervention (5 PCCs) or control (5 PCCs) group in a 1:1 ratio. The intervention group will receive training and materials to implement and deliver the adapted DPP over 12 months. The control group will continue providing usual care. The DPP will be culturally adapted using the Intervention Mapping-ADAPT (IM-ADAPT) approach. The implementation strategy will be designed using Implementation Mapping. Measures of effectiveness will be assessed at the participant level at baseline, 6 and 12 months during the intervention period, and 18 months after baseline. Implementation outcomes will be assessed at the PCC level at multiple time-points throughout the study period. Spillover will be assessed at PCC level at months -1, 6 and 18. An intention-to-treat analysis will assess effectiveness and spillover effect using generalized estimating equations. Implementation outcomes will be evaluated using a mixed-methods approach. DISCUSSION: The ALADIM study has the potential to address the gap between research and practice by employing implementation science for evaluation, adaptation and implementation of an evidence-based diabetes intervention. The findings will contribute to the development of a sustainable and scalable implementation strategy for T2D prevention, with potential implications for policy and practice at regional and national levels. TRIAL REGISTRATION: ClinicalTrials.gov, NCT06871059. Registered 10 March 2025, https://clinicaltrials.gov/study/NCT06871059.},
  address = {England},
  author = {Bennasar-Veny, Miquel and Abbate, Manuela and Colom-Rosselló, Miquel and Capitán-Moyano, Laura and Hernández-Bermúdez, Ivonne C and Ricci-Cabello, Ignacio and Yañez, Aina M and Fernandez, Maria E and investigators, ALADIM},
  journal = {Implementation science : IS},
  keywords = {evisap},
  month = {jun},
  number = 1,
  pages = {27--27},
  title = {Impact of an adapted diabetes prevention program in a spanish primary care setting: protocol for a type II hybrid effectiveness-implementation cluster-randomized trial (ALADIM)},
  volume = 20,
  year = 2025
  }
  

  %0 Journal Article
  %1 bennasarveny2025impact
  %A Bennasar-Veny, Miquel
  %A Abbate, Manuela
  %A Colom-Rosselló, Miquel
  %A Capitán-Moyano, Laura
  %A Hernández-Bermúdez, Ivonne C
  %A Ricci-Cabello, Ignacio
  %A Yañez, Aina M
  %A Fernandez, Maria E
  %A investigators, ALADIM
  %C England
  %D 2025
  %J Implementation science : IS
  %N 1
  %P 27--27
  %R 10.1186/s13012-025-01438-3
  %T Impact of an adapted diabetes prevention program in a spanish primary care setting: protocol for a type II hybrid effectiveness-implementation cluster-randomized trial (ALADIM)
  %U https://pubmed.ncbi.nlm.nih.gov/40457444
  %V 20
  %X BACKGROUND: Type 2 diabetes (T2D) is a global health concern affecting 10.5% of the adult population and is projected to rise significantly in the coming decades. Lifestyle modification programs, such as the Diabetes Prevention Program (DPP), can effectively reduce T2D risk among individuals with prediabetes. However, their implementation in real-world healthcare settings remains poor, particularly in Spain, where T2D prevalence is the highest in Europe. The ALADIM study aims to evaluate the effectiveness and implementation of an adapted DPP in Spanish Primary Care Centers (PCCs). The primary effectiveness outcome is weight, the co-primary implementation outcome is implementation fidelity. We will also assess the effect of DPP implementation on overall prediabetes management within the PCCs (spillover) by measuring the percentage of people with prediabetes receiving lifestyle advice. METHODS: The ALADIM trial is a hybrid type II effectiveness-implementation cluster-randomized controlled trial involving 10 PCCs of Mallorca (Balearic Islands, Spain). PCCs will be randomized to the intervention (5 PCCs) or control (5 PCCs) group in a 1:1 ratio. The intervention group will receive training and materials to implement and deliver the adapted DPP over 12 months. The control group will continue providing usual care. The DPP will be culturally adapted using the Intervention Mapping-ADAPT (IM-ADAPT) approach. The implementation strategy will be designed using Implementation Mapping. Measures of effectiveness will be assessed at the participant level at baseline, 6 and 12 months during the intervention period, and 18 months after baseline. Implementation outcomes will be assessed at the PCC level at multiple time-points throughout the study period. Spillover will be assessed at PCC level at months -1, 6 and 18. An intention-to-treat analysis will assess effectiveness and spillover effect using generalized estimating equations. Implementation outcomes will be evaluated using a mixed-methods approach. DISCUSSION: The ALADIM study has the potential to address the gap between research and practice by employing implementation science for evaluation, adaptation and implementation of an evidence-based diabetes intervention. The findings will contribute to the development of a sustainable and scalable implementation strategy for T2D prevention, with potential implications for policy and practice at regional and national levels. TRIAL REGISTRATION: ClinicalTrials.gov, NCT06871059. Registered 10 March 2025, https://clinicaltrials.gov/study/NCT06871059.
  

• 
  Key components of effective non-pharmacological interventions for childhood obesity: a review considering social determinants of health. Zamanillo-Campos, R; Colom-Rossello, M; Rodríguez-Calero, M A; Martín, M I; Planas, T; Núñez-Jiménez, C; Ramos, M (2025). 184(7) 449–449.

  AbstractURLBibTeXEndNoteDOIBibSonomy

  Childhood obesity, driven by an obesogenic environment, remains a public health priority. To review the effectiveness of non-pharmacological interventions for treating childhood obesity, with a focus on weight reduction and consideration of social determinants of health (SDOH). The review included randomized and quasi-experimental studies, published between August 2016 and December 2021, that evaluated the effectiveness of interventions aimed at reducing body weight in children aged 2 to 14 years with obesity. (PROSPERO ID: CRD42022301191). A total of 59 interventions were identified, showing wide variability in design, duration, components and settings. Most included physical activity (93%) and nutrition (81%), while fewer incorporated psychological support (46%) or digital tools (25%). Despite the diversity of approaches, 56% of the interventions were effective, particularly those implemented in healthcare or school settings, involving physical activity, and delivered by multidisciplinary teams. However, only six demonstrated sustained effects beyond 6 months. Risk of bias was high in over half of the studies, and only a small proportion (22%) reported participants' social characteristics such as family structure, race, or socioeconomic status. Importantly, very few interventions were designed or evaluated with explicit consideration of SDOH. CONCLUSION: Overall, effective interventions tended to target both children and parents, include multiple components-especially physical activity-and be delivered in accessible settings such as schools or primary care. Yet, the generalizability of findings is limited, as most studies involved children from relatively advantaged backgrounds. Future interventions should integrate SDOH in both design and evaluation to ensure equity and long-term effectiveness in diverse populations. WHAT IS KNOWN: • Childhood obesity remains a critical public health issue, heavily influenced by obesogenic environments and social determinants of health (SDOH). • Non-pharmacological interventions, particularly those incorporating physical activity and nutritional guidance, have been commonly used to address childhood obesity, though with varying degrees of success. WHAT IS NEW: • This review highlights that interventions delivered in healthcare or school settings by multidisciplinary teams, and involving both physical activity and parental engagement, show higher effectiveness in reducing childhood obesity. • The study identifies a significant gap in the integration of social determinants of health in both the design and evaluation of interventions, limiting their long-term impact and equity across diverse populations.

  @article{zamanillocampos2025components,
  abstract = {Childhood obesity, driven by an obesogenic environment, remains a public health priority. To review the effectiveness of non-pharmacological interventions for treating childhood obesity, with a focus on weight reduction and consideration of social determinants of health (SDOH). The review included randomized and quasi-experimental studies, published between August 2016 and December 2021, that evaluated the effectiveness of interventions aimed at reducing body weight in children aged 2 to 14 years with obesity. (PROSPERO ID: CRD42022301191). A total of 59 interventions were identified, showing wide variability in design, duration, components and settings. Most included physical activity (93%) and nutrition (81%), while fewer incorporated psychological support (46%) or digital tools (25%). Despite the diversity of approaches, 56% of the interventions were effective, particularly those implemented in healthcare or school settings, involving physical activity, and delivered by multidisciplinary teams. However, only six demonstrated sustained effects beyond 6 months. Risk of bias was high in over half of the studies, and only a small proportion (22%) reported participants' social characteristics such as family structure, race, or socioeconomic status. Importantly, very few interventions were designed or evaluated with explicit consideration of SDOH. CONCLUSION: Overall, effective interventions tended to target both children and parents, include multiple components-especially physical activity-and be delivered in accessible settings such as schools or primary care. Yet, the generalizability of findings is limited, as most studies involved children from relatively advantaged backgrounds. Future interventions should integrate SDOH in both design and evaluation to ensure equity and long-term effectiveness in diverse populations. WHAT IS KNOWN: • Childhood obesity remains a critical public health issue, heavily influenced by obesogenic environments and social determinants of health (SDOH). • Non-pharmacological interventions, particularly those incorporating physical activity and nutritional guidance, have been commonly used to address childhood obesity, though with varying degrees of success. WHAT IS NEW: • This review highlights that interventions delivered in healthcare or school settings by multidisciplinary teams, and involving both physical activity and parental engagement, show higher effectiveness in reducing childhood obesity. • The study identifies a significant gap in the integration of social determinants of health in both the design and evaluation of interventions, limiting their long-term impact and equity across diverse populations.},
  address = {Germany},
  author = {Zamanillo-Campos, R and Colom-Rossello, M and Rodríguez-Calero, M A and Martín, M I and Planas, T and Núñez-Jiménez, C and Ramos, M},
  journal = {European journal of pediatrics},
  keywords = {evisap},
  month = {jun},
  number = 7,
  pages = {449--449},
  title = {Key components of effective non-pharmacological interventions for childhood obesity: a review considering social determinants of health},
  volume = 184,
  year = 2025
  }
  

  %0 Journal Article
  %1 zamanillocampos2025components
  %A Zamanillo-Campos, R
  %A Colom-Rossello, M
  %A Rodríguez-Calero, M A
  %A Martín, M I
  %A Planas, T
  %A Núñez-Jiménez, C
  %A Ramos, M
  %C Germany
  %D 2025
  %J European journal of pediatrics
  %N 7
  %P 449--449
  %R 10.1007/s00431-025-06279-2
  %T Key components of effective non-pharmacological interventions for childhood obesity: a review considering social determinants of health
  %U https://pubmed.ncbi.nlm.nih.gov/40563002
  %V 184
  %X Childhood obesity, driven by an obesogenic environment, remains a public health priority. To review the effectiveness of non-pharmacological interventions for treating childhood obesity, with a focus on weight reduction and consideration of social determinants of health (SDOH). The review included randomized and quasi-experimental studies, published between August 2016 and December 2021, that evaluated the effectiveness of interventions aimed at reducing body weight in children aged 2 to 14 years with obesity. (PROSPERO ID: CRD42022301191). A total of 59 interventions were identified, showing wide variability in design, duration, components and settings. Most included physical activity (93%) and nutrition (81%), while fewer incorporated psychological support (46%) or digital tools (25%). Despite the diversity of approaches, 56% of the interventions were effective, particularly those implemented in healthcare or school settings, involving physical activity, and delivered by multidisciplinary teams. However, only six demonstrated sustained effects beyond 6 months. Risk of bias was high in over half of the studies, and only a small proportion (22%) reported participants' social characteristics such as family structure, race, or socioeconomic status. Importantly, very few interventions were designed or evaluated with explicit consideration of SDOH. CONCLUSION: Overall, effective interventions tended to target both children and parents, include multiple components-especially physical activity-and be delivered in accessible settings such as schools or primary care. Yet, the generalizability of findings is limited, as most studies involved children from relatively advantaged backgrounds. Future interventions should integrate SDOH in both design and evaluation to ensure equity and long-term effectiveness in diverse populations. WHAT IS KNOWN: • Childhood obesity remains a critical public health issue, heavily influenced by obesogenic environments and social determinants of health (SDOH). • Non-pharmacological interventions, particularly those incorporating physical activity and nutritional guidance, have been commonly used to address childhood obesity, though with varying degrees of success. WHAT IS NEW: • This review highlights that interventions delivered in healthcare or school settings by multidisciplinary teams, and involving both physical activity and parental engagement, show higher effectiveness in reducing childhood obesity. • The study identifies a significant gap in the integration of social determinants of health in both the design and evaluation of interventions, limiting their long-term impact and equity across diverse populations.
  

• 
  Longitudinal associations between melancholic depression and executive function in adult patients with major depressive disorder: a 12-month follow-up study. Navarra-Ventura, Guillem; Riera-Serra, Pau; Castro, Adoración; Montaño, Juan José; Roca, Miquel; Gili, Margalida (2025). 351 116636–116636.

  AbstractURLBibTeXEndNoteDOIBibSonomyDownload

  Major depressive disorder (MDD) is often associated with deficits in executive function, but the long-term cognitive impact of specific depressive subtypes, in particular melancholic depression (MelD), is underexplored. This is the first prospective study aimed at exploring longitudinal associations between MelD and executive function in adult patients with MDD. This is a secondary analysis using data from a larger project with assessments at baseline, 6 and 12 months. MelD was identified using an algorithm derived from a subset of eight items from the Inventory of Depressive Symptomatology-Self Rated, which provides a standardized framework for the identification of this specific depressive subtype. Executive function was assessed using the Cambridge Neuropsychological Test Automated Battery. Longitudinal associations between MelD and executive function, including a global domain, four subdomains (working memory, planning, response inhibition and decision-making), and eight individual variables used to calculate the composite scores of the five (sub)domains, were analyzed using linear mixed-effects models adjusted for demographic and clinical variables and psychomotor speed. One hundred and five patients (20.95 % MelD) were analyzed at baseline, 73 (17.81 % MelD) at 6 months, and 61 (19.67 % MelD) at 12 months. MelD, older age and female sex were significantly associated with worse performance in the global executive function domain, in the working memory subdomain, and in four individual variables within the working memory, planning and decision-making subdomains, independent of other demographic and clinical variables and psychomotor speed. The findings highlight MelD as a distinct risk factor for worse long-term executive function in adult patients with MDD.

  @article{navarraventura2025longitudinal,
  abstract = {Major depressive disorder (MDD) is often associated with deficits in executive function, but the long-term cognitive impact of specific depressive subtypes, in particular melancholic depression (MelD), is underexplored. This is the first prospective study aimed at exploring longitudinal associations between MelD and executive function in adult patients with MDD. This is a secondary analysis using data from a larger project with assessments at baseline, 6 and 12 months. MelD was identified using an algorithm derived from a subset of eight items from the Inventory of Depressive Symptomatology-Self Rated, which provides a standardized framework for the identification of this specific depressive subtype. Executive function was assessed using the Cambridge Neuropsychological Test Automated Battery. Longitudinal associations between MelD and executive function, including a global domain, four subdomains (working memory, planning, response inhibition and decision-making), and eight individual variables used to calculate the composite scores of the five (sub)domains, were analyzed using linear mixed-effects models adjusted for demographic and clinical variables and psychomotor speed. One hundred and five patients (20.95 % MelD) were analyzed at baseline, 73 (17.81 % MelD) at 6 months, and 61 (19.67 % MelD) at 12 months. MelD, older age and female sex were significantly associated with worse performance in the global executive function domain, in the working memory subdomain, and in four individual variables within the working memory, planning and decision-making subdomains, independent of other demographic and clinical variables and psychomotor speed. The findings highlight MelD as a distinct risk factor for worse long-term executive function in adult patients with MDD.},
  address = {Ireland},
  author = {Navarra-Ventura, Guillem and Riera-Serra, Pau and Castro, Adoración and Montaño, Juan José and Roca, Miquel and Gili, Margalida},
  journal = {Psychiatry research},
  keywords = {evisap},
  month = {jul},
  pages = {116636--116636},
  title = {Longitudinal associations between melancholic depression and executive function in adult patients with major depressive disorder: a 12-month follow-up study},
  volume = 351,
  year = 2025
  }
  

  %0 Journal Article
  %1 navarraventura2025longitudinal
  %A Navarra-Ventura, Guillem
  %A Riera-Serra, Pau
  %A Castro, Adoración
  %A Montaño, Juan José
  %A Roca, Miquel
  %A Gili, Margalida
  %C Ireland
  %D 2025
  %J Psychiatry research
  %P 116636--116636
  %R 10.1016/j.psychres.2025.116636
  %T Longitudinal associations between melancholic depression and executive function in adult patients with major depressive disorder: a 12-month follow-up study
  %U https://pubmed.ncbi.nlm.nih.gov/40651192
  %V 351
  %X Major depressive disorder (MDD) is often associated with deficits in executive function, but the long-term cognitive impact of specific depressive subtypes, in particular melancholic depression (MelD), is underexplored. This is the first prospective study aimed at exploring longitudinal associations between MelD and executive function in adult patients with MDD. This is a secondary analysis using data from a larger project with assessments at baseline, 6 and 12 months. MelD was identified using an algorithm derived from a subset of eight items from the Inventory of Depressive Symptomatology-Self Rated, which provides a standardized framework for the identification of this specific depressive subtype. Executive function was assessed using the Cambridge Neuropsychological Test Automated Battery. Longitudinal associations between MelD and executive function, including a global domain, four subdomains (working memory, planning, response inhibition and decision-making), and eight individual variables used to calculate the composite scores of the five (sub)domains, were analyzed using linear mixed-effects models adjusted for demographic and clinical variables and psychomotor speed. One hundred and five patients (20.95 % MelD) were analyzed at baseline, 73 (17.81 % MelD) at 6 months, and 61 (19.67 % MelD) at 12 months. MelD, older age and female sex were significantly associated with worse performance in the global executive function domain, in the working memory subdomain, and in four individual variables within the working memory, planning and decision-making subdomains, independent of other demographic and clinical variables and psychomotor speed. The findings highlight MelD as a distinct risk factor for worse long-term executive function in adult patients with MDD.
  

• 
  Development and assessment of an online communication skills course to optimise antibiotic prescribing for children in primary care. Arias-Alonso, Lucía; Barragán-Brun, Nieves; Elizondo-Alzola, Usue; Boldu-Minguell, Andrea; Rocha-Calderón, Claudio Alfonso; Niño-de Guzmán, Ena; Santandreu, Francisca María; Quesada-Carrasco, Fermín; Ricci-Cabello, Ignacio; Gorrotxategi-Gorrotxategi, Pedro Jesús; de la Poza-Abad, Mariam; Mas-Dalmau, Gemma; Gibert-Agulló, Anna; González-Lama, Jesús; Alonso-Coello, Pablo (2025). 26(1) 247–247.

  AbstractURLBibTeXEndNoteDOIBibSonomyDownload

  BACKGROUND: Antibiotic overprescription is a complex global problem that contributes to antibacterial resistance. Enhancing professionals' communication skills is one of the most promising interventions for optimising antibiotic prescription in respiratory tract infections in children. METHODS: We developed a communication skills course for primary care paediatricians, paediatric nurses and community pharmacists. We conducted: 1) A scoping review, 2) brainstorming and selection of themes, 3) design of content, 4) user testing, through a survey and semi-structured interviews. A multidisciplinary advisory group gave feedback throughout the design and development process. We conducted a descriptive analysis of the survey results, and we used a predefined analytical framework for qualitative content. RESULTS: The course comprised four modules with nineteen themes, which included communication theoretical content, clinical cases, complementary reading, videos, and a glossary. It also included a forum and webinars, after each module. Sixteen users completed several themes and a survey, and eight were interviewed. They rated a mean of 4 or higher (5-point scale), across most of the domains evaluated. The videos received the highest rating (4.81; SD = 0.39). Suggestions for improvement included incorporating a workshop, and featuring more representation of other professionals. The majority of professionals (93%) expressed interest in completing the course. CONCLUSION: We developed a comprehensive, evidence-based online communication skills training course to optimise antibiotic prescribing in paediatric primary care. Integrating key communication strategies and insights from a scoping review, the course equips healthcare professionals with practical tools to enhance shared decision-making and antimicrobial stewardship. TRIAL REGISTRATION: Not applicable.

  @article{ariasalonso2025development,
  abstract = {BACKGROUND: Antibiotic overprescription is a complex global problem that contributes to antibacterial resistance. Enhancing professionals' communication skills is one of the most promising interventions for optimising antibiotic prescription in respiratory tract infections in children. METHODS: We developed a communication skills course for primary care paediatricians, paediatric nurses and community pharmacists. We conducted: 1) A scoping review, 2) brainstorming and selection of themes, 3) design of content, 4) user testing, through a survey and semi-structured interviews. A multidisciplinary advisory group gave feedback throughout the design and development process. We conducted a descriptive analysis of the survey results, and we used a predefined analytical framework for qualitative content. RESULTS: The course comprised four modules with nineteen themes, which included communication theoretical content, clinical cases, complementary reading, videos, and a glossary. It also included a forum and webinars, after each module. Sixteen users completed several themes and a survey, and eight were interviewed. They rated a mean of 4 or higher (5-point scale), across most of the domains evaluated. The videos received the highest rating (4.81; SD = 0.39). Suggestions for improvement included incorporating a workshop, and featuring more representation of other professionals. The majority of professionals (93%) expressed interest in completing the course. CONCLUSION: We developed a comprehensive, evidence-based online communication skills training course to optimise antibiotic prescribing in paediatric primary care. Integrating key communication strategies and insights from a scoping review, the course equips healthcare professionals with practical tools to enhance shared decision-making and antimicrobial stewardship. TRIAL REGISTRATION: Not applicable.},
  address = {England},
  author = {Arias-Alonso, Lucía and Barragán-Brun, Nieves and Elizondo-Alzola, Usue and Boldu-Minguell, Andrea and Rocha-Calderón, Claudio Alfonso and Niño-de Guzmán, Ena and Santandreu, Francisca María and Quesada-Carrasco, Fermín and Ricci-Cabello, Ignacio and Gorrotxategi-Gorrotxategi, Pedro Jesús and de la Poza-Abad, Mariam and Mas-Dalmau, Gemma and Gibert-Agulló, Anna and González-Lama, Jesús and Alonso-Coello, Pablo},
  journal = {BMC primary care},
  keywords = {evisap},
  month = {aug},
  number = 1,
  pages = {247--247},
  title = {Development and assessment of an online communication skills course to optimise antibiotic prescribing for children in primary care},
  volume = 26,
  year = 2025
  }
  

  %0 Journal Article
  %1 ariasalonso2025development
  %A Arias-Alonso, Lucía
  %A Barragán-Brun, Nieves
  %A Elizondo-Alzola, Usue
  %A Boldu-Minguell, Andrea
  %A Rocha-Calderón, Claudio Alfonso
  %A Niño-de Guzmán, Ena
  %A Santandreu, Francisca María
  %A Quesada-Carrasco, Fermín
  %A Ricci-Cabello, Ignacio
  %A Gorrotxategi-Gorrotxategi, Pedro Jesús
  %A de la Poza-Abad, Mariam
  %A Mas-Dalmau, Gemma
  %A Gibert-Agulló, Anna
  %A González-Lama, Jesús
  %A Alonso-Coello, Pablo
  %C England
  %D 2025
  %J BMC primary care
  %N 1
  %P 247--247
  %R 10.1186/s12875-025-02919-6
  %T Development and assessment of an online communication skills course to optimise antibiotic prescribing for children in primary care
  %U https://pubmed.ncbi.nlm.nih.gov/40775754
  %V 26
  %X BACKGROUND: Antibiotic overprescription is a complex global problem that contributes to antibacterial resistance. Enhancing professionals' communication skills is one of the most promising interventions for optimising antibiotic prescription in respiratory tract infections in children. METHODS: We developed a communication skills course for primary care paediatricians, paediatric nurses and community pharmacists. We conducted: 1) A scoping review, 2) brainstorming and selection of themes, 3) design of content, 4) user testing, through a survey and semi-structured interviews. A multidisciplinary advisory group gave feedback throughout the design and development process. We conducted a descriptive analysis of the survey results, and we used a predefined analytical framework for qualitative content. RESULTS: The course comprised four modules with nineteen themes, which included communication theoretical content, clinical cases, complementary reading, videos, and a glossary. It also included a forum and webinars, after each module. Sixteen users completed several themes and a survey, and eight were interviewed. They rated a mean of 4 or higher (5-point scale), across most of the domains evaluated. The videos received the highest rating (4.81; SD = 0.39). Suggestions for improvement included incorporating a workshop, and featuring more representation of other professionals. The majority of professionals (93%) expressed interest in completing the course. CONCLUSION: We developed a comprehensive, evidence-based online communication skills training course to optimise antibiotic prescribing in paediatric primary care. Integrating key communication strategies and insights from a scoping review, the course equips healthcare professionals with practical tools to enhance shared decision-making and antimicrobial stewardship. TRIAL REGISTRATION: Not applicable.
  

• 
  Identifying the key components of a diet and lifestyle screener for people living with and beyond cancer: an e-Delphi study. Chaplin, Alice; Prohens, Lara; Wordsworth, Janna; Obrador-Hevia, Antònia; Guillot, Monica; Ricci-Cabello, Ignacio; Romaguera, Dora; Sesé, Albert (2025). 15(8) e097084-e097084.

  AbstractURLBibTeXEndNoteDOIBibSonomyDownload

  OBJECTIVES: There are currently no validated screeners that evaluate diet and lifestyle of people living with and beyond cancer (PLWBC). The purpose of this study was to reach a consensus among an international expert panel on the essential items to include in this type of instrument. DESIGN: A scientific committee developed the initial list of items, which were presented to an expert panel in a two-round-modified electronic Delphi. Panellists were asked to rate the adequacy, relevance and feasibility of self-reporting each item. Qualitative assessments were encouraged. SETTING: Four countries (Spain, UK, USA and Portugal). PARTICIPANTS: Experts working in a cancer-related health profession or cancer-related research were recruited. MAIN OUTCOME MEASURES: Items were initially categorised into seven domains (body composition, physical activity, diet, alcohol, smoking, sleep and psychosocial distress). A content validity index per item (CVI-i) and a scale-level CVI (S-CVI) were calculated (acceptable≥0.78). All items with a CVI-i≥0.78 were submitted to a final consensus meeting. RESULTS: A total of 108 items were proposed to the panel. In Round 1, 77 items were accepted, 10 items were excluded and 6 new items were proposed. During Round 2, 4 items were accepted and 19 were excluded. Diet and alcohol were merged into one domain. The final consensus meeting decided on 61 items categorised into six domains (S-CVI:0.94): body composition, physical activity, diet and alcohol, smoking, sleep and psychosocial distress. CONCLUSIONS: We identified the main items to be considered when developing a screener to evaluate diet and lifestyle in PLWBC in a clinical setting, and the results obtained will guide the content of the screener in the following validation study.

  @article{chaplin2025identifying,
  abstract = {OBJECTIVES: There are currently no validated screeners that evaluate diet and lifestyle of people living with and beyond cancer (PLWBC). The purpose of this study was to reach a consensus among an international expert panel on the essential items to include in this type of instrument. DESIGN: A scientific committee developed the initial list of items, which were presented to an expert panel in a two-round-modified electronic Delphi. Panellists were asked to rate the adequacy, relevance and feasibility of self-reporting each item. Qualitative assessments were encouraged. SETTING: Four countries (Spain, UK, USA and Portugal). PARTICIPANTS: Experts working in a cancer-related health profession or cancer-related research were recruited. MAIN OUTCOME MEASURES: Items were initially categorised into seven domains (body composition, physical activity, diet, alcohol, smoking, sleep and psychosocial distress). A content validity index per item (CVI-i) and a scale-level CVI (S-CVI) were calculated (acceptable≥0.78). All items with a CVI-i≥0.78 were submitted to a final consensus meeting. RESULTS: A total of 108 items were proposed to the panel. In Round 1, 77 items were accepted, 10 items were excluded and 6 new items were proposed. During Round 2, 4 items were accepted and 19 were excluded. Diet and alcohol were merged into one domain. The final consensus meeting decided on 61 items categorised into six domains (S-CVI:0.94): body composition, physical activity, diet and alcohol, smoking, sleep and psychosocial distress. CONCLUSIONS: We identified the main items to be considered when developing a screener to evaluate diet and lifestyle in PLWBC in a clinical setting, and the results obtained will guide the content of the screener in the following validation study.},
  address = {England},
  author = {Chaplin, Alice and Prohens, Lara and Wordsworth, Janna and Obrador-Hevia, Antònia and Guillot, Monica and Ricci-Cabello, Ignacio and Romaguera, Dora and Sesé, Albert},
  journal = {BMJ open},
  keywords = {evisap},
  month = {aug},
  number = 8,
  pages = {e097084--e097084},
  title = {Identifying the key components of a diet and lifestyle screener for people living with and beyond cancer: an e-Delphi study},
  volume = 15,
  year = 2025
  }
  

  %0 Journal Article
  %1 chaplin2025identifying
  %A Chaplin, Alice
  %A Prohens, Lara
  %A Wordsworth, Janna
  %A Obrador-Hevia, Antònia
  %A Guillot, Monica
  %A Ricci-Cabello, Ignacio
  %A Romaguera, Dora
  %A Sesé, Albert
  %C England
  %D 2025
  %J BMJ open
  %N 8
  %P e097084--e097084
  %R 10.1136/bmjopen-2024-097084
  %T Identifying the key components of a diet and lifestyle screener for people living with and beyond cancer: an e-Delphi study
  %U https://pubmed.ncbi.nlm.nih.gov/40784779
  %V 15
  %X OBJECTIVES: There are currently no validated screeners that evaluate diet and lifestyle of people living with and beyond cancer (PLWBC). The purpose of this study was to reach a consensus among an international expert panel on the essential items to include in this type of instrument. DESIGN: A scientific committee developed the initial list of items, which were presented to an expert panel in a two-round-modified electronic Delphi. Panellists were asked to rate the adequacy, relevance and feasibility of self-reporting each item. Qualitative assessments were encouraged. SETTING: Four countries (Spain, UK, USA and Portugal). PARTICIPANTS: Experts working in a cancer-related health profession or cancer-related research were recruited. MAIN OUTCOME MEASURES: Items were initially categorised into seven domains (body composition, physical activity, diet, alcohol, smoking, sleep and psychosocial distress). A content validity index per item (CVI-i) and a scale-level CVI (S-CVI) were calculated (acceptable≥0.78). All items with a CVI-i≥0.78 were submitted to a final consensus meeting. RESULTS: A total of 108 items were proposed to the panel. In Round 1, 77 items were accepted, 10 items were excluded and 6 new items were proposed. During Round 2, 4 items were accepted and 19 were excluded. Diet and alcohol were merged into one domain. The final consensus meeting decided on 61 items categorised into six domains (S-CVI:0.94): body composition, physical activity, diet and alcohol, smoking, sleep and psychosocial distress. CONCLUSIONS: We identified the main items to be considered when developing a screener to evaluate diet and lifestyle in PLWBC in a clinical setting, and the results obtained will guide the content of the screener in the following validation study.
  

• 
  Protocol: Scoping review of the association between complementary feeding, growth, and immune health in infants and toddlers-An EAACI guideline paper. Venter, Carina; Alonso-Coello, Pablo; Beltran, Jessica; Bracchiglione, Javier; Fernandez-Saenz, Karina; Riera, Pau; Solà, Ivan; Arasi, Stefania; Berni Canani, Roberto; Fleischer, David; Eguíluz-Gracia, Ibon; Meyer, Rosan; Roberts, Graham; Roth-Walter, Franziska; Santos, Alexandra F; Skypala, Isabel; Smith, Peter K; Sokolowska, Milena; Torres, Maria J; Vassilopoulou, Emilia; Walter, Jens; O’Mahony, Liam (2025). 36(8) e70145-e70145.

  AbstractURLBibTeXEndNoteDOIBibSonomy

  The European Academy of Allergy and Clinical Immunology (EAACI) is currently developing guidelines on immunomodulation and nutrition. To inform these recommendations, a scoping review will be conducted to synthesize and map the available empirical evidence on how complementary feeding affects immune health in infants and toddlers to explore the association between complementary feeding during the first year of life and immune health outcomes in children up to 3 years of age. The scoping review will be conducted using the Preferred Reporting Items for Systematic Reviews and Meta-analysis Scoping Review Extension for scoping reviews (PRISMA-ScR) guidelines. We have developed inclusion criteria using the PCC (Population, Concept and Context) format: the population will include healthy infants; the concept refers to specific factors related to introduction of complementary feeding; and the context will focus on studies conducted in settings representative of everyday nutrition and feeding practices for infants and toddlers. Evidence sources include systematic reviews. We will search in MEDLINE and Epistemonikos. Data will be extracted using a standardized form developed in REDCap, and the findings will be synthesized narratively. Only published literature will be included in this systematic review. Therefore, no ethical approval is required. The final review paper will be published in a peer-reviewed journal. OSF registration DOI: 10.17605/OSF.IO/T5F8.

  @article{venter2025protocol,
  abstract = {The European Academy of Allergy and Clinical Immunology (EAACI) is currently developing guidelines on immunomodulation and nutrition. To inform these recommendations, a scoping review will be conducted to synthesize and map the available empirical evidence on how complementary feeding affects immune health in infants and toddlers to explore the association between complementary feeding during the first year of life and immune health outcomes in children up to 3 years of age. The scoping review will be conducted using the Preferred Reporting Items for Systematic Reviews and Meta-analysis Scoping Review Extension for scoping reviews (PRISMA-ScR) guidelines. We have developed inclusion criteria using the PCC (Population, Concept and Context) format: the population will include healthy infants; the concept refers to specific factors related to introduction of complementary feeding; and the context will focus on studies conducted in settings representative of everyday nutrition and feeding practices for infants and toddlers. Evidence sources include systematic reviews. We will search in MEDLINE and Epistemonikos. Data will be extracted using a standardized form developed in REDCap, and the findings will be synthesized narratively. Only published literature will be included in this systematic review. Therefore, no ethical approval is required. The final review paper will be published in a peer-reviewed journal. OSF registration DOI: 10.17605/OSF.IO/T5F8.},
  address = {England},
  author = {Venter, Carina and Alonso-Coello, Pablo and Beltran, Jessica and Bracchiglione, Javier and Fernandez-Saenz, Karina and Riera, Pau and Solà, Ivan and Arasi, Stefania and Berni Canani, Roberto and Fleischer, David and Eguíluz-Gracia, Ibon and Meyer, Rosan and Roberts, Graham and Roth-Walter, Franziska and Santos, Alexandra F and Skypala, Isabel and Smith, Peter K and Sokolowska, Milena and Torres, Maria J and Vassilopoulou, Emilia and Walter, Jens and O'Mahony, Liam},
  journal = {Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology},
  keywords = {evisap},
  month = {aug},
  number = 8,
  pages = {e70145--e70145},
  title = {Protocol: Scoping review of the association between complementary feeding, growth, and immune health in infants and toddlers-An EAACI guideline paper},
  volume = 36,
  year = 2025
  }
  

  %0 Journal Article
  %1 venter2025protocol
  %A Venter, Carina
  %A Alonso-Coello, Pablo
  %A Beltran, Jessica
  %A Bracchiglione, Javier
  %A Fernandez-Saenz, Karina
  %A Riera, Pau
  %A Solà, Ivan
  %A Arasi, Stefania
  %A Berni Canani, Roberto
  %A Fleischer, David
  %A Eguíluz-Gracia, Ibon
  %A Meyer, Rosan
  %A Roberts, Graham
  %A Roth-Walter, Franziska
  %A Santos, Alexandra F
  %A Skypala, Isabel
  %A Smith, Peter K
  %A Sokolowska, Milena
  %A Torres, Maria J
  %A Vassilopoulou, Emilia
  %A Walter, Jens
  %A O'Mahony, Liam
  %C England
  %D 2025
  %J Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology
  %N 8
  %P e70145--e70145
  %R 10.1111/pai.70145
  %T Protocol: Scoping review of the association between complementary feeding, growth, and immune health in infants and toddlers-An EAACI guideline paper
  %U https://pubmed.ncbi.nlm.nih.gov/40747578
  %V 36
  %X The European Academy of Allergy and Clinical Immunology (EAACI) is currently developing guidelines on immunomodulation and nutrition. To inform these recommendations, a scoping review will be conducted to synthesize and map the available empirical evidence on how complementary feeding affects immune health in infants and toddlers to explore the association between complementary feeding during the first year of life and immune health outcomes in children up to 3 years of age. The scoping review will be conducted using the Preferred Reporting Items for Systematic Reviews and Meta-analysis Scoping Review Extension for scoping reviews (PRISMA-ScR) guidelines. We have developed inclusion criteria using the PCC (Population, Concept and Context) format: the population will include healthy infants; the concept refers to specific factors related to introduction of complementary feeding; and the context will focus on studies conducted in settings representative of everyday nutrition and feeding practices for infants and toddlers. Evidence sources include systematic reviews. We will search in MEDLINE and Epistemonikos. Data will be extracted using a standardized form developed in REDCap, and the findings will be synthesized narratively. Only published literature will be included in this systematic review. Therefore, no ethical approval is required. The final review paper will be published in a peer-reviewed journal. OSF registration DOI: 10.17605/OSF.IO/T5F8.
  

• 
  Use of artificial intelligence to support the assessment of the methodological quality of systematic reviews. Marques-Cruz, Manuel; Pinto, Filipe; Vieira, Rafael José; Bognanni, Antonio; Perestrelo, Paula; Gil-Mata, Sara; Duarte, Vítor Henrique; Barbosa, José Pedro; Cardoso-Fernandes, António; Martinho-Dias, Daniel; Franco-Pego, Francisco; Germini, Federico; Arienti, Chiara; Chu, Alexandro W L; Riera-Serra, Pau; Jemioło, Paweł; Rodrigues, Pedro Pereira; Fonseca, João A; Azevedo, Luís Filipe; Schünemann, Holger J; Cruz-Correia, Ricardo; Jankin, Slava; Sousa-Pinto, Bernardo (2025). 111944–111944.

  AbstractURLBibTeXEndNoteDOIBibSonomy

  INTRODUCTION: Published systematic reviews display an heterogeneous methodological quality, which can impact decision-making. Large language models (LLMs) can support and make the assessment of the methodological quality of systematic reviews more efficient, aiding in the incorporation of their evidence in guideline recommendations. We aimed to develop a LLM-based tool for supporting the assessment of the methodological quality of systematic reviews. METHODS: We assessed the performance of eight large language models (LLMs) in evaluating the methodological quality of systematic reviews. In particular, we provided 100 systematic reviews for eight LLMs (five base models and three fine-tuned models) to evaluate their methodological quality based on a 27-item validated tool (ReMarQ). The fine-tuned models had been trained with a different sample of 300 manually assessed systematic reviews. We compared the answers provided by LLMs with those independently provided by human reviewers, computing the accuracy, kappa coefficient and F1-score for this comparison. RESULTS: The best performing LLM was a fine-tuned GPT-3.5 model (mean accuracy=96.5% [95%CI=89.9-100%]; mean kappa coefficient=0.90 [95%CI=0.71-1.00]; mean F1-score=0.91 [95%CI=0.83-1.00]). This model displayed an accuracy >80% and a kappa coefficient >0.60 for all individual items. When we made this LLM assess 60 times the same set of systematic reviews, answers to 18 of 27 items were always consistent (i.e., were always the same) and only 11% of assessed systematic reviews showed inconsistency. CONCLUSION: Overall, LLMs have the potential to accurately support the assessment of the methodological quality of systematic reviews based on a validated tool comprising dichotomous items.

  @article{marquescruz2025artificial,
  abstract = {INTRODUCTION: Published systematic reviews display an heterogeneous methodological quality, which can impact decision-making. Large language models (LLMs) can support and make the assessment of the methodological quality of systematic reviews more efficient, aiding in the incorporation of their evidence in guideline recommendations. We aimed to develop a LLM-based tool for supporting the assessment of the methodological quality of systematic reviews. METHODS: We assessed the performance of eight large language models (LLMs) in evaluating the methodological quality of systematic reviews. In particular, we provided 100 systematic reviews for eight LLMs (five base models and three fine-tuned models) to evaluate their methodological quality based on a 27-item validated tool (ReMarQ). The fine-tuned models had been trained with a different sample of 300 manually assessed systematic reviews. We compared the answers provided by LLMs with those independently provided by human reviewers, computing the accuracy, kappa coefficient and F1-score for this comparison. RESULTS: The best performing LLM was a fine-tuned GPT-3.5 model (mean accuracy=96.5% [95%CI=89.9-100%]; mean kappa coefficient=0.90 [95%CI=0.71-1.00]; mean F1-score=0.91 [95%CI=0.83-1.00]). This model displayed an accuracy >80% and a kappa coefficient >0.60 for all individual items. When we made this LLM assess 60 times the same set of systematic reviews, answers to 18 of 27 items were always consistent (i.e., were always the same) and only 11% of assessed systematic reviews showed inconsistency. CONCLUSION: Overall, LLMs have the potential to accurately support the assessment of the methodological quality of systematic reviews based on a validated tool comprising dichotomous items.},
  address = {United States},
  author = {Marques-Cruz, Manuel and Pinto, Filipe and Vieira, Rafael José and Bognanni, Antonio and Perestrelo, Paula and Gil-Mata, Sara and Duarte, Vítor Henrique and Barbosa, José Pedro and Cardoso-Fernandes, António and Martinho-Dias, Daniel and Franco-Pego, Francisco and Germini, Federico and Arienti, Chiara and Chu, Alexandro W L and Riera-Serra, Pau and Jemioło, Paweł and Rodrigues, Pedro Pereira and Fonseca, João A and Azevedo, Luís Filipe and Schünemann, Holger J and Cruz-Correia, Ricardo and Jankin, Slava and Sousa-Pinto, Bernardo},
  journal = {Journal of clinical epidemiology},
  keywords = {evisap},
  month = {aug},
  pages = {111944--111944},
  title = {Use of artificial intelligence to support the assessment of the methodological quality of systematic reviews},
  year = 2025
  }
  

  %0 Journal Article
  %1 marquescruz2025artificial
  %A Marques-Cruz, Manuel
  %A Pinto, Filipe
  %A Vieira, Rafael José
  %A Bognanni, Antonio
  %A Perestrelo, Paula
  %A Gil-Mata, Sara
  %A Duarte, Vítor Henrique
  %A Barbosa, José Pedro
  %A Cardoso-Fernandes, António
  %A Martinho-Dias, Daniel
  %A Franco-Pego, Francisco
  %A Germini, Federico
  %A Arienti, Chiara
  %A Chu, Alexandro W L
  %A Riera-Serra, Pau
  %A Jemioło, Paweł
  %A Rodrigues, Pedro Pereira
  %A Fonseca, João A
  %A Azevedo, Luís Filipe
  %A Schünemann, Holger J
  %A Cruz-Correia, Ricardo
  %A Jankin, Slava
  %A Sousa-Pinto, Bernardo
  %C United States
  %D 2025
  %J Journal of clinical epidemiology
  %P 111944--111944
  %R 10.1016/j.jclinepi.2025.111944
  %T Use of artificial intelligence to support the assessment of the methodological quality of systematic reviews
  %U https://pubmed.ncbi.nlm.nih.gov/40865587
  %X INTRODUCTION: Published systematic reviews display an heterogeneous methodological quality, which can impact decision-making. Large language models (LLMs) can support and make the assessment of the methodological quality of systematic reviews more efficient, aiding in the incorporation of their evidence in guideline recommendations. We aimed to develop a LLM-based tool for supporting the assessment of the methodological quality of systematic reviews. METHODS: We assessed the performance of eight large language models (LLMs) in evaluating the methodological quality of systematic reviews. In particular, we provided 100 systematic reviews for eight LLMs (five base models and three fine-tuned models) to evaluate their methodological quality based on a 27-item validated tool (ReMarQ). The fine-tuned models had been trained with a different sample of 300 manually assessed systematic reviews. We compared the answers provided by LLMs with those independently provided by human reviewers, computing the accuracy, kappa coefficient and F1-score for this comparison. RESULTS: The best performing LLM was a fine-tuned GPT-3.5 model (mean accuracy=96.5% [95%CI=89.9-100%]; mean kappa coefficient=0.90 [95%CI=0.71-1.00]; mean F1-score=0.91 [95%CI=0.83-1.00]). This model displayed an accuracy >80% and a kappa coefficient >0.60 for all individual items. When we made this LLM assess 60 times the same set of systematic reviews, answers to 18 of 27 items were always consistent (i.e., were always the same) and only 11% of assessed systematic reviews showed inconsistency. CONCLUSION: Overall, LLMs have the potential to accurately support the assessment of the methodological quality of systematic reviews based on a validated tool comprising dichotomous items.
  

2024

• 
  Evaluation of the psychometric performance of the Spanish and Catalan versions of the patient reported experiences and Outcomes of Safety in Primary Care (PREOS-PC)-Compact questionnaire. Fiol deRoque, Maria A; Valderas, José M; Arias de la Torre, Jorge; Serrano-Ripoll, Maria J; Gens-Barberà, Montserrat; Sánchez-Freire, Encarna; Martín-Luján, Francisco M; Olry de Labry, Antonio; Ricci-Cabello, Ignacio (2024). 30(1) 2296573–2296573.

  AbstractURLBibTeXEndNoteDOIBibSonomyDownload

  BACKGROUND: Patients provide a unique, irreplaceable, and essential perspective in evaluating patient safety. The suite of Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC) tools are a notable exception to the scarcity of patient-reported patient safety measures. Full evaluation of their performance has only been attempted for the English version, thereby limiting its international applicability. OBJECTIVES: To assess the psychometric performance of the Spanish and Catalan versions of the PREOS-PC-Compact. METHODS: Cross-sectional validation study. We used Classical Test Theory methods to examine scale score distribution, internal consistency, and construct validity; and Item Response Theory (IRT) methods to further explore construct validity. RESULTS: 3287 patients completed the Spanish version, and 1007 the Catalan version. Similar results were obtained for both versions. Confirmatory Factor Analysis supported a single construct for each scale. The correlations between PREOS-PC-Compact scales and known group analysis suggested adequate construct validity (inconclusive for known groups at the provider level). All four multi-item scales demonstrated adequate internal consistency reliability (α > 0.7), which was only confirmed for test-retest reliability for 'Practice activation.' A sample between 60-90 patients per practice was estimated sufficient to produce scores with reliability > 0.7 for all scales except for harm scales. IRT models showed disordered thresholds for 'Practice activation' and 'Harm burden' but showed excellent fit after reducing the response categories. CONCLUSION: The Spanish and Catalan versions of the PREOS-PC-Compact are broadly valid and reliable tools to measure patient safety in Spanish primary care centres; confirmation of lower-than-expected test-rest reliability merits further examination .

  @article{fiolderoque2024evaluation,
  abstract = {BACKGROUND: Patients provide a unique, irreplaceable, and essential perspective in evaluating patient safety. The suite of Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC) tools are a notable exception to the scarcity of patient-reported patient safety measures. Full evaluation of their performance has only been attempted for the English version, thereby limiting its international applicability. OBJECTIVES: To assess the psychometric performance of the Spanish and Catalan versions of the PREOS-PC-Compact. METHODS: Cross-sectional validation study. We used Classical Test Theory methods to examine scale score distribution, internal consistency, and construct validity; and Item Response Theory (IRT) methods to further explore construct validity. RESULTS: 3287 patients completed the Spanish version, and 1007 the Catalan version. Similar results were obtained for both versions. Confirmatory Factor Analysis supported a single construct for each scale. The correlations between PREOS-PC-Compact scales and known group analysis suggested adequate construct validity (inconclusive for known groups at the provider level). All four multi-item scales demonstrated adequate internal consistency reliability (α > 0.7), which was only confirmed for test-retest reliability for 'Practice activation.' A sample between 60-90 patients per practice was estimated sufficient to produce scores with reliability > 0.7 for all scales except for harm scales. IRT models showed disordered thresholds for 'Practice activation' and 'Harm burden' but showed excellent fit after reducing the response categories. CONCLUSION: The Spanish and Catalan versions of the PREOS-PC-Compact are broadly valid and reliable tools to measure patient safety in Spanish primary care centres; confirmation of lower-than-expected test-rest reliability merits further examination .},
  address = {England},
  author = {Fiol deRoque, Maria A and Valderas, José M and Arias de la Torre, Jorge and Serrano-Ripoll, Maria J and Gens-Barberà, Montserrat and Sánchez-Freire, Encarna and Martín-Luján, Francisco M and Olry de Labry, Antonio and Ricci-Cabello, Ignacio},
  journal = {The European journal of general practice},
  keywords = {evisap grapp-caib},
  month = {dec},
  number = 1,
  pages = {2296573--2296573},
  title = {Evaluation of the psychometric performance of the Spanish and Catalan versions of the patient reported experiences and Outcomes of Safety in Primary Care (PREOS-PC)-Compact questionnaire},
  volume = 30,
  year = 2024
  }
  

  %0 Journal Article
  %1 fiolderoque2024evaluation
  %A Fiol deRoque, Maria A
  %A Valderas, José M
  %A Arias de la Torre, Jorge
  %A Serrano-Ripoll, Maria J
  %A Gens-Barberà, Montserrat
  %A Sánchez-Freire, Encarna
  %A Martín-Luján, Francisco M
  %A Olry de Labry, Antonio
  %A Ricci-Cabello, Ignacio
  %C England
  %D 2024
  %J The European journal of general practice
  %N 1
  %P 2296573--2296573
  %R 10.1080/13814788.2023.2296573
  %T Evaluation of the psychometric performance of the Spanish and Catalan versions of the patient reported experiences and Outcomes of Safety in Primary Care (PREOS-PC)-Compact questionnaire
  %U https://pubmed.ncbi.nlm.nih.gov/38197321
  %V 30
  %X BACKGROUND: Patients provide a unique, irreplaceable, and essential perspective in evaluating patient safety. The suite of Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC) tools are a notable exception to the scarcity of patient-reported patient safety measures. Full evaluation of their performance has only been attempted for the English version, thereby limiting its international applicability. OBJECTIVES: To assess the psychometric performance of the Spanish and Catalan versions of the PREOS-PC-Compact. METHODS: Cross-sectional validation study. We used Classical Test Theory methods to examine scale score distribution, internal consistency, and construct validity; and Item Response Theory (IRT) methods to further explore construct validity. RESULTS: 3287 patients completed the Spanish version, and 1007 the Catalan version. Similar results were obtained for both versions. Confirmatory Factor Analysis supported a single construct for each scale. The correlations between PREOS-PC-Compact scales and known group analysis suggested adequate construct validity (inconclusive for known groups at the provider level). All four multi-item scales demonstrated adequate internal consistency reliability (α > 0.7), which was only confirmed for test-retest reliability for 'Practice activation.' A sample between 60-90 patients per practice was estimated sufficient to produce scores with reliability > 0.7 for all scales except for harm scales. IRT models showed disordered thresholds for 'Practice activation' and 'Harm burden' but showed excellent fit after reducing the response categories. CONCLUSION: The Spanish and Catalan versions of the PREOS-PC-Compact are broadly valid and reliable tools to measure patient safety in Spanish primary care centres; confirmation of lower-than-expected test-rest reliability merits further examination .
  

• 
  Process evaluation of PsyCovidApp, a digital tool for mobile devices aimed at protecting the mental health of healthcare professionals during the COVID-19 pandemic: a mixed method study. Fiol deRoque, Maria A; Serrano-Ripoll, Maria J; Mira-Martínez, Sofia; Pastor-Moreno, Guadalupe; Sitges, Carolina; García-Buades, M Esther; Gervilla, Elena; Garcia-Toro, Mauro; Zamanillo-Campos, Rocío; Ricci-Cabello, Ignacio (2024). 15 1378372–1378372.

  AbstractURLBibTeXEndNoteDOIBibSonomy

  INTRODUCTION: PsyCovidApp, a digital intervention aimed at safeguarding the mental health of healthcare workers during the COVID-19 pandemic, demonstrated in a randomized clinical trial to yield significant improvements solely among healthcare workers undergoing psychotherapy or receiving psychotropic medication. OBJECTIVES: (1) To identify contextual factors and mechanisms of action that influenced the impact of PsyCovidApp during the aforementioned trial; (2) To pinpoint enhancements for optimizing its efficacy. MATERIALS AND METHODS: For the first objective, a process evaluation was conducted, amalgamating quantitative techniques (surveying 216 healthcare professionals who had utilized PsyCovidApp during the trial) and qualitative methods (in-depth interviews with 16 healthcare workers). The second objective involved a panel of seven experts, utilizing the RAND-UCLA methodology. RESULTS: The quantitative study (response rate = 40%) revealed that 22% of respondents had not fully accessed the content of PsyCovidApp. The average usage time was 22.7 min/day, being higher (p < 0.05) among consumers of psychotropic medications. Contents related to relaxation and mindfulness were most highly rated. Acceptability and usefulness scores ranged between 7.3-7.5/10 points, with higher ratings (p < 0.05) among women and older healthcare workers. The qualitative study uncovered that the primary barriers to using PsyCovidApp were workload, lack of time, and exhaustion. Its primary mechanisms of action included emotion identification, mental health regulation (e.g., insomnia, intense emotions), and learning of techniques and skills. The expert panel reached a consensus on 29 proposals to optimize PsyCovidApp. CONCLUSION: The knowledge derived from this study could inform the design and implementation of future similar digital tools.

  @article{fiolderoque2024process,
  abstract = {INTRODUCTION: PsyCovidApp, a digital intervention aimed at safeguarding the mental health of healthcare workers during the COVID-19 pandemic, demonstrated in a randomized clinical trial to yield significant improvements solely among healthcare workers undergoing psychotherapy or receiving psychotropic medication. OBJECTIVES: (1) To identify contextual factors and mechanisms of action that influenced the impact of PsyCovidApp during the aforementioned trial; (2) To pinpoint enhancements for optimizing its efficacy. MATERIALS AND METHODS: For the first objective, a process evaluation was conducted, amalgamating quantitative techniques (surveying 216 healthcare professionals who had utilized PsyCovidApp during the trial) and qualitative methods (in-depth interviews with 16 healthcare workers). The second objective involved a panel of seven experts, utilizing the RAND-UCLA methodology. RESULTS: The quantitative study (response rate = 40%) revealed that 22% of respondents had not fully accessed the content of PsyCovidApp. The average usage time was 22.7 min/day, being higher (p < 0.05) among consumers of psychotropic medications. Contents related to relaxation and mindfulness were most highly rated. Acceptability and usefulness scores ranged between 7.3-7.5/10 points, with higher ratings (p < 0.05) among women and older healthcare workers. The qualitative study uncovered that the primary barriers to using PsyCovidApp were workload, lack of time, and exhaustion. Its primary mechanisms of action included emotion identification, mental health regulation (e.g., insomnia, intense emotions), and learning of techniques and skills. The expert panel reached a consensus on 29 proposals to optimize PsyCovidApp. CONCLUSION: The knowledge derived from this study could inform the design and implementation of future similar digital tools.},
  address = {Switzerland},
  author = {Fiol deRoque, Maria A and Serrano-Ripoll, Maria J and Mira-Martínez, Sofia and Pastor-Moreno, Guadalupe and Sitges, Carolina and García-Buades, M Esther and Gervilla, Elena and Garcia-Toro, Mauro and Zamanillo-Campos, Rocío and Ricci-Cabello, Ignacio},
  journal = {Frontiers in psychology},
  keywords = {evisap grapp-caib},
  month = {mar},
  pages = {1378372--1378372},
  title = {Process evaluation of PsyCovidApp, a digital tool for mobile devices aimed at protecting the mental health of healthcare professionals during the COVID-19 pandemic: a mixed method study},
  volume = 15,
  year = 2024
  }
  

  %0 Journal Article
  %1 fiolderoque2024process
  %A Fiol deRoque, Maria A
  %A Serrano-Ripoll, Maria J
  %A Mira-Martínez, Sofia
  %A Pastor-Moreno, Guadalupe
  %A Sitges, Carolina
  %A García-Buades, M Esther
  %A Gervilla, Elena
  %A Garcia-Toro, Mauro
  %A Zamanillo-Campos, Rocío
  %A Ricci-Cabello, Ignacio
  %C Switzerland
  %D 2024
  %J Frontiers in psychology
  %P 1378372--1378372
  %R 10.3389/fpsyg.2024.1378372
  %T Process evaluation of PsyCovidApp, a digital tool for mobile devices aimed at protecting the mental health of healthcare professionals during the COVID-19 pandemic: a mixed method study
  %U https://pubmed.ncbi.nlm.nih.gov/38577118
  %V 15
  %X INTRODUCTION: PsyCovidApp, a digital intervention aimed at safeguarding the mental health of healthcare workers during the COVID-19 pandemic, demonstrated in a randomized clinical trial to yield significant improvements solely among healthcare workers undergoing psychotherapy or receiving psychotropic medication. OBJECTIVES: (1) To identify contextual factors and mechanisms of action that influenced the impact of PsyCovidApp during the aforementioned trial; (2) To pinpoint enhancements for optimizing its efficacy. MATERIALS AND METHODS: For the first objective, a process evaluation was conducted, amalgamating quantitative techniques (surveying 216 healthcare professionals who had utilized PsyCovidApp during the trial) and qualitative methods (in-depth interviews with 16 healthcare workers). The second objective involved a panel of seven experts, utilizing the RAND-UCLA methodology. RESULTS: The quantitative study (response rate = 40%) revealed that 22% of respondents had not fully accessed the content of PsyCovidApp. The average usage time was 22.7 min/day, being higher (p < 0.05) among consumers of psychotropic medications. Contents related to relaxation and mindfulness were most highly rated. Acceptability and usefulness scores ranged between 7.3-7.5/10 points, with higher ratings (p < 0.05) among women and older healthcare workers. The qualitative study uncovered that the primary barriers to using PsyCovidApp were workload, lack of time, and exhaustion. Its primary mechanisms of action included emotion identification, mental health regulation (e.g., insomnia, intense emotions), and learning of techniques and skills. The expert panel reached a consensus on 29 proposals to optimize PsyCovidApp. CONCLUSION: The knowledge derived from this study could inform the design and implementation of future similar digital tools.
  

• 
  The impact of exposure to tobacco smoke and e-cigarettes on asthma-related outcomes: Systematic review informing the EAACI guidelines on environmental science for allergic diseases and asthma. Agache, Ioana; Ricci-Cabello, Ignacio; Canelo-Aybar, Carlos; Annesi-Maesano, Isabella; Cecchi, Lorenzo; Biagioni, Benedetta; Chung, Kian Fan; D’Amato, Gennaro; Damialis, Athanasios; Del Giacco, Stefano; De Las Vecillas, Leticia; Dominguez-Ortega, Javier; Galán, Carmen; Gilles, Stefanie; Giovannini, Matteo; Holgate, Stephen; Jeebhay, Mohamed; Nadeau, Kari; Papadopoulos, Nikolaos; Quirce, Santiago; Sastre, Joaquin; Traidl-Hoffmann, Claudia; Walusiak-Skorupa, Jolanta; Salazar, Josefina; Sousa-Pinto, Bernardo; Colom, Miquel; Fiol deRoque, Maria A; Gorreto López, Lucía; Malih, Narges; Moro, Laura; Pardo, Marina García; Pazo, Patricia García; Campos, Rocío Zamanillo; Saletti-Cuesta, L; Akdis, Mubeccel; Alonso-Coello, Pablo; Jutel, Marek; Akdis, Cezmi A (2024). 10.1111/all.16151-.

  AbstractURLBibTeXEndNoteDOIBibSonomy

  To inform the clinical practice guidelines' recommendations developed by the European Academy of Allergy and Clinical Immunology systematic reviews (SR) assessed using GRADE on the impact of environmental tobacco smoke (ETS) and active smoking on the risk of new-onset asthma/recurrent wheezing (RW)/low lung function (LF), and on asthma-related outcomes. Only longitudinal studies were included, almost all on combustion cigarettes, only one assessing e-cigarettes and LF. According to the first SR (67 studies), prenatal ETS increases the risk of RW (moderate certainty evidence) and may increase the risk of new-onset asthma and of low LF (low certainty evidence). Postnatal ETS increases the risk of new-onset asthma and of RW (moderate certainty evidence) and may impact LF (low certainty evidence). Combined in utero and postnatal ETS may increase the risk of new-onset asthma (low certainty evidence) and increases the risk of RW (moderate certainty evidence). According to the second SR (24 studies), ETS increases the risk of severe asthma exacerbations and impairs asthma control and LF (moderate certainty evidence). According to the third SR (25 studies), active smoking increases the risk of severe asthma exacerbations and of suboptimal asthma control (moderate certainty evidence) and may impact asthma-related quality-of-life and LF (low certainty evidence).

  @article{agache2024impact,
  abstract = {To inform the clinical practice guidelines' recommendations developed by the European Academy of Allergy and Clinical Immunology systematic reviews (SR) assessed using GRADE on the impact of environmental tobacco smoke (ETS) and active smoking on the risk of new-onset asthma/recurrent wheezing (RW)/low lung function (LF), and on asthma-related outcomes. Only longitudinal studies were included, almost all on combustion cigarettes, only one assessing e-cigarettes and LF. According to the first SR (67 studies), prenatal ETS increases the risk of RW (moderate certainty evidence) and may increase the risk of new-onset asthma and of low LF (low certainty evidence). Postnatal ETS increases the risk of new-onset asthma and of RW (moderate certainty evidence) and may impact LF (low certainty evidence). Combined in utero and postnatal ETS may increase the risk of new-onset asthma (low certainty evidence) and increases the risk of RW (moderate certainty evidence). According to the second SR (24 studies), ETS increases the risk of severe asthma exacerbations and impairs asthma control and LF (moderate certainty evidence). According to the third SR (25 studies), active smoking increases the risk of severe asthma exacerbations and of suboptimal asthma control (moderate certainty evidence) and may impact asthma-related quality-of-life and LF (low certainty evidence).},
  address = {Denmark},
  author = {Agache, Ioana and Ricci-Cabello, Ignacio and Canelo-Aybar, Carlos and Annesi-Maesano, Isabella and Cecchi, Lorenzo and Biagioni, Benedetta and Chung, Kian Fan and D'Amato, Gennaro and Damialis, Athanasios and Del Giacco, Stefano and De Las Vecillas, Leticia and Dominguez-Ortega, Javier and Galán, Carmen and Gilles, Stefanie and Giovannini, Matteo and Holgate, Stephen and Jeebhay, Mohamed and Nadeau, Kari and Papadopoulos, Nikolaos and Quirce, Santiago and Sastre, Joaquin and Traidl-Hoffmann, Claudia and Walusiak-Skorupa, Jolanta and Salazar, Josefina and Sousa-Pinto, Bernardo and Colom, Miquel and Fiol deRoque, Maria A and Gorreto López, Lucía and Malih, Narges and Moro, Laura and Pardo, Marina García and Pazo, Patricia García and Campos, Rocío Zamanillo and Saletti-Cuesta, L and Akdis, Mubeccel and Alonso-Coello, Pablo and Jutel, Marek and Akdis, Cezmi A},
  journal = {Allergy},
  keywords = {evisap grapp-caib},
  month = {may},
  pages = {10.1111/all.16151--},
  title = {The impact of exposure to tobacco smoke and e-cigarettes on asthma-related outcomes: Systematic review informing the EAACI guidelines on environmental science for allergic diseases and asthma},
  year = 2024
  }
  

  %0 Journal Article
  %1 agache2024impact
  %A Agache, Ioana
  %A Ricci-Cabello, Ignacio
  %A Canelo-Aybar, Carlos
  %A Annesi-Maesano, Isabella
  %A Cecchi, Lorenzo
  %A Biagioni, Benedetta
  %A Chung, Kian Fan
  %A D'Amato, Gennaro
  %A Damialis, Athanasios
  %A Del Giacco, Stefano
  %A De Las Vecillas, Leticia
  %A Dominguez-Ortega, Javier
  %A Galán, Carmen
  %A Gilles, Stefanie
  %A Giovannini, Matteo
  %A Holgate, Stephen
  %A Jeebhay, Mohamed
  %A Nadeau, Kari
  %A Papadopoulos, Nikolaos
  %A Quirce, Santiago
  %A Sastre, Joaquin
  %A Traidl-Hoffmann, Claudia
  %A Walusiak-Skorupa, Jolanta
  %A Salazar, Josefina
  %A Sousa-Pinto, Bernardo
  %A Colom, Miquel
  %A Fiol deRoque, Maria A
  %A Gorreto López, Lucía
  %A Malih, Narges
  %A Moro, Laura
  %A Pardo, Marina García
  %A Pazo, Patricia García
  %A Campos, Rocío Zamanillo
  %A Saletti-Cuesta, L
  %A Akdis, Mubeccel
  %A Alonso-Coello, Pablo
  %A Jutel, Marek
  %A Akdis, Cezmi A
  %C Denmark
  %D 2024
  %J Allergy
  %P 10.1111/all.16151--
  %R 10.1111/all.16151
  %T The impact of exposure to tobacco smoke and e-cigarettes on asthma-related outcomes: Systematic review informing the EAACI guidelines on environmental science for allergic diseases and asthma
  %U https://pubmed.ncbi.nlm.nih.gov/38783343
  %X To inform the clinical practice guidelines' recommendations developed by the European Academy of Allergy and Clinical Immunology systematic reviews (SR) assessed using GRADE on the impact of environmental tobacco smoke (ETS) and active smoking on the risk of new-onset asthma/recurrent wheezing (RW)/low lung function (LF), and on asthma-related outcomes. Only longitudinal studies were included, almost all on combustion cigarettes, only one assessing e-cigarettes and LF. According to the first SR (67 studies), prenatal ETS increases the risk of RW (moderate certainty evidence) and may increase the risk of new-onset asthma and of low LF (low certainty evidence). Postnatal ETS increases the risk of new-onset asthma and of RW (moderate certainty evidence) and may impact LF (low certainty evidence). Combined in utero and postnatal ETS may increase the risk of new-onset asthma (low certainty evidence) and increases the risk of RW (moderate certainty evidence). According to the second SR (24 studies), ETS increases the risk of severe asthma exacerbations and impairs asthma control and LF (moderate certainty evidence). According to the third SR (25 studies), active smoking increases the risk of severe asthma exacerbations and of suboptimal asthma control (moderate certainty evidence) and may impact asthma-related quality-of-life and LF (low certainty evidence).
  

• 
  Impact of an SMS intervention to support type 2 diabetes self-management: DiabeText clinical trial. Zamanillo-Campos, Rocío; Fiol-DeRoque, Maria Antonia; Serrano-Ripoll, Maria Jesús; Llobera, Joan; Taltavull-Aparicio, Joana María; Leiva, Alfonso; Ripoll-Amengual, Joana; Angullo-Martínez, Escarlata; Socias, Isabel; Masmiquel, Luis; Konieczna, Jadwiga; Zaforteza-Dezcallar, María; Boronat-Moreiro, Maria Asunción; Mira-Martínez, Sofía; Gervilla-García, Elena; Ricci-Cabello, Ignacio (2024). BJGP.2024.0206-.

  AbstractURLBibTeXEndNoteDOIBibSonomy

  BACKGROUND: Complications arising from uncontrolled Type 2 Diabetes Mellitus (T2DM) pose a significant burden on individuals' well-being and healthcare resources. Digital interventions may play a key role in mitigating such complications by supporting patients to adequately self-manage their condition. AIM: To assess the impact of DiabeText, a new theory-based, patient-centered, mobile health intervention integrated with electronic health records to send tailored short text messages to support T2DM self-management. DESIGN AND SETTING: Pragmatic, Phase III, 12-month, two-arm randomized clinical trial with T2DM primary care patients in Spain. METHOD: 742 participants with suboptimal glycemic control (HbA1c>7.5) were randomly allocated to a control (usual care) or intervention (DiabeText) group. The DiabeText group received, in addition to usual care, 165 messages focused on healthy lifestyle and medication adherence. PRIMARY OUTCOME: glycated hemoglobin (HbA1c). SECONDARY OUTCOMES: medication possession ratio, quality of life (EQ-5D-5L), diabetes self-efficacy (DSES); and self-reported adherence to medication, Mediterranean diet (MEDAS-14), and physical activity (IPAQ). RESULTS: Over the 12-month period, we observed no significant differences in HbA1c between the intervention and the control groups (Beta=-0.025 (-0.198 to 0.147; p=0.772)). In comparison with the control group, the DiabeText group showed significant (p<0.05) improvements in self-reported medication adherence (OR=1.4; 95%CI: 1.0 to 1.9), DSES (Cohen's d=0.35), and EQ5D-5L (Cohen's d=0.18) scores; but not in the rest of secondary outcomes. CONCLUSION: DiabeText successfully improved quality of life, diabetes self-management, and self-reported medication adherence in primary care patients with T2DM. Further research is needed to enhance its effects on physiological outcomes.

  @article{zamanillocampos2024impact,
  abstract = {BACKGROUND: Complications arising from uncontrolled Type 2 Diabetes Mellitus (T2DM) pose a significant burden on individuals' well-being and healthcare resources. Digital interventions may play a key role in mitigating such complications by supporting patients to adequately self-manage their condition. AIM: To assess the impact of DiabeText, a new theory-based, patient-centered, mobile health intervention integrated with electronic health records to send tailored short text messages to support T2DM self-management. DESIGN AND SETTING: Pragmatic, Phase III, 12-month, two-arm randomized clinical trial with T2DM primary care patients in Spain. METHOD: 742 participants with suboptimal glycemic control (HbA1c>7.5) were randomly allocated to a control (usual care) or intervention (DiabeText) group. The DiabeText group received, in addition to usual care, 165 messages focused on healthy lifestyle and medication adherence. PRIMARY OUTCOME: glycated hemoglobin (HbA1c). SECONDARY OUTCOMES: medication possession ratio, quality of life (EQ-5D-5L), diabetes self-efficacy (DSES); and self-reported adherence to medication, Mediterranean diet (MEDAS-14), and physical activity (IPAQ). RESULTS: Over the 12-month period, we observed no significant differences in HbA1c between the intervention and the control groups (Beta=-0.025 (-0.198 to 0.147; p=0.772)). In comparison with the control group, the DiabeText group showed significant (p<0.05) improvements in self-reported medication adherence (OR=1.4; 95%CI: 1.0 to 1.9), DSES (Cohen's d=0.35), and EQ5D-5L (Cohen's d=0.18) scores; but not in the rest of secondary outcomes. CONCLUSION: DiabeText successfully improved quality of life, diabetes self-management, and self-reported medication adherence in primary care patients with T2DM. Further research is needed to enhance its effects on physiological outcomes.},
  address = {England},
  author = {Zamanillo-Campos, Rocío and Fiol-DeRoque, Maria Antonia and Serrano-Ripoll, Maria Jesús and Llobera, Joan and Taltavull-Aparicio, Joana María and Leiva, Alfonso and Ripoll-Amengual, Joana and Angullo-Martínez, Escarlata and Socias, Isabel and Masmiquel, Luis and Konieczna, Jadwiga and Zaforteza-Dezcallar, María and Boronat-Moreiro, Maria Asunción and Mira-Martínez, Sofía and Gervilla-García, Elena and Ricci-Cabello, Ignacio},
  journal = {The British journal of general practice : the journal of the Royal College of General Practitioners},
  keywords = {evisap grapp-caib},
  month = {oct},
  pages = {BJGP.2024.0206--},
  title = {Impact of an SMS intervention to support type 2 diabetes self-management: DiabeText clinical trial},
  year = 2024
  }
  

  %0 Journal Article
  %1 zamanillocampos2024impact
  %A Zamanillo-Campos, Rocío
  %A Fiol-DeRoque, Maria Antonia
  %A Serrano-Ripoll, Maria Jesús
  %A Llobera, Joan
  %A Taltavull-Aparicio, Joana María
  %A Leiva, Alfonso
  %A Ripoll-Amengual, Joana
  %A Angullo-Martínez, Escarlata
  %A Socias, Isabel
  %A Masmiquel, Luis
  %A Konieczna, Jadwiga
  %A Zaforteza-Dezcallar, María
  %A Boronat-Moreiro, Maria Asunción
  %A Mira-Martínez, Sofía
  %A Gervilla-García, Elena
  %A Ricci-Cabello, Ignacio
  %C England
  %D 2024
  %J The British journal of general practice : the journal of the Royal College of General Practitioners
  %P BJGP.2024.0206--
  %R 10.3399/BJGP.2024.0206
  %T Impact of an SMS intervention to support type 2 diabetes self-management: DiabeText clinical trial
  %U https://pubmed.ncbi.nlm.nih.gov/39362693
  %X BACKGROUND: Complications arising from uncontrolled Type 2 Diabetes Mellitus (T2DM) pose a significant burden on individuals' well-being and healthcare resources. Digital interventions may play a key role in mitigating such complications by supporting patients to adequately self-manage their condition. AIM: To assess the impact of DiabeText, a new theory-based, patient-centered, mobile health intervention integrated with electronic health records to send tailored short text messages to support T2DM self-management. DESIGN AND SETTING: Pragmatic, Phase III, 12-month, two-arm randomized clinical trial with T2DM primary care patients in Spain. METHOD: 742 participants with suboptimal glycemic control (HbA1c>7.5) were randomly allocated to a control (usual care) or intervention (DiabeText) group. The DiabeText group received, in addition to usual care, 165 messages focused on healthy lifestyle and medication adherence. PRIMARY OUTCOME: glycated hemoglobin (HbA1c). SECONDARY OUTCOMES: medication possession ratio, quality of life (EQ-5D-5L), diabetes self-efficacy (DSES); and self-reported adherence to medication, Mediterranean diet (MEDAS-14), and physical activity (IPAQ). RESULTS: Over the 12-month period, we observed no significant differences in HbA1c between the intervention and the control groups (Beta=-0.025 (-0.198 to 0.147; p=0.772)). In comparison with the control group, the DiabeText group showed significant (p<0.05) improvements in self-reported medication adherence (OR=1.4; 95%CI: 1.0 to 1.9), DSES (Cohen's d=0.35), and EQ5D-5L (Cohen's d=0.18) scores; but not in the rest of secondary outcomes. CONCLUSION: DiabeText successfully improved quality of life, diabetes self-management, and self-reported medication adherence in primary care patients with T2DM. Further research is needed to enhance its effects on physiological outcomes.
  

• 
  Reporting of Participant Race and Ethnicity from COVID-19 Randomized Controlled Drug and Biologicals Trials: A Scoping Review. Pranić, Shelly Melissa; Estevão, Maria Dulce; Vasanthan, Lenny T; Pérez-Neri, Iván; Pulumati, Anika; de Lima Junior, Fábio Antonio Serra; Malih, Narges; Mishra, Vinayak; Thompson, Jacqueline; Nnate, Daniel (2024). mxae006-.

  AbstractURLBibTeXEndNoteDOIBibSonomy

  Racial and ethnic minorities have been disproportionally burdened by hospitalization and death due to COVID-19. Participation of individuals of diverse races and ethnicities in clinical trials according to study-level characteristics of randomized controlled trials (RCT) that test effectiveness of COVID-19 drugs could be insightful for future researchers. The objective of this scoping review was to describe frequency of race and ethnicity reported as demographic variables and specific reporting of race and ethnicity according to COVID-19 RCT characteristics. We conducted comprehensive searches in Pubmed, ProQuest, WHO Database, and Cochrane Central Register of Controlled Trials, and gray literature via preprint servers from 1/1/2020 to 5/4/2022. We included RCTs on emergency- or conditionally-approved COVID-19 drug interventions (remdesivir, baricitinib, and molnupiravir) with or without comparators. Self-reported race as American Indian/Pacific Islander, Asian, Black/African American, or White, ethnicity as Hispanic/Latinx, study design characteristics, and participant-relevant data were collected. A total of 17 RCTs with 17935 participants was included. Most (n=13, 76%) reported at least one race and ethnicity and were US-based, industry-funded RCTs. Asian, Black, Latinx, and White participants were mostly enrolled in RCTs that studied remdesivir. Native American and Hawaiian participants were mostly assessed for progression to high-flow oxygen/non-invasive ventilation. Time to recovery was assessed predominantly in Black and White participants, while hospitalization or death was mostly assessed in Asian, Latinx, and multi-race participants. Trialists should be aware of RCT-level factors and characteristics that may be associated with low participation of racial and ethnic minorities, which could inform evidence-based interventions to increase minority participation.

  @article{pranic2024reporting,
  abstract = {Racial and ethnic minorities have been disproportionally burdened by hospitalization and death due to COVID-19. Participation of individuals of diverse races and ethnicities in clinical trials according to study-level characteristics of randomized controlled trials (RCT) that test effectiveness of COVID-19 drugs could be insightful for future researchers. The objective of this scoping review was to describe frequency of race and ethnicity reported as demographic variables and specific reporting of race and ethnicity according to COVID-19 RCT characteristics. We conducted comprehensive searches in Pubmed, ProQuest, WHO Database, and Cochrane Central Register of Controlled Trials, and gray literature via preprint servers from 1/1/2020 to 5/4/2022. We included RCTs on emergency- or conditionally-approved COVID-19 drug interventions (remdesivir, baricitinib, and molnupiravir) with or without comparators. Self-reported race as American Indian/Pacific Islander, Asian, Black/African American, or White, ethnicity as Hispanic/Latinx, study design characteristics, and participant-relevant data were collected. A total of 17 RCTs with 17935 participants was included. Most (n=13, 76%) reported at least one race and ethnicity and were US-based, industry-funded RCTs. Asian, Black, Latinx, and White participants were mostly enrolled in RCTs that studied remdesivir. Native American and Hawaiian participants were mostly assessed for progression to high-flow oxygen/non-invasive ventilation. Time to recovery was assessed predominantly in Black and White participants, while hospitalization or death was mostly assessed in Asian, Latinx, and multi-race participants. Trialists should be aware of RCT-level factors and characteristics that may be associated with low participation of racial and ethnic minorities, which could inform evidence-based interventions to increase minority participation.},
  address = {United States},
  author = {Pranić, Shelly Melissa and Estevão, Maria Dulce and Vasanthan, Lenny T and Pérez-Neri, Iván and Pulumati, Anika and de Lima Junior, Fábio Antonio Serra and Malih, Narges and Mishra, Vinayak and Thompson, Jacqueline and Nnate, Daniel},
  journal = {Epidemiologic reviews},
  keywords = {evisap grapp-caib},
  month = {nov},
  pages = {mxae006--},
  title = {Reporting of Participant Race and Ethnicity from COVID-19 Randomized Controlled Drug and Biologicals Trials: A Scoping Review},
  year = 2024
  }
  

  %0 Journal Article
  %1 pranic2024reporting
  %A Pranić, Shelly Melissa
  %A Estevão, Maria Dulce
  %A Vasanthan, Lenny T
  %A Pérez-Neri, Iván
  %A Pulumati, Anika
  %A de Lima Junior, Fábio Antonio Serra
  %A Malih, Narges
  %A Mishra, Vinayak
  %A Thompson, Jacqueline
  %A Nnate, Daniel
  %C United States
  %D 2024
  %J Epidemiologic reviews
  %P mxae006--
  %R 10.1093/epirev/mxae006
  %T Reporting of Participant Race and Ethnicity from COVID-19 Randomized Controlled Drug and Biologicals Trials: A Scoping Review
  %U https://pubmed.ncbi.nlm.nih.gov/39673248
  %X Racial and ethnic minorities have been disproportionally burdened by hospitalization and death due to COVID-19. Participation of individuals of diverse races and ethnicities in clinical trials according to study-level characteristics of randomized controlled trials (RCT) that test effectiveness of COVID-19 drugs could be insightful for future researchers. The objective of this scoping review was to describe frequency of race and ethnicity reported as demographic variables and specific reporting of race and ethnicity according to COVID-19 RCT characteristics. We conducted comprehensive searches in Pubmed, ProQuest, WHO Database, and Cochrane Central Register of Controlled Trials, and gray literature via preprint servers from 1/1/2020 to 5/4/2022. We included RCTs on emergency- or conditionally-approved COVID-19 drug interventions (remdesivir, baricitinib, and molnupiravir) with or without comparators. Self-reported race as American Indian/Pacific Islander, Asian, Black/African American, or White, ethnicity as Hispanic/Latinx, study design characteristics, and participant-relevant data were collected. A total of 17 RCTs with 17935 participants was included. Most (n=13, 76%) reported at least one race and ethnicity and were US-based, industry-funded RCTs. Asian, Black, Latinx, and White participants were mostly enrolled in RCTs that studied remdesivir. Native American and Hawaiian participants were mostly assessed for progression to high-flow oxygen/non-invasive ventilation. Time to recovery was assessed predominantly in Black and White participants, while hospitalization or death was mostly assessed in Asian, Latinx, and multi-race participants. Trialists should be aware of RCT-level factors and characteristics that may be associated with low participation of racial and ethnic minorities, which could inform evidence-based interventions to increase minority participation.
  

• 
  Evaluation of SINERGIAPS, an intervention to improve patient safety in primary healthcare centers in Spain based on patients’ perceptions and experiences: a protocol for a hybrid type I randomized clinical trial. Fiol deRoque, Maria A; Mansilla, Georgina Vidal; Maderuelo-Fernández, José A; Tamayo-Morales, Olaya; Martín-Luján, Francisco; Astier-Peña, Pilar; Chacón-Docampo, Macarena; Orrego, Carola; Gens-Barberà, Montserrat; Andreu-Rodrigo, Pilar; Ricci-Cabello, Ignacio; team, SinergiAPS (2024). 12 1324940–1324940.

  AbstractURLBibTeXEndNoteDOIBibSonomyDownload

  BACKGROUND: Adverse events in the primary care setting result in a direct cost equivalent to at least 2.5% of total healthcare spending. Across OECD countries, they lead to more than seven million avoidable hospital admissions annually. In this manuscript, we describe the protocol of a trial aimed at evaluating the effectiveness of SinergiAPS (a patient-centered audit and feedback intervention) in reducing avoidable hospital admission and explore the factors that may affect its implementation. METHODS: We will conduct a 24-month, parallel, open-label, multicenter, pragmatic, hybrid type 1 randomized clinical trial. 118 primary healthcare centers with wide geographical distribution in Spain will be randomly assigned (ratio 1:1) to two groups. The intervention group will receive two audits (baseline and intermediate at 12 months) based on information collected through the administration of the PREOS-PC questionnaire (a measure of patient-reported patient safety) to a convenience sample of 100 patients per center. The intervention group will receive reports on the results of both audits, along with educational resources aimed at facilitating the design and implementation of safety improvement plans. The control group will receive care as usual. The primary outcome will be the rate of avoidable hospitalizations (administrative data). Secondary outcomes: patient-reported patient safety experiences and outcomes (PREOS-PC questionnaire); patient safety culture as perceived by professionals (MOSPSC questionnaire); adverse events reported by healthcare professionals (ad hoc questionnaire); the number of safety improvement actions which the re has implemented (ad hoc questionnaire). Outcome data will be collected at baseline and 24 months follow-up. For the evaluation of the implementation of the SinergiAPS intervention, we will draw on the Consolidated Framework for Implementation Research (CFIR). We will collect and analyze qualitative and quantitative data (30 individual interviews, implementation logbooks; questionnaires for professionals from intervention centers, and level of use of the SinergiAPS web tool). DISCUSSION: This study will expand the scarce body of evidence existing regarding the effects and implementation of interventions aimed at promoting patient and family engagement in primary healthcare, specifically for enhancing patient safety. The study has the potential to produce an impact on clinical practice, healthcare systems, and population health.Clinical Trial Registration: https://clinicaltrials.gov/study/NCT05958108?term=sinergiAPS&rank=1 (NCT05958108).

  @article{fiolderoque2024evaluation,
  abstract = {BACKGROUND: Adverse events in the primary care setting result in a direct cost equivalent to at least 2.5% of total healthcare spending. Across OECD countries, they lead to more than seven million avoidable hospital admissions annually. In this manuscript, we describe the protocol of a trial aimed at evaluating the effectiveness of SinergiAPS (a patient-centered audit and feedback intervention) in reducing avoidable hospital admission and explore the factors that may affect its implementation. METHODS: We will conduct a 24-month, parallel, open-label, multicenter, pragmatic, hybrid type 1 randomized clinical trial. 118 primary healthcare centers with wide geographical distribution in Spain will be randomly assigned (ratio 1:1) to two groups. The intervention group will receive two audits (baseline and intermediate at 12 months) based on information collected through the administration of the PREOS-PC questionnaire (a measure of patient-reported patient safety) to a convenience sample of 100 patients per center. The intervention group will receive reports on the results of both audits, along with educational resources aimed at facilitating the design and implementation of safety improvement plans. The control group will receive care as usual. The primary outcome will be the rate of avoidable hospitalizations (administrative data). Secondary outcomes: patient-reported patient safety experiences and outcomes (PREOS-PC questionnaire); patient safety culture as perceived by professionals (MOSPSC questionnaire); adverse events reported by healthcare professionals (ad hoc questionnaire); the number of safety improvement actions which the re has implemented (ad hoc questionnaire). Outcome data will be collected at baseline and 24 months follow-up. For the evaluation of the implementation of the SinergiAPS intervention, we will draw on the Consolidated Framework for Implementation Research (CFIR). We will collect and analyze qualitative and quantitative data (30 individual interviews, implementation logbooks; questionnaires for professionals from intervention centers, and level of use of the SinergiAPS web tool). DISCUSSION: This study will expand the scarce body of evidence existing regarding the effects and implementation of interventions aimed at promoting patient and family engagement in primary healthcare, specifically for enhancing patient safety. The study has the potential to produce an impact on clinical practice, healthcare systems, and population health.Clinical Trial Registration: https://clinicaltrials.gov/study/NCT05958108?term=sinergiAPS&rank=1 (NCT05958108).},
  address = {Switzerland},
  author = {Fiol deRoque, Maria A and Mansilla, Georgina Vidal and Maderuelo-Fernández, José A and Tamayo-Morales, Olaya and Martín-Luján, Francisco and Astier-Peña, Pilar and Chacón-Docampo, Macarena and Orrego, Carola and Gens-Barberà, Montserrat and Andreu-Rodrigo, Pilar and Ricci-Cabello, Ignacio and team, SinergiAPS},
  journal = {Frontiers in public health},
  keywords = {evisap myown},
  month = {mar},
  pages = {1324940--1324940},
  title = {Evaluation of SINERGIAPS, an intervention to improve patient safety in primary healthcare centers in Spain based on patients' perceptions and experiences: a protocol for a hybrid type I randomized clinical trial},
  volume = 12,
  year = 2024
  }
  

  %0 Journal Article
  %1 fiolderoque2024evaluation
  %A Fiol deRoque, Maria A
  %A Mansilla, Georgina Vidal
  %A Maderuelo-Fernández, José A
  %A Tamayo-Morales, Olaya
  %A Martín-Luján, Francisco
  %A Astier-Peña, Pilar
  %A Chacón-Docampo, Macarena
  %A Orrego, Carola
  %A Gens-Barberà, Montserrat
  %A Andreu-Rodrigo, Pilar
  %A Ricci-Cabello, Ignacio
  %A team, SinergiAPS
  %C Switzerland
  %D 2024
  %J Frontiers in public health
  %P 1324940--1324940
  %R 10.3389/fpubh.2024.1324940
  %T Evaluation of SINERGIAPS, an intervention to improve patient safety in primary healthcare centers in Spain based on patients' perceptions and experiences: a protocol for a hybrid type I randomized clinical trial
  %U https://pubmed.ncbi.nlm.nih.gov/38596515
  %V 12
  %X BACKGROUND: Adverse events in the primary care setting result in a direct cost equivalent to at least 2.5% of total healthcare spending. Across OECD countries, they lead to more than seven million avoidable hospital admissions annually. In this manuscript, we describe the protocol of a trial aimed at evaluating the effectiveness of SinergiAPS (a patient-centered audit and feedback intervention) in reducing avoidable hospital admission and explore the factors that may affect its implementation. METHODS: We will conduct a 24-month, parallel, open-label, multicenter, pragmatic, hybrid type 1 randomized clinical trial. 118 primary healthcare centers with wide geographical distribution in Spain will be randomly assigned (ratio 1:1) to two groups. The intervention group will receive two audits (baseline and intermediate at 12 months) based on information collected through the administration of the PREOS-PC questionnaire (a measure of patient-reported patient safety) to a convenience sample of 100 patients per center. The intervention group will receive reports on the results of both audits, along with educational resources aimed at facilitating the design and implementation of safety improvement plans. The control group will receive care as usual. The primary outcome will be the rate of avoidable hospitalizations (administrative data). Secondary outcomes: patient-reported patient safety experiences and outcomes (PREOS-PC questionnaire); patient safety culture as perceived by professionals (MOSPSC questionnaire); adverse events reported by healthcare professionals (ad hoc questionnaire); the number of safety improvement actions which the re has implemented (ad hoc questionnaire). Outcome data will be collected at baseline and 24 months follow-up. For the evaluation of the implementation of the SinergiAPS intervention, we will draw on the Consolidated Framework for Implementation Research (CFIR). We will collect and analyze qualitative and quantitative data (30 individual interviews, implementation logbooks; questionnaires for professionals from intervention centers, and level of use of the SinergiAPS web tool). DISCUSSION: This study will expand the scarce body of evidence existing regarding the effects and implementation of interventions aimed at promoting patient and family engagement in primary healthcare, specifically for enhancing patient safety. The study has the potential to produce an impact on clinical practice, healthcare systems, and population health.Clinical Trial Registration: https://clinicaltrials.gov/study/NCT05958108?term=sinergiAPS&rank=1 (NCT05958108).
  

• 
  Validity of nutrition screening tools for risk of malnutrition among hospitalized adult patients: A systematic review and meta-analysis. Cortés-Aguilar, Regina; Malih, Narges; Abbate, Manuela; Fresneda, Sergio; Yañez, Aina; Bennasar-Veny, Miquel (2024). 43(5) 1094–1116.

  AbstractURLBibTeXEndNoteDOIBibSonomy

  BACKGROUNDS & AIMS: Malnutrition is prevalent among hospitalized patients in developed countries, contributing to negative health outcomes and increased healthcare costs. Timely identification and management of malnutrition are crucial. The lack of a universally accepted definition and standardized diagnostic criteria for malnutrition has led to the development of various screening tools, each with varying validity. This complicates early identification of malnutrition, hindering effective intervention strategies. This systematic review and meta-analysis aimed to identify the most valid and reliable nutritional screening tool for assessing the risk of malnutrition in hospitalized adults. METHODS: A systematic literature search was conducted to identify validation studies published from inception to November 2023, in the Pubmed/MEDLINE, Embase, and CINAHL databases. This systematic review was registered in INPLASY (INPLASY202090028). The risk of bias and quality of included studies were assessed using the Quality Assessment of Diagnostic Accuracy Studies version 2 (QUADAS-2). Meta-analyses were performed for screening tools accuracy using the symmetric hierarchical summary receiver operative characteristics models. RESULTS: Of the 1646 articles retrieved, 60 met the inclusion criteria and were included in the systematic review, and 21 were included in the meta-analysis. A total of 51 malnutrition risk screening tools and 9 reference standards were identified. The meta-analyses assessed four common malnutrition risk screening tools against two reference standards (Subjective Global Assessment [SGA] and European Society for Clinical Nutrition and Metabolism [ESPEN] criteria). The Malnutrition Universal Screening Tool (MUST) vs SGA had a sensitivity (95% Confidence Interval) of 0.84 (0.73-0.91), and specificity of 0.85 (0.75-0.91). The MUST vs ESPEN had a sensitivity of 0.97 (0.53-0.99) and specificity of 0.80 (0.50-0.94). The Malnutrition Screening Tool (MST) vs SGA had a sensitivity of 0.81 (0.67-0.90) and specificity of 0.79 (0.72-0.74). The Mini Nutritional Assessment-Short Form (MNA-SF) vs ESPEN had a sensitivity of 0.99 (0.41-0.99) and specificity of 0.60 (0.45-0.73). The Nutrition Universal Screening Tool-2002 (NRS-2002) vs SGA had a sensitivity of 0.76 (0.58-0.87) and specificity of 0.86 (0.76-0.93). CONCLUSIONS: The MUST demonstrated high accuracy in detecting malnutrition risk in hospitalized adults. However, the quality of the studies included varied greatly, possibly introducing bias in the results. Future research should compare tools within a specific patient population using a valid and universal gold standard to ensure improved patient care and outcomes.

  @article{cortesaguilar2024validity,
  abstract = {BACKGROUNDS & AIMS: Malnutrition is prevalent among hospitalized patients in developed countries, contributing to negative health outcomes and increased healthcare costs. Timely identification and management of malnutrition are crucial. The lack of a universally accepted definition and standardized diagnostic criteria for malnutrition has led to the development of various screening tools, each with varying validity. This complicates early identification of malnutrition, hindering effective intervention strategies. This systematic review and meta-analysis aimed to identify the most valid and reliable nutritional screening tool for assessing the risk of malnutrition in hospitalized adults. METHODS: A systematic literature search was conducted to identify validation studies published from inception to November 2023, in the Pubmed/MEDLINE, Embase, and CINAHL databases. This systematic review was registered in INPLASY (INPLASY202090028). The risk of bias and quality of included studies were assessed using the Quality Assessment of Diagnostic Accuracy Studies version 2 (QUADAS-2). Meta-analyses were performed for screening tools accuracy using the symmetric hierarchical summary receiver operative characteristics models. RESULTS: Of the 1646 articles retrieved, 60 met the inclusion criteria and were included in the systematic review, and 21 were included in the meta-analysis. A total of 51 malnutrition risk screening tools and 9 reference standards were identified. The meta-analyses assessed four common malnutrition risk screening tools against two reference standards (Subjective Global Assessment [SGA] and European Society for Clinical Nutrition and Metabolism [ESPEN] criteria). The Malnutrition Universal Screening Tool (MUST) vs SGA had a sensitivity (95% Confidence Interval) of 0.84 (0.73-0.91), and specificity of 0.85 (0.75-0.91). The MUST vs ESPEN had a sensitivity of 0.97 (0.53-0.99) and specificity of 0.80 (0.50-0.94). The Malnutrition Screening Tool (MST) vs SGA had a sensitivity of 0.81 (0.67-0.90) and specificity of 0.79 (0.72-0.74). The Mini Nutritional Assessment-Short Form (MNA-SF) vs ESPEN had a sensitivity of 0.99 (0.41-0.99) and specificity of 0.60 (0.45-0.73). The Nutrition Universal Screening Tool-2002 (NRS-2002) vs SGA had a sensitivity of 0.76 (0.58-0.87) and specificity of 0.86 (0.76-0.93). CONCLUSIONS: The MUST demonstrated high accuracy in detecting malnutrition risk in hospitalized adults. However, the quality of the studies included varied greatly, possibly introducing bias in the results. Future research should compare tools within a specific patient population using a valid and universal gold standard to ensure improved patient care and outcomes.},
  address = {England},
  author = {Cortés-Aguilar, Regina and Malih, Narges and Abbate, Manuela and Fresneda, Sergio and Yañez, Aina and Bennasar-Veny, Miquel},
  journal = {Clinical nutrition (Edinburgh, Scotland)},
  keywords = {evisap grapp-caib},
  month = {mar},
  number = 5,
  pages = {1094--1116},
  title = {Validity of nutrition screening tools for risk of malnutrition among hospitalized adult patients: A systematic review and meta-analysis},
  volume = 43,
  year = 2024
  }
  

  %0 Journal Article
  %1 cortesaguilar2024validity
  %A Cortés-Aguilar, Regina
  %A Malih, Narges
  %A Abbate, Manuela
  %A Fresneda, Sergio
  %A Yañez, Aina
  %A Bennasar-Veny, Miquel
  %C England
  %D 2024
  %J Clinical nutrition (Edinburgh, Scotland)
  %N 5
  %P 1094--1116
  %R 10.1016/j.clnu.2024.03.008
  %T Validity of nutrition screening tools for risk of malnutrition among hospitalized adult patients: A systematic review and meta-analysis
  %U https://pubmed.ncbi.nlm.nih.gov/38582013
  %V 43
  %X BACKGROUNDS & AIMS: Malnutrition is prevalent among hospitalized patients in developed countries, contributing to negative health outcomes and increased healthcare costs. Timely identification and management of malnutrition are crucial. The lack of a universally accepted definition and standardized diagnostic criteria for malnutrition has led to the development of various screening tools, each with varying validity. This complicates early identification of malnutrition, hindering effective intervention strategies. This systematic review and meta-analysis aimed to identify the most valid and reliable nutritional screening tool for assessing the risk of malnutrition in hospitalized adults. METHODS: A systematic literature search was conducted to identify validation studies published from inception to November 2023, in the Pubmed/MEDLINE, Embase, and CINAHL databases. This systematic review was registered in INPLASY (INPLASY202090028). The risk of bias and quality of included studies were assessed using the Quality Assessment of Diagnostic Accuracy Studies version 2 (QUADAS-2). Meta-analyses were performed for screening tools accuracy using the symmetric hierarchical summary receiver operative characteristics models. RESULTS: Of the 1646 articles retrieved, 60 met the inclusion criteria and were included in the systematic review, and 21 were included in the meta-analysis. A total of 51 malnutrition risk screening tools and 9 reference standards were identified. The meta-analyses assessed four common malnutrition risk screening tools against two reference standards (Subjective Global Assessment [SGA] and European Society for Clinical Nutrition and Metabolism [ESPEN] criteria). The Malnutrition Universal Screening Tool (MUST) vs SGA had a sensitivity (95% Confidence Interval) of 0.84 (0.73-0.91), and specificity of 0.85 (0.75-0.91). The MUST vs ESPEN had a sensitivity of 0.97 (0.53-0.99) and specificity of 0.80 (0.50-0.94). The Malnutrition Screening Tool (MST) vs SGA had a sensitivity of 0.81 (0.67-0.90) and specificity of 0.79 (0.72-0.74). The Mini Nutritional Assessment-Short Form (MNA-SF) vs ESPEN had a sensitivity of 0.99 (0.41-0.99) and specificity of 0.60 (0.45-0.73). The Nutrition Universal Screening Tool-2002 (NRS-2002) vs SGA had a sensitivity of 0.76 (0.58-0.87) and specificity of 0.86 (0.76-0.93). CONCLUSIONS: The MUST demonstrated high accuracy in detecting malnutrition risk in hospitalized adults. However, the quality of the studies included varied greatly, possibly introducing bias in the results. Future research should compare tools within a specific patient population using a valid and universal gold standard to ensure improved patient care and outcomes.
  

• 
  Frequency of use and adequacy of Cochrane risk of bias tool 2 in non-Cochrane systematic reviews published in 2020: Meta-research study. Babić, Andrija; Barcot, Ognjen; Visković, Tomislav; Šarić, Frano; Kirkovski, Aleksandar; Barun, Ivana; Križanac, Zvonimir; Ananda, Roshan Arjun; Fuentes Barreiro, Yuli Viviana; Malih, Narges; Dimcea, Daiana Anne-Marie; Ordulj, Josipa; Weerasekara, Ishanka; Spezia, Matteo; Žuljević, Marija Franka; Šuto, Jelena; Tancredi, Luca; Pijuk, Anđela; Sammali, Susanna; Iascone, Veronica; von Groote, Thilo; Poklepović Peričić, Tina; Puljak, Livia (2024). 10.1002/jrsm.1695-.

  AbstractURLBibTeXEndNoteDOIBibSonomy

  Risk of bias (RoB) assessment is essential to the systematic review methodology. The new version of the Cochrane RoB tool for randomized trials (RoB 2) was published in 2019 to address limitations identified since the first version of the tool was published in 2008 and to increase the reliability of assessments. This study analyzed the frequency of usage of the RoB 2 and the adequacy of reporting the RoB 2 assessments in non-Cochrane reviews published in 2020. This meta-research study included non-Cochrane systematic reviews of interventions published in 2020. For the reviews that used the RoB 2 tool, we analyzed the reporting of the RoB 2 assessment. Among 3880 included reviews, the Cochrane RoB 1 tool was the most frequently used (N = 2228; 57.4%), followed by the Cochrane RoB 2 tool (N = 267; 6.9%). From 267 reviews that reported using the RoB 2 tool, 213 (79.8%) actually used it. In 26 (12.2%) reviews, erroneous statements were used to indicate the RoB 2 assessment. Only 20 (9.4%) reviews presented a complete RoB 2 assessment with a detailed table of answers to all signaling questions. The judgment of risk of bias by the RoB 2 tool was not justified by a comment in 158 (74.2%) reviews. Only in 33 (14.5%) of reviews the judgment in all domains was justified in the accompanying comment. In most reviews (81.7%), the RoB was inadequately assessed at the study level. In conclusion, the majority of non-Cochrane reviews published in 2020 still used the Cochrane RoB 1 tool. Many reviews used the RoB 2 tool inadequately. Further studies about the uptake and the use of the RoB 2 tool are needed.

  @article{babic2024frequency,
  abstract = {Risk of bias (RoB) assessment is essential to the systematic review methodology. The new version of the Cochrane RoB tool for randomized trials (RoB 2) was published in 2019 to address limitations identified since the first version of the tool was published in 2008 and to increase the reliability of assessments. This study analyzed the frequency of usage of the RoB 2 and the adequacy of reporting the RoB 2 assessments in non-Cochrane reviews published in 2020. This meta-research study included non-Cochrane systematic reviews of interventions published in 2020. For the reviews that used the RoB 2 tool, we analyzed the reporting of the RoB 2 assessment. Among 3880 included reviews, the Cochrane RoB 1 tool was the most frequently used (N = 2228; 57.4%), followed by the Cochrane RoB 2 tool (N = 267; 6.9%). From 267 reviews that reported using the RoB 2 tool, 213 (79.8%) actually used it. In 26 (12.2%) reviews, erroneous statements were used to indicate the RoB 2 assessment. Only 20 (9.4%) reviews presented a complete RoB 2 assessment with a detailed table of answers to all signaling questions. The judgment of risk of bias by the RoB 2 tool was not justified by a comment in 158 (74.2%) reviews. Only in 33 (14.5%) of reviews the judgment in all domains was justified in the accompanying comment. In most reviews (81.7%), the RoB was inadequately assessed at the study level. In conclusion, the majority of non-Cochrane reviews published in 2020 still used the Cochrane RoB 1 tool. Many reviews used the RoB 2 tool inadequately. Further studies about the uptake and the use of the RoB 2 tool are needed.},
  address = {England},
  author = {Babić, Andrija and Barcot, Ognjen and Visković, Tomislav and Šarić, Frano and Kirkovski, Aleksandar and Barun, Ivana and Križanac, Zvonimir and Ananda, Roshan Arjun and Fuentes Barreiro, Yuli Viviana and Malih, Narges and Dimcea, Daiana Anne-Marie and Ordulj, Josipa and Weerasekara, Ishanka and Spezia, Matteo and Žuljević, Marija Franka and Šuto, Jelena and Tancredi, Luca and Pijuk, Anđela and Sammali, Susanna and Iascone, Veronica and von Groote, Thilo and Poklepović Peričić, Tina and Puljak, Livia},
  journal = {Research synthesis methods},
  keywords = {evisap grapp-caib},
  month = {jan},
  pages = {10.1002/jrsm.1695--},
  title = {Frequency of use and adequacy of Cochrane risk of bias tool 2 in non-Cochrane systematic reviews published in 2020: Meta-research study},
  year = 2024
  }
  

  %0 Journal Article
  %1 babic2024frequency
  %A Babić, Andrija
  %A Barcot, Ognjen
  %A Visković, Tomislav
  %A Šarić, Frano
  %A Kirkovski, Aleksandar
  %A Barun, Ivana
  %A Križanac, Zvonimir
  %A Ananda, Roshan Arjun
  %A Fuentes Barreiro, Yuli Viviana
  %A Malih, Narges
  %A Dimcea, Daiana Anne-Marie
  %A Ordulj, Josipa
  %A Weerasekara, Ishanka
  %A Spezia, Matteo
  %A Žuljević, Marija Franka
  %A Šuto, Jelena
  %A Tancredi, Luca
  %A Pijuk, Anđela
  %A Sammali, Susanna
  %A Iascone, Veronica
  %A von Groote, Thilo
  %A Poklepović Peričić, Tina
  %A Puljak, Livia
  %C England
  %D 2024
  %J Research synthesis methods
  %P 10.1002/jrsm.1695--
  %R 10.1002/jrsm.1695
  %T Frequency of use and adequacy of Cochrane risk of bias tool 2 in non-Cochrane systematic reviews published in 2020: Meta-research study
  %U https://pubmed.ncbi.nlm.nih.gov/38262609
  %X Risk of bias (RoB) assessment is essential to the systematic review methodology. The new version of the Cochrane RoB tool for randomized trials (RoB 2) was published in 2019 to address limitations identified since the first version of the tool was published in 2008 and to increase the reliability of assessments. This study analyzed the frequency of usage of the RoB 2 and the adequacy of reporting the RoB 2 assessments in non-Cochrane reviews published in 2020. This meta-research study included non-Cochrane systematic reviews of interventions published in 2020. For the reviews that used the RoB 2 tool, we analyzed the reporting of the RoB 2 assessment. Among 3880 included reviews, the Cochrane RoB 1 tool was the most frequently used (N = 2228; 57.4%), followed by the Cochrane RoB 2 tool (N = 267; 6.9%). From 267 reviews that reported using the RoB 2 tool, 213 (79.8%) actually used it. In 26 (12.2%) reviews, erroneous statements were used to indicate the RoB 2 assessment. Only 20 (9.4%) reviews presented a complete RoB 2 assessment with a detailed table of answers to all signaling questions. The judgment of risk of bias by the RoB 2 tool was not justified by a comment in 158 (74.2%) reviews. Only in 33 (14.5%) of reviews the judgment in all domains was justified in the accompanying comment. In most reviews (81.7%), the RoB was inadequately assessed at the study level. In conclusion, the majority of non-Cochrane reviews published in 2020 still used the Cochrane RoB 1 tool. Many reviews used the RoB 2 tool inadequately. Further studies about the uptake and the use of the RoB 2 tool are needed.
  

• 
  Preparatory work for the safety evaluation by EFSA of Human-identical Milk Oligosaccharides as Novel Foods. Malih, Narges; Konieczna, Jadwiga; Fernandez, Mar Nafria; Fiol deRoque, Maria Antonia; Zamanillo-Campos, Rocío; Ricci-Cabello, Ignacio (2024). 21 8955E.

  AbstractURLBibTeXEndNoteBibSonomy

  Abstract Background and aims This report describes a scoping literature review as preparatory work for the safety evaluation by EFSA of Human-identical Milk Oligosaccharides (HiMOs) as Novel Foods (NFs). The main objective was to gather information on the concentrations of Human Milk Oligosaccharides (HMOs) in human milk, both individual and total, and the combinations/mixtures of HiMOs/HMOs in commercially available products or those reported in the literature. Methods A scoping literature review was conducted, including a search strategy implemented in biomedical (PubMed) and multidisciplinary (Web of Science) databases from 2013 to March 2024, supplemented by an ad hoc search for primary studies included in two key recent systematic reviews and grey literature searches on relevant food business operators' websites. Both primary and secondary studies were selected to determine the individual concentrations of target HMOs, the total concentration of HMOs and relevant HMO fractions, and the combinations/mixtures of HiMOs/HMOs. Only studies with full text published in English or Spanish were eligible, excluding patents, editorials, conference abstracts, books, and dissertations. Results The structured searches yielded 2,851 unique references, with 218 selected for full-text evaluation and 36 additional unique references from the key systematic reviews. Ultimately, 171 publications were included in the review. Fourteen companies related to HiMOs were identified through grey literature. In most publications, concentration data for multiple groups of donors (e.g., based on factors like secretor status or lactation period) were reported. By groups of donors, the mean total concentration of HMOs in milk (excluding colostrum) was 6,740 mg/L, whereas the mean by publication was 5,341 mg/L. By publication, the mean concentrations of individual HMOs (mg/L, excluding colostrum) were: LNnT 288, LNT 971, 2'-FL 1,468, 3-FL 800, DFL 232, 3'-SL 212, 6'-SL 365, LNFP I 738, and LNT/LNnT 611. By groups of donors, the mean concentrations (mg/L, excluding colostrum) were: LNnT 382, LNT 1064.1, 2'-FL 1685, 3-FL 907, DFL 303, 3'-SL 225, 6'-SL 435, LNFP I 773, and LNT/LNnT 882. By publication, the mean concentration (mg/L) of groups of HMOs mean concentrations (excluding colostrum) was: 4,577 for total neutral; 851 for total acidic; 4,635 for total acidic fucosylated; 1,631 for α-1-3/4-fucosylated; 3,304 for α-1-2-fucosylated; 1,601 for non-fucosylated; 1,505 for total sialyllated; 2,293 for acidic sialyllated. By group of donors, the mean concentration (mg/L) of groups of HMOs mean concentrations (excluding colostrum) was: 3,942 for total neutral; 1,032 for total acidic; 6,477 for total acidic fucosylated; 1,650 for α-1-3/4-fucosylated; 3,748 for α-1-2-fucosylated; 2,026 for non-fucosylated; 1,957 for total sialyllated; 2,293 for acidic sialyllated. The most frequent combinations of HMOs/HiMOs were LNnT + 2'-FL (24 products, 32%) and 2'-FL + 3'-SL (12 products, 16%). Conclusions The findings of this review will support EFSA in the safety evaluation of HiMOs as NFs, in accordance with the EC mandate (M-2023-00157).

  @article{malih2024preparatory,
  abstract = {Abstract Background and aims This report describes a scoping literature review as preparatory work for the safety evaluation by EFSA of Human-identical Milk Oligosaccharides (HiMOs) as Novel Foods (NFs). The main objective was to gather information on the concentrations of Human Milk Oligosaccharides (HMOs) in human milk, both individual and total, and the combinations/mixtures of HiMOs/HMOs in commercially available products or those reported in the literature. Methods A scoping literature review was conducted, including a search strategy implemented in biomedical (PubMed) and multidisciplinary (Web of Science) databases from 2013 to March 2024, supplemented by an ad hoc search for primary studies included in two key recent systematic reviews and grey literature searches on relevant food business operators' websites. Both primary and secondary studies were selected to determine the individual concentrations of target HMOs, the total concentration of HMOs and relevant HMO fractions, and the combinations/mixtures of HiMOs/HMOs. Only studies with full text published in English or Spanish were eligible, excluding patents, editorials, conference abstracts, books, and dissertations. Results The structured searches yielded 2,851 unique references, with 218 selected for full-text evaluation and 36 additional unique references from the key systematic reviews. Ultimately, 171 publications were included in the review. Fourteen companies related to HiMOs were identified through grey literature. In most publications, concentration data for multiple groups of donors (e.g., based on factors like secretor status or lactation period) were reported. By groups of donors, the mean total concentration of HMOs in milk (excluding colostrum) was 6,740 mg/L, whereas the mean by publication was 5,341 mg/L. By publication, the mean concentrations of individual HMOs (mg/L, excluding colostrum) were: LNnT 288, LNT 971, 2'-FL 1,468, 3-FL 800, DFL 232, 3'-SL 212, 6'-SL 365, LNFP I 738, and LNT/LNnT 611. By groups of donors, the mean concentrations (mg/L, excluding colostrum) were: LNnT 382, LNT 1064.1, 2'-FL 1685, 3-FL 907, DFL 303, 3'-SL 225, 6'-SL 435, LNFP I 773, and LNT/LNnT 882. By publication, the mean concentration (mg/L) of groups of HMOs mean concentrations (excluding colostrum) was: 4,577 for total neutral; 851 for total acidic; 4,635 for total acidic fucosylated; 1,631 for α-1-3/4-fucosylated; 3,304 for α-1-2-fucosylated; 1,601 for non-fucosylated; 1,505 for total sialyllated; 2,293 for acidic sialyllated. By group of donors, the mean concentration (mg/L) of groups of HMOs mean concentrations (excluding colostrum) was: 3,942 for total neutral; 1,032 for total acidic; 6,477 for total acidic fucosylated; 1,650 for α-1-3/4-fucosylated; 3,748 for α-1-2-fucosylated; 2,026 for non-fucosylated; 1,957 for total sialyllated; 2,293 for acidic sialyllated. The most frequent combinations of HMOs/HiMOs were LNnT + 2'-FL (24 products, 32%) and 2'-FL + 3'-SL (12 products, 16%). Conclusions The findings of this review will support EFSA in the safety evaluation of HiMOs as NFs, in accordance with the EC mandate (M-2023-00157).},
  author = {Malih, Narges and Konieczna, Jadwiga and Fernandez, Mar Nafria and Fiol deRoque, Maria Antonia and Zamanillo-Campos, Rocío and Ricci-Cabello, Ignacio},
  booktitle = {EFSA Supporting Publications},
  keywords = {evisap},
  pages = {8955E},
  series = 7,
  title = {Preparatory work for the safety evaluation by EFSA of Human-identical Milk Oligosaccharides as Novel Foods},
  volume = 21,
  year = 2024
  }
  

  %0 Journal Article
  %1 malih2024preparatory
  %A Malih, Narges
  %A Konieczna, Jadwiga
  %A Fernandez, Mar Nafria
  %A Fiol deRoque, Maria Antonia
  %A Zamanillo-Campos, Rocío
  %A Ricci-Cabello, Ignacio
  %B EFSA Supporting Publications
  %D 2024
  %P 8955E
  %T Preparatory work for the safety evaluation by EFSA of Human-identical Milk Oligosaccharides as Novel Foods
  %U https://efsa.onlinelibrary.wiley.com/doi/abs/10.2903/sp.efsa.2024.EN-8955
  %V 21
  %X Abstract Background and aims This report describes a scoping literature review as preparatory work for the safety evaluation by EFSA of Human-identical Milk Oligosaccharides (HiMOs) as Novel Foods (NFs). The main objective was to gather information on the concentrations of Human Milk Oligosaccharides (HMOs) in human milk, both individual and total, and the combinations/mixtures of HiMOs/HMOs in commercially available products or those reported in the literature. Methods A scoping literature review was conducted, including a search strategy implemented in biomedical (PubMed) and multidisciplinary (Web of Science) databases from 2013 to March 2024, supplemented by an ad hoc search for primary studies included in two key recent systematic reviews and grey literature searches on relevant food business operators' websites. Both primary and secondary studies were selected to determine the individual concentrations of target HMOs, the total concentration of HMOs and relevant HMO fractions, and the combinations/mixtures of HiMOs/HMOs. Only studies with full text published in English or Spanish were eligible, excluding patents, editorials, conference abstracts, books, and dissertations. Results The structured searches yielded 2,851 unique references, with 218 selected for full-text evaluation and 36 additional unique references from the key systematic reviews. Ultimately, 171 publications were included in the review. Fourteen companies related to HiMOs were identified through grey literature. In most publications, concentration data for multiple groups of donors (e.g., based on factors like secretor status or lactation period) were reported. By groups of donors, the mean total concentration of HMOs in milk (excluding colostrum) was 6,740 mg/L, whereas the mean by publication was 5,341 mg/L. By publication, the mean concentrations of individual HMOs (mg/L, excluding colostrum) were: LNnT 288, LNT 971, 2'-FL 1,468, 3-FL 800, DFL 232, 3'-SL 212, 6'-SL 365, LNFP I 738, and LNT/LNnT 611. By groups of donors, the mean concentrations (mg/L, excluding colostrum) were: LNnT 382, LNT 1064.1, 2'-FL 1685, 3-FL 907, DFL 303, 3'-SL 225, 6'-SL 435, LNFP I 773, and LNT/LNnT 882. By publication, the mean concentration (mg/L) of groups of HMOs mean concentrations (excluding colostrum) was: 4,577 for total neutral; 851 for total acidic; 4,635 for total acidic fucosylated; 1,631 for α-1-3/4-fucosylated; 3,304 for α-1-2-fucosylated; 1,601 for non-fucosylated; 1,505 for total sialyllated; 2,293 for acidic sialyllated. By group of donors, the mean concentration (mg/L) of groups of HMOs mean concentrations (excluding colostrum) was: 3,942 for total neutral; 1,032 for total acidic; 6,477 for total acidic fucosylated; 1,650 for α-1-3/4-fucosylated; 3,748 for α-1-2-fucosylated; 2,026 for non-fucosylated; 1,957 for total sialyllated; 2,293 for acidic sialyllated. The most frequent combinations of HMOs/HiMOs were LNnT + 2'-FL (24 products, 32%) and 2'-FL + 3'-SL (12 products, 16%). Conclusions The findings of this review will support EFSA in the safety evaluation of HiMOs as NFs, in accordance with the EC mandate (M-2023-00157).
  

• 
  Prevalence of musculoskeletal disorders among hotel housekeepers and cleaners: A systematic review with meta-analysis. Sánchez-Rodríguez, Cristian; Capitán-Moyano, Laura; Malih, Narges; Yáñez, Aina M; Bennasar-Veny, Miquel; Velasco-Roldán, Olga; Bulilete, Oana; Llobera-Canaves, Joan (2024). 69 102890–102890.

  AbstractURLBibTeXEndNoteDOIBibSonomy

  BACKGROUND: Musculoskeletal disorders (MSD) are among the most frequent and costly occupational health problems with a rising prevalence globally. OBJECTIVE: This systematic review with meta-analysis was conducted to know and evaluate the prevalence of MSD by anatomic location among hotel housekeepers (HHs) and cleaners. METHODS: Electronic searches were conducted in PubMed, Web of Science, Scopus, Dialnet Plus, PEDro and Cochrane Database for Systematic Reviews using a search strategy to identify cross-sectional studies reporting on the prevalence of MSD in HHs or cleaners. The risk of bias was assessed with Joanna Briggs Institute tool for systematic reviews. A random-effects model was used in the meta-analysis. RESULTS: Nineteen studies were included in the systematic review, nine of them in the meta-analysis (n = 2299). The study sample sizes ranged from 24 to 1043 participants. The Standardized Nordic Musculoskeletal Questionnaire was the most common tool used to assess MSD among both HHs and cleaners (9/19 of the included studies). The three most affected anatomic locations were the low back 53.9% (95% CI: 43.3-64.6), shoulders 41.4% (95% CI: 27.1-55.8), and wrists/hands 40.1% (95% CI: 24.5-55.7). CONCLUSIONS: HHs and cleaners have a high prevalence of MSD. Low back pain is the most prevalent MSD among both HHs and cleaners affecting up to one of two people.

  @article{sanchezrodriguez2024prevalence,
  abstract = {BACKGROUND: Musculoskeletal disorders (MSD) are among the most frequent and costly occupational health problems with a rising prevalence globally. OBJECTIVE: This systematic review with meta-analysis was conducted to know and evaluate the prevalence of MSD by anatomic location among hotel housekeepers (HHs) and cleaners. METHODS: Electronic searches were conducted in PubMed, Web of Science, Scopus, Dialnet Plus, PEDro and Cochrane Database for Systematic Reviews using a search strategy to identify cross-sectional studies reporting on the prevalence of MSD in HHs or cleaners. The risk of bias was assessed with Joanna Briggs Institute tool for systematic reviews. A random-effects model was used in the meta-analysis. RESULTS: Nineteen studies were included in the systematic review, nine of them in the meta-analysis (n = 2299). The study sample sizes ranged from 24 to 1043 participants. The Standardized Nordic Musculoskeletal Questionnaire was the most common tool used to assess MSD among both HHs and cleaners (9/19 of the included studies). The three most affected anatomic locations were the low back 53.9% (95% CI: 43.3-64.6), shoulders 41.4% (95% CI: 27.1-55.8), and wrists/hands 40.1% (95% CI: 24.5-55.7). CONCLUSIONS: HHs and cleaners have a high prevalence of MSD. Low back pain is the most prevalent MSD among both HHs and cleaners affecting up to one of two people.},
  address = {Netherlands},
  author = {Sánchez-Rodríguez, Cristian and Capitán-Moyano, Laura and Malih, Narges and Yáñez, Aina M and Bennasar-Veny, Miquel and Velasco-Roldán, Olga and Bulilete, Oana and Llobera-Canaves, Joan},
  journal = {Musculoskeletal science & practice},
  keywords = {evisap},
  month = {feb},
  pages = {102890--102890},
  title = {Prevalence of musculoskeletal disorders among hotel housekeepers and cleaners: A systematic review with meta-analysis},
  volume = 69,
  year = 2024
  }
  

  %0 Journal Article
  %1 sanchezrodriguez2024prevalence
  %A Sánchez-Rodríguez, Cristian
  %A Capitán-Moyano, Laura
  %A Malih, Narges
  %A Yáñez, Aina M
  %A Bennasar-Veny, Miquel
  %A Velasco-Roldán, Olga
  %A Bulilete, Oana
  %A Llobera-Canaves, Joan
  %C Netherlands
  %D 2024
  %J Musculoskeletal science & practice
  %P 102890--102890
  %R 10.1016/j.msksp.2023.102890
  %T Prevalence of musculoskeletal disorders among hotel housekeepers and cleaners: A systematic review with meta-analysis
  %U https://pubmed.ncbi.nlm.nih.gov/38081106
  %V 69
  %X BACKGROUND: Musculoskeletal disorders (MSD) are among the most frequent and costly occupational health problems with a rising prevalence globally. OBJECTIVE: This systematic review with meta-analysis was conducted to know and evaluate the prevalence of MSD by anatomic location among hotel housekeepers (HHs) and cleaners. METHODS: Electronic searches were conducted in PubMed, Web of Science, Scopus, Dialnet Plus, PEDro and Cochrane Database for Systematic Reviews using a search strategy to identify cross-sectional studies reporting on the prevalence of MSD in HHs or cleaners. The risk of bias was assessed with Joanna Briggs Institute tool for systematic reviews. A random-effects model was used in the meta-analysis. RESULTS: Nineteen studies were included in the systematic review, nine of them in the meta-analysis (n = 2299). The study sample sizes ranged from 24 to 1043 participants. The Standardized Nordic Musculoskeletal Questionnaire was the most common tool used to assess MSD among both HHs and cleaners (9/19 of the included studies). The three most affected anatomic locations were the low back 53.9% (95% CI: 43.3-64.6), shoulders 41.4% (95% CI: 27.1-55.8), and wrists/hands 40.1% (95% CI: 24.5-55.7). CONCLUSIONS: HHs and cleaners have a high prevalence of MSD. Low back pain is the most prevalent MSD among both HHs and cleaners affecting up to one of two people.
  

• 
  Impact of COVID-19 on mental health of health care workers in Spain: a mix-methods study. Ripoll, J; Chela, X; Briones-VozmedianoFiol-de Roque, E Ma; Zamanillo-Campos, R; Ricci-Cabello, I; Llobera, J; Calafat-Villalonga, C; Serrano-Ripoll, M J (2024). 24(1) 463–463.

  AbstractURLBibTeXEndNoteDOIBibSonomyDownload

  BACKGROUND: Spain's lockdown measures couldn't prevent the severe impact of the COVID-19 first wave, leading to high infections, deaths, and strain on healthcare workers (HCWs). This study aimed to explore the mental health impact on HCWs in the Balearic Islands during the initial months of the pandemic, the influencing factors, and the experiences of those in a COVID-19 environment. METHODS: Using a mixed-methods approach, the study encompassed quantitative and qualitative elements. Cross-sectional survey data from April to June 2020 comprised HCWs who were emailed invitations. The survey covered demographics, work, clinical and COVID-19 variables, along with psychological distress and PTSD symptoms, using validated measures. Additionally, semi-structured interviews with HCWs offered qualitative insights. RESULTS: Three hundred thirty-six HCWs averaging 46.8 years, mainly women (79.2%), primarily nurses in primary care with over 10 years of experience. Anxiety symptoms were reported by 28.8%, 65.1% noted worsened sleep quality, and 27.7% increased psychoactive drug usage. Psychological distress affected 55.2%, while 27.9% exhibited PTSD symptoms. Gender, age, experience, COVID-19 patient contact, and workload correlated with distress, PTSD symptoms, sleep quality, and psychoactive drug usage. Interviews uncovered discomfort sources, such as fear of infection and lack of control, leading to coping strategies like information avoidance and seeking support. LIMITATIONS: Static cross-sectional design, non-probabilistic sample, and telephone interviews affecting non-verbal cues, with interviews conducted during early pandemic lockdown. CONCLUSIONS: HCWs faced significant psychological distress during the pandemic's first wave, underscoring the necessity for robust support and resources to counteract its impact on mental health.

  @article{ripoll2024impact,
  abstract = {BACKGROUND: Spain's lockdown measures couldn't prevent the severe impact of the COVID-19 first wave, leading to high infections, deaths, and strain on healthcare workers (HCWs). This study aimed to explore the mental health impact on HCWs in the Balearic Islands during the initial months of the pandemic, the influencing factors, and the experiences of those in a COVID-19 environment. METHODS: Using a mixed-methods approach, the study encompassed quantitative and qualitative elements. Cross-sectional survey data from April to June 2020 comprised HCWs who were emailed invitations. The survey covered demographics, work, clinical and COVID-19 variables, along with psychological distress and PTSD symptoms, using validated measures. Additionally, semi-structured interviews with HCWs offered qualitative insights. RESULTS: Three hundred thirty-six HCWs averaging 46.8 years, mainly women (79.2%), primarily nurses in primary care with over 10 years of experience. Anxiety symptoms were reported by 28.8%, 65.1% noted worsened sleep quality, and 27.7% increased psychoactive drug usage. Psychological distress affected 55.2%, while 27.9% exhibited PTSD symptoms. Gender, age, experience, COVID-19 patient contact, and workload correlated with distress, PTSD symptoms, sleep quality, and psychoactive drug usage. Interviews uncovered discomfort sources, such as fear of infection and lack of control, leading to coping strategies like information avoidance and seeking support. LIMITATIONS: Static cross-sectional design, non-probabilistic sample, and telephone interviews affecting non-verbal cues, with interviews conducted during early pandemic lockdown. CONCLUSIONS: HCWs faced significant psychological distress during the pandemic's first wave, underscoring the necessity for robust support and resources to counteract its impact on mental health.},
  address = {England},
  author = {Ripoll, J and Chela, X and Briones-VozmedianoFiol-de Roque, E Ma and Zamanillo-Campos, R and Ricci-Cabello, I and Llobera, J and Calafat-Villalonga, C and Serrano-Ripoll, M J},
  journal = {BMC public health},
  keywords = {evisap grapp-caib},
  month = {feb},
  number = 1,
  pages = {463--463},
  title = {Impact of COVID-19 on mental health of health care workers in Spain: a mix-methods study},
  volume = 24,
  year = 2024
  }
  

  %0 Journal Article
  %1 ripoll2024impact
  %A Ripoll, J
  %A Chela, X
  %A Briones-VozmedianoFiol-de Roque, E Ma
  %A Zamanillo-Campos, R
  %A Ricci-Cabello, I
  %A Llobera, J
  %A Calafat-Villalonga, C
  %A Serrano-Ripoll, M J
  %C England
  %D 2024
  %J BMC public health
  %N 1
  %P 463--463
  %R 10.1186/s12889-024-17979-z
  %T Impact of COVID-19 on mental health of health care workers in Spain: a mix-methods study
  %U https://pubmed.ncbi.nlm.nih.gov/38355471
  %V 24
  %X BACKGROUND: Spain's lockdown measures couldn't prevent the severe impact of the COVID-19 first wave, leading to high infections, deaths, and strain on healthcare workers (HCWs). This study aimed to explore the mental health impact on HCWs in the Balearic Islands during the initial months of the pandemic, the influencing factors, and the experiences of those in a COVID-19 environment. METHODS: Using a mixed-methods approach, the study encompassed quantitative and qualitative elements. Cross-sectional survey data from April to June 2020 comprised HCWs who were emailed invitations. The survey covered demographics, work, clinical and COVID-19 variables, along with psychological distress and PTSD symptoms, using validated measures. Additionally, semi-structured interviews with HCWs offered qualitative insights. RESULTS: Three hundred thirty-six HCWs averaging 46.8 years, mainly women (79.2%), primarily nurses in primary care with over 10 years of experience. Anxiety symptoms were reported by 28.8%, 65.1% noted worsened sleep quality, and 27.7% increased psychoactive drug usage. Psychological distress affected 55.2%, while 27.9% exhibited PTSD symptoms. Gender, age, experience, COVID-19 patient contact, and workload correlated with distress, PTSD symptoms, sleep quality, and psychoactive drug usage. Interviews uncovered discomfort sources, such as fear of infection and lack of control, leading to coping strategies like information avoidance and seeking support. LIMITATIONS: Static cross-sectional design, non-probabilistic sample, and telephone interviews affecting non-verbal cues, with interviews conducted during early pandemic lockdown. CONCLUSIONS: HCWs faced significant psychological distress during the pandemic's first wave, underscoring the necessity for robust support and resources to counteract its impact on mental health.
  

• 
  Depression and lifestyle among university students: A one-year follow-up study. Roldán-Espínola, Lorenzo; Riera-Serra, Pau; Roca, Miquel; García-Toro, Mauro; Coronado-Simsic, Victoria; Castro, Adoración; Navarra-Ventura, Guillem; Vilagut, Gemma; Alayo, Itxaso; Ballester, Laura; Blasco, María Jesús; Almenara, José; Cebrià, Ana Isabel; Echeburúa, Enrique; Gabilondo, Andrea; Lagares, Carolina; Piqueras, José Antonio; Soto-Sanz, Victoria; Mortier, Philippe; Kessler, Ronald C.; Alonso, Jordi; Forteza-Rey, Inés; Gili, Margalida (2024). 38(3) 100250.

  AbstractURLBibTeXEndNoteDOIBibSonomyDownload

  Background and objectives University stage is a risk period for development of mental disorders and major depression disorder (MDD) is one of the most prevalent disorders. There is increasing evidence about the influence of lifestyle factors on depression onset and maintenance, nevertheless there is a great heterogeneity between analyzed lifestyle factors and few longitudinal studies has been carried out. The current study aims to longitudinally assess the influence of lifestyle on MDD courses among first-year university students. Methods First-onset and persistence of MDD and lifestyle trajectories are measured using baseline and 12-months follow-up online surveys. Multivariate logistic regression analyses were performed to study longitudinal risk/protective associations between lifestyle factors and MDD. Results 1,292 participants were included. Mean age of included participants at baseline was 18.5 (SD= 1.16) and 75.7 % were female. First-onset and persistence of MDD at T2 were 10.3 % and 38.9 % respectively. Maintenance of healthy sleep (Adjusted Odds Ratio (aOR) = 0.26; 95 % CI =0.12–0.58) and physical activity (aOR = 0.24; 95 % CI = 0.10–0.58) were protectively associated against MDD first-onset. Adoption of healthy levels of social support showed a protective effect against MDD persistence (aOR = 0.17; 95 % CI = 0.07–0.44). Conclusions Lifestyle should be considered in order to improve depression prevention strategies among university students. Sleep, physical activity, and social support seem to have a crucial role in the onset and persistence of depression among this population.

  @article{RN65,
  abstract = {Background and objectives University stage is a risk period for development of mental disorders and major depression disorder (MDD) is one of the most prevalent disorders. There is increasing evidence about the influence of lifestyle factors on depression onset and maintenance, nevertheless there is a great heterogeneity between analyzed lifestyle factors and few longitudinal studies has been carried out. The current study aims to longitudinally assess the influence of lifestyle on MDD courses among first-year university students. Methods First-onset and persistence of MDD and lifestyle trajectories are measured using baseline and 12-months follow-up online surveys. Multivariate logistic regression analyses were performed to study longitudinal risk/protective associations between lifestyle factors and MDD. Results 1,292 participants were included. Mean age of included participants at baseline was 18.5 (SD= 1.16) and 75.7 % were female. First-onset and persistence of MDD at T2 were 10.3 % and 38.9 % respectively. Maintenance of healthy sleep (Adjusted Odds Ratio (aOR) = 0.26; 95 % CI =0.12–0.58) and physical activity (aOR = 0.24; 95 % CI = 0.10–0.58) were protectively associated against MDD first-onset. Adoption of healthy levels of social support showed a protective effect against MDD persistence (aOR = 0.17; 95 % CI = 0.07–0.44). Conclusions Lifestyle should be considered in order to improve depression prevention strategies among university students. Sleep, physical activity, and social support seem to have a crucial role in the onset and persistence of depression among this population.},
  author = {Roldán-Espínola, Lorenzo and Riera-Serra, Pau and Roca, Miquel and García-Toro, Mauro and Coronado-Simsic, Victoria and Castro, Adoración and Navarra-Ventura, Guillem and Vilagut, Gemma and Alayo, Itxaso and Ballester, Laura and Blasco, María Jesús and Almenara, José and Cebrià, Ana Isabel and Echeburúa, Enrique and Gabilondo, Andrea and Lagares, Carolina and Piqueras, José Antonio and Soto-Sanz, Victoria and Mortier, Philippe and Kessler, Ronald C. and Alonso, Jordi and Forteza-Rey, Inés and Gili, Margalida},
  journal = {The European Journal of Psychiatry},
  keywords = {evisap},
  number = 3,
  pages = 100250,
  title = {Depression and lifestyle among university students: A one-year follow-up study},
  type = {Journal Article},
  volume = 38,
  year = 2024
  }
  

  %0 Journal Article
  %1 RN65
  %A Roldán-Espínola, Lorenzo
  %A Riera-Serra, Pau
  %A Roca, Miquel
  %A García-Toro, Mauro
  %A Coronado-Simsic, Victoria
  %A Castro, Adoración
  %A Navarra-Ventura, Guillem
  %A Vilagut, Gemma
  %A Alayo, Itxaso
  %A Ballester, Laura
  %A Blasco, María Jesús
  %A Almenara, José
  %A Cebrià, Ana Isabel
  %A Echeburúa, Enrique
  %A Gabilondo, Andrea
  %A Lagares, Carolina
  %A Piqueras, José Antonio
  %A Soto-Sanz, Victoria
  %A Mortier, Philippe
  %A Kessler, Ronald C.
  %A Alonso, Jordi
  %A Forteza-Rey, Inés
  %A Gili, Margalida
  %D 2024
  %J The European Journal of Psychiatry
  %N 3
  %P 100250
  %R https://doi.org/10.1016/j.ejpsy.2024.100250
  %T Depression and lifestyle among university students: A one-year follow-up study
  %U https://www.sciencedirect.com/science/article/pii/S0213616324000016
  %V 38
  %X Background and objectives University stage is a risk period for development of mental disorders and major depression disorder (MDD) is one of the most prevalent disorders. There is increasing evidence about the influence of lifestyle factors on depression onset and maintenance, nevertheless there is a great heterogeneity between analyzed lifestyle factors and few longitudinal studies has been carried out. The current study aims to longitudinally assess the influence of lifestyle on MDD courses among first-year university students. Methods First-onset and persistence of MDD and lifestyle trajectories are measured using baseline and 12-months follow-up online surveys. Multivariate logistic regression analyses were performed to study longitudinal risk/protective associations between lifestyle factors and MDD. Results 1,292 participants were included. Mean age of included participants at baseline was 18.5 (SD= 1.16) and 75.7 % were female. First-onset and persistence of MDD at T2 were 10.3 % and 38.9 % respectively. Maintenance of healthy sleep (Adjusted Odds Ratio (aOR) = 0.26; 95 % CI =0.12–0.58) and physical activity (aOR = 0.24; 95 % CI = 0.10–0.58) were protectively associated against MDD first-onset. Adoption of healthy levels of social support showed a protective effect against MDD persistence (aOR = 0.17; 95 % CI = 0.07–0.44). Conclusions Lifestyle should be considered in order to improve depression prevention strategies among university students. Sleep, physical activity, and social support seem to have a crucial role in the onset and persistence of depression among this population.
  

• 
  Factors associated with high and low mental well-being in Spanish university students. Navarra-Ventura, Guillem; Riera-Serra, Pau; Roca, Miquel; Gili, Margalida; García-Toro, Mauro; Vilagut, Gemma; Alayo, Itxaso; Ballester, Laura; Blasco, Maria Jesús; Castellví, Pere; Colom, Joan; Casajuana, Cristina; Gabilondo, Andrea; Lagares, Carolina; Almenara, José; Miranda-Mendizabal, Andrea; Mortier, Philippe; Piqueras, José Antonio; Soto-Sanz, Victoria; Alonso, Jordi; study group, UNIVERSAL (2024). 356 424–435.

  AbstractURLBibTeXEndNoteDOIBibSonomyDownload

  BACKGROUND: Previous studies conducted in various nationally representative samples of the general population show that positive mental health is related to social prosperity. However, specific studies in university populations are scarce. In this study, we set out to explore factors associated with mental well-being (MWB) in a representative sample of first-year university students in Spain. METHODS: MWB was assessed with the short version of the Warwick-Edinburgh Mental Well-Being Scale. Multinomial logistic regressions were performed to explore the association between different blocks of factors, including relational, adversity, stress, lifestyle, spiritual, health, and self-perceived health variables with high and low MWB, controlling for sociodemographic and university-related variables. RESULTS: Data from 2082 students (18.6 ± 1.2 years; 56.6 % females) were analysed. Being male, being born in a foreign country, "high" self-perceived support, and "high" self-perceived mental health increased the odds of high MWB. Growing up in the suburbs, stressful experiences, and anxiety disorders reduced the odds of high MWB. Mood and anxiety disorders increased the odds of low MWB. "Middle" self-perceived support, sleeping ≥8 h per day, and "high" self-perceived mental health reduced the odds of low MWB. LIMITATIONS: The cross-sectional design precludes establishing causal relationships. Data were collected in the 2014-15 academic year using self-reported online surveys. CONCLUSION: The factors associated with high and low MWB do not always mirror each other, so specific plans are needed to successfully address each of the two poles. Interventions and policies targeting these factors for health promotion and disease prevention would improve the MWB of university students.

  @article{navarraventura2024factors,
  abstract = {BACKGROUND: Previous studies conducted in various nationally representative samples of the general population show that positive mental health is related to social prosperity. However, specific studies in university populations are scarce. In this study, we set out to explore factors associated with mental well-being (MWB) in a representative sample of first-year university students in Spain. METHODS: MWB was assessed with the short version of the Warwick-Edinburgh Mental Well-Being Scale. Multinomial logistic regressions were performed to explore the association between different blocks of factors, including relational, adversity, stress, lifestyle, spiritual, health, and self-perceived health variables with high and low MWB, controlling for sociodemographic and university-related variables. RESULTS: Data from 2082 students (18.6 ± 1.2 years; 56.6 % females) were analysed. Being male, being born in a foreign country, "high" self-perceived support, and "high" self-perceived mental health increased the odds of high MWB. Growing up in the suburbs, stressful experiences, and anxiety disorders reduced the odds of high MWB. Mood and anxiety disorders increased the odds of low MWB. "Middle" self-perceived support, sleeping ≥8 h per day, and "high" self-perceived mental health reduced the odds of low MWB. LIMITATIONS: The cross-sectional design precludes establishing causal relationships. Data were collected in the 2014-15 academic year using self-reported online surveys. CONCLUSION: The factors associated with high and low MWB do not always mirror each other, so specific plans are needed to successfully address each of the two poles. Interventions and policies targeting these factors for health promotion and disease prevention would improve the MWB of university students.},
  address = {Netherlands},
  author = {Navarra-Ventura, Guillem and Riera-Serra, Pau and Roca, Miquel and Gili, Margalida and García-Toro, Mauro and Vilagut, Gemma and Alayo, Itxaso and Ballester, Laura and Blasco, Maria Jesús and Castellví, Pere and Colom, Joan and Casajuana, Cristina and Gabilondo, Andrea and Lagares, Carolina and Almenara, José and Miranda-Mendizabal, Andrea and Mortier, Philippe and Piqueras, José Antonio and Soto-Sanz, Victoria and Alonso, Jordi and study group, UNIVERSAL},
  journal = {Journal of affective disorders},
  keywords = {evisap},
  month = {jul},
  pages = {424--435},
  title = {Factors associated with high and low mental well-being in Spanish university students},
  volume = 356,
  year = 2024
  }
  

  %0 Journal Article
  %1 navarraventura2024factors
  %A Navarra-Ventura, Guillem
  %A Riera-Serra, Pau
  %A Roca, Miquel
  %A Gili, Margalida
  %A García-Toro, Mauro
  %A Vilagut, Gemma
  %A Alayo, Itxaso
  %A Ballester, Laura
  %A Blasco, Maria Jesús
  %A Castellví, Pere
  %A Colom, Joan
  %A Casajuana, Cristina
  %A Gabilondo, Andrea
  %A Lagares, Carolina
  %A Almenara, José
  %A Miranda-Mendizabal, Andrea
  %A Mortier, Philippe
  %A Piqueras, José Antonio
  %A Soto-Sanz, Victoria
  %A Alonso, Jordi
  %A study group, UNIVERSAL
  %C Netherlands
  %D 2024
  %J Journal of affective disorders
  %P 424--435
  %R 10.1016/j.jad.2024.04.056
  %T Factors associated with high and low mental well-being in Spanish university students
  %U https://pubmed.ncbi.nlm.nih.gov/38631424
  %V 356
  %X BACKGROUND: Previous studies conducted in various nationally representative samples of the general population show that positive mental health is related to social prosperity. However, specific studies in university populations are scarce. In this study, we set out to explore factors associated with mental well-being (MWB) in a representative sample of first-year university students in Spain. METHODS: MWB was assessed with the short version of the Warwick-Edinburgh Mental Well-Being Scale. Multinomial logistic regressions were performed to explore the association between different blocks of factors, including relational, adversity, stress, lifestyle, spiritual, health, and self-perceived health variables with high and low MWB, controlling for sociodemographic and university-related variables. RESULTS: Data from 2082 students (18.6 ± 1.2 years; 56.6 % females) were analysed. Being male, being born in a foreign country, "high" self-perceived support, and "high" self-perceived mental health increased the odds of high MWB. Growing up in the suburbs, stressful experiences, and anxiety disorders reduced the odds of high MWB. Mood and anxiety disorders increased the odds of low MWB. "Middle" self-perceived support, sleeping ≥8 h per day, and "high" self-perceived mental health reduced the odds of low MWB. LIMITATIONS: The cross-sectional design precludes establishing causal relationships. Data were collected in the 2014-15 academic year using self-reported online surveys. CONCLUSION: The factors associated with high and low MWB do not always mirror each other, so specific plans are needed to successfully address each of the two poles. Interventions and policies targeting these factors for health promotion and disease prevention would improve the MWB of university students.
  

2023

• 
  DiabeText, a mobile health intervention to support medication taking and healthy lifestyle in adults with type 2 diabetes: Study protocol for a randomized controlled trial. Zamanillo-Campos, R.; Fiol-DeRoque, M. A.; Serrano-Ripoll, M. J.; Mira-Martínez, S.; Llobera-Canaves, J.; Taltavull-Aparicio, J. M.; Leiva-Rus, A.; Ripoll-Amengual, J.; Angullo-Martínez, E.; Socias-Buades, I. M.; Masmiquel-Comas, L.; Konieczna, J.; Zaforteza-Dezcallar, M.; Boronat-Moreiro, M. A.; Gervilla-García, E.; Ricci-Cabello, I. (2023). 136 107399.

  AbstractBibTeXEndNoteDOIBibSonomyDownload

  AIM: To evaluate the effectiveness of DiabeText, a low-intensity, multifaceted, mobile health (mHealth) intervention to support medication taking and lifestyle change targeted to people with type 2 diabetes (T2D). DESIGN: Phase III, 12-months, two-arm (1:1 allocation ratio), randomized parallel-group trial. METHODS: We will recruit 740 adults with glycated hemoglobin (A1c) >8% (>64 mmol/mol) and with at least one prescription of a non-insulin antidiabetic drug. They will be allocated to a control (usual care) group or an intervention (DiabeText messaging intervention) group. The primary outcome measure will be A1c at 12 months follow-up. Secondary outcomes will include medication possession ratio and behavioral and psychological outcomes. DISCUSSION: Recent trials suggest that digital health interventions can effectively support diabetes self-management improving T2D control and reducing important T2D complications. In Spain this type of interventions is understudied. IMPACT: This trial will strengthen the evidence base of the impact of mHealth interventions to support diabetes self-management. If effective, DiabeText may offer a low-cost and highly scalable strategy to improve health at the population level in a sustainable way. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT05006872; Official Title: Supporting People with Type 2 Diabetes in Effective Use of their Medicine Through a System Comprising Mobile Health Technology Integrated with Clinical Care.

  @article{RN43,
  abstract = {AIM: To evaluate the effectiveness of DiabeText, a low-intensity, multifaceted, mobile health (mHealth) intervention to support medication taking and lifestyle change targeted to people with type 2 diabetes (T2D). DESIGN: Phase III, 12-months, two-arm (1:1 allocation ratio), randomized parallel-group trial. METHODS: We will recruit 740 adults with glycated hemoglobin (A1c) >8% (>64 mmol/mol) and with at least one prescription of a non-insulin antidiabetic drug. They will be allocated to a control (usual care) group or an intervention (DiabeText messaging intervention) group. The primary outcome measure will be A1c at 12 months follow-up. Secondary outcomes will include medication possession ratio and behavioral and psychological outcomes. DISCUSSION: Recent trials suggest that digital health interventions can effectively support diabetes self-management improving T2D control and reducing important T2D complications. In Spain this type of interventions is understudied. IMPACT: This trial will strengthen the evidence base of the impact of mHealth interventions to support diabetes self-management. If effective, DiabeText may offer a low-cost and highly scalable strategy to improve health at the population level in a sustainable way. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT05006872; Official Title: Supporting People with Type 2 Diabetes in Effective Use of their Medicine Through a System Comprising Mobile Health Technology Integrated with Clinical Care.},
  author = {Zamanillo-Campos, R. and Fiol-DeRoque, M. A. and Serrano-Ripoll, M. J. and Mira-Martínez, S. and Llobera-Canaves, J. and Taltavull-Aparicio, J. M. and Leiva-Rus, A. and Ripoll-Amengual, J. and Angullo-Martínez, E. and Socias-Buades, I. M. and Masmiquel-Comas, L. and Konieczna, J. and Zaforteza-Dezcallar, M. and Boronat-Moreiro, M. A. and Gervilla-García, E. and Ricci-Cabello, I.},
  journal = {Contemp Clin Trials},
  keywords = {evisap grapp-caib},
  pages = 107399,
  title = {DiabeText, a mobile health intervention to support medication taking and healthy lifestyle in adults with type 2 diabetes: Study protocol for a randomized controlled trial},
  type = {Journal Article},
  volume = 136,
  year = 2023
  }
  

  %0 Journal Article
  %1 RN43
  %A Zamanillo-Campos, R.
  %A Fiol-DeRoque, M. A.
  %A Serrano-Ripoll, M. J.
  %A Mira-Martínez, S.
  %A Llobera-Canaves, J.
  %A Taltavull-Aparicio, J. M.
  %A Leiva-Rus, A.
  %A Ripoll-Amengual, J.
  %A Angullo-Martínez, E.
  %A Socias-Buades, I. M.
  %A Masmiquel-Comas, L.
  %A Konieczna, J.
  %A Zaforteza-Dezcallar, M.
  %A Boronat-Moreiro, M. A.
  %A Gervilla-García, E.
  %A Ricci-Cabello, I.
  %D 2023
  %J Contemp Clin Trials
  %P 107399
  %R 10.1016/j.cct.2023.107399
  %T DiabeText, a mobile health intervention to support medication taking and healthy lifestyle in adults with type 2 diabetes: Study protocol for a randomized controlled trial
  %V 136
  %X AIM: To evaluate the effectiveness of DiabeText, a low-intensity, multifaceted, mobile health (mHealth) intervention to support medication taking and lifestyle change targeted to people with type 2 diabetes (T2D). DESIGN: Phase III, 12-months, two-arm (1:1 allocation ratio), randomized parallel-group trial. METHODS: We will recruit 740 adults with glycated hemoglobin (A1c) >8% (>64 mmol/mol) and with at least one prescription of a non-insulin antidiabetic drug. They will be allocated to a control (usual care) group or an intervention (DiabeText messaging intervention) group. The primary outcome measure will be A1c at 12 months follow-up. Secondary outcomes will include medication possession ratio and behavioral and psychological outcomes. DISCUSSION: Recent trials suggest that digital health interventions can effectively support diabetes self-management improving T2D control and reducing important T2D complications. In Spain this type of interventions is understudied. IMPACT: This trial will strengthen the evidence base of the impact of mHealth interventions to support diabetes self-management. If effective, DiabeText may offer a low-cost and highly scalable strategy to improve health at the population level in a sustainable way. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT05006872; Official Title: Supporting People with Type 2 Diabetes in Effective Use of their Medicine Through a System Comprising Mobile Health Technology Integrated with Clinical Care.
  

• 
  Horizon scanning on microorganisms and their products obtained by new developments in biotechnology. Ballester, Ana-Rosa; Roqué, Marta; Ricci-Cabello, Ignacio; Rotger, Andreu; Malih, Narges (2023). 20(12) 8503E.

  AbstractURLBibTeXEndNoteDOIBibSonomyDownload

  Abstract Background The aim of this horizon scanning is to map applications of new genomic techniques (NGTs) developed after Directive 2001/18/EC to obtain genetically modified microorganisms (GMMs) of categories 3 and 4, with an application to the agri-food and feed sectors; as well as understanding their relevant safety and risk assessment aspects. Methods The review comprised systematic comprehensive searches for the identification of relevant applications: i) structured electronic searches in Medline, EMBASE, and Web of Science, and ii) searches in on-line resources, including websites of companies, regulatory agencies, patents, and registries. Results we identified 35 GMMs meeting the eligibility criteria. An evidence table (available in a separate file) offers a detailed description of their characteristics. Most of the GMMs were developed or commercialised by institutions in China or USA (14 and 10 cases, respectively). Of the 35 GMMs identified, 11 were bacteria, 22 yeasts, one fungal endophyte, and one microalga. As for use, 30 GMMs were used as (or as a source of) food or food additives, three as (or as a source of) feed or feed additives, and two for agricultural purposes. Eight GMMs are already commercialized, 9 are published in patent applications, and 18 are under development. When considering the purpose of the new traits introduced, 10 GMMs modify flavours in food; 10 increase the bioproduction of compounds; seven improve food profile/composition; two boost immunity/reduce toxicity in feed additives; five optimize food production processes, and one increases nitrogen-fixation as fertiliser. Only three identified GMMs have been subjected to an authorisation process by national or international authorities, and risk assessment studies are scarcely available. The findings of this horizon scan illustrate the growing worldwide adoption of NGTs in producing GMMs for application in the food and feed sectors.

  @article{RN24,
  abstract = {Abstract Background The aim of this horizon scanning is to map applications of new genomic techniques (NGTs) developed after Directive 2001/18/EC to obtain genetically modified microorganisms (GMMs) of categories 3 and 4, with an application to the agri-food and feed sectors; as well as understanding their relevant safety and risk assessment aspects. Methods The review comprised systematic comprehensive searches for the identification of relevant applications: i) structured electronic searches in Medline, EMBASE, and Web of Science, and ii) searches in on-line resources, including websites of companies, regulatory agencies, patents, and registries. Results we identified 35 GMMs meeting the eligibility criteria. An evidence table (available in a separate file) offers a detailed description of their characteristics. Most of the GMMs were developed or commercialised by institutions in China or USA (14 and 10 cases, respectively). Of the 35 GMMs identified, 11 were bacteria, 22 yeasts, one fungal endophyte, and one microalga. As for use, 30 GMMs were used as (or as a source of) food or food additives, three as (or as a source of) feed or feed additives, and two for agricultural purposes. Eight GMMs are already commercialized, 9 are published in patent applications, and 18 are under development. When considering the purpose of the new traits introduced, 10 GMMs modify flavours in food; 10 increase the bioproduction of compounds; seven improve food profile/composition; two boost immunity/reduce toxicity in feed additives; five optimize food production processes, and one increases nitrogen-fixation as fertiliser. Only three identified GMMs have been subjected to an authorisation process by national or international authorities, and risk assessment studies are scarcely available. The findings of this horizon scan illustrate the growing worldwide adoption of NGTs in producing GMMs for application in the food and feed sectors.},
  author = {Ballester, Ana-Rosa and Roqué, Marta and Ricci-Cabello, Ignacio and Rotger, Andreu and Malih, Narges},
  journal = {EFSA Supporting Publications},
  keywords = {evisap grapp-caib},
  number = 12,
  pages = {8503E},
  title = {Horizon scanning on microorganisms and their products obtained by new developments in biotechnology},
  type = {Journal Article},
  volume = 20,
  year = 2023
  }
  

  %0 Journal Article
  %1 RN24
  %A Ballester, Ana-Rosa
  %A Roqué, Marta
  %A Ricci-Cabello, Ignacio
  %A Rotger, Andreu
  %A Malih, Narges
  %D 2023
  %J EFSA Supporting Publications
  %N 12
  %P 8503E
  %R https://doi.org/10.2903/sp.efsa.2023.EN-8503
  %T Horizon scanning on microorganisms and their products obtained by new developments in biotechnology
  %U https://doi.org/10.2903/sp.efsa.2023.EN-8503
  %V 20
  %X Abstract Background The aim of this horizon scanning is to map applications of new genomic techniques (NGTs) developed after Directive 2001/18/EC to obtain genetically modified microorganisms (GMMs) of categories 3 and 4, with an application to the agri-food and feed sectors; as well as understanding their relevant safety and risk assessment aspects. Methods The review comprised systematic comprehensive searches for the identification of relevant applications: i) structured electronic searches in Medline, EMBASE, and Web of Science, and ii) searches in on-line resources, including websites of companies, regulatory agencies, patents, and registries. Results we identified 35 GMMs meeting the eligibility criteria. An evidence table (available in a separate file) offers a detailed description of their characteristics. Most of the GMMs were developed or commercialised by institutions in China or USA (14 and 10 cases, respectively). Of the 35 GMMs identified, 11 were bacteria, 22 yeasts, one fungal endophyte, and one microalga. As for use, 30 GMMs were used as (or as a source of) food or food additives, three as (or as a source of) feed or feed additives, and two for agricultural purposes. Eight GMMs are already commercialized, 9 are published in patent applications, and 18 are under development. When considering the purpose of the new traits introduced, 10 GMMs modify flavours in food; 10 increase the bioproduction of compounds; seven improve food profile/composition; two boost immunity/reduce toxicity in feed additives; five optimize food production processes, and one increases nitrogen-fixation as fertiliser. Only three identified GMMs have been subjected to an authorisation process by national or international authorities, and risk assessment studies are scarcely available. The findings of this horizon scan illustrate the growing worldwide adoption of NGTs in producing GMMs for application in the food and feed sectors.
  

• 
  Clinical predictors of suicidal ideation, suicide attempts and suicide death in depressive disorder: a systematic review and meta-analysis. Riera-Serra, P.; Navarra-Ventura, G.; Castro, A.; Gili, M.; Salazar-Cedillo, A.; Ricci-Cabello, I.; Roldán-Espínola, L.; Coronado-Simsic, V.; García-Toro, M.; Gómez-Juanes, R.; Roca, M. (2023).

  AbstractBibTeXEndNoteDOIBibSonomyDownload

  AIM: To evaluate the effectiveness of DiabeText, a low-intensity, multifaceted, mobile health (mHealth) intervention to support medication taking and lifestyle change targeted to people with type 2 diabetes (T2D). DESIGN: Phase III, 12-months, two-arm (1:1 allocation ratio), randomized parallel-group trial. METHODS: We will recruit 740 adults with glycated hemoglobin (A1c) >8% (>64 mmol/mol) and with at least one prescription of a non-insulin antidiabetic drug. They will be allocated to a control (usual care) group or an intervention (DiabeText messaging intervention) group. The primary outcome measure will be A1c at 12 months follow-up. Secondary outcomes will include medication possession ratio and behavioral and psychological outcomes. DISCUSSION: Recent trials suggest that digital health interventions can effectively support diabetes self-management improving T2D control and reducing important T2D complications. In Spain this type of interventions is understudied. IMPACT: This trial will strengthen the evidence base of the impact of mHealth interventions to support diabetes self-management. If effective, DiabeText may offer a low-cost and highly scalable strategy to improve health at the population level in a sustainable way. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT05006872; Official Title: Supporting People with Type 2 Diabetes in Effective Use of their Medicine Through a System Comprising Mobile Health Technology Integrated with Clinical Care.

  @article{RN42,
  abstract = {AIM: To evaluate the effectiveness of DiabeText, a low-intensity, multifaceted, mobile health (mHealth) intervention to support medication taking and lifestyle change targeted to people with type 2 diabetes (T2D). DESIGN: Phase III, 12-months, two-arm (1:1 allocation ratio), randomized parallel-group trial. METHODS: We will recruit 740 adults with glycated hemoglobin (A1c) >8% (>64 mmol/mol) and with at least one prescription of a non-insulin antidiabetic drug. They will be allocated to a control (usual care) group or an intervention (DiabeText messaging intervention) group. The primary outcome measure will be A1c at 12 months follow-up. Secondary outcomes will include medication possession ratio and behavioral and psychological outcomes. DISCUSSION: Recent trials suggest that digital health interventions can effectively support diabetes self-management improving T2D control and reducing important T2D complications. In Spain this type of interventions is understudied. IMPACT: This trial will strengthen the evidence base of the impact of mHealth interventions to support diabetes self-management. If effective, DiabeText may offer a low-cost and highly scalable strategy to improve health at the population level in a sustainable way. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT05006872; Official Title: Supporting People with Type 2 Diabetes in Effective Use of their Medicine Through a System Comprising Mobile Health Technology Integrated with Clinical Care.},
  author = {Riera-Serra, P. and Navarra-Ventura, G. and Castro, A. and Gili, M. and Salazar-Cedillo, A. and Ricci-Cabello, I. and Roldán-Espínola, L. and Coronado-Simsic, V. and García-Toro, M. and Gómez-Juanes, R. and Roca, M.},
  journal = {Eur Arch Psychiatry Clin Neurosci},
  keywords = {evisap grapp-caib},
  title = {Clinical predictors of suicidal ideation, suicide attempts and suicide death in depressive disorder: a systematic review and meta-analysis},
  type = {Journal Article},
  year = 2023
  }
  

  %0 Journal Article
  %1 RN42
  %A Riera-Serra, P.
  %A Navarra-Ventura, G.
  %A Castro, A.
  %A Gili, M.
  %A Salazar-Cedillo, A.
  %A Ricci-Cabello, I.
  %A Roldán-Espínola, L.
  %A Coronado-Simsic, V.
  %A García-Toro, M.
  %A Gómez-Juanes, R.
  %A Roca, M.
  %D 2023
  %J Eur Arch Psychiatry Clin Neurosci
  %R 10.1007/s00406-023-01716-5
  %T Clinical predictors of suicidal ideation, suicide attempts and suicide death in depressive disorder: a systematic review and meta-analysis
  %X AIM: To evaluate the effectiveness of DiabeText, a low-intensity, multifaceted, mobile health (mHealth) intervention to support medication taking and lifestyle change targeted to people with type 2 diabetes (T2D). DESIGN: Phase III, 12-months, two-arm (1:1 allocation ratio), randomized parallel-group trial. METHODS: We will recruit 740 adults with glycated hemoglobin (A1c) >8% (>64 mmol/mol) and with at least one prescription of a non-insulin antidiabetic drug. They will be allocated to a control (usual care) group or an intervention (DiabeText messaging intervention) group. The primary outcome measure will be A1c at 12 months follow-up. Secondary outcomes will include medication possession ratio and behavioral and psychological outcomes. DISCUSSION: Recent trials suggest that digital health interventions can effectively support diabetes self-management improving T2D control and reducing important T2D complications. In Spain this type of interventions is understudied. IMPACT: This trial will strengthen the evidence base of the impact of mHealth interventions to support diabetes self-management. If effective, DiabeText may offer a low-cost and highly scalable strategy to improve health at the population level in a sustainable way. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT05006872; Official Title: Supporting People with Type 2 Diabetes in Effective Use of their Medicine Through a System Comprising Mobile Health Technology Integrated with Clinical Care.
  

• 
  Development and evaluation of DiabeText, a personalized mHealth intervention to support medication adherence and lifestyle change behaviour in patients with type 2 diabetes in Spain: A mixed-methods phase II pragmatic randomized controlled clinical trial. Zamanillo-Campos, R.; Fiol deRoque, M. A.; Serrano-Ripoll, M. J.; Mira-Martínez, S.; Ricci-Cabello, I. (2023). 176 105103.

  AbstractBibTeXEndNoteDOIBibSonomyDownload

  BACKGROUND: Despite the increasing interest in text-messaging interventions to support healthcare delivery, the available evidence about their effectiveness is still limited. OBJECTIVES: 1) to develop DiabeText, an intervention delivering automated, tailored brief text messages to support diabetes self-management; 2) to explore the potential impact of DiabeText on self-management behavior and glycaemic control, and; 3) to examine the feasibility of conducting a future phase III randomized clinical trial to evaluate the effectiveness of DiabeText. METHODS: 3-month, two-arm, randomized feasibility trial (ClinicalTrials.gov: NCT04738591) with patients with type 2 diabetes (HbA1c > 8%). Participants were allocated to the control (usual care) or DiabeText group (usual care + five text messages per week). Outcomes were: recruitment rate; follow-up rate, missing data; medication adherence; adherence to Mediterranean diet; physical activity; and HbA1c. In addition, after delivering the intervention, we conducted a qualitative study involving 14 semi-structured interviews with participants allocated to the DiabeText group, to understand their views about the intervention. RESULTS: From 444 screened people, we recruited 207 participants (recruitment rate = 47%), of which 179 completed the post-intervention interview (follow-up rate = 86%). We sent 7,355 SMS during the intervention period, of which 99% successfully reached the participants. At post-intervention, DiabeText was associated with non-statistically significant (p > 0.05) improvements in adherence to medication (OR = 2.0; 95%CI 1.0 to 4.2), Mediterranean diet (1.7; 0.9 to 3.2), and physical activity (1.7; 0.9 to 3.1). No between-group differences were observed in mean HbA1c (p = 0.670). The qualitative study indicated that participants perceived DiabeText as a helpful resource because it increased their awareness about the importance of adequate self-management and the sense of being cared for. CONCLUSIONS: DiabeText is the first system in Spain to integrate patient-generated and routinely collected clinical data to deliver tailored text messages to support diabetes self-management. More robust trials are needed to determine its effectiveness and cost-efficacy.

  @article{RN1,
  abstract = {BACKGROUND: Despite the increasing interest in text-messaging interventions to support healthcare delivery, the available evidence about their effectiveness is still limited. OBJECTIVES: 1) to develop DiabeText, an intervention delivering automated, tailored brief text messages to support diabetes self-management; 2) to explore the potential impact of DiabeText on self-management behavior and glycaemic control, and; 3) to examine the feasibility of conducting a future phase III randomized clinical trial to evaluate the effectiveness of DiabeText. METHODS: 3-month, two-arm, randomized feasibility trial (ClinicalTrials.gov: NCT04738591) with patients with type 2 diabetes (HbA1c > 8%). Participants were allocated to the control (usual care) or DiabeText group (usual care + five text messages per week). Outcomes were: recruitment rate; follow-up rate, missing data; medication adherence; adherence to Mediterranean diet; physical activity; and HbA1c. In addition, after delivering the intervention, we conducted a qualitative study involving 14 semi-structured interviews with participants allocated to the DiabeText group, to understand their views about the intervention. RESULTS: From 444 screened people, we recruited 207 participants (recruitment rate = 47%), of which 179 completed the post-intervention interview (follow-up rate = 86%). We sent 7,355 SMS during the intervention period, of which 99% successfully reached the participants. At post-intervention, DiabeText was associated with non-statistically significant (p > 0.05) improvements in adherence to medication (OR = 2.0; 95%CI 1.0 to 4.2), Mediterranean diet (1.7; 0.9 to 3.2), and physical activity (1.7; 0.9 to 3.1). No between-group differences were observed in mean HbA1c (p = 0.670). The qualitative study indicated that participants perceived DiabeText as a helpful resource because it increased their awareness about the importance of adequate self-management and the sense of being cared for. CONCLUSIONS: DiabeText is the first system in Spain to integrate patient-generated and routinely collected clinical data to deliver tailored text messages to support diabetes self-management. More robust trials are needed to determine its effectiveness and cost-efficacy.},
  author = {Zamanillo-Campos, R. and Fiol deRoque, M. A. and Serrano-Ripoll, M. J. and Mira-Martínez, S. and Ricci-Cabello, I.},
  journal = {Int J Med Inform},
  keywords = {evisap grapp-caib},
  pages = 105103,
  title = {Development and evaluation of DiabeText, a personalized mHealth intervention to support medication adherence and lifestyle change behaviour in patients with type 2 diabetes in Spain: A mixed-methods phase II pragmatic randomized controlled clinical trial},
  type = {Journal Article},
  volume = 176,
  year = 2023
  }
  

  %0 Journal Article
  %1 RN1
  %A Zamanillo-Campos, R.
  %A Fiol deRoque, M. A.
  %A Serrano-Ripoll, M. J.
  %A Mira-Martínez, S.
  %A Ricci-Cabello, I.
  %D 2023
  %J Int J Med Inform
  %P 105103
  %R 10.1016/j.ijmedinf.2023.105103
  %T Development and evaluation of DiabeText, a personalized mHealth intervention to support medication adherence and lifestyle change behaviour in patients with type 2 diabetes in Spain: A mixed-methods phase II pragmatic randomized controlled clinical trial
  %V 176
  %X BACKGROUND: Despite the increasing interest in text-messaging interventions to support healthcare delivery, the available evidence about their effectiveness is still limited. OBJECTIVES: 1) to develop DiabeText, an intervention delivering automated, tailored brief text messages to support diabetes self-management; 2) to explore the potential impact of DiabeText on self-management behavior and glycaemic control, and; 3) to examine the feasibility of conducting a future phase III randomized clinical trial to evaluate the effectiveness of DiabeText. METHODS: 3-month, two-arm, randomized feasibility trial (ClinicalTrials.gov: NCT04738591) with patients with type 2 diabetes (HbA1c > 8%). Participants were allocated to the control (usual care) or DiabeText group (usual care + five text messages per week). Outcomes were: recruitment rate; follow-up rate, missing data; medication adherence; adherence to Mediterranean diet; physical activity; and HbA1c. In addition, after delivering the intervention, we conducted a qualitative study involving 14 semi-structured interviews with participants allocated to the DiabeText group, to understand their views about the intervention. RESULTS: From 444 screened people, we recruited 207 participants (recruitment rate = 47%), of which 179 completed the post-intervention interview (follow-up rate = 86%). We sent 7,355 SMS during the intervention period, of which 99% successfully reached the participants. At post-intervention, DiabeText was associated with non-statistically significant (p > 0.05) improvements in adherence to medication (OR = 2.0; 95%CI 1.0 to 4.2), Mediterranean diet (1.7; 0.9 to 3.2), and physical activity (1.7; 0.9 to 3.1). No between-group differences were observed in mean HbA1c (p = 0.670). The qualitative study indicated that participants perceived DiabeText as a helpful resource because it increased their awareness about the importance of adequate self-management and the sense of being cared for. CONCLUSIONS: DiabeText is the first system in Spain to integrate patient-generated and routinely collected clinical data to deliver tailored text messages to support diabetes self-management. More robust trials are needed to determine its effectiveness and cost-efficacy.
  

• 
  Characteristics and impact of interventions to support healthcare providers’ compliance with guideline recommendations for breast cancer: a systematic literature review. Ricci-Cabello, I.; Carvallo-Castañeda, D.; Vásquez-Mejía, A.; Alonso-Coello, P.; Saz-Parkinson, Z.; Parmelli, E.; Morgano, G. P.; Rigau, D.; Solà, I.; Neamtiu, L.; Niño-de Guzmán, E. (2023). 18(1) 17.

  AbstractBibTeXEndNoteDOIBibSonomyDownload

  BACKGROUND: Breast cancer clinical practice guidelines (CPGs) offer evidence-based recommendations to improve quality of healthcare for patients. Suboptimal compliance with breast cancer guideline recommendations remains frequent, and has been associated with a decreased survival. The aim of this systematic review was to characterize and determine the impact of available interventions to support healthcare providers' compliance with CPGs recommendations in breast cancer healthcare. METHODS: We searched for systematic reviews and primary studies in PubMed and Embase (from inception to May 2021). We included experimental and observational studies reporting on the use of interventions to support compliance with breast cancer CPGs. Eligibility assessment, data extraction and critical appraisal was conducted by one reviewer, and cross-checked by a second reviewer. Using the same approach, we synthesized the characteristics and the effects of the interventions by type of intervention (according to the EPOC taxonomy), and applied the GRADE framework to assess the certainty of evidence. RESULTS: We identified 35 primary studies reporting on 24 different interventions. Most frequently described interventions consisted in computerized decision support systems (12 studies); educational interventions (seven), audit and feedback (two), and multifaceted interventions (nine). There is low quality evidence that educational interventions targeted to healthcare professionals may improve compliance with recommendations concerning breast cancer screening, diagnosis and treatment. There is moderate quality evidence that reminder systems for healthcare professionals improve compliance with recommendations concerning breast cancer screening. There is low quality evidence that multifaceted interventions may improve compliance with recommendations concerning breast cancer screening. The effectiveness of the remaining types of interventions identified have not been evaluated with appropriate study designs for such purpose. There is very limited data on the costs of implementing these interventions. CONCLUSIONS: Different types of interventions to support compliance with breast cancer CPGs recommendations are available, and most of them show positive effects. More robust trials are needed to strengthen the available evidence base concerning their efficacy. Gathering data on the costs of implementing the proposed interventions is needed to inform decisions about their widespread implementation. TRIAL REGISTRATION: CRD42018092884 (PROSPERO).

  @article{RN122,
  abstract = {BACKGROUND: Breast cancer clinical practice guidelines (CPGs) offer evidence-based recommendations to improve quality of healthcare for patients. Suboptimal compliance with breast cancer guideline recommendations remains frequent, and has been associated with a decreased survival. The aim of this systematic review was to characterize and determine the impact of available interventions to support healthcare providers' compliance with CPGs recommendations in breast cancer healthcare. METHODS: We searched for systematic reviews and primary studies in PubMed and Embase (from inception to May 2021). We included experimental and observational studies reporting on the use of interventions to support compliance with breast cancer CPGs. Eligibility assessment, data extraction and critical appraisal was conducted by one reviewer, and cross-checked by a second reviewer. Using the same approach, we synthesized the characteristics and the effects of the interventions by type of intervention (according to the EPOC taxonomy), and applied the GRADE framework to assess the certainty of evidence. RESULTS: We identified 35 primary studies reporting on 24 different interventions. Most frequently described interventions consisted in computerized decision support systems (12 studies); educational interventions (seven), audit and feedback (two), and multifaceted interventions (nine). There is low quality evidence that educational interventions targeted to healthcare professionals may improve compliance with recommendations concerning breast cancer screening, diagnosis and treatment. There is moderate quality evidence that reminder systems for healthcare professionals improve compliance with recommendations concerning breast cancer screening. There is low quality evidence that multifaceted interventions may improve compliance with recommendations concerning breast cancer screening. The effectiveness of the remaining types of interventions identified have not been evaluated with appropriate study designs for such purpose. There is very limited data on the costs of implementing these interventions. CONCLUSIONS: Different types of interventions to support compliance with breast cancer CPGs recommendations are available, and most of them show positive effects. More robust trials are needed to strengthen the available evidence base concerning their efficacy. Gathering data on the costs of implementing the proposed interventions is needed to inform decisions about their widespread implementation. TRIAL REGISTRATION: CRD42018092884 (PROSPERO).},
  author = {Ricci-Cabello, I. and Carvallo-Castañeda, D. and Vásquez-Mejía, A. and Alonso-Coello, P. and Saz-Parkinson, Z. and Parmelli, E. and Morgano, G. P. and Rigau, D. and Solà, I. and Neamtiu, L. and Niño-de Guzmán, E.},
  journal = {Implement Sci},
  keywords = {evisap grapp-caib},
  number = 1,
  pages = 17,
  title = {Characteristics and impact of interventions to support healthcare providers' compliance with guideline recommendations for breast cancer: a systematic literature review},
  type = {Journal Article},
  volume = 18,
  year = 2023
  }
  

  %0 Journal Article
  %1 RN122
  %A Ricci-Cabello, I.
  %A Carvallo-Castañeda, D.
  %A Vásquez-Mejía, A.
  %A Alonso-Coello, P.
  %A Saz-Parkinson, Z.
  %A Parmelli, E.
  %A Morgano, G. P.
  %A Rigau, D.
  %A Solà, I.
  %A Neamtiu, L.
  %A Niño-de Guzmán, E.
  %D 2023
  %J Implement Sci
  %N 1
  %P 17
  %R 10.1186/s13012-023-01267-2
  %T Characteristics and impact of interventions to support healthcare providers' compliance with guideline recommendations for breast cancer: a systematic literature review
  %V 18
  %X BACKGROUND: Breast cancer clinical practice guidelines (CPGs) offer evidence-based recommendations to improve quality of healthcare for patients. Suboptimal compliance with breast cancer guideline recommendations remains frequent, and has been associated with a decreased survival. The aim of this systematic review was to characterize and determine the impact of available interventions to support healthcare providers' compliance with CPGs recommendations in breast cancer healthcare. METHODS: We searched for systematic reviews and primary studies in PubMed and Embase (from inception to May 2021). We included experimental and observational studies reporting on the use of interventions to support compliance with breast cancer CPGs. Eligibility assessment, data extraction and critical appraisal was conducted by one reviewer, and cross-checked by a second reviewer. Using the same approach, we synthesized the characteristics and the effects of the interventions by type of intervention (according to the EPOC taxonomy), and applied the GRADE framework to assess the certainty of evidence. RESULTS: We identified 35 primary studies reporting on 24 different interventions. Most frequently described interventions consisted in computerized decision support systems (12 studies); educational interventions (seven), audit and feedback (two), and multifaceted interventions (nine). There is low quality evidence that educational interventions targeted to healthcare professionals may improve compliance with recommendations concerning breast cancer screening, diagnosis and treatment. There is moderate quality evidence that reminder systems for healthcare professionals improve compliance with recommendations concerning breast cancer screening. There is low quality evidence that multifaceted interventions may improve compliance with recommendations concerning breast cancer screening. The effectiveness of the remaining types of interventions identified have not been evaluated with appropriate study designs for such purpose. There is very limited data on the costs of implementing these interventions. CONCLUSIONS: Different types of interventions to support compliance with breast cancer CPGs recommendations are available, and most of them show positive effects. More robust trials are needed to strengthen the available evidence base concerning their efficacy. Gathering data on the costs of implementing the proposed interventions is needed to inform decisions about their widespread implementation. TRIAL REGISTRATION: CRD42018092884 (PROSPERO).
  

• 
  Interventions to reduce cancer screening inequities: the perspective and role of patients, advocacy groups, and empowerment organizations. Richardson-Parry, A.; Baas, C.; Donde, S.; Ferraiolo, B.; Karmo, M.; Maravic, Z.; Münter, L.; Ricci-Cabello, I.; Silva, M.; Tinianov, S.; Valderas, J. M.; Woodruff, S.; van Vugt, J. (2023). 22(1) 19.

  AbstractBibTeXEndNoteDOIBibSonomyDownload

  BACKGROUND: Health inequities lead to low rates of cancer screening in certain populations, such as low-income and ethnic minority groups. Different interventions to address this have been developed with mixed results. However, interventions are not always developed in collaboration with the people they target. The aim of our article is to present the viewpoint of patients, survivors, advocates, and lay persons on interventions to increase cancer screening from a health inequity perspective. METHODS: We prepared talking points to guide discussions between coauthors, who included representatives from nine patient and survivor advocacy groups, organizations working for citizen/patient empowerment, and health equity experts. Perspectives and opinions were first collected through video conferencing meetings and a first draft of the paper was prepared. All authors, read through, revised, and discussed the contents to reach an agreement on the final perspectives to be presented. RESULTS: Several themes were identified: it is important to not view screening as a discrete event; barriers underlying an individual's access and willingness to undergo screening span across a continuum; individually tailored interventions are likely to be more effective than a one-size fits-all approach because they may better accommodate the person's personal beliefs, knowledge, behaviors, and preferences; targeting people who are unknown to medical services and largely unreachable is a major challenge; including professional patient advocacy groups and relevant lay persons in the cocreation of interventions at all stages of design, implementation, and evaluation is essential along with relevant stakeholders (healthcare professionals, researchers, local government and community organizations etc). CONCLUSIONS: Interventions to address cancer screening inequity currently do not adequately solve the issue, especially from the viewpoint of patients, survivors, and lay persons. Several core pathways should be focused on when designing and implementing interventions: advancing individually tailored interventions; digital tools and social media; peer-based approaches; empowerment; addressing policy and system barriers; better design of interventions; and collaboration, including the involvement of patients and patient advocacy organizations.

  @article{RN129,
  abstract = {BACKGROUND: Health inequities lead to low rates of cancer screening in certain populations, such as low-income and ethnic minority groups. Different interventions to address this have been developed with mixed results. However, interventions are not always developed in collaboration with the people they target. The aim of our article is to present the viewpoint of patients, survivors, advocates, and lay persons on interventions to increase cancer screening from a health inequity perspective. METHODS: We prepared talking points to guide discussions between coauthors, who included representatives from nine patient and survivor advocacy groups, organizations working for citizen/patient empowerment, and health equity experts. Perspectives and opinions were first collected through video conferencing meetings and a first draft of the paper was prepared. All authors, read through, revised, and discussed the contents to reach an agreement on the final perspectives to be presented. RESULTS: Several themes were identified: it is important to not view screening as a discrete event; barriers underlying an individual's access and willingness to undergo screening span across a continuum; individually tailored interventions are likely to be more effective than a one-size fits-all approach because they may better accommodate the person's personal beliefs, knowledge, behaviors, and preferences; targeting people who are unknown to medical services and largely unreachable is a major challenge; including professional patient advocacy groups and relevant lay persons in the cocreation of interventions at all stages of design, implementation, and evaluation is essential along with relevant stakeholders (healthcare professionals, researchers, local government and community organizations etc). CONCLUSIONS: Interventions to address cancer screening inequity currently do not adequately solve the issue, especially from the viewpoint of patients, survivors, and lay persons. Several core pathways should be focused on when designing and implementing interventions: advancing individually tailored interventions; digital tools and social media; peer-based approaches; empowerment; addressing policy and system barriers; better design of interventions; and collaboration, including the involvement of patients and patient advocacy organizations.},
  author = {Richardson-Parry, A. and Baas, C. and Donde, S. and Ferraiolo, B. and Karmo, M. and Maravic, Z. and Münter, L. and Ricci-Cabello, I. and Silva, M. and Tinianov, S. and Valderas, J. M. and Woodruff, S. and van Vugt, J.},
  journal = {Int J Equity Health},
  keywords = {evisap grapp-caib},
  number = 1,
  pages = 19,
  title = {Interventions to reduce cancer screening inequities: the perspective and role of patients, advocacy groups, and empowerment organizations},
  type = {Journal Article},
  volume = 22,
  year = 2023
  }
  

  %0 Journal Article
  %1 RN129
  %A Richardson-Parry, A.
  %A Baas, C.
  %A Donde, S.
  %A Ferraiolo, B.
  %A Karmo, M.
  %A Maravic, Z.
  %A Münter, L.
  %A Ricci-Cabello, I.
  %A Silva, M.
  %A Tinianov, S.
  %A Valderas, J. M.
  %A Woodruff, S.
  %A van Vugt, J.
  %D 2023
  %J Int J Equity Health
  %N 1
  %P 19
  %R 10.1186/s12939-023-01841-6
  %T Interventions to reduce cancer screening inequities: the perspective and role of patients, advocacy groups, and empowerment organizations
  %V 22
  %X BACKGROUND: Health inequities lead to low rates of cancer screening in certain populations, such as low-income and ethnic minority groups. Different interventions to address this have been developed with mixed results. However, interventions are not always developed in collaboration with the people they target. The aim of our article is to present the viewpoint of patients, survivors, advocates, and lay persons on interventions to increase cancer screening from a health inequity perspective. METHODS: We prepared talking points to guide discussions between coauthors, who included representatives from nine patient and survivor advocacy groups, organizations working for citizen/patient empowerment, and health equity experts. Perspectives and opinions were first collected through video conferencing meetings and a first draft of the paper was prepared. All authors, read through, revised, and discussed the contents to reach an agreement on the final perspectives to be presented. RESULTS: Several themes were identified: it is important to not view screening as a discrete event; barriers underlying an individual's access and willingness to undergo screening span across a continuum; individually tailored interventions are likely to be more effective than a one-size fits-all approach because they may better accommodate the person's personal beliefs, knowledge, behaviors, and preferences; targeting people who are unknown to medical services and largely unreachable is a major challenge; including professional patient advocacy groups and relevant lay persons in the cocreation of interventions at all stages of design, implementation, and evaluation is essential along with relevant stakeholders (healthcare professionals, researchers, local government and community organizations etc). CONCLUSIONS: Interventions to address cancer screening inequity currently do not adequately solve the issue, especially from the viewpoint of patients, survivors, and lay persons. Several core pathways should be focused on when designing and implementing interventions: advancing individually tailored interventions; digital tools and social media; peer-based approaches; empowerment; addressing policy and system barriers; better design of interventions; and collaboration, including the involvement of patients and patient advocacy organizations.
  

• 
  Effect of physical activity and different exercise modalities on glycemic control in people with prediabetes: a systematic review and meta-analysis of randomized controlled trials. Bennasar-Veny, M.; Malih, N.; Galmes-Panades, A. M.; Hernandez-Bermudez, I. C.; Garcia-Coll, N.; Ricci-Cabello, I.; Yañez, A. M. (2023). 14 1233312.

  AbstractBibTeXEndNoteDOIBibSonomyDownload

  BACKGROUND: Numerous studies have shown the beneficial effects of exercise on glycemic control in people with prediabetes. However, the most effective exercise modality for improving glycemic control remains unclear. We aimed to assess which exercise training modality is most effective in improving glycemic control in a population with prediabetes. METHODS: We conducted searches in Pubmed/MEDLINE, EMBASE, SPORTDiscus, Web of Science, PEDro, BVS, and the Cochrane Library from inception to June 2022. Included studies reported fasting plasma glucose (FPG), glycated hemoglobin (HbA1c), and 2-hour postprandial (2hPP) levels and implemented an exercise program lasting at least 12 weeks in adults with prediabetes. We performed a direct meta-analysis using a random-effects model and a network meta-analysis. Cochran's Q statistic and the inconsistency I(2) test were used to assess the heterogenicity between studies. RESULTS: Twenty trials were included, with 15 trials (comprising 775 participants with prediabetes) combined in the meta-analysis, and 13 in the network meta-analysis. The meta-analysis results did not show a statistically significant reduction in fasting plasma glucose (FPG) after aerobic training (AT) intervention compared to a control group (mean (95%CI) difference = -5.18 (-13.48; 3.12) mg/dL, Z=1.22, p=0.22). However, a difference of -7.25 (-13.79; -0.71) mg/dL, p=0.03, in FPG after interval training (IT) intervention was detected compared to a control group. After resistance training (RT) intervention, FPG was significantly lower -6.71 (-12.65,-0.77) mg/dL, Z=2.21, p=0.03, and HbA1c by -0.13 (-0.55, 0.29), p=0.54, compared to the control group. The impact of RT compared to no intervention on 2hPP was not statistically significant (p=0.26). The network meta-analysis did not show statistical significance. Most of the studies presented an unclear risk of bias, and a low and very low-quality of evidence. According to the GRADE criteria, the strength of the body of evidence was low. CONCLUSION: Resistance training and IT had demonstrated benefits on glycemic indices, especially on FPG, in a population with prediabetes. Further studies with larger sample sizes and a more robust methodology that compare different types of exercise modalities, frequencies, and durations, are needed to establish a beneficial exercise intervention. SYSTEMATIC REVIEW REGISTRATION: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=370688, identifier CRD42022370688.

  @article{RN125,
  abstract = {BACKGROUND: Numerous studies have shown the beneficial effects of exercise on glycemic control in people with prediabetes. However, the most effective exercise modality for improving glycemic control remains unclear. We aimed to assess which exercise training modality is most effective in improving glycemic control in a population with prediabetes. METHODS: We conducted searches in Pubmed/MEDLINE, EMBASE, SPORTDiscus, Web of Science, PEDro, BVS, and the Cochrane Library from inception to June 2022. Included studies reported fasting plasma glucose (FPG), glycated hemoglobin (HbA1c), and 2-hour postprandial (2hPP) levels and implemented an exercise program lasting at least 12 weeks in adults with prediabetes. We performed a direct meta-analysis using a random-effects model and a network meta-analysis. Cochran's Q statistic and the inconsistency I(2) test were used to assess the heterogenicity between studies. RESULTS: Twenty trials were included, with 15 trials (comprising 775 participants with prediabetes) combined in the meta-analysis, and 13 in the network meta-analysis. The meta-analysis results did not show a statistically significant reduction in fasting plasma glucose (FPG) after aerobic training (AT) intervention compared to a control group (mean (95%CI) difference = -5.18 (-13.48; 3.12) mg/dL, Z=1.22, p=0.22). However, a difference of -7.25 (-13.79; -0.71) mg/dL, p=0.03, in FPG after interval training (IT) intervention was detected compared to a control group. After resistance training (RT) intervention, FPG was significantly lower -6.71 (-12.65,-0.77) mg/dL, Z=2.21, p=0.03, and HbA1c by -0.13 (-0.55, 0.29), p=0.54, compared to the control group. The impact of RT compared to no intervention on 2hPP was not statistically significant (p=0.26). The network meta-analysis did not show statistical significance. Most of the studies presented an unclear risk of bias, and a low and very low-quality of evidence. According to the GRADE criteria, the strength of the body of evidence was low. CONCLUSION: Resistance training and IT had demonstrated benefits on glycemic indices, especially on FPG, in a population with prediabetes. Further studies with larger sample sizes and a more robust methodology that compare different types of exercise modalities, frequencies, and durations, are needed to establish a beneficial exercise intervention. SYSTEMATIC REVIEW REGISTRATION: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=370688, identifier CRD42022370688.},
  author = {Bennasar-Veny, M. and Malih, N. and Galmes-Panades, A. M. and Hernandez-Bermudez, I. C. and Garcia-Coll, N. and Ricci-Cabello, I. and Yañez, A. M.},
  journal = {Front Endocrinol (Lausanne)},
  keywords = {evisap grapp-caib},
  pages = 1233312,
  title = {Effect of physical activity and different exercise modalities on glycemic control in people with prediabetes: a systematic review and meta-analysis of randomized controlled trials},
  type = {Journal Article},
  volume = 14,
  year = 2023
  }
  

  %0 Journal Article
  %1 RN125
  %A Bennasar-Veny, M.
  %A Malih, N.
  %A Galmes-Panades, A. M.
  %A Hernandez-Bermudez, I. C.
  %A Garcia-Coll, N.
  %A Ricci-Cabello, I.
  %A Yañez, A. M.
  %D 2023
  %J Front Endocrinol (Lausanne)
  %P 1233312
  %R 10.3389/fendo.2023.1233312
  %T Effect of physical activity and different exercise modalities on glycemic control in people with prediabetes: a systematic review and meta-analysis of randomized controlled trials
  %V 14
  %X BACKGROUND: Numerous studies have shown the beneficial effects of exercise on glycemic control in people with prediabetes. However, the most effective exercise modality for improving glycemic control remains unclear. We aimed to assess which exercise training modality is most effective in improving glycemic control in a population with prediabetes. METHODS: We conducted searches in Pubmed/MEDLINE, EMBASE, SPORTDiscus, Web of Science, PEDro, BVS, and the Cochrane Library from inception to June 2022. Included studies reported fasting plasma glucose (FPG), glycated hemoglobin (HbA1c), and 2-hour postprandial (2hPP) levels and implemented an exercise program lasting at least 12 weeks in adults with prediabetes. We performed a direct meta-analysis using a random-effects model and a network meta-analysis. Cochran's Q statistic and the inconsistency I(2) test were used to assess the heterogenicity between studies. RESULTS: Twenty trials were included, with 15 trials (comprising 775 participants with prediabetes) combined in the meta-analysis, and 13 in the network meta-analysis. The meta-analysis results did not show a statistically significant reduction in fasting plasma glucose (FPG) after aerobic training (AT) intervention compared to a control group (mean (95%CI) difference = -5.18 (-13.48; 3.12) mg/dL, Z=1.22, p=0.22). However, a difference of -7.25 (-13.79; -0.71) mg/dL, p=0.03, in FPG after interval training (IT) intervention was detected compared to a control group. After resistance training (RT) intervention, FPG was significantly lower -6.71 (-12.65,-0.77) mg/dL, Z=2.21, p=0.03, and HbA1c by -0.13 (-0.55, 0.29), p=0.54, compared to the control group. The impact of RT compared to no intervention on 2hPP was not statistically significant (p=0.26). The network meta-analysis did not show statistical significance. Most of the studies presented an unclear risk of bias, and a low and very low-quality of evidence. According to the GRADE criteria, the strength of the body of evidence was low. CONCLUSION: Resistance training and IT had demonstrated benefits on glycemic indices, especially on FPG, in a population with prediabetes. Further studies with larger sample sizes and a more robust methodology that compare different types of exercise modalities, frequencies, and durations, are needed to establish a beneficial exercise intervention. SYSTEMATIC REVIEW REGISTRATION: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=370688, identifier CRD42022370688.
  

• 
  Non-adherence to non-insulin glucose-lowering drugs: Prevalence, predictors and impact on glycemic control and insulin initiation. A longitudinal cohort study in a large primary care database in Spain. Zamanillo-Campos, R.; Zaforteza Dezcallar, M.; Boronat Moreiro, M. A.; Leiva Rus, A.; Ripoll Amengual, J.; Konieczna, J.; Fiol deRoque, M. A.; Ricci-Cabello, I. (2023). 29(1) 2268838.

  AbstractBibTeXEndNoteDOIBibSonomyDownload

  BACKGROUND: A better understanding of patient non-adherence to type 2 diabetes medication is needed to design effective interventions to address this issue. OBJECTIVES: (1) To estimate the prevalence of non-adherence to diabetes medication; (2) to examine its impact on glycemic control and insulin initiation; (3) to develop and validate a prediction model of non-adherence. METHODS: We conducted a longitudinal cohort study based on data from electronic health records. We included adult patients registered within the Health Service of the Balearic Islands (Spain) starting a new prescription of a non-insulin glucose-lowering drug between January 2016 and December 2018. We calculated non-adherence at 12 months follow-up, defined as medication possession ratio (MPR) ≤ 80%. We fitted multivariable regression models to examine the association between non-adherence and glycemic control and insulin initiation and identified predictors of non-adherence. RESULTS: Of 18,119 patients identified, after 12 months follow-up, 5,740 (31.68%) were non-adherent. Compared with non-adherent, adherent patients presented lower HbA1c levels (mean difference = -0.32%; 95%CI = -0.38%; -0.27%) and were less likely to initiate insulin (aOR = 0.77; 95%CI = 0.63; 0.94). A predictive model explained 22.3% of the variation and presented a satisfactory performance (AUC = 0.721; Brier score = 0.177). The most important predictors of non-adherence were: non-Spanish nationality, currently working, low adherence to previous drugs, taking biguanides, smoker and absence of hypertension. CONCLUSION: Around one-third of the patients do not adhere to their non-insulin glucose-lowering drugs. More research is needed to optimise the performance of the predicting model before considering its implementation in routine clinical practice.

  @article{RN138,
  abstract = {BACKGROUND: A better understanding of patient non-adherence to type 2 diabetes medication is needed to design effective interventions to address this issue. OBJECTIVES: (1) To estimate the prevalence of non-adherence to diabetes medication; (2) to examine its impact on glycemic control and insulin initiation; (3) to develop and validate a prediction model of non-adherence. METHODS: We conducted a longitudinal cohort study based on data from electronic health records. We included adult patients registered within the Health Service of the Balearic Islands (Spain) starting a new prescription of a non-insulin glucose-lowering drug between January 2016 and December 2018. We calculated non-adherence at 12 months follow-up, defined as medication possession ratio (MPR) ≤ 80%. We fitted multivariable regression models to examine the association between non-adherence and glycemic control and insulin initiation and identified predictors of non-adherence. RESULTS: Of 18,119 patients identified, after 12 months follow-up, 5,740 (31.68%) were non-adherent. Compared with non-adherent, adherent patients presented lower HbA1c levels (mean difference = -0.32%; 95%CI = -0.38%; -0.27%) and were less likely to initiate insulin (aOR = 0.77; 95%CI = 0.63; 0.94). A predictive model explained 22.3% of the variation and presented a satisfactory performance (AUC = 0.721; Brier score = 0.177). The most important predictors of non-adherence were: non-Spanish nationality, currently working, low adherence to previous drugs, taking biguanides, smoker and absence of hypertension. CONCLUSION: Around one-third of the patients do not adhere to their non-insulin glucose-lowering drugs. More research is needed to optimise the performance of the predicting model before considering its implementation in routine clinical practice.},
  author = {Zamanillo-Campos, R. and Zaforteza Dezcallar, M. and Boronat Moreiro, M. A. and Leiva Rus, A. and Ripoll Amengual, J. and Konieczna, J. and Fiol deRoque, M. A. and Ricci-Cabello, I.},
  journal = {Eur J Gen Pract},
  keywords = {evisap grapp-caib},
  number = 1,
  pages = 2268838,
  title = {Non-adherence to non-insulin glucose-lowering drugs: Prevalence, predictors and impact on glycemic control and insulin initiation. A longitudinal cohort study in a large primary care database in Spain},
  type = {Journal Article},
  volume = 29,
  year = 2023
  }
  

  %0 Journal Article
  %1 RN138
  %A Zamanillo-Campos, R.
  %A Zaforteza Dezcallar, M.
  %A Boronat Moreiro, M. A.
  %A Leiva Rus, A.
  %A Ripoll Amengual, J.
  %A Konieczna, J.
  %A Fiol deRoque, M. A.
  %A Ricci-Cabello, I.
  %D 2023
  %J Eur J Gen Pract
  %N 1
  %P 2268838
  %R 10.1080/13814788.2023.2268838
  %T Non-adherence to non-insulin glucose-lowering drugs: Prevalence, predictors and impact on glycemic control and insulin initiation. A longitudinal cohort study in a large primary care database in Spain
  %V 29
  %X BACKGROUND: A better understanding of patient non-adherence to type 2 diabetes medication is needed to design effective interventions to address this issue. OBJECTIVES: (1) To estimate the prevalence of non-adherence to diabetes medication; (2) to examine its impact on glycemic control and insulin initiation; (3) to develop and validate a prediction model of non-adherence. METHODS: We conducted a longitudinal cohort study based on data from electronic health records. We included adult patients registered within the Health Service of the Balearic Islands (Spain) starting a new prescription of a non-insulin glucose-lowering drug between January 2016 and December 2018. We calculated non-adherence at 12 months follow-up, defined as medication possession ratio (MPR) ≤ 80%. We fitted multivariable regression models to examine the association between non-adherence and glycemic control and insulin initiation and identified predictors of non-adherence. RESULTS: Of 18,119 patients identified, after 12 months follow-up, 5,740 (31.68%) were non-adherent. Compared with non-adherent, adherent patients presented lower HbA1c levels (mean difference = -0.32%; 95%CI = -0.38%; -0.27%) and were less likely to initiate insulin (aOR = 0.77; 95%CI = 0.63; 0.94). A predictive model explained 22.3% of the variation and presented a satisfactory performance (AUC = 0.721; Brier score = 0.177). The most important predictors of non-adherence were: non-Spanish nationality, currently working, low adherence to previous drugs, taking biguanides, smoker and absence of hypertension. CONCLUSION: Around one-third of the patients do not adhere to their non-insulin glucose-lowering drugs. More research is needed to optimise the performance of the predicting model before considering its implementation in routine clinical practice.
  

• 
  A Diet Profiling Algorithm (DPA) to Rank Diet Quality Suitable to Implement in Digital Tools-A Test Study in a Cohort of Lactating Women. Alonso-Bernáldez, Marta; Palou-March, Andreu; Zamanillo-Campos, Rocío; Palou, Andreu; Palou, Mariona; Serra, Francisca (2023). 15(6) 1337-.

  AbstractURLBibTeXEndNoteDOIBibSonomy

  Although nutrient profiling systems can empower consumers towards healthier food choices, there is still a need to assess diet quality to obtain an overall perspective. The purpose of this study was to develop a diet profiling algorithm (DPA) to evaluate nutritional diet quality, which gives a final score from 1 to 3 with an associated color (green-yellow-orange). It ranks the total carbohydrate/total fiber ratio, and energy from saturated fats and sodium as potentially negative inputs, while fiber and protein are assumed as positive items. Then, the total fat/total carbohydrate ratio is calculated to evaluate the macronutrient distribution, as well as a food group analysis. To test the DPA performance, diets of a lactating women cohort were analyzed, and a correlation analysis between DPA and breast milk leptin levels was performed. Diets classified as low quality showed a higher intake of negative inputs, along with higher energy and fat intakes. This was reflected in body mass index (BMI) and food groups, indicating that women with the worst scores tended to choose tastier and less satiating foods. In conclusion, the DPA was developed and tested in a sample population. This tool can be easily implemented in digital nutrition platforms, contributing to real-time dietary follow-up of patients and progress monitoring, leading to further dietary adjustment.

  @article{alonsobernaldez2023profiling,
  abstract = {Although nutrient profiling systems can empower consumers towards healthier food choices, there is still a need to assess diet quality to obtain an overall perspective. The purpose of this study was to develop a diet profiling algorithm (DPA) to evaluate nutritional diet quality, which gives a final score from 1 to 3 with an associated color (green-yellow-orange). It ranks the total carbohydrate/total fiber ratio, and energy from saturated fats and sodium as potentially negative inputs, while fiber and protein are assumed as positive items. Then, the total fat/total carbohydrate ratio is calculated to evaluate the macronutrient distribution, as well as a food group analysis. To test the DPA performance, diets of a lactating women cohort were analyzed, and a correlation analysis between DPA and breast milk leptin levels was performed. Diets classified as low quality showed a higher intake of negative inputs, along with higher energy and fat intakes. This was reflected in body mass index (BMI) and food groups, indicating that women with the worst scores tended to choose tastier and less satiating foods. In conclusion, the DPA was developed and tested in a sample population. This tool can be easily implemented in digital nutrition platforms, contributing to real-time dietary follow-up of patients and progress monitoring, leading to further dietary adjustment.},
  address = {Switzerland},
  author = {Alonso-Bernáldez, Marta and Palou-March, Andreu and Zamanillo-Campos, Rocío and Palou, Andreu and Palou, Mariona and Serra, Francisca},
  journal = {Nutrients},
  keywords = {evisap},
  month = {mar},
  number = 6,
  pages = {1337--},
  title = {A Diet Profiling Algorithm (DPA) to Rank Diet Quality Suitable to Implement in Digital Tools-A Test Study in a Cohort of Lactating Women},
  volume = 15,
  year = 2023
  }
  

  %0 Journal Article
  %1 alonsobernaldez2023profiling
  %A Alonso-Bernáldez, Marta
  %A Palou-March, Andreu
  %A Zamanillo-Campos, Rocío
  %A Palou, Andreu
  %A Palou, Mariona
  %A Serra, Francisca
  %C Switzerland
  %D 2023
  %J Nutrients
  %N 6
  %P 1337--
  %R 10.3390/nu15061337
  %T A Diet Profiling Algorithm (DPA) to Rank Diet Quality Suitable to Implement in Digital Tools-A Test Study in a Cohort of Lactating Women
  %U https://pubmed.ncbi.nlm.nih.gov/36986066
  %V 15
  %X Although nutrient profiling systems can empower consumers towards healthier food choices, there is still a need to assess diet quality to obtain an overall perspective. The purpose of this study was to develop a diet profiling algorithm (DPA) to evaluate nutritional diet quality, which gives a final score from 1 to 3 with an associated color (green-yellow-orange). It ranks the total carbohydrate/total fiber ratio, and energy from saturated fats and sodium as potentially negative inputs, while fiber and protein are assumed as positive items. Then, the total fat/total carbohydrate ratio is calculated to evaluate the macronutrient distribution, as well as a food group analysis. To test the DPA performance, diets of a lactating women cohort were analyzed, and a correlation analysis between DPA and breast milk leptin levels was performed. Diets classified as low quality showed a higher intake of negative inputs, along with higher energy and fat intakes. This was reflected in body mass index (BMI) and food groups, indicating that women with the worst scores tended to choose tastier and less satiating foods. In conclusion, the DPA was developed and tested in a sample population. This tool can be easily implemented in digital nutrition platforms, contributing to real-time dietary follow-up of patients and progress monitoring, leading to further dietary adjustment.
  

2022

• 
  Development and Evaluation of a Digital Health Intervention to Prevent Type 2 Diabetes in Primary Care: The PREDIABETEXT Study Protocol for a Randomised Clinical Trial. Galmes-Panades, Aina M; Angullo, Escarlata; Mira-Martínez, Sofía; Bennasar-Veny, Miquel; Zamanillo-Campos, Rocío; Gómez-Juanes, Rocío; Konieczna, Jadwiga; Jiménez, Rafael; Serrano-Ripoll, Maria Jesús; Fiol deRoque, Maria Antonia; Miralles, Jerónima; Yañez, Aina M; Romaguera, Dora; Vidal-Thomas, Maria Clara; Llobera-Canaves, Joan; García-Toro, Mauro; Vicens, Catalina; Gervilla-García, Elena; Oña, José Iván; Malih, Narges; Leiva, Alfonso; Bulilete, Oana; Montaño, Juan José; Gili, Margalida; Roca, Miquel; Ricci-Cabello, Ignacio (2022). 19(22) 14706-.

  AbstractURLBibTeXEndNoteDOIBibSonomyDownload

  BACKGROUND: Type 2 diabetes mellitus (T2DM) is a highly prevalent disease associated with an increased risk of comorbidities, premature death, and health costs. Prediabetes is a stage of glucose alteration previous to T2DM, that can be reversed. The aim of the study is to develop and evaluate a low-intensity, multifaceted, digital intervention to prevent T2DM. The intervention comprises: (1) the use of mobile health technology to send tailored text messages promoting lifestyle changes to people at risk of T2DM and (2) the provision of online education to primary healthcare physicians and nurses about management of prediabetes. METHODS: In stages 1-4 we will design, develop and pilot-test the intervention. In Stage 5 we will conduct a phase II, six-month, three-arm, cluster randomized, clinical trial with 42 primary care professionals and 420 patients at risk of T2DM. Patients will be allocated to a control group (usual care), intervention A (patient messaging intervention), or intervention B (patient messaging intervention plus online education to their primary healthcare professionals). The primary outcome will be glycated haemoglobin. All the procedures obtained ethical approval in June 2021 (CEI-IB Ref No: IB4495/21PI). DISCUSSION: Digital health interventions can effectively prevent T2DM and reduce important T2DM risk factors such as overweight or hypertension. In Spain, this type of intervention is understudied. Moreover, there is controversy regarding the type of digital health interventions that are more effective. Findings from this study may contribute to address T2DM prevention, through a low-cost and easily implementable intervention.

  @article{galmespanades2022development,
  abstract = {BACKGROUND: Type 2 diabetes mellitus (T2DM) is a highly prevalent disease associated with an increased risk of comorbidities, premature death, and health costs. Prediabetes is a stage of glucose alteration previous to T2DM, that can be reversed. The aim of the study is to develop and evaluate a low-intensity, multifaceted, digital intervention to prevent T2DM. The intervention comprises: (1) the use of mobile health technology to send tailored text messages promoting lifestyle changes to people at risk of T2DM and (2) the provision of online education to primary healthcare physicians and nurses about management of prediabetes. METHODS: In stages 1-4 we will design, develop and pilot-test the intervention. In Stage 5 we will conduct a phase II, six-month, three-arm, cluster randomized, clinical trial with 42 primary care professionals and 420 patients at risk of T2DM. Patients will be allocated to a control group (usual care), intervention A (patient messaging intervention), or intervention B (patient messaging intervention plus online education to their primary healthcare professionals). The primary outcome will be glycated haemoglobin. All the procedures obtained ethical approval in June 2021 (CEI-IB Ref No: IB4495/21PI). DISCUSSION: Digital health interventions can effectively prevent T2DM and reduce important T2DM risk factors such as overweight or hypertension. In Spain, this type of intervention is understudied. Moreover, there is controversy regarding the type of digital health interventions that are more effective. Findings from this study may contribute to address T2DM prevention, through a low-cost and easily implementable intervention.},
  address = {Switzerland},
  author = {Galmes-Panades, Aina M and Angullo, Escarlata and Mira-Martínez, Sofía and Bennasar-Veny, Miquel and Zamanillo-Campos, Rocío and Gómez-Juanes, Rocío and Konieczna, Jadwiga and Jiménez, Rafael and Serrano-Ripoll, Maria Jesús and Fiol deRoque, Maria Antonia and Miralles, Jerónima and Yañez, Aina M and Romaguera, Dora and Vidal-Thomas, Maria Clara and Llobera-Canaves, Joan and García-Toro, Mauro and Vicens, Catalina and Gervilla-García, Elena and Oña, José Iván and Malih, Narges and Leiva, Alfonso and Bulilete, Oana and Montaño, Juan José and Gili, Margalida and Roca, Miquel and Ricci-Cabello, Ignacio},
  journal = {International journal of environmental research and public health},
  keywords = {evisap},
  month = {nov},
  number = 22,
  pages = {14706--},
  title = {Development and Evaluation of a Digital Health Intervention to Prevent Type 2 Diabetes in Primary Care: The PREDIABETEXT Study Protocol for a Randomised Clinical Trial},
  volume = 19,
  year = 2022
  }
  

  %0 Journal Article
  %1 galmespanades2022development
  %A Galmes-Panades, Aina M
  %A Angullo, Escarlata
  %A Mira-Martínez, Sofía
  %A Bennasar-Veny, Miquel
  %A Zamanillo-Campos, Rocío
  %A Gómez-Juanes, Rocío
  %A Konieczna, Jadwiga
  %A Jiménez, Rafael
  %A Serrano-Ripoll, Maria Jesús
  %A Fiol deRoque, Maria Antonia
  %A Miralles, Jerónima
  %A Yañez, Aina M
  %A Romaguera, Dora
  %A Vidal-Thomas, Maria Clara
  %A Llobera-Canaves, Joan
  %A García-Toro, Mauro
  %A Vicens, Catalina
  %A Gervilla-García, Elena
  %A Oña, José Iván
  %A Malih, Narges
  %A Leiva, Alfonso
  %A Bulilete, Oana
  %A Montaño, Juan José
  %A Gili, Margalida
  %A Roca, Miquel
  %A Ricci-Cabello, Ignacio
  %C Switzerland
  %D 2022
  %J International journal of environmental research and public health
  %N 22
  %P 14706--
  %R 10.3390/ijerph192214706
  %T Development and Evaluation of a Digital Health Intervention to Prevent Type 2 Diabetes in Primary Care: The PREDIABETEXT Study Protocol for a Randomised Clinical Trial
  %U https://pubmed.ncbi.nlm.nih.gov/36429423
  %V 19
  %X BACKGROUND: Type 2 diabetes mellitus (T2DM) is a highly prevalent disease associated with an increased risk of comorbidities, premature death, and health costs. Prediabetes is a stage of glucose alteration previous to T2DM, that can be reversed. The aim of the study is to develop and evaluate a low-intensity, multifaceted, digital intervention to prevent T2DM. The intervention comprises: (1) the use of mobile health technology to send tailored text messages promoting lifestyle changes to people at risk of T2DM and (2) the provision of online education to primary healthcare physicians and nurses about management of prediabetes. METHODS: In stages 1-4 we will design, develop and pilot-test the intervention. In Stage 5 we will conduct a phase II, six-month, three-arm, cluster randomized, clinical trial with 42 primary care professionals and 420 patients at risk of T2DM. Patients will be allocated to a control group (usual care), intervention A (patient messaging intervention), or intervention B (patient messaging intervention plus online education to their primary healthcare professionals). The primary outcome will be glycated haemoglobin. All the procedures obtained ethical approval in June 2021 (CEI-IB Ref No: IB4495/21PI). DISCUSSION: Digital health interventions can effectively prevent T2DM and reduce important T2DM risk factors such as overweight or hypertension. In Spain, this type of intervention is understudied. Moreover, there is controversy regarding the type of digital health interventions that are more effective. Findings from this study may contribute to address T2DM prevention, through a low-cost and easily implementable intervention.
  

• 
  Efficacy of Different Modalities and Frequencies of Physical Exercise on Glucose Control in People with Prediabetes (GLYCEX Randomised Trial). Galmes-Panades, A. M.; Bennasar-Veny, M.; Oliver, P.; Garcia-Coll, N.; Chaplin, A.; Fresneda, S.; Gallardo-Alfaro, L.; García-Ruano, C.; Konieczna, J.; Leiva, A.; Masmiquel, L.; Pico, C.; Ricci-Cabello, I.; Romaguera, D.; Rivera, R.; Sanchis, P.; Vidal-Conti, J.; Yañez, A. M. (2022). 12(12)

  AbstractBibTeXEndNoteDOIBibSonomyDownload

  To assess the efficacy of different modalities and frequencies of physical exercise on glycaemic control in adults with prediabetes. A two-phase, parallel, randomised, controlled clinical trial will be carried out, in 210 participants. In phase 1, 120 participants will be randomized into four arms: (1) aerobic exercise, (2) aerobic exercise combined with resistance, (3) high-intensity intervallic exercise and (4) control group. In phase 2, 90 new participants will be randomized into three arms, using the exercise modality that showed the best glycaemic control in phase 1 in the following manner: (1) frequency of 5 days/week, (2) frequency of 3 days/week and (3) frequency of 2 days/week. The control group (n = 30) will be included in phase 1 to evaluate the effect of any type of intervention versus no intervention. Data collection will be performed at baseline and after 15 weeks of follow up. Sociodemographic data, medication, comorbidity, blood biochemical parameters, blood pressure, anthropometric measurements, body composition, physical activity, sedentary lifestyle, diet, smoking, alcohol consumption, quality of life and sleep questionnaires will be collected. Physical activity, sedentary behaviour and sleep will be further determined with an accelerometer, and continuous glycaemia will be determined with a glycaemic monitor, both during seven days, at two time points. The main dependent variable will be the reduction in the mean amplitude of glycaemic excursions. The impact of these interventions on health will also be evaluated through gene expression analysis in peripheral blood cells. The results of this study will contribute to a better understanding of the mechanisms behind the glucose response to physical exercise in a population with prediabetes as well as improve physical exercise prescriptions for diabetes prevention. Increasing glycaemic control in people with prediabetes through physical exercise offers an opportunity to prevent diabetes and reduce associated comorbidities and health costs.

  @article{RN1,
  abstract = {To assess the efficacy of different modalities and frequencies of physical exercise on glycaemic control in adults with prediabetes. A two-phase, parallel, randomised, controlled clinical trial will be carried out, in 210 participants. In phase 1, 120 participants will be randomized into four arms: (1) aerobic exercise, (2) aerobic exercise combined with resistance, (3) high-intensity intervallic exercise and (4) control group. In phase 2, 90 new participants will be randomized into three arms, using the exercise modality that showed the best glycaemic control in phase 1 in the following manner: (1) frequency of 5 days/week, (2) frequency of 3 days/week and (3) frequency of 2 days/week. The control group (n = 30) will be included in phase 1 to evaluate the effect of any type of intervention versus no intervention. Data collection will be performed at baseline and after 15 weeks of follow up. Sociodemographic data, medication, comorbidity, blood biochemical parameters, blood pressure, anthropometric measurements, body composition, physical activity, sedentary lifestyle, diet, smoking, alcohol consumption, quality of life and sleep questionnaires will be collected. Physical activity, sedentary behaviour and sleep will be further determined with an accelerometer, and continuous glycaemia will be determined with a glycaemic monitor, both during seven days, at two time points. The main dependent variable will be the reduction in the mean amplitude of glycaemic excursions. The impact of these interventions on health will also be evaluated through gene expression analysis in peripheral blood cells. The results of this study will contribute to a better understanding of the mechanisms behind the glucose response to physical exercise in a population with prediabetes as well as improve physical exercise prescriptions for diabetes prevention. Increasing glycaemic control in people with prediabetes through physical exercise offers an opportunity to prevent diabetes and reduce associated comorbidities and health costs.},
  author = {Galmes-Panades, A. M. and Bennasar-Veny, M. and Oliver, P. and Garcia-Coll, N. and Chaplin, A. and Fresneda, S. and Gallardo-Alfaro, L. and García-Ruano, C. and Konieczna, J. and Leiva, A. and Masmiquel, L. and Pico, C. and Ricci-Cabello, I. and Romaguera, D. and Rivera, R. and Sanchis, P. and Vidal-Conti, J. and Yañez, A. M.},
  journal = {Metabolites},
  keywords = {evisap grapp-caib},
  number = 12,
  title = {Efficacy of Different Modalities and Frequencies of Physical Exercise on Glucose Control in People with Prediabetes (GLYCEX Randomised Trial)},
  type = {Journal Article},
  volume = 12,
  year = 2022
  }
  

  %0 Journal Article
  %1 RN1
  %A Galmes-Panades, A. M.
  %A Bennasar-Veny, M.
  %A Oliver, P.
  %A Garcia-Coll, N.
  %A Chaplin, A.
  %A Fresneda, S.
  %A Gallardo-Alfaro, L.
  %A García-Ruano, C.
  %A Konieczna, J.
  %A Leiva, A.
  %A Masmiquel, L.
  %A Pico, C.
  %A Ricci-Cabello, I.
  %A Romaguera, D.
  %A Rivera, R.
  %A Sanchis, P.
  %A Vidal-Conti, J.
  %A Yañez, A. M.
  %D 2022
  %J Metabolites
  %N 12
  %R 10.3390/metabo12121286
  %T Efficacy of Different Modalities and Frequencies of Physical Exercise on Glucose Control in People with Prediabetes (GLYCEX Randomised Trial)
  %V 12
  %X To assess the efficacy of different modalities and frequencies of physical exercise on glycaemic control in adults with prediabetes. A two-phase, parallel, randomised, controlled clinical trial will be carried out, in 210 participants. In phase 1, 120 participants will be randomized into four arms: (1) aerobic exercise, (2) aerobic exercise combined with resistance, (3) high-intensity intervallic exercise and (4) control group. In phase 2, 90 new participants will be randomized into three arms, using the exercise modality that showed the best glycaemic control in phase 1 in the following manner: (1) frequency of 5 days/week, (2) frequency of 3 days/week and (3) frequency of 2 days/week. The control group (n = 30) will be included in phase 1 to evaluate the effect of any type of intervention versus no intervention. Data collection will be performed at baseline and after 15 weeks of follow up. Sociodemographic data, medication, comorbidity, blood biochemical parameters, blood pressure, anthropometric measurements, body composition, physical activity, sedentary lifestyle, diet, smoking, alcohol consumption, quality of life and sleep questionnaires will be collected. Physical activity, sedentary behaviour and sleep will be further determined with an accelerometer, and continuous glycaemia will be determined with a glycaemic monitor, both during seven days, at two time points. The main dependent variable will be the reduction in the mean amplitude of glycaemic excursions. The impact of these interventions on health will also be evaluated through gene expression analysis in peripheral blood cells. The results of this study will contribute to a better understanding of the mechanisms behind the glucose response to physical exercise in a population with prediabetes as well as improve physical exercise prescriptions for diabetes prevention. Increasing glycaemic control in people with prediabetes through physical exercise offers an opportunity to prevent diabetes and reduce associated comorbidities and health costs.
  

• 
  Nutritional counseling for cow’s milk protein allergy in infants from birth to 2 y of ages: Scoping review. Zamanillo-Campos, Rocío; Coto Alonso, Laura; Fuentes Martín, María Jesús; Nevot Escusa, Patricia; Tejón Fernández, Marta (2022). 98 111633.

  AbstractURLBibTeXEndNoteDOIBibSonomy

  Objectives Cow's milk protein allergy (CMPA) is a clinical condition that requires appropriate nutritional counseling during breastfeeding and the introduction of complementary feeding. Using evidence-based dietetic advice is critical for correct growth and development during childhood. The aim of this study was to review the most recent literature on nutritional counseling aimed at infants between 0 and 2 y of age diagnosed with CMPA. Methods Six databases were searched and updated on August 22, 2020. Retrieved articles were screened in duplicate and independently by all the authors, and these were selected according to the following inclusion criteria: clinical trials, reviews, meta-analyses, and clinical practice guidelines published since 2013 on any dietetic intervention aimed at infant populations between 0 and 2 y of age with CMPA. Critical appraisal through the AGREE instrument and CASP tools enabled the risk of bias assessment. Results We obtained 2874 results, of which 40 were included for reviewing. The retrieved information enabled us to answer all the research questions, including aspects of the nutritional counseling aimed at mothers who breastfeed infants with CMPA, as well as infants during breastfeeding and the introduction of complementary feeding. We also reviewed the specific nutritional requirements of infants with CMPA to assess nutritional supplementation and the evidence available on the use of probiotics, prebiotics, and symbiotics. Conclusions This scoping review collected, in a structured and comprehensive way, the most recent available information regarding nutritional counseling in CMPA for a successful dietetic intervention of the casuistry that may arise during early infancy.

  @article{ZAMANILLOCAMPOS2022111633,
  abstract = {Objectives Cow's milk protein allergy (CMPA) is a clinical condition that requires appropriate nutritional counseling during breastfeeding and the introduction of complementary feeding. Using evidence-based dietetic advice is critical for correct growth and development during childhood. The aim of this study was to review the most recent literature on nutritional counseling aimed at infants between 0 and 2 y of age diagnosed with CMPA. Methods Six databases were searched and updated on August 22, 2020. Retrieved articles were screened in duplicate and independently by all the authors, and these were selected according to the following inclusion criteria: clinical trials, reviews, meta-analyses, and clinical practice guidelines published since 2013 on any dietetic intervention aimed at infant populations between 0 and 2 y of age with CMPA. Critical appraisal through the AGREE instrument and CASP tools enabled the risk of bias assessment. Results We obtained 2874 results, of which 40 were included for reviewing. The retrieved information enabled us to answer all the research questions, including aspects of the nutritional counseling aimed at mothers who breastfeed infants with CMPA, as well as infants during breastfeeding and the introduction of complementary feeding. We also reviewed the specific nutritional requirements of infants with CMPA to assess nutritional supplementation and the evidence available on the use of probiotics, prebiotics, and symbiotics. Conclusions This scoping review collected, in a structured and comprehensive way, the most recent available information regarding nutritional counseling in CMPA for a successful dietetic intervention of the casuistry that may arise during early infancy.},
  author = {Zamanillo-Campos, Rocío and Coto Alonso, Laura and Fuentes Martín, María Jesús and Nevot Escusa, Patricia and Tejón Fernández, Marta},
  journal = {Nutrition},
  keywords = {evisap},
  pages = 111633,
  title = {Nutritional counseling for cow's milk protein allergy in infants from birth to 2 y of ages: Scoping review},
  volume = 98,
  year = 2022
  }
  

  %0 Journal Article
  %1 ZAMANILLOCAMPOS2022111633
  %A Zamanillo-Campos, Rocío
  %A Coto Alonso, Laura
  %A Fuentes Martín, María Jesús
  %A Nevot Escusa, Patricia
  %A Tejón Fernández, Marta
  %D 2022
  %J Nutrition
  %P 111633
  %R https://doi.org/10.1016/j.nut.2022.111633
  %T Nutritional counseling for cow's milk protein allergy in infants from birth to 2 y of ages: Scoping review
  %U https://www.sciencedirect.com/science/article/pii/S0899900722000466
  %V 98
  %X Objectives Cow's milk protein allergy (CMPA) is a clinical condition that requires appropriate nutritional counseling during breastfeeding and the introduction of complementary feeding. Using evidence-based dietetic advice is critical for correct growth and development during childhood. The aim of this study was to review the most recent literature on nutritional counseling aimed at infants between 0 and 2 y of age diagnosed with CMPA. Methods Six databases were searched and updated on August 22, 2020. Retrieved articles were screened in duplicate and independently by all the authors, and these were selected according to the following inclusion criteria: clinical trials, reviews, meta-analyses, and clinical practice guidelines published since 2013 on any dietetic intervention aimed at infant populations between 0 and 2 y of age with CMPA. Critical appraisal through the AGREE instrument and CASP tools enabled the risk of bias assessment. Results We obtained 2874 results, of which 40 were included for reviewing. The retrieved information enabled us to answer all the research questions, including aspects of the nutritional counseling aimed at mothers who breastfeed infants with CMPA, as well as infants during breastfeeding and the introduction of complementary feeding. We also reviewed the specific nutritional requirements of infants with CMPA to assess nutritional supplementation and the evidence available on the use of probiotics, prebiotics, and symbiotics. Conclusions This scoping review collected, in a structured and comprehensive way, the most recent available information regarding nutritional counseling in CMPA for a successful dietetic intervention of the casuistry that may arise during early infancy.
  

• 
  Patients’ Views on the Design of DiabeText, a New mHealth Intervention to Improve Adherence to Oral Antidiabetes Medication in Spain: A Qualitative Study. Zamanillo-Campos, Rocío; Serrano-Ripoll, Maria Jesús; Taltavull-Aparicio, Joana Maria; Gervilla-Garc’ia, Elena; Ripoll, Joana; Fiol deRoque, Maria Antonia; Boylan, Anne-Marie; Ricci-Cabello, Ignacio (2022). 19(3) 1902.

  URLBibTeXEndNoteDOIBibSonomyDownload

  @article{Zamanillo_Campos_2022,
  author = {Zamanillo-Campos, Rocío and Serrano-Ripoll, Maria Jesús and Taltavull-Aparicio, Joana Maria and Gervilla-Garc'ia, Elena and Ripoll, Joana and Fiol deRoque, Maria Antonia and Boylan, Anne-Marie and Ricci-Cabello, Ignacio},
  journal = {International Journal of Environmental Research and Public Health},
  keywords = {evisap grapp-caib},
  month = {feb},
  number = 3,
  pages = 1902,
  publisher = {MDPI AG},
  title = {Patients' Views on the Design of DiabeText, a New mHealth Intervention to Improve Adherence to Oral Antidiabetes Medication in Spain: A Qualitative Study},
  volume = 19,
  year = 2022
  }
  

  %0 Journal Article
  %1 Zamanillo_Campos_2022
  %A Zamanillo-Campos, Rocío
  %A Serrano-Ripoll, Maria Jesús
  %A Taltavull-Aparicio, Joana Maria
  %A Gervilla-Garc'ia, Elena
  %A Ripoll, Joana
  %A Fiol deRoque, Maria Antonia
  %A Boylan, Anne-Marie
  %A Ricci-Cabello, Ignacio
  %D 2022
  %I MDPI AG
  %J International Journal of Environmental Research and Public Health
  %N 3
  %P 1902
  %R 10.3390/ijerph19031902
  %T Patients' Views on the Design of DiabeText, a New mHealth Intervention to Improve Adherence to Oral Antidiabetes Medication in Spain: A Qualitative Study
  %U https://doi.org/10.3390%2Fijerph19031902
  %V 19
  

• 
  Impact of Smartphone App-Based Psychological Interventions for Reducing Depressive Symptoms in People With Depression: Systematic Literature Review and Meta-analysis of Randomized Controlled Trials. Serrano-Ripoll, M. J.; Zamanillo-Campos, R.; Fiol-DeRoque, M. A.; Castro, A.; Ricci-Cabello, I. (2022). 10(1) e29621.

  AbstractBibTeXEndNoteDOIBibSonomyDownload

  BACKGROUND: Depression is a serious, disabling mental disorder that severely affects quality of life. Patients with depression often do not receive adequate treatment. App-based psychotherapy is considered to have great potential to treat depression owing to its reach and easy accessibility. OBJECTIVE: We aim to analyze the impact of app-based psychological interventions for reducing depressive symptoms in people with depression. METHODS: We conducted a systematic literature review and meta-analysis. We searched Medline, Embase, PsycINFO, Web of Science, and Cochrane Central Register of Controlled Trials from inception to December 23, 2020. We selected randomized controlled trials to examine the impact of app-based psychological interventions for reducing depressive symptoms in people with depression. Study selection, data extraction, and critical appraisal (using the Cochrane Risk of Bias tool for randomized studies and the ROBINS-I tool for nonrandomized studies) were conducted independently by 2 reviewers. Where possible, we pooled data using random effects meta-analyses to obtain estimates of the effect size of the intervention. We conducted post hoc meta-regression analyses to explore the factors associated with intervention success. RESULTS: After screening 3468 unique references retrieved from bibliographic searches and assessing the eligibility of 79 full texts, we identified 12 trials (2859 participants) evaluating 14 different interventions. Of 14 trials, 7 (58%) were conducted in the United States; 3 (25%) trials, in Asia (Japan, South Korea, and China); 1 (8%) trial, in Australia; and 1 (8%) trial, in Germany. Of the 12 trials, 5 (42%) trials presented a low risk of bias. The mean duration of the interventions was 6.6 (SD 2.8) weeks. Two-thirds of the interventions were based on cognitive behavioral therapy alone or included it in combination with cognitive control therapy, positive psychology, brief behavioral activation, or mindfulness- and acceptance-based therapy. With no evidence of publication bias, a pooled analysis of 83% (10/12) of the trials and 86% (12/14) of the interventions showed that app-based interventions, compared with a control group receiving usual care or minimal intervention, produced a moderate reduction in depressive symptoms (standardized mean difference [SMD] -0.51, 95% CI -0.69 to -0.33; 2018/2859, 70.58% of the participants; I(2)=70%). Our meta-regression analyses indicated that there was a greater reduction in symptoms of depression (P=.04) in trials that included participants with moderate to severe depression (SMD -0.67, 95% CI -0.79 to -0.55), compared with trials with participants exhibiting mild to moderate depression (SMD -0.15, 95% CI -0.43 to -0.12). CONCLUSIONS: App-based interventions targeted at people with depression produce moderate reductions in the symptoms of depression. More methodologically robust trials are needed to confirm our findings, determine which intervention features are associated with greater improvements, and identify those populations most likely to benefit from this type of intervention. TRIAL REGISTRATION: PROSPERO CRD42019145689; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=145689.

  @article{RN16,
  abstract = {BACKGROUND: Depression is a serious, disabling mental disorder that severely affects quality of life. Patients with depression often do not receive adequate treatment. App-based psychotherapy is considered to have great potential to treat depression owing to its reach and easy accessibility. OBJECTIVE: We aim to analyze the impact of app-based psychological interventions for reducing depressive symptoms in people with depression. METHODS: We conducted a systematic literature review and meta-analysis. We searched Medline, Embase, PsycINFO, Web of Science, and Cochrane Central Register of Controlled Trials from inception to December 23, 2020. We selected randomized controlled trials to examine the impact of app-based psychological interventions for reducing depressive symptoms in people with depression. Study selection, data extraction, and critical appraisal (using the Cochrane Risk of Bias tool for randomized studies and the ROBINS-I tool for nonrandomized studies) were conducted independently by 2 reviewers. Where possible, we pooled data using random effects meta-analyses to obtain estimates of the effect size of the intervention. We conducted post hoc meta-regression analyses to explore the factors associated with intervention success. RESULTS: After screening 3468 unique references retrieved from bibliographic searches and assessing the eligibility of 79 full texts, we identified 12 trials (2859 participants) evaluating 14 different interventions. Of 14 trials, 7 (58%) were conducted in the United States; 3 (25%) trials, in Asia (Japan, South Korea, and China); 1 (8%) trial, in Australia; and 1 (8%) trial, in Germany. Of the 12 trials, 5 (42%) trials presented a low risk of bias. The mean duration of the interventions was 6.6 (SD 2.8) weeks. Two-thirds of the interventions were based on cognitive behavioral therapy alone or included it in combination with cognitive control therapy, positive psychology, brief behavioral activation, or mindfulness- and acceptance-based therapy. With no evidence of publication bias, a pooled analysis of 83% (10/12) of the trials and 86% (12/14) of the interventions showed that app-based interventions, compared with a control group receiving usual care or minimal intervention, produced a moderate reduction in depressive symptoms (standardized mean difference [SMD] -0.51, 95% CI -0.69 to -0.33; 2018/2859, 70.58% of the participants; I(2)=70%). Our meta-regression analyses indicated that there was a greater reduction in symptoms of depression (P=.04) in trials that included participants with moderate to severe depression (SMD -0.67, 95% CI -0.79 to -0.55), compared with trials with participants exhibiting mild to moderate depression (SMD -0.15, 95% CI -0.43 to -0.12). CONCLUSIONS: App-based interventions targeted at people with depression produce moderate reductions in the symptoms of depression. More methodologically robust trials are needed to confirm our findings, determine which intervention features are associated with greater improvements, and identify those populations most likely to benefit from this type of intervention. TRIAL REGISTRATION: PROSPERO CRD42019145689; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=145689.},
  author = {Serrano-Ripoll, M. J. and Zamanillo-Campos, R. and Fiol-DeRoque, M. A. and Castro, A. and Ricci-Cabello, I.},
  journal = {JMIR Mhealth Uhealth},
  keywords = {evisap grapp-caib myown},
  number = 1,
  pages = {e29621},
  title = {Impact of Smartphone App-Based Psychological Interventions for Reducing Depressive Symptoms in People With Depression: Systematic Literature Review and Meta-analysis of Randomized Controlled Trials},
  type = {Journal Article},
  volume = 10,
  year = 2022
  }
  

  %0 Journal Article
  %1 RN16
  %A Serrano-Ripoll, M. J.
  %A Zamanillo-Campos, R.
  %A Fiol-DeRoque, M. A.
  %A Castro, A.
  %A Ricci-Cabello, I.
  %D 2022
  %J JMIR Mhealth Uhealth
  %N 1
  %P e29621
  %R 10.2196/29621
  %T Impact of Smartphone App-Based Psychological Interventions for Reducing Depressive Symptoms in People With Depression: Systematic Literature Review and Meta-analysis of Randomized Controlled Trials
  %V 10
  %X BACKGROUND: Depression is a serious, disabling mental disorder that severely affects quality of life. Patients with depression often do not receive adequate treatment. App-based psychotherapy is considered to have great potential to treat depression owing to its reach and easy accessibility. OBJECTIVE: We aim to analyze the impact of app-based psychological interventions for reducing depressive symptoms in people with depression. METHODS: We conducted a systematic literature review and meta-analysis. We searched Medline, Embase, PsycINFO, Web of Science, and Cochrane Central Register of Controlled Trials from inception to December 23, 2020. We selected randomized controlled trials to examine the impact of app-based psychological interventions for reducing depressive symptoms in people with depression. Study selection, data extraction, and critical appraisal (using the Cochrane Risk of Bias tool for randomized studies and the ROBINS-I tool for nonrandomized studies) were conducted independently by 2 reviewers. Where possible, we pooled data using random effects meta-analyses to obtain estimates of the effect size of the intervention. We conducted post hoc meta-regression analyses to explore the factors associated with intervention success. RESULTS: After screening 3468 unique references retrieved from bibliographic searches and assessing the eligibility of 79 full texts, we identified 12 trials (2859 participants) evaluating 14 different interventions. Of 14 trials, 7 (58%) were conducted in the United States; 3 (25%) trials, in Asia (Japan, South Korea, and China); 1 (8%) trial, in Australia; and 1 (8%) trial, in Germany. Of the 12 trials, 5 (42%) trials presented a low risk of bias. The mean duration of the interventions was 6.6 (SD 2.8) weeks. Two-thirds of the interventions were based on cognitive behavioral therapy alone or included it in combination with cognitive control therapy, positive psychology, brief behavioral activation, or mindfulness- and acceptance-based therapy. With no evidence of publication bias, a pooled analysis of 83% (10/12) of the trials and 86% (12/14) of the interventions showed that app-based interventions, compared with a control group receiving usual care or minimal intervention, produced a moderate reduction in depressive symptoms (standardized mean difference [SMD] -0.51, 95% CI -0.69 to -0.33; 2018/2859, 70.58% of the participants; I(2)=70%). Our meta-regression analyses indicated that there was a greater reduction in symptoms of depression (P=.04) in trials that included participants with moderate to severe depression (SMD -0.67, 95% CI -0.79 to -0.55), compared with trials with participants exhibiting mild to moderate depression (SMD -0.15, 95% CI -0.43 to -0.12). CONCLUSIONS: App-based interventions targeted at people with depression produce moderate reductions in the symptoms of depression. More methodologically robust trials are needed to confirm our findings, determine which intervention features are associated with greater improvements, and identify those populations most likely to benefit from this type of intervention. TRIAL REGISTRATION: PROSPERO CRD42019145689; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=145689.
  

• 
  Feasibility of the SINERGIAPS ("Sinergias entre profesionales y pacientes para una Atención Primaria Segura") intervention for improving patient safety in primary care. Serrano-Ripoll, M. J.; Fiol deRoque, M. A.; Valderas, J. M.; Zamanillo-Campos, R.; Llobera, J.; de Labry Lima, A. O.; Pastor-Moreno, G.; Ricci-Cabello, I. (2022).

  AbstractURLBibTeXEndNoteDOIBibSonomy

  AIM: The primary aim was to examine the feasibility of intervention delivery and of trial procedures. Secondary aims were to study the intervention uptake; its acceptability and perceived utility; and its potential to improve safety culture and avoidable hospital admissions. METHODS: We conducted a 3-month, single-arm feasibility study in 10 primary care (PC) centres in Spain. Centres received information regarding patients' experiences of safety (through the Patient Reported Experiences and Outcomes of Safety in Primary Care [PREOS-PC] questionnaire), and were instructed to plan safety improvements based on that feedback. We used a bespoke online tool to recruit PC professionals, collect patient feedback, and deliver it to the centres, and to collect outcome data (patient safety culture [Medical Office Survey on Patient Safety Culture, MOSPSC questionnaire]). We measured recruitment and follow-up rates and intervention uptake (based on the number of safety improvement plans registered). We conducted semistructured interviews with 9 professionals to explore the intervention acceptability and perceived utility. RESULTS: Of 256 professionals invited, 120 (47%) agreed to participate, and 97 completed baseline and postintervention measures. Of 780 patients invited, 585 (75%) completed the PREOS-PC questionnaire. Five of 10 centres (50%) designed an improvement plan, providing 27 plans in total (range per centre, 1-14). The intervention was perceived as a novel strategy for improving safety, although the healthcare professionals identified several factors limiting its acceptability and utility: lack of feedback at the individual professional level; potentially unrepresentative sample of patients providing feedback; and number of educational materials deemed overwhelming. DISCUSSION: It is feasible to deliver the proposed intervention so long as the identified limitations are addressed.

  @article{RN9,
  abstract = {AIM: The primary aim was to examine the feasibility of intervention delivery and of trial procedures. Secondary aims were to study the intervention uptake; its acceptability and perceived utility; and its potential to improve safety culture and avoidable hospital admissions. METHODS: We conducted a 3-month, single-arm feasibility study in 10 primary care (PC) centres in Spain. Centres received information regarding patients' experiences of safety (through the Patient Reported Experiences and Outcomes of Safety in Primary Care [PREOS-PC] questionnaire), and were instructed to plan safety improvements based on that feedback. We used a bespoke online tool to recruit PC professionals, collect patient feedback, and deliver it to the centres, and to collect outcome data (patient safety culture [Medical Office Survey on Patient Safety Culture, MOSPSC questionnaire]). We measured recruitment and follow-up rates and intervention uptake (based on the number of safety improvement plans registered). We conducted semistructured interviews with 9 professionals to explore the intervention acceptability and perceived utility. RESULTS: Of 256 professionals invited, 120 (47%) agreed to participate, and 97 completed baseline and postintervention measures. Of 780 patients invited, 585 (75%) completed the PREOS-PC questionnaire. Five of 10 centres (50%) designed an improvement plan, providing 27 plans in total (range per centre, 1-14). The intervention was perceived as a novel strategy for improving safety, although the healthcare professionals identified several factors limiting its acceptability and utility: lack of feedback at the individual professional level; potentially unrepresentative sample of patients providing feedback; and number of educational materials deemed overwhelming. DISCUSSION: It is feasible to deliver the proposed intervention so long as the identified limitations are addressed.},
  author = {Serrano-Ripoll, M. J. and Fiol deRoque, M. A. and Valderas, J. M. and Zamanillo-Campos, R. and Llobera, J. and de Labry Lima, A. O. and Pastor-Moreno, G. and Ricci-Cabello, I.},
  journal = {Fam Pract},
  keywords = {evisap grapp-caib myown},
  title = {Feasibility of the SINERGIAPS ("Sinergias entre profesionales y pacientes para una Atención Primaria Segura") intervention for improving patient safety in primary care},
  type = {Journal Article},
  year = 2022
  }
  

  %0 Journal Article
  %1 RN9
  %A Serrano-Ripoll, M. J.
  %A Fiol deRoque, M. A.
  %A Valderas, J. M.
  %A Zamanillo-Campos, R.
  %A Llobera, J.
  %A de Labry Lima, A. O.
  %A Pastor-Moreno, G.
  %A Ricci-Cabello, I.
  %D 2022
  %J Fam Pract
  %R 10.1093/fampra/cmac015
  %T Feasibility of the SINERGIAPS ("Sinergias entre profesionales y pacientes para una Atención Primaria Segura") intervention for improving patient safety in primary care
  %U https://academic.oup.com/fampra/advance-article-abstract/doi/10.1093/fampra/cmac015/6543662?redirectedFrom=fulltext
  %X AIM: The primary aim was to examine the feasibility of intervention delivery and of trial procedures. Secondary aims were to study the intervention uptake; its acceptability and perceived utility; and its potential to improve safety culture and avoidable hospital admissions. METHODS: We conducted a 3-month, single-arm feasibility study in 10 primary care (PC) centres in Spain. Centres received information regarding patients' experiences of safety (through the Patient Reported Experiences and Outcomes of Safety in Primary Care [PREOS-PC] questionnaire), and were instructed to plan safety improvements based on that feedback. We used a bespoke online tool to recruit PC professionals, collect patient feedback, and deliver it to the centres, and to collect outcome data (patient safety culture [Medical Office Survey on Patient Safety Culture, MOSPSC questionnaire]). We measured recruitment and follow-up rates and intervention uptake (based on the number of safety improvement plans registered). We conducted semistructured interviews with 9 professionals to explore the intervention acceptability and perceived utility. RESULTS: Of 256 professionals invited, 120 (47%) agreed to participate, and 97 completed baseline and postintervention measures. Of 780 patients invited, 585 (75%) completed the PREOS-PC questionnaire. Five of 10 centres (50%) designed an improvement plan, providing 27 plans in total (range per centre, 1-14). The intervention was perceived as a novel strategy for improving safety, although the healthcare professionals identified several factors limiting its acceptability and utility: lack of feedback at the individual professional level; potentially unrepresentative sample of patients providing feedback; and number of educational materials deemed overwhelming. DISCUSSION: It is feasible to deliver the proposed intervention so long as the identified limitations are addressed.
  

• 
  Development of 2 Short Patient-Report Questionnaires of Patient Safety in Primary Care. Mounce, Luke T A; Salema, Nde-Eshimuni; Gangannagaripalli, Jaheeda; Ricci-Cabello, Ignacio; Avery, Anthony J; Kadam, Umesh T; Valderas, José M (2022). 18(3) 161–170.

  AbstractURLBibTeXEndNoteDOIBibSonomy

  OBJECTIVES: The Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC) is a valid and reliable instrument (61 items across 5 domains) of patients' perceptions of safety. Stakeholder feedback has supported shorter versions for improving choice and facilitating uptake of routine patient-centered evaluation. We sought to develop 2 shorter versions of PREOS-PC: one including the shortest possible scales that met established measurement performance standards and a screening version including a single item per domain. METHODS: A total of 1244 patients from 45 general practices across England completed PREOS-PC questionnaires. All scale items in PREOS-PC underwent Item Response Theory analysis, applying standard criteria for the item reduction. Cognitive debriefing from 10 patient interviews allowed for the assessment of the instruments' readability. The instruments' psychometrics properties were reassessed in a validation sample of 1557 patients in 21 English general practices. RESULTS: "PREOS-PC Compact" includes 25 items and 2 open-ended questions across the 5 domains, 44% of the length of the original instrument. "PREOS-PC Screen" consists of 6 items: the best-performing single items for 2 domains, 1 item modified from original items for each of the remaining 3 domains, and 1 open-ended question. The evaluation of the instruments confirmed they were acceptable to patients and met standards for readability; construct, convergent, and divergent validity; and reliability. CONCLUSIONS: PREOS-PC Compact meets high-performance standards while reducing patient burden for routine monitoring of patient safety in primary care. PREOS-PC Screen is a concise tool apt for incorporation into audits and to target more in-depth review as needed.

  @article{mounce2022development,
  abstract = {OBJECTIVES: The Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC) is a valid and reliable instrument (61 items across 5 domains) of patients' perceptions of safety. Stakeholder feedback has supported shorter versions for improving choice and facilitating uptake of routine patient-centered evaluation. We sought to develop 2 shorter versions of PREOS-PC: one including the shortest possible scales that met established measurement performance standards and a screening version including a single item per domain. METHODS: A total of 1244 patients from 45 general practices across England completed PREOS-PC questionnaires. All scale items in PREOS-PC underwent Item Response Theory analysis, applying standard criteria for the item reduction. Cognitive debriefing from 10 patient interviews allowed for the assessment of the instruments' readability. The instruments' psychometrics properties were reassessed in a validation sample of 1557 patients in 21 English general practices. RESULTS: "PREOS-PC Compact" includes 25 items and 2 open-ended questions across the 5 domains, 44% of the length of the original instrument. "PREOS-PC Screen" consists of 6 items: the best-performing single items for 2 domains, 1 item modified from original items for each of the remaining 3 domains, and 1 open-ended question. The evaluation of the instruments confirmed they were acceptable to patients and met standards for readability; construct, convergent, and divergent validity; and reliability. CONCLUSIONS: PREOS-PC Compact meets high-performance standards while reducing patient burden for routine monitoring of patient safety in primary care. PREOS-PC Screen is a concise tool apt for incorporation into audits and to target more in-depth review as needed.},
  address = {United States},
  author = {Mounce, Luke T A and Salema, Nde-Eshimuni and Gangannagaripalli, Jaheeda and Ricci-Cabello, Ignacio and Avery, Anthony J and Kadam, Umesh T and Valderas, José M},
  journal = {Journal of patient safety},
  keywords = {evisap},
  month = {apr},
  number = 3,
  pages = {161--170},
  title = {Development of 2 Short Patient-Report Questionnaires of Patient Safety in Primary Care},
  volume = 18,
  year = 2022
  }
  

  %0 Journal Article
  %1 mounce2022development
  %A Mounce, Luke T A
  %A Salema, Nde-Eshimuni
  %A Gangannagaripalli, Jaheeda
  %A Ricci-Cabello, Ignacio
  %A Avery, Anthony J
  %A Kadam, Umesh T
  %A Valderas, José M
  %C United States
  %D 2022
  %J Journal of patient safety
  %N 3
  %P 161--170
  %R 10.1097/PTS.0000000000000880
  %T Development of 2 Short Patient-Report Questionnaires of Patient Safety in Primary Care
  %U https://pubmed.ncbi.nlm.nih.gov/35344976
  %V 18
  %X OBJECTIVES: The Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC) is a valid and reliable instrument (61 items across 5 domains) of patients' perceptions of safety. Stakeholder feedback has supported shorter versions for improving choice and facilitating uptake of routine patient-centered evaluation. We sought to develop 2 shorter versions of PREOS-PC: one including the shortest possible scales that met established measurement performance standards and a screening version including a single item per domain. METHODS: A total of 1244 patients from 45 general practices across England completed PREOS-PC questionnaires. All scale items in PREOS-PC underwent Item Response Theory analysis, applying standard criteria for the item reduction. Cognitive debriefing from 10 patient interviews allowed for the assessment of the instruments' readability. The instruments' psychometrics properties were reassessed in a validation sample of 1557 patients in 21 English general practices. RESULTS: "PREOS-PC Compact" includes 25 items and 2 open-ended questions across the 5 domains, 44% of the length of the original instrument. "PREOS-PC Screen" consists of 6 items: the best-performing single items for 2 domains, 1 item modified from original items for each of the remaining 3 domains, and 1 open-ended question. The evaluation of the instruments confirmed they were acceptable to patients and met standards for readability; construct, convergent, and divergent validity; and reliability. CONCLUSIONS: PREOS-PC Compact meets high-performance standards while reducing patient burden for routine monitoring of patient safety in primary care. PREOS-PC Screen is a concise tool apt for incorporation into audits and to target more in-depth review as needed.
  

• 
  Perspectives and Views of Primary Care Professionals Regarding DiabeText, a New mHealth Intervention to Support Adherence to Antidiabetic Medication in Spain: A Qualitative Study. Zamanillo-Campos, Rocío; Serrano-Ripoll, Maria Jesús; Taltavull-Aparicio, Joana Maria; Gervilla-Garc’ia, Elena; Ripoll, Joana; Fiol deRoque, Maria Antonia; Boylan, Anne-Marie; Ricci-Cabello, Ignacio (SDFSDF, ed.) (2022). 19(7) 4237.

  URLBibTeXEndNoteDOIBibSonomyDownload

  @article{Zamanillo_Campos_2022,
  author = {Zamanillo-Campos, Rocío and Serrano-Ripoll, Maria Jesús and Taltavull-Aparicio, Joana Maria and Gervilla-Garc'ia, Elena and Ripoll, Joana and Fiol deRoque, Maria Antonia and Boylan, Anne-Marie and Ricci-Cabello, Ignacio},
  editor = {SDFSDF},
  journal = {International Journal of Environmental Research and Public Health},
  keywords = {evisap myown},
  month = {apr},
  number = 7,
  pages = 4237,
  publisher = {MDPI AG},
  title = {Perspectives and Views of Primary Care Professionals Regarding DiabeText, a New mHealth Intervention to Support Adherence to Antidiabetic Medication in Spain: A Qualitative Study},
  volume = 19,
  year = 2022
  }
  

  %0 Journal Article
  %1 Zamanillo_Campos_2022
  %A Zamanillo-Campos, Rocío
  %A Serrano-Ripoll, Maria Jesús
  %A Taltavull-Aparicio, Joana Maria
  %A Gervilla-Garc'ia, Elena
  %A Ripoll, Joana
  %A Fiol deRoque, Maria Antonia
  %A Boylan, Anne-Marie
  %A Ricci-Cabello, Ignacio
  %D 2022
  %E SDFSDF,
  %I MDPI AG
  %J International Journal of Environmental Research and Public Health
  %N 7
  %P 4237
  %R 10.3390/ijerph19074237
  %T Perspectives and Views of Primary Care Professionals Regarding DiabeText, a New mHealth Intervention to Support Adherence to Antidiabetic Medication in Spain: A Qualitative Study
  %U https://doi.org/10.3390%2Fijerph19074237
  %V 19
  

• 
  Cross-Cultural Adaptation, Validation, and Piloting of the Patient Reported Experiences and Outcomes of Safety in Primary Care Questionnaire for Its Use in Spain. Serrano-Ripoll, María J; Llobera, Joan; Valderas, José M; de Labry Lima, Antonio Olry; Fiol deRoque, María A; Ripoll, Joana; Ricci-Cabello, Ignacio (2022). 18(2) 102–110.

  AbstractURLBibTeXEndNoteDOIBibSonomy

  OBJECTIVE: This study aimed to cross-culturally adapt, validate, and pilot the Patient Reported Experiences and Outcomes of Safety in Primary Care questionnaire for its use in Spain. METHODS: After setting up an expert panel to determine its content validity, the questionnaire was translated and back-translated, and subjected to cognitive testing. The questionnaire was piloted in a cross-sectional study in 10 primary health care centers in Spain. Fifty patients per center completed the questionnaire while waiting for an appointment. We estimated (i) the acceptability of the questionnaire (response rate), (ii) scores distribution (floor and ceiling effects), (iii) internal consistency (Cronbach α), and (iv) construct validity (exploratory factor analyses and correlation between scales). To examine patients' evaluations of patient safety, we followed a mixed-methods approach: (i) statistical analyses at the scale and item levels based on responses to standardized items and (ii) qualitative content analysis based on responses to open-ended questions. RESULTS: Complete data were collected from 493 patients (participation rate, 77%). A ceiling effect was observed for 3 scales ("safety problems," "harm severity," "harm needs"). The internal consistency was adequate (α > 0.7) for the majority of scales. Exploratory factor analysis and correlation between scales suggested an appropriate construct validity. Two hundred twenty-six (45.8%) respondents experienced at least 1 safety problem, and 109 (23.2%) reported harm in the previous 12 months. CONCLUSIONS: The multidimensional primary health care patient safety instrument Patient Reported Experiences and Outcomes of Safety in Primary Care is now available for its use in Spain. Initial testing demonstrates its potential for use in primary care. Future developments will further address its use in actual clinical practice.

  @article{serranoripoll2022crosscultural,
  abstract = {OBJECTIVE: This study aimed to cross-culturally adapt, validate, and pilot the Patient Reported Experiences and Outcomes of Safety in Primary Care questionnaire for its use in Spain. METHODS: After setting up an expert panel to determine its content validity, the questionnaire was translated and back-translated, and subjected to cognitive testing. The questionnaire was piloted in a cross-sectional study in 10 primary health care centers in Spain. Fifty patients per center completed the questionnaire while waiting for an appointment. We estimated (i) the acceptability of the questionnaire (response rate), (ii) scores distribution (floor and ceiling effects), (iii) internal consistency (Cronbach α), and (iv) construct validity (exploratory factor analyses and correlation between scales). To examine patients' evaluations of patient safety, we followed a mixed-methods approach: (i) statistical analyses at the scale and item levels based on responses to standardized items and (ii) qualitative content analysis based on responses to open-ended questions. RESULTS: Complete data were collected from 493 patients (participation rate, 77%). A ceiling effect was observed for 3 scales ("safety problems," "harm severity," "harm needs"). The internal consistency was adequate (α > 0.7) for the majority of scales. Exploratory factor analysis and correlation between scales suggested an appropriate construct validity. Two hundred twenty-six (45.8%) respondents experienced at least 1 safety problem, and 109 (23.2%) reported harm in the previous 12 months. CONCLUSIONS: The multidimensional primary health care patient safety instrument Patient Reported Experiences and Outcomes of Safety in Primary Care is now available for its use in Spain. Initial testing demonstrates its potential for use in primary care. Future developments will further address its use in actual clinical practice.},
  address = {United States},
  author = {Serrano-Ripoll, María J and Llobera, Joan and Valderas, José M and de Labry Lima, Antonio Olry and Fiol deRoque, María A and Ripoll, Joana and Ricci-Cabello, Ignacio},
  journal = {Journal of patient safety},
  keywords = {evisap},
  month = {mar},
  number = 2,
  pages = {102--110},
  title = {Cross-Cultural Adaptation, Validation, and Piloting of the Patient Reported Experiences and Outcomes of Safety in Primary Care Questionnaire for Its Use in Spain},
  volume = 18,
  year = 2022
  }
  

  %0 Journal Article
  %1 serranoripoll2022crosscultural
  %A Serrano-Ripoll, María J
  %A Llobera, Joan
  %A Valderas, José M
  %A de Labry Lima, Antonio Olry
  %A Fiol deRoque, María A
  %A Ripoll, Joana
  %A Ricci-Cabello, Ignacio
  %C United States
  %D 2022
  %J Journal of patient safety
  %N 2
  %P 102--110
  %R 10.1097/PTS.0000000000000819
  %T Cross-Cultural Adaptation, Validation, and Piloting of the Patient Reported Experiences and Outcomes of Safety in Primary Care Questionnaire for Its Use in Spain
  %U https://pubmed.ncbi.nlm.nih.gov/35188925
  %V 18
  %X OBJECTIVE: This study aimed to cross-culturally adapt, validate, and pilot the Patient Reported Experiences and Outcomes of Safety in Primary Care questionnaire for its use in Spain. METHODS: After setting up an expert panel to determine its content validity, the questionnaire was translated and back-translated, and subjected to cognitive testing. The questionnaire was piloted in a cross-sectional study in 10 primary health care centers in Spain. Fifty patients per center completed the questionnaire while waiting for an appointment. We estimated (i) the acceptability of the questionnaire (response rate), (ii) scores distribution (floor and ceiling effects), (iii) internal consistency (Cronbach α), and (iv) construct validity (exploratory factor analyses and correlation between scales). To examine patients' evaluations of patient safety, we followed a mixed-methods approach: (i) statistical analyses at the scale and item levels based on responses to standardized items and (ii) qualitative content analysis based on responses to open-ended questions. RESULTS: Complete data were collected from 493 patients (participation rate, 77%). A ceiling effect was observed for 3 scales ("safety problems," "harm severity," "harm needs"). The internal consistency was adequate (α > 0.7) for the majority of scales. Exploratory factor analysis and correlation between scales suggested an appropriate construct validity. Two hundred twenty-six (45.8%) respondents experienced at least 1 safety problem, and 109 (23.2%) reported harm in the previous 12 months. CONCLUSIONS: The multidimensional primary health care patient safety instrument Patient Reported Experiences and Outcomes of Safety in Primary Care is now available for its use in Spain. Initial testing demonstrates its potential for use in primary care. Future developments will further address its use in actual clinical practice.
  

• 
  Longitudinal association of dietary carbohydrate quality with visceral fat deposition and other adiposity indicators. Zamanillo-Campos, Rocío; Chaplin, Alice; Romaguera, Dora; Abete, Itziar; Salas-Salvadó, Jordi; Martín, Vicente; Estruch, Ramón; Vidal, Josep; Ruiz-Canela, Miguel; Babio, Nancy; Fiol, Francisca; de Paz, José Antonio; Casas, Rosa; Olbeyra, Romina; Martínez-González, Miguel A; García-Gavilán, Jesús F; Goday, Albert; Fernandez-Lazaro, Cesar I; Martínez, J Alfredo; Hu, Frank B; Konieczna, Jadwiga (2022). 41(10) 2264–2274.

  AbstractURLBibTeXEndNoteDOIBibSonomy

  BACKGROUND & AIMS: The quality of dietary carbohydrates rather than total carbohydrate intake may determine the accumulation of visceral fat; however, to date, few studies have examined the impact of diet on adiposity using specific imaging techniques. Thus, the aim of this prospective study was to investigate the association between concurrent changes in carbohydrate quality index (CQI) and objectively-quantified adiposity distribution over a year. METHODS: We analyzed a cohort of 1476 participants aged 55-75 years with overweight/obesity and metabolic syndrome (MetS) from the PREDIMED-Plus randomized controlled trial. Dietary intake information was obtained at baseline, 6- and 12-months from a validated 143-item semi-quantitative food-frequency questionnaire, and CQI (range: 4 to 20) was calculated based on four dietary criteria: total dietary fibre, glycemic index, wholegrain/total grain carbohydrate ratio, and solid/total carbohydrate ratio. Overall and regional adiposity (total body fat, visceral fat and android-to-gynoid fat ratio) was quantified using dual-energy X-ray absorptiometry at all three time points. Multiple adjusted linear mixed-effects models were used to assess associations between concurrent changes in repeatedly measured CQI and adiposity over time. RESULTS: After controlling for potential confounding factors, a 3-point increment in CQI over 12-month follow-up was associated with a decrease in visceral fat (β -0.067 z-score, 95% CI -0.088; -0.046, p < 0.001), android-to-gynoid fat ratio (-0.038, -0.059; -0.017, p < 0.001), and total fat (-0.064, -0.080; -0.047, p < 0.001). Fibre intake and the ratio of wholegrain/total grain showed the strongest inverse associations with all adiposity indicators. CONCLUSIONS: In this prospective cohort of older adults with overweight/obesity and MetS, we found that improvements in dietary carbohydrate quality over a year were associated with concurrent favorable changes in visceral and overall fat deposition. These associations were mostly driven by dietary fibre and the wholegrain/total grain ratio. TRIAL REGISTRATION: The trial was registered at the International Standard Randomized. CONTROLLED TRIAL: (ISRCTN: http://www.isrctn.com/ISRCTN89898870) with number 89898870 and registration date of 24 July 2014, retrospectively registered.

  @article{zamanillocampos2022longitudinal,
  abstract = {BACKGROUND & AIMS: The quality of dietary carbohydrates rather than total carbohydrate intake may determine the accumulation of visceral fat; however, to date, few studies have examined the impact of diet on adiposity using specific imaging techniques. Thus, the aim of this prospective study was to investigate the association between concurrent changes in carbohydrate quality index (CQI) and objectively-quantified adiposity distribution over a year. METHODS: We analyzed a cohort of 1476 participants aged 55-75 years with overweight/obesity and metabolic syndrome (MetS) from the PREDIMED-Plus randomized controlled trial. Dietary intake information was obtained at baseline, 6- and 12-months from a validated 143-item semi-quantitative food-frequency questionnaire, and CQI (range: 4 to 20) was calculated based on four dietary criteria: total dietary fibre, glycemic index, wholegrain/total grain carbohydrate ratio, and solid/total carbohydrate ratio. Overall and regional adiposity (total body fat, visceral fat and android-to-gynoid fat ratio) was quantified using dual-energy X-ray absorptiometry at all three time points. Multiple adjusted linear mixed-effects models were used to assess associations between concurrent changes in repeatedly measured CQI and adiposity over time. RESULTS: After controlling for potential confounding factors, a 3-point increment in CQI over 12-month follow-up was associated with a decrease in visceral fat (β -0.067 z-score, 95% CI -0.088; -0.046, p < 0.001), android-to-gynoid fat ratio (-0.038, -0.059; -0.017, p < 0.001), and total fat (-0.064, -0.080; -0.047, p < 0.001). Fibre intake and the ratio of wholegrain/total grain showed the strongest inverse associations with all adiposity indicators. CONCLUSIONS: In this prospective cohort of older adults with overweight/obesity and MetS, we found that improvements in dietary carbohydrate quality over a year were associated with concurrent favorable changes in visceral and overall fat deposition. These associations were mostly driven by dietary fibre and the wholegrain/total grain ratio. TRIAL REGISTRATION: The trial was registered at the International Standard Randomized. CONTROLLED TRIAL: (ISRCTN: http://www.isrctn.com/ISRCTN89898870) with number 89898870 and registration date of 24 July 2014, retrospectively registered.},
  address = {England},
  author = {Zamanillo-Campos, Rocío and Chaplin, Alice and Romaguera, Dora and Abete, Itziar and Salas-Salvadó, Jordi and Martín, Vicente and Estruch, Ramón and Vidal, Josep and Ruiz-Canela, Miguel and Babio, Nancy and Fiol, Francisca and de Paz, José Antonio and Casas, Rosa and Olbeyra, Romina and Martínez-González, Miguel A and García-Gavilán, Jesús F and Goday, Albert and Fernandez-Lazaro, Cesar I and Martínez, J Alfredo and Hu, Frank B and Konieczna, Jadwiga},
  journal = {Clinical nutrition (Edinburgh, Scotland)},
  keywords = {evisap},
  month = {oct},
  number = 10,
  pages = {2264--2274},
  title = {Longitudinal association of dietary carbohydrate quality with visceral fat deposition and other adiposity indicators},
  volume = 41,
  year = 2022
  }
  

  %0 Journal Article
  %1 zamanillocampos2022longitudinal
  %A Zamanillo-Campos, Rocío
  %A Chaplin, Alice
  %A Romaguera, Dora
  %A Abete, Itziar
  %A Salas-Salvadó, Jordi
  %A Martín, Vicente
  %A Estruch, Ramón
  %A Vidal, Josep
  %A Ruiz-Canela, Miguel
  %A Babio, Nancy
  %A Fiol, Francisca
  %A de Paz, José Antonio
  %A Casas, Rosa
  %A Olbeyra, Romina
  %A Martínez-González, Miguel A
  %A García-Gavilán, Jesús F
  %A Goday, Albert
  %A Fernandez-Lazaro, Cesar I
  %A Martínez, J Alfredo
  %A Hu, Frank B
  %A Konieczna, Jadwiga
  %C England
  %D 2022
  %J Clinical nutrition (Edinburgh, Scotland)
  %N 10
  %P 2264--2274
  %R 10.1016/j.clnu.2022.08.008
  %T Longitudinal association of dietary carbohydrate quality with visceral fat deposition and other adiposity indicators
  %U https://pubmed.ncbi.nlm.nih.gov/36084360
  %V 41
  %X BACKGROUND & AIMS: The quality of dietary carbohydrates rather than total carbohydrate intake may determine the accumulation of visceral fat; however, to date, few studies have examined the impact of diet on adiposity using specific imaging techniques. Thus, the aim of this prospective study was to investigate the association between concurrent changes in carbohydrate quality index (CQI) and objectively-quantified adiposity distribution over a year. METHODS: We analyzed a cohort of 1476 participants aged 55-75 years with overweight/obesity and metabolic syndrome (MetS) from the PREDIMED-Plus randomized controlled trial. Dietary intake information was obtained at baseline, 6- and 12-months from a validated 143-item semi-quantitative food-frequency questionnaire, and CQI (range: 4 to 20) was calculated based on four dietary criteria: total dietary fibre, glycemic index, wholegrain/total grain carbohydrate ratio, and solid/total carbohydrate ratio. Overall and regional adiposity (total body fat, visceral fat and android-to-gynoid fat ratio) was quantified using dual-energy X-ray absorptiometry at all three time points. Multiple adjusted linear mixed-effects models were used to assess associations between concurrent changes in repeatedly measured CQI and adiposity over time. RESULTS: After controlling for potential confounding factors, a 3-point increment in CQI over 12-month follow-up was associated with a decrease in visceral fat (β -0.067 z-score, 95% CI -0.088; -0.046, p < 0.001), android-to-gynoid fat ratio (-0.038, -0.059; -0.017, p < 0.001), and total fat (-0.064, -0.080; -0.047, p < 0.001). Fibre intake and the ratio of wholegrain/total grain showed the strongest inverse associations with all adiposity indicators. CONCLUSIONS: In this prospective cohort of older adults with overweight/obesity and MetS, we found that improvements in dietary carbohydrate quality over a year were associated with concurrent favorable changes in visceral and overall fat deposition. These associations were mostly driven by dietary fibre and the wholegrain/total grain ratio. TRIAL REGISTRATION: The trial was registered at the International Standard Randomized. CONTROLLED TRIAL: (ISRCTN: http://www.isrctn.com/ISRCTN89898870) with number 89898870 and registration date of 24 July 2014, retrospectively registered.
  

2021

• 
  Specific Quality of Life Assessment by the NutriQoL® Questionnaire Among Patients Receiving Home Enteral Nutrition. Zamanillo Campos, Rocío; Colomar Ferrer, María Teresa; Ruiz López, Rosa María; Sanchís Cortés, María Pilar; Urgelés Planella, Joan Ramón (2021). 45(3) 490–498.

  AbstractURLBibTeXEndNoteDOIBibSonomy

  BACKGROUND: Home enteral nutrition (HEN), including tube feeding and oral supplementation, can improve or worsen quality of life (QoL). The specific assessment of factors affecting QoL may identify the inherent problems associated with HEN. The aim of this study was to evaluate whether the validated NutriQoL® questionnaire is useful for assessing the QoL and the factors influencing it in patients receiving HEN. METHODS: A total of 78 patients receiving HEN completed both the NutriQoL and the SF-12 questionnaires during their routine visits to nutrition service at the hospital. RESULTS: Ninety percent of patients receiving HEN had cancer, 58% received oral supplements, and 42% received tube feeding. At recruitment, the mean score ± SD of the NutriQoL was 66 ± 14, whereas that of the SF-12 was 40 ± 9. A positive correlation between NutriQoL and SF-12 scores (ρ = 0.5; P < .001) was found. Multivariate analysis showed that HEN type (oral vs tube) (odds ratio [OR], 5.6; 95% CI 2.0-15.3; P = .001) and the absence of secondary effects (OR, 3.0; 95% CI, 1.2-7.9; P = .024) were both variables explaining NutriQoL results adjusted by sex and age. The SF-12 results did not show associations with nutrition factors. On visit 2, we observed significant improvements in NutriQoL results. CONCLUSION: The NutriQoL questionnaire identifies specific problems that affect the QoL of patients receiving HEN, whereas SF-12 does not. The route of entry and the occurrence of complications influence specific QoL. NutriQoL is a useful tool to identify the factors that worsen the QoL in patients receiving HEN.

  @article{zamanillocampos2021specific,
  abstract = {BACKGROUND: Home enteral nutrition (HEN), including tube feeding and oral supplementation, can improve or worsen quality of life (QoL). The specific assessment of factors affecting QoL may identify the inherent problems associated with HEN. The aim of this study was to evaluate whether the validated NutriQoL® questionnaire is useful for assessing the QoL and the factors influencing it in patients receiving HEN. METHODS: A total of 78 patients receiving HEN completed both the NutriQoL and the SF-12 questionnaires during their routine visits to nutrition service at the hospital. RESULTS: Ninety percent of patients receiving HEN had cancer, 58% received oral supplements, and 42% received tube feeding. At recruitment, the mean score ± SD of the NutriQoL was 66 ± 14, whereas that of the SF-12 was 40 ± 9. A positive correlation between NutriQoL and SF-12 scores (ρ = 0.5; P < .001) was found. Multivariate analysis showed that HEN type (oral vs tube) (odds ratio [OR], 5.6; 95% CI 2.0-15.3; P = .001) and the absence of secondary effects (OR, 3.0; 95% CI, 1.2-7.9; P = .024) were both variables explaining NutriQoL results adjusted by sex and age. The SF-12 results did not show associations with nutrition factors. On visit 2, we observed significant improvements in NutriQoL results. CONCLUSION: The NutriQoL questionnaire identifies specific problems that affect the QoL of patients receiving HEN, whereas SF-12 does not. The route of entry and the occurrence of complications influence specific QoL. NutriQoL is a useful tool to identify the factors that worsen the QoL in patients receiving HEN.},
  address = {United States},
  author = {Zamanillo Campos, Rocío and Colomar Ferrer, María Teresa and Ruiz López, Rosa María and Sanchís Cortés, María Pilar and Urgelés Planella, Joan Ramón},
  journal = {JPEN. Journal of parenteral and enteral nutrition},
  keywords = {evisap},
  month = {mar},
  number = 3,
  pages = {490--498},
  title = {Specific Quality of Life Assessment by the NutriQoL® Questionnaire Among Patients Receiving Home Enteral Nutrition},
  volume = 45,
  year = 2021
  }
  

  %0 Journal Article
  %1 zamanillocampos2021specific
  %A Zamanillo Campos, Rocío
  %A Colomar Ferrer, María Teresa
  %A Ruiz López, Rosa María
  %A Sanchís Cortés, María Pilar
  %A Urgelés Planella, Joan Ramón
  %C United States
  %D 2021
  %J JPEN. Journal of parenteral and enteral nutrition
  %N 3
  %P 490--498
  %R 10.1002/jpen.1852
  %T Specific Quality of Life Assessment by the NutriQoL® Questionnaire Among Patients Receiving Home Enteral Nutrition
  %U https://pubmed.ncbi.nlm.nih.gov/32459026
  %V 45
  %X BACKGROUND: Home enteral nutrition (HEN), including tube feeding and oral supplementation, can improve or worsen quality of life (QoL). The specific assessment of factors affecting QoL may identify the inherent problems associated with HEN. The aim of this study was to evaluate whether the validated NutriQoL® questionnaire is useful for assessing the QoL and the factors influencing it in patients receiving HEN. METHODS: A total of 78 patients receiving HEN completed both the NutriQoL and the SF-12 questionnaires during their routine visits to nutrition service at the hospital. RESULTS: Ninety percent of patients receiving HEN had cancer, 58% received oral supplements, and 42% received tube feeding. At recruitment, the mean score ± SD of the NutriQoL was 66 ± 14, whereas that of the SF-12 was 40 ± 9. A positive correlation between NutriQoL and SF-12 scores (ρ = 0.5; P < .001) was found. Multivariate analysis showed that HEN type (oral vs tube) (odds ratio [OR], 5.6; 95% CI 2.0-15.3; P = .001) and the absence of secondary effects (OR, 3.0; 95% CI, 1.2-7.9; P = .024) were both variables explaining NutriQoL results adjusted by sex and age. The SF-12 results did not show associations with nutrition factors. On visit 2, we observed significant improvements in NutriQoL results. CONCLUSION: The NutriQoL questionnaire identifies specific problems that affect the QoL of patients receiving HEN, whereas SF-12 does not. The route of entry and the occurrence of complications influence specific QoL. NutriQoL is a useful tool to identify the factors that worsen the QoL in patients receiving HEN.
  

• 
  Assessing the Impact of Multi-Morbidity and Related Constructs on Patient Reported Safety in Primary Care: Generalized Structural Equation Modelling of Observational Data. Ricci-Cabello, Ignacio; Ya~nez-Juan, Aina Mar’ia; Fiol deRoque, Maria A.; Leiva, Alfonso; Canaves, Joan Llobera; Parmentier, Fabrice B. R.; Valderas, Jose M. (2021). 10(8) 1782.

  AbstractURLBibTeXEndNoteDOIBibSonomyDownload

  We aimed to examine the complex relationships between patient safety processes and outcomes and multimorbidity using a comprehensive set of constructs: multimorbidity, polypharmacy, discordant comorbidity (diseases not sharing either pathogenesis nor management), morbidity burden and patient complexity. We used cross-sectional data from 4782 patients in 69 primary care centres in Spain. We constructed generalized structural equation models to examine the associations between multimorbidity constructs and patient-reported patient safety (PREOS-PC questionnaire). These associations were modelled through direct and indirect (mediated by increased interactions with healthcare) pathways. For women, a consistent association between higher levels of the multimorbidity constructs and lower levels of patient safety was observed via either pathway. The findings for men replicated these observations for polypharmacy, morbidity burden and patient complexity via indirect pathways. However, direct pathways showed unexpected associations between higher levels of multimorbidity and better safety. The consistent association between multimorbidity constructs and worse patient safety among women makes it advisable to target this group for the development of interventions, with particular attention to the role of comorbidity discordance. Further research, particularly qualitative research, is needed for clarifying the complex associations among men.

  @article{Ricci_Cabello_2021,
  abstract = {We aimed to examine the complex relationships between patient safety processes and outcomes and multimorbidity using a comprehensive set of constructs: multimorbidity, polypharmacy, discordant comorbidity (diseases not sharing either pathogenesis nor management), morbidity burden and patient complexity. We used cross-sectional data from 4782 patients in 69 primary care centres in Spain. We constructed generalized structural equation models to examine the associations between multimorbidity constructs and patient-reported patient safety (PREOS-PC questionnaire). These associations were modelled through direct and indirect (mediated by increased interactions with healthcare) pathways. For women, a consistent association between higher levels of the multimorbidity constructs and lower levels of patient safety was observed via either pathway. The findings for men replicated these observations for polypharmacy, morbidity burden and patient complexity via indirect pathways. However, direct pathways showed unexpected associations between higher levels of multimorbidity and better safety. The consistent association between multimorbidity constructs and worse patient safety among women makes it advisable to target this group for the development of interventions, with particular attention to the role of comorbidity discordance. Further research, particularly qualitative research, is needed for clarifying the complex associations among men.},
  author = {Ricci-Cabello, Ignacio and Ya~nez-Juan, Aina Mar'ia and Fiol deRoque, Maria A. and Leiva, Alfonso and Canaves, Joan Llobera and Parmentier, Fabrice B. R. and Valderas, Jose M.},
  journal = {Journal of Clinical Medicine},
  keywords = {evisap grapp-caib myown},
  month = {apr},
  number = 8,
  pages = 1782,
  publisher = {MDPI AG},
  title = {Assessing the Impact of Multi-Morbidity and Related Constructs on Patient Reported Safety in Primary Care: Generalized Structural Equation Modelling of Observational Data},
  volume = 10,
  year = 2021
  }
  

  %0 Journal Article
  %1 Ricci_Cabello_2021
  %A Ricci-Cabello, Ignacio
  %A Ya~nez-Juan, Aina Mar'ia
  %A Fiol deRoque, Maria A.
  %A Leiva, Alfonso
  %A Canaves, Joan Llobera
  %A Parmentier, Fabrice B. R.
  %A Valderas, Jose M.
  %D 2021
  %I MDPI AG
  %J Journal of Clinical Medicine
  %N 8
  %P 1782
  %R 10.3390/jcm10081782
  %T Assessing the Impact of Multi-Morbidity and Related Constructs on Patient Reported Safety in Primary Care: Generalized Structural Equation Modelling of Observational Data
  %U https://doi.org/10.3390%2Fjcm10081782
  %V 10
  %X We aimed to examine the complex relationships between patient safety processes and outcomes and multimorbidity using a comprehensive set of constructs: multimorbidity, polypharmacy, discordant comorbidity (diseases not sharing either pathogenesis nor management), morbidity burden and patient complexity. We used cross-sectional data from 4782 patients in 69 primary care centres in Spain. We constructed generalized structural equation models to examine the associations between multimorbidity constructs and patient-reported patient safety (PREOS-PC questionnaire). These associations were modelled through direct and indirect (mediated by increased interactions with healthcare) pathways. For women, a consistent association between higher levels of the multimorbidity constructs and lower levels of patient safety was observed via either pathway. The findings for men replicated these observations for polypharmacy, morbidity burden and patient complexity via indirect pathways. However, direct pathways showed unexpected associations between higher levels of multimorbidity and better safety. The consistent association between multimorbidity constructs and worse patient safety among women makes it advisable to target this group for the development of interventions, with particular attention to the role of comorbidity discordance. Further research, particularly qualitative research, is needed for clarifying the complex associations among men.
  

• 
  Prevalence and age patterns of depression in the United Kingdom. A population-based study. Arias de la Torre, Jorge; Vilagut, Gemma; Ronaldson, Amy; Dregan, Alex; Ricci-Cabello, Ignacio; Hatch, Stephani L; Serrano-Blanco, Antoni; Valderas, Jose M; Hotopf, Matthew; Alonso, Jordi (2021). 279 164–172.

  AbstractURLBibTeXEndNoteDOIBibSonomy

  Methods A representative sample of the UK population (n=17,152) from the European Health Interview Survey of 2014 was included in the analyses. The Patient Health Questionnaire (PHQ-8) was used to assess the prevalence of depressive symptoms and of probable depressive disorder. Prevalence estimates (95%CI) were calculated. The association between prevalence and age was assessed using multivariable multinomial logistic and logistic regression models. All analyses were carried out for the total sample and stratified by sex. Results The prevalence of depressive symptoms ranged from 11.3% (10.6-11.9) for mild, to 3.3% (3.0-3.7) for severe symptoms. The prevalence of probable depressive disorder was 7.5% (95%CI: 7.0-8.0). A significantly higher prevalence of probable depressive disorder was found in those aged 45 to 59 years old compared with those aged 16 to 29. For the prevalence of severe depressive symptoms those age differences were even higher: 2.55 times higher (5.38 for men and 1.75 for women). Limitations The cross-sectional design precludes stablishing the direction of the relationship between age and the prevalence. Conclusions The prevalence and age patterns of depression in the UK were described. A peak in the prevalence was identified during middle adulthood. These results could serve as a reference for the monitoring of depression in the UK and the development of preventive strategies, particularly in the high-risk population groups identified.

  @article{ARIASDELATORRE2021164,
  abstract = {Methods A representative sample of the UK population (n=17,152) from the European Health Interview Survey of 2014 was included in the analyses. The Patient Health Questionnaire (PHQ-8) was used to assess the prevalence of depressive symptoms and of probable depressive disorder. Prevalence estimates (95%CI) were calculated. The association between prevalence and age was assessed using multivariable multinomial logistic and logistic regression models. All analyses were carried out for the total sample and stratified by sex. Results The prevalence of depressive symptoms ranged from 11.3% (10.6-11.9) for mild, to 3.3% (3.0-3.7) for severe symptoms. The prevalence of probable depressive disorder was 7.5% (95%CI: 7.0-8.0). A significantly higher prevalence of probable depressive disorder was found in those aged 45 to 59 years old compared with those aged 16 to 29. For the prevalence of severe depressive symptoms those age differences were even higher: 2.55 times higher (5.38 for men and 1.75 for women). Limitations The cross-sectional design precludes stablishing the direction of the relationship between age and the prevalence. Conclusions The prevalence and age patterns of depression in the UK were described. A peak in the prevalence was identified during middle adulthood. These results could serve as a reference for the monitoring of depression in the UK and the development of preventive strategies, particularly in the high-risk population groups identified.},
  author = {Arias de la Torre, Jorge and Vilagut, Gemma and Ronaldson, Amy and Dregan, Alex and Ricci-Cabello, Ignacio and Hatch, Stephani L and Serrano-Blanco, Antoni and Valderas, Jose M and Hotopf, Matthew and Alonso, Jordi},
  journal = {Journal of Affective Disorders},
  keywords = {evisap},
  pages = {164-172},
  title = {Prevalence and age patterns of depression in the United Kingdom. A population-based study},
  volume = 279,
  year = 2021
  }
  

  %0 Journal Article
  %1 ARIASDELATORRE2021164
  %A Arias de la Torre, Jorge
  %A Vilagut, Gemma
  %A Ronaldson, Amy
  %A Dregan, Alex
  %A Ricci-Cabello, Ignacio
  %A Hatch, Stephani L
  %A Serrano-Blanco, Antoni
  %A Valderas, Jose M
  %A Hotopf, Matthew
  %A Alonso, Jordi
  %D 2021
  %J Journal of Affective Disorders
  %P 164-172
  %R https://doi.org/10.1016/j.jad.2020.09.129
  %T Prevalence and age patterns of depression in the United Kingdom. A population-based study
  %U https://www.sciencedirect.com/science/article/pii/S0165032720328263
  %V 279
  %X Methods A representative sample of the UK population (n=17,152) from the European Health Interview Survey of 2014 was included in the analyses. The Patient Health Questionnaire (PHQ-8) was used to assess the prevalence of depressive symptoms and of probable depressive disorder. Prevalence estimates (95%CI) were calculated. The association between prevalence and age was assessed using multivariable multinomial logistic and logistic regression models. All analyses were carried out for the total sample and stratified by sex. Results The prevalence of depressive symptoms ranged from 11.3% (10.6-11.9) for mild, to 3.3% (3.0-3.7) for severe symptoms. The prevalence of probable depressive disorder was 7.5% (95%CI: 7.0-8.0). A significantly higher prevalence of probable depressive disorder was found in those aged 45 to 59 years old compared with those aged 16 to 29. For the prevalence of severe depressive symptoms those age differences were even higher: 2.55 times higher (5.38 for men and 1.75 for women). Limitations The cross-sectional design precludes stablishing the direction of the relationship between age and the prevalence. Conclusions The prevalence and age patterns of depression in the UK were described. A peak in the prevalence was identified during middle adulthood. These results could serve as a reference for the monitoring of depression in the UK and the development of preventive strategies, particularly in the high-risk population groups identified.
  

• 
  A Mobile Phone-Based Intervention to Reduce Mental Health Problems in Health Care Workers During the COVID-19 Pandemic (PsyCovidApp): Randomized Controlled Trial. Fiol-DeRoque, M. A.; Serrano-Ripoll, M. J.; Jiménez, R.; Zamanillo-Campos, R.; Yáñez-Juan, A. M.; Bennasar-Veny, M.; Leiva, A.; Gervilla, E.; García-Buades, M. E.; García-Toro, M.; Alonso-Coello, P.; Pastor-Moreno, G.; Ruiz-Pérez, I.; Sitges, C.; García-Campayo, J.; Llobera-Cánaves, J.; Ricci-Cabello, I. (2021). 9(5) e27039.

  AbstractBibTeXEndNoteDOIBibSonomyDownload

  BACKGROUND: The global health emergency generated by the COVID-19 pandemic is posing an unprecedented challenge to health care workers, who are facing heavy workloads under psychologically difficult situations. Mental mobile Health (mHealth) interventions are now being widely deployed due to their attractive implementation features, despite the lack of evidence about their efficacy in this specific population and context. OBJECTIVE: The aim of this trial is to evaluate the effectiveness of a psychoeducational, mindfulness-based mHealth intervention to reduce mental health problems in health care workers during the COVID-19 pandemic. METHODS: We conducted a blinded, parallel-group, controlled trial in Spain. Health care workers providing face-to-face health care to patients with COVID-19 were randomly assigned (1:1) to receive the PsyCovidApp intervention (an app targeting emotional skills, healthy lifestyle behavior, burnout, and social support) or a control app (general recommendations about mental health care) for 2 weeks. The participants were blinded to their group allocation. Data were collected telephonically at baseline and after 2 weeks by trained health psychologists. The primary outcome was a composite of depression, anxiety, and stress (overall score on the Depression Anxiety Stress Scale-21 [DASS-21]). Secondary outcomes were insomnia (Insomnia Severity Index), burnout (Maslach Burnout Inventory Human Services Survey), posttraumatic stress (Davidson Trauma Scale), self-efficacy (General Self-Efficacy Scale), and DASS-21 individual scale scores. Differences between groups were analyzed using general linear modeling according to an intention-to-treat protocol. Additionally, we measured the usability of the PsyCovidApp (System Usability Scale). The outcome data collectors and trial statisticians were unaware of the treatment allocation. RESULTS: Between May 14 and July 25, 2020, 482 health care workers were recruited and randomly assigned to PsyCovidApp (n=248) or the control app (n=234). At 2 weeks, complete outcome data were available for 436/482 participants (90.5%). No significant differences were observed between the groups at 2 weeks in the primary outcome (standardized mean difference -0.04; 95% CI -0.11 to 0.04; P=.15) or in the other outcomes. In our prespecified subgroup analyses, we observed significant improvements among health care workers consuming psychotropic medications (n=79) in the primary outcome (-0.29; 95% CI -0.48 to -0.09; P=.004), and in posttraumatic stress, insomnia, anxiety, and stress. Similarly, among health care workers receiving psychotherapy (n=43), we observed improvements in the primary outcome (-0.25; 95% CI -0.49 to -0.02; P=.02), and in insomnia, anxiety, and stress. The mean usability score of PsyCovidApp was high (87.21/100, SD 12.65). After the trial, 208/221 participants in the intervention group (94.1%) asked to regain access to PsyCovidApp, indicating high acceptability. CONCLUSIONS: In health care workers assisting patients with COVID-19 in Spain, PsyCovidApp, compared with a control app, reduced mental health problems at 2 weeks only among health care workers receiving psychotherapy or psychotropic medications. TRIAL REGISTRATION: ClinicalTrials.gov NCT04393818; https://clinicaltrials.gov/ct2/show/NCT04393818.

  @article{RN22,
  abstract = {BACKGROUND: The global health emergency generated by the COVID-19 pandemic is posing an unprecedented challenge to health care workers, who are facing heavy workloads under psychologically difficult situations. Mental mobile Health (mHealth) interventions are now being widely deployed due to their attractive implementation features, despite the lack of evidence about their efficacy in this specific population and context. OBJECTIVE: The aim of this trial is to evaluate the effectiveness of a psychoeducational, mindfulness-based mHealth intervention to reduce mental health problems in health care workers during the COVID-19 pandemic. METHODS: We conducted a blinded, parallel-group, controlled trial in Spain. Health care workers providing face-to-face health care to patients with COVID-19 were randomly assigned (1:1) to receive the PsyCovidApp intervention (an app targeting emotional skills, healthy lifestyle behavior, burnout, and social support) or a control app (general recommendations about mental health care) for 2 weeks. The participants were blinded to their group allocation. Data were collected telephonically at baseline and after 2 weeks by trained health psychologists. The primary outcome was a composite of depression, anxiety, and stress (overall score on the Depression Anxiety Stress Scale-21 [DASS-21]). Secondary outcomes were insomnia (Insomnia Severity Index), burnout (Maslach Burnout Inventory Human Services Survey), posttraumatic stress (Davidson Trauma Scale), self-efficacy (General Self-Efficacy Scale), and DASS-21 individual scale scores. Differences between groups were analyzed using general linear modeling according to an intention-to-treat protocol. Additionally, we measured the usability of the PsyCovidApp (System Usability Scale). The outcome data collectors and trial statisticians were unaware of the treatment allocation. RESULTS: Between May 14 and July 25, 2020, 482 health care workers were recruited and randomly assigned to PsyCovidApp (n=248) or the control app (n=234). At 2 weeks, complete outcome data were available for 436/482 participants (90.5%). No significant differences were observed between the groups at 2 weeks in the primary outcome (standardized mean difference -0.04; 95% CI -0.11 to 0.04; P=.15) or in the other outcomes. In our prespecified subgroup analyses, we observed significant improvements among health care workers consuming psychotropic medications (n=79) in the primary outcome (-0.29; 95% CI -0.48 to -0.09; P=.004), and in posttraumatic stress, insomnia, anxiety, and stress. Similarly, among health care workers receiving psychotherapy (n=43), we observed improvements in the primary outcome (-0.25; 95% CI -0.49 to -0.02; P=.02), and in insomnia, anxiety, and stress. The mean usability score of PsyCovidApp was high (87.21/100, SD 12.65). After the trial, 208/221 participants in the intervention group (94.1%) asked to regain access to PsyCovidApp, indicating high acceptability. CONCLUSIONS: In health care workers assisting patients with COVID-19 in Spain, PsyCovidApp, compared with a control app, reduced mental health problems at 2 weeks only among health care workers receiving psychotherapy or psychotropic medications. TRIAL REGISTRATION: ClinicalTrials.gov NCT04393818; https://clinicaltrials.gov/ct2/show/NCT04393818.},
  author = {Fiol-DeRoque, M. A. and Serrano-Ripoll, M. J. and Jiménez, R. and Zamanillo-Campos, R. and Yáñez-Juan, A. M. and Bennasar-Veny, M. and Leiva, A. and Gervilla, E. and García-Buades, M. E. and García-Toro, M. and Alonso-Coello, P. and Pastor-Moreno, G. and Ruiz-Pérez, I. and Sitges, C. and García-Campayo, J. and Llobera-Cánaves, J. and Ricci-Cabello, I.},
  journal = {JMIR Mhealth Uhealth},
  keywords = {evisap grapp-caib},
  number = 5,
  pages = {e27039},
  title = {A Mobile Phone-Based Intervention to Reduce Mental Health Problems in Health Care Workers During the COVID-19 Pandemic (PsyCovidApp): Randomized Controlled Trial},
  type = {Journal Article},
  volume = 9,
  year = 2021
  }
  

  %0 Journal Article
  %1 RN22
  %A Fiol-DeRoque, M. A.
  %A Serrano-Ripoll, M. J.
  %A Jiménez, R.
  %A Zamanillo-Campos, R.
  %A Yáñez-Juan, A. M.
  %A Bennasar-Veny, M.
  %A Leiva, A.
  %A Gervilla, E.
  %A García-Buades, M. E.
  %A García-Toro, M.
  %A Alonso-Coello, P.
  %A Pastor-Moreno, G.
  %A Ruiz-Pérez, I.
  %A Sitges, C.
  %A García-Campayo, J.
  %A Llobera-Cánaves, J.
  %A Ricci-Cabello, I.
  %D 2021
  %J JMIR Mhealth Uhealth
  %N 5
  %P e27039
  %R 10.2196/27039
  %T A Mobile Phone-Based Intervention to Reduce Mental Health Problems in Health Care Workers During the COVID-19 Pandemic (PsyCovidApp): Randomized Controlled Trial
  %V 9
  %X BACKGROUND: The global health emergency generated by the COVID-19 pandemic is posing an unprecedented challenge to health care workers, who are facing heavy workloads under psychologically difficult situations. Mental mobile Health (mHealth) interventions are now being widely deployed due to their attractive implementation features, despite the lack of evidence about their efficacy in this specific population and context. OBJECTIVE: The aim of this trial is to evaluate the effectiveness of a psychoeducational, mindfulness-based mHealth intervention to reduce mental health problems in health care workers during the COVID-19 pandemic. METHODS: We conducted a blinded, parallel-group, controlled trial in Spain. Health care workers providing face-to-face health care to patients with COVID-19 were randomly assigned (1:1) to receive the PsyCovidApp intervention (an app targeting emotional skills, healthy lifestyle behavior, burnout, and social support) or a control app (general recommendations about mental health care) for 2 weeks. The participants were blinded to their group allocation. Data were collected telephonically at baseline and after 2 weeks by trained health psychologists. The primary outcome was a composite of depression, anxiety, and stress (overall score on the Depression Anxiety Stress Scale-21 [DASS-21]). Secondary outcomes were insomnia (Insomnia Severity Index), burnout (Maslach Burnout Inventory Human Services Survey), posttraumatic stress (Davidson Trauma Scale), self-efficacy (General Self-Efficacy Scale), and DASS-21 individual scale scores. Differences between groups were analyzed using general linear modeling according to an intention-to-treat protocol. Additionally, we measured the usability of the PsyCovidApp (System Usability Scale). The outcome data collectors and trial statisticians were unaware of the treatment allocation. RESULTS: Between May 14 and July 25, 2020, 482 health care workers were recruited and randomly assigned to PsyCovidApp (n=248) or the control app (n=234). At 2 weeks, complete outcome data were available for 436/482 participants (90.5%). No significant differences were observed between the groups at 2 weeks in the primary outcome (standardized mean difference -0.04; 95% CI -0.11 to 0.04; P=.15) or in the other outcomes. In our prespecified subgroup analyses, we observed significant improvements among health care workers consuming psychotropic medications (n=79) in the primary outcome (-0.29; 95% CI -0.48 to -0.09; P=.004), and in posttraumatic stress, insomnia, anxiety, and stress. Similarly, among health care workers receiving psychotherapy (n=43), we observed improvements in the primary outcome (-0.25; 95% CI -0.49 to -0.02; P=.02), and in insomnia, anxiety, and stress. The mean usability score of PsyCovidApp was high (87.21/100, SD 12.65). After the trial, 208/221 participants in the intervention group (94.1%) asked to regain access to PsyCovidApp, indicating high acceptability. CONCLUSIONS: In health care workers assisting patients with COVID-19 in Spain, PsyCovidApp, compared with a control app, reduced mental health problems at 2 weeks only among health care workers receiving psychotherapy or psychotropic medications. TRIAL REGISTRATION: ClinicalTrials.gov NCT04393818; https://clinicaltrials.gov/ct2/show/NCT04393818.
  

• 
  Identifying Factors Leading to Harm in English General Practices: A Mixed-Methods Study Based on Patient Experiences Integrating Structural Equation Modeling and Qualitative Content Analysis. Ricci-Cabello, Ignacio; Gangannagaripalli, Jaheeda; Mounce, Luke T. A.; Valderas, Jose Mar’ia (2021). 17(1) e20-e27.

  AbstractURLBibTeXEndNoteDOIBibSonomy

  OBJECTIVE: The aim of the study was to identify the main factors leading to harm in primary care based on the experiences reported by patients. METHODS: We conducted a mixed-methods, cross-sectional study in 45 primary care centers in England. A random sample of 6736 patients was invited to complete the Patient-Reported Experiences and Outcomes of Safety in Primary Care questionnaire. We fitted structural equation modeling on the quantitative data (n = 1244 respondents) to identify contributory factors and primary incidents leading to harm. We conducted content analyses of responses to seven open-ended questions (n = 386) to obtain deeper insight into patient perceptions of the causes of harm experienced. Results from quantitative and qualitative analyses were triangulated. RESULTS: Patients reported harm related to physical health (13%), pain (11%), and mental health (19%) and harm that increased limitations in social activities (14%). Physical harm was associated with incidents affecting diagnosis (β = 0.43; delayed and wrong), and treatment (0.12; delayed, wrong treatment, or dose), which were in turn associated with incidents with patient-provider communication, coordination between providers, appointments, and laboratory tests. Pain was associated with laboratory tests (0.21; caused when collecting blood or tissue samples) and with problems booking an appointment when needed (0.13; delaying treatment for pain). Harm to mental health was associated with incidents related to the following: diagnosis (0.28), patient-provider communication (0.18), appointments (0.17), coordination between different providers (0.14), and laboratory tests (0.12). Harm increasing limitations in social activities was associated with incidents related to diagnosis (0.42) and diagnostic and monitoring procedures (0.20). CONCLUSIONS: Our findings suggest the need for patient-centered strategies to reduce harm in primary care focusing on the improvement of the quality of diagnosis and patient-provider communication.

  @article{Ricci_Cabello_2021,
  abstract = {OBJECTIVE: The aim of the study was to identify the main factors leading to harm in primary care based on the experiences reported by patients. METHODS: We conducted a mixed-methods, cross-sectional study in 45 primary care centers in England. A random sample of 6736 patients was invited to complete the Patient-Reported Experiences and Outcomes of Safety in Primary Care questionnaire. We fitted structural equation modeling on the quantitative data (n = 1244 respondents) to identify contributory factors and primary incidents leading to harm. We conducted content analyses of responses to seven open-ended questions (n = 386) to obtain deeper insight into patient perceptions of the causes of harm experienced. Results from quantitative and qualitative analyses were triangulated. RESULTS: Patients reported harm related to physical health (13%), pain (11%), and mental health (19%) and harm that increased limitations in social activities (14%). Physical harm was associated with incidents affecting diagnosis (β = 0.43; delayed and wrong), and treatment (0.12; delayed, wrong treatment, or dose), which were in turn associated with incidents with patient-provider communication, coordination between providers, appointments, and laboratory tests. Pain was associated with laboratory tests (0.21; caused when collecting blood or tissue samples) and with problems booking an appointment when needed (0.13; delaying treatment for pain). Harm to mental health was associated with incidents related to the following: diagnosis (0.28), patient-provider communication (0.18), appointments (0.17), coordination between different providers (0.14), and laboratory tests (0.12). Harm increasing limitations in social activities was associated with incidents related to diagnosis (0.42) and diagnostic and monitoring procedures (0.20). CONCLUSIONS: Our findings suggest the need for patient-centered strategies to reduce harm in primary care focusing on the improvement of the quality of diagnosis and patient-provider communication.},
  author = {Ricci-Cabello, Ignacio and Gangannagaripalli, Jaheeda and Mounce, Luke T. A. and Valderas, Jose Mar'ia},
  journal = {Journal of Patient Safety},
  keywords = {evisap},
  month = {jan},
  number = 1,
  pages = {e20--e27},
  publisher = {Ovid Technologies (Wolters Kluwer Health)},
  title = {Identifying Factors Leading to Harm in English General Practices: A Mixed-Methods Study Based on Patient Experiences Integrating Structural Equation Modeling and Qualitative Content Analysis},
  volume = 17,
  year = 2021
  }
  

  %0 Journal Article
  %1 Ricci_Cabello_2021
  %A Ricci-Cabello, Ignacio
  %A Gangannagaripalli, Jaheeda
  %A Mounce, Luke T. A.
  %A Valderas, Jose Mar'ia
  %D 2021
  %I Ovid Technologies (Wolters Kluwer Health)
  %J Journal of Patient Safety
  %N 1
  %P e20--e27
  %R 10.1097/pts.0000000000000669
  %T Identifying Factors Leading to Harm in English General Practices: A Mixed-Methods Study Based on Patient Experiences Integrating Structural Equation Modeling and Qualitative Content Analysis
  %U https://doi.org/10.1097%2Fpts.0000000000000669
  %V 17
  %X OBJECTIVE: The aim of the study was to identify the main factors leading to harm in primary care based on the experiences reported by patients. METHODS: We conducted a mixed-methods, cross-sectional study in 45 primary care centers in England. A random sample of 6736 patients was invited to complete the Patient-Reported Experiences and Outcomes of Safety in Primary Care questionnaire. We fitted structural equation modeling on the quantitative data (n = 1244 respondents) to identify contributory factors and primary incidents leading to harm. We conducted content analyses of responses to seven open-ended questions (n = 386) to obtain deeper insight into patient perceptions of the causes of harm experienced. Results from quantitative and qualitative analyses were triangulated. RESULTS: Patients reported harm related to physical health (13%), pain (11%), and mental health (19%) and harm that increased limitations in social activities (14%). Physical harm was associated with incidents affecting diagnosis (β = 0.43; delayed and wrong), and treatment (0.12; delayed, wrong treatment, or dose), which were in turn associated with incidents with patient-provider communication, coordination between providers, appointments, and laboratory tests. Pain was associated with laboratory tests (0.21; caused when collecting blood or tissue samples) and with problems booking an appointment when needed (0.13; delaying treatment for pain). Harm to mental health was associated with incidents related to the following: diagnosis (0.28), patient-provider communication (0.18), appointments (0.17), coordination between different providers (0.14), and laboratory tests (0.12). Harm increasing limitations in social activities was associated with incidents related to diagnosis (0.42) and diagnostic and monitoring procedures (0.20). CONCLUSIONS: Our findings suggest the need for patient-centered strategies to reduce harm in primary care focusing on the improvement of the quality of diagnosis and patient-provider communication.
  

• 
  Effect of a mobile-based intervention on mental health in frontline healthcare workers against COVID-19: Protocol for a randomized controlled trial. Serrano-Ripoll, M. J.; Ricci-Cabello, I.; Jiménez, R.; Zamanillo-Campos, R.; Yañez-Juan, A. M.; Bennasar-Veny, M.; Sitges, C.; Gervilla, E.; Leiva, A.; García-Campayo, J.; García-Buades, M. E.; García-Toro, M.; Pastor-Moreno, G.; Ruiz-Perez, I.; Alonso-Coello, P.; Llobera, J.; Fiol deRoque, M. A. (2021). 77(6) 2898–2907.

  AbstractURLBibTeXEndNoteDOIBibSonomyDownload

  AIM: To evaluate the impact of a psychoeducational, mobile health intervention based on cognitive behavioural therapy and mindfulness-based approaches on the mental health of healthcare workers at the frontline against COVID-19 in Spain. DESIGN: We will carry out a two-week, individually randomized, parallel group, controlled trial. Participants will be individually randomized to receive the PsyCovidApp intervention or control App intervention. METHODS: The PsyCovidApp intervention will include five modules: emotional skills, lifestyle behaviour, work stress and burnout, social support, and practical tools. Healthcare workers having attended patients with COVID-19 will be randomized to receive the PsyCovidApp intervention (intervention group) or a control App intervention (control group). A total of 440 healthcare workers will be necessary to assure statistical power. Measures will be collected telephonically by a team of psychologists at baseline and immediately after the 2 weeks intervention period. Measures will include stress, depression and anxiety (DASS-21 questionnaire-primary endpoint), insomnia (ISI), burnout (MBI-HSS), post-traumatic stress disorder (DTS), and self-efficacy (GSE). The study was funded in May 2020, and was ethically approved in June 2020. Trial participants, outcome assessors and data analysts will be blinded to group allocation. DISCUSSION: Despite the increasing use of mobile health interventions to deliver mental health care, this area of research is still on its infancy. This study will help increase the scientific evidence about the effectiveness of this type of intervention on this specific population and context. IMPACT: Despite the lack of solid evidence about their effectiveness, mobile-based health interventions are already being widely implemented because of their low cost and high scalability. The findings from this study will help health services and organizations to make informed decisions in relation to the development and implementation of this type of interventions, allowing them pondering not only their attractive implementability features, but also empirical data about its benefits. CLINICAL TRIAL REGISTRATION: NCT04393818 (ClinicalTrials.gov identifier). APPROVED FUNDING: May 2020.

  @article{RN28,
  abstract = {AIM: To evaluate the impact of a psychoeducational, mobile health intervention based on cognitive behavioural therapy and mindfulness-based approaches on the mental health of healthcare workers at the frontline against COVID-19 in Spain. DESIGN: We will carry out a two-week, individually randomized, parallel group, controlled trial. Participants will be individually randomized to receive the PsyCovidApp intervention or control App intervention. METHODS: The PsyCovidApp intervention will include five modules: emotional skills, lifestyle behaviour, work stress and burnout, social support, and practical tools. Healthcare workers having attended patients with COVID-19 will be randomized to receive the PsyCovidApp intervention (intervention group) or a control App intervention (control group). A total of 440 healthcare workers will be necessary to assure statistical power. Measures will be collected telephonically by a team of psychologists at baseline and immediately after the 2 weeks intervention period. Measures will include stress, depression and anxiety (DASS-21 questionnaire-primary endpoint), insomnia (ISI), burnout (MBI-HSS), post-traumatic stress disorder (DTS), and self-efficacy (GSE). The study was funded in May 2020, and was ethically approved in June 2020. Trial participants, outcome assessors and data analysts will be blinded to group allocation. DISCUSSION: Despite the increasing use of mobile health interventions to deliver mental health care, this area of research is still on its infancy. This study will help increase the scientific evidence about the effectiveness of this type of intervention on this specific population and context. IMPACT: Despite the lack of solid evidence about their effectiveness, mobile-based health interventions are already being widely implemented because of their low cost and high scalability. The findings from this study will help health services and organizations to make informed decisions in relation to the development and implementation of this type of interventions, allowing them pondering not only their attractive implementability features, but also empirical data about its benefits. CLINICAL TRIAL REGISTRATION: NCT04393818 (ClinicalTrials.gov identifier). APPROVED FUNDING: May 2020.},
  author = {Serrano-Ripoll, M. J. and Ricci-Cabello, I. and Jiménez, R. and Zamanillo-Campos, R. and Yañez-Juan, A. M. and Bennasar-Veny, M. and Sitges, C. and Gervilla, E. and Leiva, A. and García-Campayo, J. and García-Buades, M. E. and García-Toro, M. and Pastor-Moreno, G. and Ruiz-Perez, I. and Alonso-Coello, P. and Llobera, J. and Fiol deRoque, M. A.},
  journal = {J Adv Nurs},
  keywords = {evisap grapp-caib},
  number = 6,
  pages = {2898-2907},
  title = {Effect of a mobile-based intervention on mental health in frontline healthcare workers against COVID-19: Protocol for a randomized controlled trial},
  type = {Journal Article},
  volume = 77,
  year = 2021
  }
  

  %0 Journal Article
  %1 RN28
  %A Serrano-Ripoll, M. J.
  %A Ricci-Cabello, I.
  %A Jiménez, R.
  %A Zamanillo-Campos, R.
  %A Yañez-Juan, A. M.
  %A Bennasar-Veny, M.
  %A Sitges, C.
  %A Gervilla, E.
  %A Leiva, A.
  %A García-Campayo, J.
  %A García-Buades, M. E.
  %A García-Toro, M.
  %A Pastor-Moreno, G.
  %A Ruiz-Perez, I.
  %A Alonso-Coello, P.
  %A Llobera, J.
  %A Fiol deRoque, M. A.
  %D 2021
  %J J Adv Nurs
  %N 6
  %P 2898-2907
  %R 10.1111/jan.14813
  %T Effect of a mobile-based intervention on mental health in frontline healthcare workers against COVID-19: Protocol for a randomized controlled trial
  %U https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8250879/pdf/JAN-77-2898.pdf
  %V 77
  %X AIM: To evaluate the impact of a psychoeducational, mobile health intervention based on cognitive behavioural therapy and mindfulness-based approaches on the mental health of healthcare workers at the frontline against COVID-19 in Spain. DESIGN: We will carry out a two-week, individually randomized, parallel group, controlled trial. Participants will be individually randomized to receive the PsyCovidApp intervention or control App intervention. METHODS: The PsyCovidApp intervention will include five modules: emotional skills, lifestyle behaviour, work stress and burnout, social support, and practical tools. Healthcare workers having attended patients with COVID-19 will be randomized to receive the PsyCovidApp intervention (intervention group) or a control App intervention (control group). A total of 440 healthcare workers will be necessary to assure statistical power. Measures will be collected telephonically by a team of psychologists at baseline and immediately after the 2 weeks intervention period. Measures will include stress, depression and anxiety (DASS-21 questionnaire-primary endpoint), insomnia (ISI), burnout (MBI-HSS), post-traumatic stress disorder (DTS), and self-efficacy (GSE). The study was funded in May 2020, and was ethically approved in June 2020. Trial participants, outcome assessors and data analysts will be blinded to group allocation. DISCUSSION: Despite the increasing use of mobile health interventions to deliver mental health care, this area of research is still on its infancy. This study will help increase the scientific evidence about the effectiveness of this type of intervention on this specific population and context. IMPACT: Despite the lack of solid evidence about their effectiveness, mobile-based health interventions are already being widely implemented because of their low cost and high scalability. The findings from this study will help health services and organizations to make informed decisions in relation to the development and implementation of this type of interventions, allowing them pondering not only their attractive implementability features, but also empirical data about its benefits. CLINICAL TRIAL REGISTRATION: NCT04393818 (ClinicalTrials.gov identifier). APPROVED FUNDING: May 2020.
  

• 
  Common practices and beliefs in the preparation of complementary infant feeding in a Spanish sample: a cross-sectional study. Zamanillo Campos, Rocío; Rovira Boixadera, Laia; Rendo Urteaga, Tara (2021). 38(5) 919–934.

  AbstractURLBibTeXEndNoteDOIBibSonomy

  Introduction: complementary feeding together with breast milk should cover the nutritional needs of children from 6 months onwards. Thus, inadequate dietary practices can lead to poor nutritional intake. The objective of this study was to examine infant food handling and cooking in Spanish households. Methodology: a cross-sectional study was carried out using an online survey in non-institutionalized adults living in Spain who usually prepare infant food for children under 2 years of age. Results: a total of 1,944 people (37.4 ± 6 years; 65.5 % women) answered the survey. Of these, 72 % prepared mainly mashed foods and 21 % used store-bought baby cereals frequently. Zucchini (39 %), chicken (62 %), hake (64 %) and banana (44 %) were the most commonly used foods. Boiling (63 %) and freezing (59 %) were the most widely used culinary and preservation practices. An inappropriate use of salt and some unsafe foods (large fish and chard) was identified, whereas olive oil and eggs were offered below the current nutritional recommendations. Conclusion: the population surveyed preferred to use mashed foods to feed children under 2 years of age. Even though they were aware that homemade food is nutritionally better, on certain occasions they offer store-bought baby cereal. Furthermore, some inappropriate feeding practices were detected, highlighting the need to implement nutritional education policies regarding infant food preparation.

  @article{zamanillocampos2021common,
  abstract = {Introduction: complementary feeding together with breast milk should cover the nutritional needs of children from 6 months onwards. Thus, inadequate dietary practices can lead to poor nutritional intake. The objective of this study was to examine infant food handling and cooking in Spanish households. Methodology: a cross-sectional study was carried out using an online survey in non-institutionalized adults living in Spain who usually prepare infant food for children under 2 years of age. Results: a total of 1,944 people (37.4 ± 6 years; 65.5 % women) answered the survey. Of these, 72 % prepared mainly mashed foods and 21 % used store-bought baby cereals frequently. Zucchini (39 %), chicken (62 %), hake (64 %) and banana (44 %) were the most commonly used foods. Boiling (63 %) and freezing (59 %) were the most widely used culinary and preservation practices. An inappropriate use of salt and some unsafe foods (large fish and chard) was identified, whereas olive oil and eggs were offered below the current nutritional recommendations. Conclusion: the population surveyed preferred to use mashed foods to feed children under 2 years of age. Even though they were aware that homemade food is nutritionally better, on certain occasions they offer store-bought baby cereal. Furthermore, some inappropriate feeding practices were detected, highlighting the need to implement nutritional education policies regarding infant food preparation.},
  address = {Spain},
  author = {Zamanillo Campos, Rocío and Rovira Boixadera, Laia and Rendo Urteaga, Tara},
  journal = {Nutricion hospitalaria},
  keywords = {evisap},
  month = {oct},
  number = 5,
  pages = {919--934},
  title = {Common practices and beliefs in the preparation of complementary infant feeding in a Spanish sample: a cross-sectional study},
  volume = 38,
  year = 2021
  }
  

  %0 Journal Article
  %1 zamanillocampos2021common
  %A Zamanillo Campos, Rocío
  %A Rovira Boixadera, Laia
  %A Rendo Urteaga, Tara
  %C Spain
  %D 2021
  %J Nutricion hospitalaria
  %N 5
  %P 919--934
  %R 10.20960/nh.03527
  %T Common practices and beliefs in the preparation of complementary infant feeding in a Spanish sample: a cross-sectional study
  %U https://pubmed.ncbi.nlm.nih.gov/34176276
  %V 38
  %X Introduction: complementary feeding together with breast milk should cover the nutritional needs of children from 6 months onwards. Thus, inadequate dietary practices can lead to poor nutritional intake. The objective of this study was to examine infant food handling and cooking in Spanish households. Methodology: a cross-sectional study was carried out using an online survey in non-institutionalized adults living in Spain who usually prepare infant food for children under 2 years of age. Results: a total of 1,944 people (37.4 ± 6 years; 65.5 % women) answered the survey. Of these, 72 % prepared mainly mashed foods and 21 % used store-bought baby cereals frequently. Zucchini (39 %), chicken (62 %), hake (64 %) and banana (44 %) were the most commonly used foods. Boiling (63 %) and freezing (59 %) were the most widely used culinary and preservation practices. An inappropriate use of salt and some unsafe foods (large fish and chard) was identified, whereas olive oil and eggs were offered below the current nutritional recommendations. Conclusion: the population surveyed preferred to use mashed foods to feed children under 2 years of age. Even though they were aware that homemade food is nutritionally better, on certain occasions they offer store-bought baby cereal. Furthermore, some inappropriate feeding practices were detected, highlighting the need to implement nutritional education policies regarding infant food preparation.
  

• 
  Insomnia and sleep quality in healthcare workers fighting against COVID-19: a systematic review of the literature and meta-analysis. Serrano-Ripoll, M. J.; Zamanillo-Campos, R.; Castro, A.; Fiol-de Roque, M. A.; Ricci-Cabello, I. (2021). 49(4) 155–179.

  AbstractBibTeXEndNoteBibSonomyDownload

  The COVID-19 pandemic has the potential to significant- ly affect the mental health of healthcare workers, who stand in the frontline of this crisis. Insomnia is often related to exposure to stressful situations, such as the current health crisis, as well as other mental disorders, physical conditions and work-related problems. The objectives of this systematic review were: 1) to examine the impact of the current health pandemic produced by COVID-19 on insomnia and sleep quality of health professionals, and 2) to identify risk factors associated with insomnia. After a literature search in MEDLINE, EMBASE, and PsycINFO, 18 relevant studies were identified. The prevalence of insomnia estimated by random effects meta-analysis was 38% (95%CI= 37 to 39%), being slightly higher in women (29%, 95%CI= 27% to 30%) than in men (24%, 95%CI= 21 to 27%). The main risk factor associated with insomnia was working in a high-risk environment, followed by female sex and having a lower educational level. The high figures of self-reported insomnia and poor sleep quality observed indicate the need to develop interventions aimed at mitigating and caring for the mental health of healthcare workers fighting against this pandemic.

  @article{RN179,
  abstract = {The COVID-19 pandemic has the potential to significant- ly affect the mental health of healthcare workers, who stand in the frontline of this crisis. Insomnia is often related to exposure to stressful situations, such as the current health crisis, as well as other mental disorders, physical conditions and work-related problems. The objectives of this systematic review were: 1) to examine the impact of the current health pandemic produced by COVID-19 on insomnia and sleep quality of health professionals, and 2) to identify risk factors associated with insomnia. After a literature search in MEDLINE, EMBASE, and PsycINFO, 18 relevant studies were identified. The prevalence of insomnia estimated by random effects meta-analysis was 38% (95%CI= 37 to 39%), being slightly higher in women (29%, 95%CI= 27% to 30%) than in men (24%, 95%CI= 21 to 27%). The main risk factor associated with insomnia was working in a high-risk environment, followed by female sex and having a lower educational level. The high figures of self-reported insomnia and poor sleep quality observed indicate the need to develop interventions aimed at mitigating and caring for the mental health of healthcare workers fighting against this pandemic.},
  author = {Serrano-Ripoll, M. J. and Zamanillo-Campos, R. and Castro, A. and Fiol-de Roque, M. A. and Ricci-Cabello, I.},
  journal = {Actas Esp Psiquiatr},
  keywords = {evisap grapp-caib},
  number = 4,
  pages = {155-179},
  title = {Insomnia and sleep quality in healthcare workers fighting against COVID-19: a systematic review of the literature and meta-analysis},
  type = {Journal Article},
  volume = 49,
  year = 2021
  }
  

  %0 Journal Article
  %1 RN179
  %A Serrano-Ripoll, M. J.
  %A Zamanillo-Campos, R.
  %A Castro, A.
  %A Fiol-de Roque, M. A.
  %A Ricci-Cabello, I.
  %D 2021
  %J Actas Esp Psiquiatr
  %N 4
  %P 155-179
  %T Insomnia and sleep quality in healthcare workers fighting against COVID-19: a systematic review of the literature and meta-analysis
  %V 49
  %X The COVID-19 pandemic has the potential to significant- ly affect the mental health of healthcare workers, who stand in the frontline of this crisis. Insomnia is often related to exposure to stressful situations, such as the current health crisis, as well as other mental disorders, physical conditions and work-related problems. The objectives of this systematic review were: 1) to examine the impact of the current health pandemic produced by COVID-19 on insomnia and sleep quality of health professionals, and 2) to identify risk factors associated with insomnia. After a literature search in MEDLINE, EMBASE, and PsycINFO, 18 relevant studies were identified. The prevalence of insomnia estimated by random effects meta-analysis was 38% (95%CI= 37 to 39%), being slightly higher in women (29%, 95%CI= 27% to 30%) than in men (24%, 95%CI= 21 to 27%). The main risk factor associated with insomnia was working in a high-risk environment, followed by female sex and having a lower educational level. The high figures of self-reported insomnia and poor sleep quality observed indicate the need to develop interventions aimed at mitigating and caring for the mental health of healthcare workers fighting against this pandemic.
  

• 
  Routine provision of feedback from patient-reported outcome measurements to healthcare providers and patients in clinical practice. Gibbons, C.; Porter, I.; Gonçalves-Bradley, D. C.; Stoilov, S.; Ricci-Cabello, I.; Tsangaris, E.; Gangannagaripalli, J.; Davey, A.; Gibbons, E. J.; Kotzeva, A.; Evans, J.; van der Wees, P. J.; Kontopantelis, E.; Greenhalgh, J.; Bower, P.; Alonso, J.; Valderas, J. M. (2021). 10(10) Cd011589.

  AbstractBibTeXEndNoteDOIBibSonomyDownload

  BACKGROUND: Patient-reported outcomes measures (PROMs) assess a patient's subjective appraisal of health outcomes from their own perspective. Despite hypothesised benefits that feedback  on PROMs can support decision-making in clinical practice and improve outcomes, there is uncertainty surrounding the effectiveness of PROMs feedback. OBJECTIVES: To assess the effects of PROMs feedback to patients, or healthcare workers, or both on patient-reported health outcomes and processes of care. SEARCH METHODS: We searched MEDLINE, Embase, CENTRAL, two other databases and two clinical trial registries on 5 October 2020. We searched grey literature and consulted experts in the field. SELECTION CRITERIA: Two review authors independently screened and selected studies for inclusion. We included randomised trials directly comparing the effects on outcomes and processes of care of PROMs feedback to healthcare professionals and patients, or both with the impact of not providing such information. DATA COLLECTION AND ANALYSIS: Two groups of two authors independently extracted data from the included studies and evaluated study quality. We followed standard methodological procedures expected by Cochrane and EPOC. We used the GRADE approach to assess the certainty of the evidence. We conducted meta-analyses of the results where possible. MAIN RESULTS: We identified 116 randomised trials which assessed the effectiveness of PROMs feedback in improving processes or outcomes of care, or both in a broad range of disciplines including psychiatry, primary care, and oncology. Studies were conducted across diverse ambulatory primary and secondary care settings in North America, Europe and Australasia. A total of 49,785 patients were included across all the studies. The certainty of the evidence varied between very low and moderate. Many of the studies included in the review were at risk of performance and detection bias. The evidence suggests moderate certainty that PROMs feedback probably improves quality of life (standardised mean difference (SMD) 0.15, 95% confidence interval (CI) 0.05 to 0.26; 11 studies; 2687 participants), and leads to an increase in patient-physician communication (SMD 0.36, 95% CI 0.21 to 0.52; 5 studies; 658 participants), diagnosis and notation (risk ratio (RR) 1.73, 95% CI 1.44 to 2.08; 21 studies; 7223 participants), and disease control (RR 1.25, 95% CI 1.10 to 1.41; 14 studies; 2806 participants). The intervention probably makes little or no difference for general health perceptions (SMD 0.04, 95% CI -0.17 to 0.24; 2 studies, 552 participants; low-certainty evidence), social functioning (SMD 0.02, 95% CI -0.06 to 0.09; 15 studies; 2632 participants; moderate-certainty evidence), and pain (SMD 0.00, 95% CI -0.09 to 0.08; 9 studies; 2386 participants; moderate-certainty evidence). We are uncertain about the effect of PROMs feedback on physical functioning (14 studies; 2788 participants) and mental functioning (34 studies; 7782 participants), as well as fatigue (4 studies; 741 participants), as the certainty of the evidence was very low. We did not find studies reporting on adverse effects defined as distress following or related to PROM completion. AUTHORS' CONCLUSIONS: PROM feedback probably produces moderate improvements in communication between healthcare professionals and patients as well as in diagnosis and notation, and disease control, and small improvements to quality of life. Our confidence in the effects is limited by the risk of bias, heterogeneity and small number of trials conducted to assess outcomes of interest. It is unclear whether   many of these improvements are clinically meaningful or sustainable in the long term. There is a need for more high-quality studies in this area, particularly studies which employ cluster designs and utilise techniques to maintain allocation concealment.

  @article{RN163,
  abstract = {BACKGROUND: Patient-reported outcomes measures (PROMs) assess a patient's subjective appraisal of health outcomes from their own perspective. Despite hypothesised benefits that feedback  on PROMs can support decision-making in clinical practice and improve outcomes, there is uncertainty surrounding the effectiveness of PROMs feedback. OBJECTIVES: To assess the effects of PROMs feedback to patients, or healthcare workers, or both on patient-reported health outcomes and processes of care. SEARCH METHODS: We searched MEDLINE, Embase, CENTRAL, two other databases and two clinical trial registries on 5 October 2020. We searched grey literature and consulted experts in the field. SELECTION CRITERIA: Two review authors independently screened and selected studies for inclusion. We included randomised trials directly comparing the effects on outcomes and processes of care of PROMs feedback to healthcare professionals and patients, or both with the impact of not providing such information. DATA COLLECTION AND ANALYSIS: Two groups of two authors independently extracted data from the included studies and evaluated study quality. We followed standard methodological procedures expected by Cochrane and EPOC. We used the GRADE approach to assess the certainty of the evidence. We conducted meta-analyses of the results where possible. MAIN RESULTS: We identified 116 randomised trials which assessed the effectiveness of PROMs feedback in improving processes or outcomes of care, or both in a broad range of disciplines including psychiatry, primary care, and oncology. Studies were conducted across diverse ambulatory primary and secondary care settings in North America, Europe and Australasia. A total of 49,785 patients were included across all the studies. The certainty of the evidence varied between very low and moderate. Many of the studies included in the review were at risk of performance and detection bias. The evidence suggests moderate certainty that PROMs feedback probably improves quality of life (standardised mean difference (SMD) 0.15, 95% confidence interval (CI) 0.05 to 0.26; 11 studies; 2687 participants), and leads to an increase in patient-physician communication (SMD 0.36, 95% CI 0.21 to 0.52; 5 studies; 658 participants), diagnosis and notation (risk ratio (RR) 1.73, 95% CI 1.44 to 2.08; 21 studies; 7223 participants), and disease control (RR 1.25, 95% CI 1.10 to 1.41; 14 studies; 2806 participants). The intervention probably makes little or no difference for general health perceptions (SMD 0.04, 95% CI -0.17 to 0.24; 2 studies, 552 participants; low-certainty evidence), social functioning (SMD 0.02, 95% CI -0.06 to 0.09; 15 studies; 2632 participants; moderate-certainty evidence), and pain (SMD 0.00, 95% CI -0.09 to 0.08; 9 studies; 2386 participants; moderate-certainty evidence). We are uncertain about the effect of PROMs feedback on physical functioning (14 studies; 2788 participants) and mental functioning (34 studies; 7782 participants), as well as fatigue (4 studies; 741 participants), as the certainty of the evidence was very low. We did not find studies reporting on adverse effects defined as distress following or related to PROM completion. AUTHORS' CONCLUSIONS: PROM feedback probably produces moderate improvements in communication between healthcare professionals and patients as well as in diagnosis and notation, and disease control, and small improvements to quality of life. Our confidence in the effects is limited by the risk of bias, heterogeneity and small number of trials conducted to assess outcomes of interest. It is unclear whether   many of these improvements are clinically meaningful or sustainable in the long term. There is a need for more high-quality studies in this area, particularly studies which employ cluster designs and utilise techniques to maintain allocation concealment.},
  author = {Gibbons, C. and Porter, I. and Gonçalves-Bradley, D. C. and Stoilov, S. and Ricci-Cabello, I. and Tsangaris, E. and Gangannagaripalli, J. and Davey, A. and Gibbons, E. J. and Kotzeva, A. and Evans, J. and van der Wees, P. J. and Kontopantelis, E. and Greenhalgh, J. and Bower, P. and Alonso, J. and Valderas, J. M.},
  journal = {Cochrane Database Syst Rev},
  keywords = {evisap grapp-caib myown},
  number = 10,
  pages = {Cd011589},
  title = {Routine provision of feedback from patient-reported outcome measurements to healthcare providers and patients in clinical practice},
  type = {Journal Article},
  volume = 10,
  year = 2021
  }
  

  %0 Journal Article
  %1 RN163
  %A Gibbons, C.
  %A Porter, I.
  %A Gonçalves-Bradley, D. C.
  %A Stoilov, S.
  %A Ricci-Cabello, I.
  %A Tsangaris, E.
  %A Gangannagaripalli, J.
  %A Davey, A.
  %A Gibbons, E. J.
  %A Kotzeva, A.
  %A Evans, J.
  %A van der Wees, P. J.
  %A Kontopantelis, E.
  %A Greenhalgh, J.
  %A Bower, P.
  %A Alonso, J.
  %A Valderas, J. M.
  %D 2021
  %J Cochrane Database Syst Rev
  %N 10
  %P Cd011589
  %R 10.1002/14651858.CD011589.pub2
  %T Routine provision of feedback from patient-reported outcome measurements to healthcare providers and patients in clinical practice
  %V 10
  %X BACKGROUND: Patient-reported outcomes measures (PROMs) assess a patient's subjective appraisal of health outcomes from their own perspective. Despite hypothesised benefits that feedback  on PROMs can support decision-making in clinical practice and improve outcomes, there is uncertainty surrounding the effectiveness of PROMs feedback. OBJECTIVES: To assess the effects of PROMs feedback to patients, or healthcare workers, or both on patient-reported health outcomes and processes of care. SEARCH METHODS: We searched MEDLINE, Embase, CENTRAL, two other databases and two clinical trial registries on 5 October 2020. We searched grey literature and consulted experts in the field. SELECTION CRITERIA: Two review authors independently screened and selected studies for inclusion. We included randomised trials directly comparing the effects on outcomes and processes of care of PROMs feedback to healthcare professionals and patients, or both with the impact of not providing such information. DATA COLLECTION AND ANALYSIS: Two groups of two authors independently extracted data from the included studies and evaluated study quality. We followed standard methodological procedures expected by Cochrane and EPOC. We used the GRADE approach to assess the certainty of the evidence. We conducted meta-analyses of the results where possible. MAIN RESULTS: We identified 116 randomised trials which assessed the effectiveness of PROMs feedback in improving processes or outcomes of care, or both in a broad range of disciplines including psychiatry, primary care, and oncology. Studies were conducted across diverse ambulatory primary and secondary care settings in North America, Europe and Australasia. A total of 49,785 patients were included across all the studies. The certainty of the evidence varied between very low and moderate. Many of the studies included in the review were at risk of performance and detection bias. The evidence suggests moderate certainty that PROMs feedback probably improves quality of life (standardised mean difference (SMD) 0.15, 95% confidence interval (CI) 0.05 to 0.26; 11 studies; 2687 participants), and leads to an increase in patient-physician communication (SMD 0.36, 95% CI 0.21 to 0.52; 5 studies; 658 participants), diagnosis and notation (risk ratio (RR) 1.73, 95% CI 1.44 to 2.08; 21 studies; 7223 participants), and disease control (RR 1.25, 95% CI 1.10 to 1.41; 14 studies; 2806 participants). The intervention probably makes little or no difference for general health perceptions (SMD 0.04, 95% CI -0.17 to 0.24; 2 studies, 552 participants; low-certainty evidence), social functioning (SMD 0.02, 95% CI -0.06 to 0.09; 15 studies; 2632 participants; moderate-certainty evidence), and pain (SMD 0.00, 95% CI -0.09 to 0.08; 9 studies; 2386 participants; moderate-certainty evidence). We are uncertain about the effect of PROMs feedback on physical functioning (14 studies; 2788 participants) and mental functioning (34 studies; 7782 participants), as well as fatigue (4 studies; 741 participants), as the certainty of the evidence was very low. We did not find studies reporting on adverse effects defined as distress following or related to PROM completion. AUTHORS' CONCLUSIONS: PROM feedback probably produces moderate improvements in communication between healthcare professionals and patients as well as in diagnosis and notation, and disease control, and small improvements to quality of life. Our confidence in the effects is limited by the risk of bias, heterogeneity and small number of trials conducted to assess outcomes of interest. It is unclear whether   many of these improvements are clinically meaningful or sustainable in the long term. There is a need for more high-quality studies in this area, particularly studies which employ cluster designs and utilise techniques to maintain allocation concealment.
  

• 
  Vitamin D recommendations in clinical guidelines: A systematic review, quality evaluation and analysis of potential predictors. Fraile Navarro, D.; López García-Franco, A.; Niño de Guzmán, E.; Rabassa, M.; Zamanillo Campos, R.; Pardo-Hernández, H.; Ricci-Cabello, I.; Canelo-Aybar, C.; Meneses-Echavez, J. F.; Yepes-Nuñez, J. J.; Kuindersma, J.; Gich Saladich, I.; Alonso-Coello, P. (2021). 75(11) e14805.

  AbstractBibTeXEndNoteDOIBibSonomy

  BACKGROUND: Vitamin D has been widely promoted for bone health through supplementation and fortification of the general adult population. However, there is growing evidence that does not support these strategies. Our aim is to review the quality and recommendations on vitamin D nutritional and clinical practice guidelines and to explore predictive factors for their direction and strength. METHODS: We searched three databases and two guideline repositories from 2010 onwards. We performed a descriptive analysis, a quality appraisal using AGREE II scores (Appraisal of Guidelines Research and Evaluation) and a bivariate analysis evaluating the association between direction and strength of recommendations, AGREE II domains' scores and pre-specified characteristics. RESULTS: We included 34 guidelines, 44.1% recommended, 26.5% suggested and 29.4% did not recommend vitamin D supplementation. Guidelines that scored higher for "editorial independence" and "overall quality score" were less likely to recommend or suggest vitamin D supplementation (median 68.8 vs 35.4; P = .001 and 58.3 vs 37.5; P = .02). Guidance produced by government organisations and those that reported source of funding were associated with higher AGREE II scores. Unclear role of source of funding was associated with recommending or suggesting vitamin D supplementation (P = .034). Editorial independence was an independent predictor for recommending or suggesting vitamin D supplementation (OR 1.09; CI95% 1.02 to 1.16; P = .006). CONCLUSIONS: Policymakers, clinicians and patients should be aware that lower quality guidelines and those reporting conflicts of interest are more likely to promote vitamin D supplementation. Guideline organisations should improve the quality of their recommendations' development and the management of conflicts of interest. Users and editors should be aware of these findings when using and appraising guidelines.

  @article{RN160,
  abstract = {BACKGROUND: Vitamin D has been widely promoted for bone health through supplementation and fortification of the general adult population. However, there is growing evidence that does not support these strategies. Our aim is to review the quality and recommendations on vitamin D nutritional and clinical practice guidelines and to explore predictive factors for their direction and strength. METHODS: We searched three databases and two guideline repositories from 2010 onwards. We performed a descriptive analysis, a quality appraisal using AGREE II scores (Appraisal of Guidelines Research and Evaluation) and a bivariate analysis evaluating the association between direction and strength of recommendations, AGREE II domains' scores and pre-specified characteristics. RESULTS: We included 34 guidelines, 44.1% recommended, 26.5% suggested and 29.4% did not recommend vitamin D supplementation. Guidelines that scored higher for "editorial independence" and "overall quality score" were less likely to recommend or suggest vitamin D supplementation (median 68.8 vs 35.4; P = .001 and 58.3 vs 37.5; P = .02). Guidance produced by government organisations and those that reported source of funding were associated with higher AGREE II scores. Unclear role of source of funding was associated with recommending or suggesting vitamin D supplementation (P = .034). Editorial independence was an independent predictor for recommending or suggesting vitamin D supplementation (OR 1.09; CI95% 1.02 to 1.16; P = .006). CONCLUSIONS: Policymakers, clinicians and patients should be aware that lower quality guidelines and those reporting conflicts of interest are more likely to promote vitamin D supplementation. Guideline organisations should improve the quality of their recommendations' development and the management of conflicts of interest. Users and editors should be aware of these findings when using and appraising guidelines.},
  author = {Fraile Navarro, D. and López García-Franco, A. and Niño de Guzmán, E. and Rabassa, M. and Zamanillo Campos, R. and Pardo-Hernández, H. and Ricci-Cabello, I. and Canelo-Aybar, C. and Meneses-Echavez, J. F. and Yepes-Nuñez, J. J. and Kuindersma, J. and Gich Saladich, I. and Alonso-Coello, P.},
  journal = {Int J Clin Pract},
  keywords = {evisap grapp-caib myown},
  number = 11,
  pages = {e14805},
  title = {Vitamin D recommendations in clinical guidelines: A systematic review, quality evaluation and analysis of potential predictors},
  type = {Journal Article},
  volume = 75,
  year = 2021
  }
  

  %0 Journal Article
  %1 RN160
  %A Fraile Navarro, D.
  %A López García-Franco, A.
  %A Niño de Guzmán, E.
  %A Rabassa, M.
  %A Zamanillo Campos, R.
  %A Pardo-Hernández, H.
  %A Ricci-Cabello, I.
  %A Canelo-Aybar, C.
  %A Meneses-Echavez, J. F.
  %A Yepes-Nuñez, J. J.
  %A Kuindersma, J.
  %A Gich Saladich, I.
  %A Alonso-Coello, P.
  %D 2021
  %J Int J Clin Pract
  %N 11
  %P e14805
  %R 10.1111/ijcp.14805
  %T Vitamin D recommendations in clinical guidelines: A systematic review, quality evaluation and analysis of potential predictors
  %V 75
  %X BACKGROUND: Vitamin D has been widely promoted for bone health through supplementation and fortification of the general adult population. However, there is growing evidence that does not support these strategies. Our aim is to review the quality and recommendations on vitamin D nutritional and clinical practice guidelines and to explore predictive factors for their direction and strength. METHODS: We searched three databases and two guideline repositories from 2010 onwards. We performed a descriptive analysis, a quality appraisal using AGREE II scores (Appraisal of Guidelines Research and Evaluation) and a bivariate analysis evaluating the association between direction and strength of recommendations, AGREE II domains' scores and pre-specified characteristics. RESULTS: We included 34 guidelines, 44.1% recommended, 26.5% suggested and 29.4% did not recommend vitamin D supplementation. Guidelines that scored higher for "editorial independence" and "overall quality score" were less likely to recommend or suggest vitamin D supplementation (median 68.8 vs 35.4; P = .001 and 58.3 vs 37.5; P = .02). Guidance produced by government organisations and those that reported source of funding were associated with higher AGREE II scores. Unclear role of source of funding was associated with recommending or suggesting vitamin D supplementation (P = .034). Editorial independence was an independent predictor for recommending or suggesting vitamin D supplementation (OR 1.09; CI95% 1.02 to 1.16; P = .006). CONCLUSIONS: Policymakers, clinicians and patients should be aware that lower quality guidelines and those reporting conflicts of interest are more likely to promote vitamin D supplementation. Guideline organisations should improve the quality of their recommendations' development and the management of conflicts of interest. Users and editors should be aware of these findings when using and appraising guidelines.
  

• 
  Impacto de la pandemia de COVID-19 en la seguridad del paciente percibida por los pacientes en Atención Primaria. Fiol deRoque, Maria A.; Serrano-Ripol, Maria J.; Gens-Barberà, Montserrat; Sánchez, Encarna; Mayer, Miguel A.; Martín-Luján, Francisco; Valderas, José M.; Ricci-Cabello, Ignacio (2021). 53 102222.

  AbstractURLBibTeXEndNoteDOIBibSonomyDownload

  Resumen Objetivo Evaluar el impacto de los cambios introducidos en respuesta a la pandemia sobre la seguridad del paciente (SP) percibida por los pacientes en Atención Primaria. Diseño Estudio observacional prospectivo de panel (centro de salud [CS]) basado en dos encuestas transversales. Emplazamiento 29 CS de tres regiones sanitarias de España (Mallorca, Cataluña Central y Camp de Tarragona). Participantes Muestreo aleatorio de pacientes que consultaron los CS antes (n=2.199) y durante (n=1.955) la pandemia. Mediciones principales Se administró el cuestionario validado PREOS-PC, que evalúa la SP experimentada por los pacientes atendidos en Atención Primaria. Se compararon las puntuaciones medias en las escalas «experiencias de errores» y «daño» en ambos períodos y se realizaron análisis de regresión multinivel para estudiar las variaciones en las características de los pacientes y de los CS asociadas a la percepción de peores niveles de seguridad. Se realizó un análisis cualitativo de contenido sobre las experiencias de los pacientes durante la pandemia. Resultados Las puntuaciones de «errores» y «daño» empeoraron significativamente durante el período de COVID-19 (92,65 a 88,81 [d de Cohen=0,27]; y 96,92 a 79,97 [d=0,70], respectivamente). Se observó un mayor empeoramiento en mujeres, personas con menor nivel educativo, peor estado de salud y con más años adscritos al centro. También se observaron diferencias en función de la región sanitaria. Conclusiones Durante la pandemia ha empeorado la SP percibida por los pacientes atendidos en Atención Primaria, siendo el impacto desigual según las características sociodemográficas de los pacientes y el perfil de los centros de salud. Objective To evaluate the impact of the changes introduced in response to the pandemic on patient-reported patient safety in Primary Care. Design Prospective observational panel study (health center) based on two cross-sectional surveys. Setting 29 Primary Health Care centers from three Spanish health regions (Mallorca, Catalunya Central and Camp de Tarragona). Participants Random sample of patients visiting their centers before (n=2199 patients) and during the pandemic (n=1955 patients) Main measurements We used the PREOS-PC questionnaire, a validated instrument which assesses patient-reported patient safety in Primary Care. We compared mean scores of the “experiences of errors” and “harm” scales in both periods, and built multilevel regression analyzes to study the variations in patient and center characteristics associated with worse levels of safety. A qualitative (content) analysis of patients’ experiences during the pandemic was also performed. Results The “experiences of errors” and “harm” scales scores significantly worsened during the COVID-19 period (92.65 to 88.81 (Cohen's d=0.27); and 96.92 to 79.97 (d=0.70), respectively). Patient and center characteristics associated to worsened scores were: women, people with a lower educational level, worse health status, more years assigned to the center, and health region. Conclusions During the pandemic, a perceptible worsening in patient safety perceived by patients treated in Primary Care has been observed, which has differentially affected patients according to their sociodemographic characteristics or health center profiles.

  @article{FIOLDEROQUE2021102222,
  abstract = {Resumen Objetivo Evaluar el impacto de los cambios introducidos en respuesta a la pandemia sobre la seguridad del paciente (SP) percibida por los pacientes en Atención Primaria. Diseño Estudio observacional prospectivo de panel (centro de salud [CS]) basado en dos encuestas transversales. Emplazamiento 29 CS de tres regiones sanitarias de España (Mallorca, Cataluña Central y Camp de Tarragona). Participantes Muestreo aleatorio de pacientes que consultaron los CS antes (n=2.199) y durante (n=1.955) la pandemia. Mediciones principales Se administró el cuestionario validado PREOS-PC, que evalúa la SP experimentada por los pacientes atendidos en Atención Primaria. Se compararon las puntuaciones medias en las escalas «experiencias de errores» y «daño» en ambos períodos y se realizaron análisis de regresión multinivel para estudiar las variaciones en las características de los pacientes y de los CS asociadas a la percepción de peores niveles de seguridad. Se realizó un análisis cualitativo de contenido sobre las experiencias de los pacientes durante la pandemia. Resultados Las puntuaciones de «errores» y «daño» empeoraron significativamente durante el período de COVID-19 (92,65 a 88,81 [d de Cohen=0,27]; y 96,92 a 79,97 [d=0,70], respectivamente). Se observó un mayor empeoramiento en mujeres, personas con menor nivel educativo, peor estado de salud y con más años adscritos al centro. También se observaron diferencias en función de la región sanitaria. Conclusiones Durante la pandemia ha empeorado la SP percibida por los pacientes atendidos en Atención Primaria, siendo el impacto desigual según las características sociodemográficas de los pacientes y el perfil de los centros de salud. Objective To evaluate the impact of the changes introduced in response to the pandemic on patient-reported patient safety in Primary Care. Design Prospective observational panel study (health center) based on two cross-sectional surveys. Setting 29 Primary Health Care centers from three Spanish health regions (Mallorca, Catalunya Central and Camp de Tarragona). Participants Random sample of patients visiting their centers before (n=2199 patients) and during the pandemic (n=1955 patients) Main measurements We used the PREOS-PC questionnaire, a validated instrument which assesses patient-reported patient safety in Primary Care. We compared mean scores of the “experiences of errors” and “harm” scales in both periods, and built multilevel regression analyzes to study the variations in patient and center characteristics associated with worse levels of safety. A qualitative (content) analysis of patients’ experiences during the pandemic was also performed. Results The “experiences of errors” and “harm” scales scores significantly worsened during the COVID-19 period (92.65 to 88.81 (Cohen's d=0.27); and 96.92 to 79.97 (d=0.70), respectively). Patient and center characteristics associated to worsened scores were: women, people with a lower educational level, worse health status, more years assigned to the center, and health region. Conclusions During the pandemic, a perceptible worsening in patient safety perceived by patients treated in Primary Care has been observed, which has differentially affected patients according to their sociodemographic characteristics or health center profiles.},
  author = {Fiol deRoque, Maria A. and Serrano-Ripol, Maria J. and Gens-Barberà, Montserrat and Sánchez, Encarna and Mayer, Miguel A. and Martín-Luján, Francisco and Valderas, José M. and Ricci-Cabello, Ignacio},
  journal = {Atención Primaria},
  keywords = {evisap grapp-caib myown},
  note = {Seguridad del Paciente en Atencion Primaria},
  pages = 102222,
  title = {Impacto de la pandemia de COVID-19 en la seguridad del paciente percibida por los pacientes en Atención Primaria},
  volume = 53,
  year = 2021
  }
  

  %0 Journal Article
  %1 FIOLDEROQUE2021102222
  %A Fiol deRoque, Maria A.
  %A Serrano-Ripol, Maria J.
  %A Gens-Barberà, Montserrat
  %A Sánchez, Encarna
  %A Mayer, Miguel A.
  %A Martín-Luján, Francisco
  %A Valderas, José M.
  %A Ricci-Cabello, Ignacio
  %D 2021
  %J Atención Primaria
  %P 102222
  %R https://doi.org/10.1016/j.aprim.2021.102222
  %T Impacto de la pandemia de COVID-19 en la seguridad del paciente percibida por los pacientes en Atención Primaria
  %U https://www.sciencedirect.com/science/article/pii/S0212656721002560
  %V 53
  %X Resumen Objetivo Evaluar el impacto de los cambios introducidos en respuesta a la pandemia sobre la seguridad del paciente (SP) percibida por los pacientes en Atención Primaria. Diseño Estudio observacional prospectivo de panel (centro de salud [CS]) basado en dos encuestas transversales. Emplazamiento 29 CS de tres regiones sanitarias de España (Mallorca, Cataluña Central y Camp de Tarragona). Participantes Muestreo aleatorio de pacientes que consultaron los CS antes (n=2.199) y durante (n=1.955) la pandemia. Mediciones principales Se administró el cuestionario validado PREOS-PC, que evalúa la SP experimentada por los pacientes atendidos en Atención Primaria. Se compararon las puntuaciones medias en las escalas «experiencias de errores» y «daño» en ambos períodos y se realizaron análisis de regresión multinivel para estudiar las variaciones en las características de los pacientes y de los CS asociadas a la percepción de peores niveles de seguridad. Se realizó un análisis cualitativo de contenido sobre las experiencias de los pacientes durante la pandemia. Resultados Las puntuaciones de «errores» y «daño» empeoraron significativamente durante el período de COVID-19 (92,65 a 88,81 [d de Cohen=0,27]; y 96,92 a 79,97 [d=0,70], respectivamente). Se observó un mayor empeoramiento en mujeres, personas con menor nivel educativo, peor estado de salud y con más años adscritos al centro. También se observaron diferencias en función de la región sanitaria. Conclusiones Durante la pandemia ha empeorado la SP percibida por los pacientes atendidos en Atención Primaria, siendo el impacto desigual según las características sociodemográficas de los pacientes y el perfil de los centros de salud. Objective To evaluate the impact of the changes introduced in response to the pandemic on patient-reported patient safety in Primary Care. Design Prospective observational panel study (health center) based on two cross-sectional surveys. Setting 29 Primary Health Care centers from three Spanish health regions (Mallorca, Catalunya Central and Camp de Tarragona). Participants Random sample of patients visiting their centers before (n=2199 patients) and during the pandemic (n=1955 patients) Main measurements We used the PREOS-PC questionnaire, a validated instrument which assesses patient-reported patient safety in Primary Care. We compared mean scores of the “experiences of errors” and “harm” scales in both periods, and built multilevel regression analyzes to study the variations in patient and center characteristics associated with worse levels of safety. A qualitative (content) analysis of patients’ experiences during the pandemic was also performed. Results The “experiences of errors” and “harm” scales scores significantly worsened during the COVID-19 period (92.65 to 88.81 (Cohen's d=0.27); and 96.92 to 79.97 (d=0.70), respectively). Patient and center characteristics associated to worsened scores were: women, people with a lower educational level, worse health status, more years assigned to the center, and health region. Conclusions During the pandemic, a perceptible worsening in patient safety perceived by patients treated in Primary Care has been observed, which has differentially affected patients according to their sociodemographic characteristics or health center profiles.
  

• 
  Adherence to Lifestyle Interventions for Treatment of Adults with Depression: A Systematic Review and Meta-Analysis. Castro, A.; Roca, M.; Ricci-Cabello, I.; García-Toro, M.; Riera-Serra, P.; Coronado-Simsic, V.; Pérez-Ara, MÁ; Gili, M. (2021). 18(24) 13268.

  AbstractURLBibTeXEndNoteDOIBibSonomyDownload

  The aim of this systematic review was to determine the adherence to lifestyle interventions for adults with depression and to estimate the dropout rates in trials examining the impact of these interventions. A bibliographic search was conducted in PubMed, Embase, PsycINFO, the Cochrane library, and several sources of grey literature. We included randomised controlled trials examining the impact of multiple lifestyle interventions on depressive symptomatology in adults when compared to control or other active treatments. Two reviewers independently screened citations, extracted the relevant data, and assessed the risk of bias using Cochrane tools. A random effects meta-analysis of proportions was used to summarise the proportion of participants who completed the intervention and to determine the proportion of dropouts at post-treatment assessment. Multiple subgroup analyses were also carried out. We identified six trials. The meta-analysis of proportions showed that 53% (95%CI 49% to 58%) of the participants assigned to the intervention group fully adhered to the intervention program. The weighted mean proportion of completed intervention sessions was 66%. The pooled trial dropout rate was 22% (95%CI 20% to 24%). Around half of adults with depression adhere to lifestyle interventions. Future research is needed to develop interventions to support adherence to lifestyle interventions in depressive patients.

  @article{Castro_2021,
  abstract = {The aim of this systematic review was to determine the adherence to lifestyle interventions for adults with depression and to estimate the dropout rates in trials examining the impact of these interventions. A bibliographic search was conducted in PubMed, Embase, PsycINFO, the Cochrane library, and several sources of grey literature. We included randomised controlled trials examining the impact of multiple lifestyle interventions on depressive symptomatology in adults when compared to control or other active treatments. Two reviewers independently screened citations, extracted the relevant data, and assessed the risk of bias using Cochrane tools. A random effects meta-analysis of proportions was used to summarise the proportion of participants who completed the intervention and to determine the proportion of dropouts at post-treatment assessment. Multiple subgroup analyses were also carried out. We identified six trials. The meta-analysis of proportions showed that 53% (95%CI 49% to 58%) of the participants assigned to the intervention group fully adhered to the intervention program. The weighted mean proportion of completed intervention sessions was 66%. The pooled trial dropout rate was 22% (95%CI 20% to 24%). Around half of adults with depression adhere to lifestyle interventions. Future research is needed to develop interventions to support adherence to lifestyle interventions in depressive patients.},
  author = {Castro, A. and Roca, M. and Ricci-Cabello, I. and García-Toro, M. and Riera-Serra, P. and Coronado-Simsic, V. and Pérez-Ara, MÁ and Gili, M.},
  journal = {International Journal of Environmental Research and Public Health},
  keywords = {evisap grapp-caib myown},
  month = {dec},
  number = 24,
  pages = 13268,
  publisher = {MDPI AG},
  title = {Adherence to Lifestyle Interventions for Treatment of Adults with Depression: A Systematic Review and Meta-Analysis},
  volume = 18,
  year = 2021
  }
  

  %0 Journal Article
  %1 Castro_2021
  %A Castro, A.
  %A Roca, M.
  %A Ricci-Cabello, I.
  %A García-Toro, M.
  %A Riera-Serra, P.
  %A Coronado-Simsic, V.
  %A Pérez-Ara, MÁ
  %A Gili, M.
  %D 2021
  %I MDPI AG
  %J International Journal of Environmental Research and Public Health
  %N 24
  %P 13268
  %R 10.3390/ijerph182413268
  %T Adherence to Lifestyle Interventions for Treatment of Adults with Depression: A Systematic Review and Meta-Analysis
  %U https://doi.org/10.3390%2Fijerph182413268
  %V 18
  %X The aim of this systematic review was to determine the adherence to lifestyle interventions for adults with depression and to estimate the dropout rates in trials examining the impact of these interventions. A bibliographic search was conducted in PubMed, Embase, PsycINFO, the Cochrane library, and several sources of grey literature. We included randomised controlled trials examining the impact of multiple lifestyle interventions on depressive symptomatology in adults when compared to control or other active treatments. Two reviewers independently screened citations, extracted the relevant data, and assessed the risk of bias using Cochrane tools. A random effects meta-analysis of proportions was used to summarise the proportion of participants who completed the intervention and to determine the proportion of dropouts at post-treatment assessment. Multiple subgroup analyses were also carried out. We identified six trials. The meta-analysis of proportions showed that 53% (95%CI 49% to 58%) of the participants assigned to the intervention group fully adhered to the intervention program. The weighted mean proportion of completed intervention sessions was 66%. The pooled trial dropout rate was 22% (95%CI 20% to 24%). Around half of adults with depression adhere to lifestyle interventions. Future research is needed to develop interventions to support adherence to lifestyle interventions in depressive patients.
  

• 
  Nurse-led telephone intervention for lifestyle changes on glycaemic control in people with prediabetes: Study protocol for a randomized controlled trial. Abbate, M.; Fresneda, S.; Yañez, A.; Ricci-Cabello, I.; Galmes-Panades, A. M.; Aguilo, A.; Bennasar-Veny, M. (2021). 77(7) 3204–3217.

  AbstractBibTeXEndNoteDOIBibSonomy

  AIM: To evaluate the effectiveness of a nurse-led personalized telephone lifestyle intervention versus automated SMSs in the reduction of fasting plasma glucose in adults with prediabetes. DESIGN: The PREDIPHONE is a randomized controlled, parallel, two arms, superiority trial with 15 months of follow-up. Participants will be randomized to either the intervention group (teleconsultations) or the active control group (SMSs). METHODS: A total of 428 participants will be randomized in a 1:1 ratio to one of the two arms and followed up during 9 months. The teleconsultations group will receive nurse-led personalized advice, while the SMSs group will receive 4-5 brief SMSs a week. Participants in both groups will receive evidence-based recommendations for diet and physical activity (PA). Outcome measures will be collected at baseline, months 4 and 9 and at month 15, to evaluate post-intervention effects. DISCUSSION: Prevention of diabetes through the implementation of lifestyle interventions remains an important priority. The current pandemic situation has magnified its urgency as it heavily affected the functionality of the healthcare system. Moreover, it created the need of remotely delivering preventative interventions. This study will provide insights on the effectiveness and feasibility of a telephone-based intervention led by nurses in the amelioration of risk factors associated with diabetes. IMPACT: Findings from this study will offer health services decision-makers sound evidence regarding an alternative method to face-to-face consultations that could be practical, acceptable and inexpensive, and that concretely answers the need for easily implementable prevention strategies. TRIAL REGISTRATION: NCT04735640 (ClinicalTrials.gov identifier). PROTOCOL VERSION: V1.0, 18/02/2021.

  @article{RN154,
  abstract = {AIM: To evaluate the effectiveness of a nurse-led personalized telephone lifestyle intervention versus automated SMSs in the reduction of fasting plasma glucose in adults with prediabetes. DESIGN: The PREDIPHONE is a randomized controlled, parallel, two arms, superiority trial with 15 months of follow-up. Participants will be randomized to either the intervention group (teleconsultations) or the active control group (SMSs). METHODS: A total of 428 participants will be randomized in a 1:1 ratio to one of the two arms and followed up during 9 months. The teleconsultations group will receive nurse-led personalized advice, while the SMSs group will receive 4-5 brief SMSs a week. Participants in both groups will receive evidence-based recommendations for diet and physical activity (PA). Outcome measures will be collected at baseline, months 4 and 9 and at month 15, to evaluate post-intervention effects. DISCUSSION: Prevention of diabetes through the implementation of lifestyle interventions remains an important priority. The current pandemic situation has magnified its urgency as it heavily affected the functionality of the healthcare system. Moreover, it created the need of remotely delivering preventative interventions. This study will provide insights on the effectiveness and feasibility of a telephone-based intervention led by nurses in the amelioration of risk factors associated with diabetes. IMPACT: Findings from this study will offer health services decision-makers sound evidence regarding an alternative method to face-to-face consultations that could be practical, acceptable and inexpensive, and that concretely answers the need for easily implementable prevention strategies. TRIAL REGISTRATION: NCT04735640 (ClinicalTrials.gov identifier). PROTOCOL VERSION: V1.0, 18/02/2021.},
  author = {Abbate, M. and Fresneda, S. and Yañez, A. and Ricci-Cabello, I. and Galmes-Panades, A. M. and Aguilo, A. and Bennasar-Veny, M.},
  journal = {J Adv Nurs},
  keywords = {evisap grapp-caib myown},
  number = 7,
  pages = {3204-3217},
  title = {Nurse-led telephone intervention for lifestyle changes on glycaemic control in people with prediabetes: Study protocol for a randomized controlled trial},
  type = {Journal Article},
  volume = 77,
  year = 2021
  }
  

  %0 Journal Article
  %1 RN154
  %A Abbate, M.
  %A Fresneda, S.
  %A Yañez, A.
  %A Ricci-Cabello, I.
  %A Galmes-Panades, A. M.
  %A Aguilo, A.
  %A Bennasar-Veny, M.
  %D 2021
  %J J Adv Nurs
  %N 7
  %P 3204-3217
  %R 10.1111/jan.14842
  %T Nurse-led telephone intervention for lifestyle changes on glycaemic control in people with prediabetes: Study protocol for a randomized controlled trial
  %V 77
  %X AIM: To evaluate the effectiveness of a nurse-led personalized telephone lifestyle intervention versus automated SMSs in the reduction of fasting plasma glucose in adults with prediabetes. DESIGN: The PREDIPHONE is a randomized controlled, parallel, two arms, superiority trial with 15 months of follow-up. Participants will be randomized to either the intervention group (teleconsultations) or the active control group (SMSs). METHODS: A total of 428 participants will be randomized in a 1:1 ratio to one of the two arms and followed up during 9 months. The teleconsultations group will receive nurse-led personalized advice, while the SMSs group will receive 4-5 brief SMSs a week. Participants in both groups will receive evidence-based recommendations for diet and physical activity (PA). Outcome measures will be collected at baseline, months 4 and 9 and at month 15, to evaluate post-intervention effects. DISCUSSION: Prevention of diabetes through the implementation of lifestyle interventions remains an important priority. The current pandemic situation has magnified its urgency as it heavily affected the functionality of the healthcare system. Moreover, it created the need of remotely delivering preventative interventions. This study will provide insights on the effectiveness and feasibility of a telephone-based intervention led by nurses in the amelioration of risk factors associated with diabetes. IMPACT: Findings from this study will offer health services decision-makers sound evidence regarding an alternative method to face-to-face consultations that could be practical, acceptable and inexpensive, and that concretely answers the need for easily implementable prevention strategies. TRIAL REGISTRATION: NCT04735640 (ClinicalTrials.gov identifier). PROTOCOL VERSION: V1.0, 18/02/2021.
  

• 
  STOPP/START interventions to improve medicines management for people aged 65 years and over: a realist synthesis Gangannagaripalli, Jaheeda; Porter, Ian; Davey, Antoinette; Ricci Cabello, Ignacio; Greenhalgh, Joanne; Anderson, Rob; Briscoe, Simon; Hughes, Carmel; Payne, Rupert; Cockcroft, Emma; Harris, Jim; Bramwell, Charlotte; Valderas, Jose M (2021). NIHR Journals Library, Southampton (UK).

  AbstractURLBibTeXEndNoteDOIBibSonomy

  BACKGROUND: Drug-related problems and potentially inappropriate prescribing impose a huge burden on patients and the health-care system. The most widely used tools for appropriate prescription in older adults in England and in other European countries are the Screening Tool of Older People’s Prescriptions (STOPP)/Screening Tool to Alert to the Right Treatment (START) tools. STOPP/START tools support medicines optimisation for older adults. OBJECTIVES: To identify, test and refine the programme theories underlying how interventions based on the STOPP/START tools are intended to work, for whom, in what circumstances and why, as well as the resource use and cost requirements or impacts. DESIGN: A realist synthesis. SETTING: Primary care, hospital care and nursing homes. PATIENTS: Patients aged ≥ 65 years. INTERVENTIONS: Any intervention based on the use of the STOPP/START tools. REVIEW METHODS: Database and web-searching was carried out to retrieve relevant evidence to identify and test programme theories about how interventions based on the use of the STOPP/START tools work. A project reference group made up of health-care professionals, NHS decision-makers, older people, carers and members of the public was set up. In phase 1 we identified programme theories about STOPP/START interventions on how, for whom, in what contexts and why they are intended to work. We searched the peer-reviewed and grey literature to identify documents relevant to the research questions. We interviewed experts in the field in our reference group to gain input on our list of candidate context–mechanism–outcome configurations, to identify additional context–mechanism–outcome configurations and to identify additional literature and/or relevant concepts. In phase 2 we reviewed and synthesised relevant published and unpublished empirical evidence and tested the programme theories using evidence from a larger set of empirical studies. RESULTS: We developed a single logic model structured around three key mechanisms: (1) personalisation, (2) systematisation and (3) evidence implementation. Personalisation: STOPP/START-based interventions are based on shared decision-making, taking into account patient preferences, experiences and expectations (mechanisms), leading to increased patient awareness, adherence, satisfaction, empowerment and quality of life (outcomes). Systematisation: STOPP/START tools provide a standardised/systematic approach for medication reviews (mechanisms), leading to changes in professional and organisational culture and burden/costs (outcomes). Evidence implementation: delivery of STOPP/START-based interventions is based on the implementation of best evidence (mechanisms), reducing adverse outcomes through appropriate prescribing/deprescribing (outcomes). For theory testing, we identified 40 studies of the impact of STOPP/START-based interventions in hospital settings, nursing homes, primary care and community pharmacies. Most of the interventions used multiple mechanisms. We found support for the impact of the personalisation and evidence implementation mechanisms on selected outcome variables, but similar impact was achieved by interventions not relying on these mechanisms. We also observed that the impact of interventions was linked to the proximity of the selected outcomes to the intervention in the logic model, resulting in a clearer benefit for appropriateness of prescribing, adverse drug events and prescription costs. LIMITATIONS: None of the available studies had been explicitly designed for evaluating underlying causal mechanisms, and qualitative information was sparse. CONCLUSIONS: No particular configuration of the interventions is associated with a greater likelihood of improved outcomes in given settings. STUDY REGISTRATION: This study is registered as PROSPERO CRD42018110795. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 9, No. 23. See the NIHR Journals Library website for further project information.

  @book{gangannagaripalli2021stoppstart,
  abstract = {BACKGROUND: Drug-related problems and potentially inappropriate prescribing impose a huge burden on patients and the health-care system. The most widely used tools for appropriate prescription in older adults in England and in other European countries are the Screening Tool of Older People’s Prescriptions (STOPP)/Screening Tool to Alert to the Right Treatment (START) tools. STOPP/START tools support medicines optimisation for older adults. OBJECTIVES: To identify, test and refine the programme theories underlying how interventions based on the STOPP/START tools are intended to work, for whom, in what circumstances and why, as well as the resource use and cost requirements or impacts. DESIGN: A realist synthesis. SETTING: Primary care, hospital care and nursing homes. PATIENTS: Patients aged ≥ 65 years. INTERVENTIONS: Any intervention based on the use of the STOPP/START tools. REVIEW METHODS: Database and web-searching was carried out to retrieve relevant evidence to identify and test programme theories about how interventions based on the use of the STOPP/START tools work. A project reference group made up of health-care professionals, NHS decision-makers, older people, carers and members of the public was set up. In phase 1 we identified programme theories about STOPP/START interventions on how, for whom, in what contexts and why they are intended to work. We searched the peer-reviewed and grey literature to identify documents relevant to the research questions. We interviewed experts in the field in our reference group to gain input on our list of candidate context–mechanism–outcome configurations, to identify additional context–mechanism–outcome configurations and to identify additional literature and/or relevant concepts. In phase 2 we reviewed and synthesised relevant published and unpublished empirical evidence and tested the programme theories using evidence from a larger set of empirical studies. RESULTS: We developed a single logic model structured around three key mechanisms: (1) personalisation, (2) systematisation and (3) evidence implementation. Personalisation: STOPP/START-based interventions are based on shared decision-making, taking into account patient preferences, experiences and expectations (mechanisms), leading to increased patient awareness, adherence, satisfaction, empowerment and quality of life (outcomes). Systematisation: STOPP/START tools provide a standardised/systematic approach for medication reviews (mechanisms), leading to changes in professional and organisational culture and burden/costs (outcomes). Evidence implementation: delivery of STOPP/START-based interventions is based on the implementation of best evidence (mechanisms), reducing adverse outcomes through appropriate prescribing/deprescribing (outcomes). For theory testing, we identified 40 studies of the impact of STOPP/START-based interventions in hospital settings, nursing homes, primary care and community pharmacies. Most of the interventions used multiple mechanisms. We found support for the impact of the personalisation and evidence implementation mechanisms on selected outcome variables, but similar impact was achieved by interventions not relying on these mechanisms. We also observed that the impact of interventions was linked to the proximity of the selected outcomes to the intervention in the logic model, resulting in a clearer benefit for appropriateness of prescribing, adverse drug events and prescription costs. LIMITATIONS: None of the available studies had been explicitly designed for evaluating underlying causal mechanisms, and qualitative information was sparse. CONCLUSIONS: No particular configuration of the interventions is associated with a greater likelihood of improved outcomes in given settings. STUDY REGISTRATION: This study is registered as PROSPERO CRD42018110795. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 9, No. 23. See the NIHR Journals Library website for further project information.},
  address = {Southampton (UK)},
  author = {Gangannagaripalli, Jaheeda and Porter, Ian and Davey, Antoinette and Ricci Cabello, Ignacio and Greenhalgh, Joanne and Anderson, Rob and Briscoe, Simon and Hughes, Carmel and Payne, Rupert and Cockcroft, Emma and Harris, Jim and Bramwell, Charlotte and Valderas, Jose M},
  keywords = {evisap},
  month = {nov},
  publisher = {NIHR Journals Library},
  title = {STOPP/START interventions to improve medicines management for people aged 65 years and over: a realist synthesis},
  year = 2021
  }
  

  %0 Book
  %1 gangannagaripalli2021stoppstart
  %A Gangannagaripalli, Jaheeda
  %A Porter, Ian
  %A Davey, Antoinette
  %A Ricci Cabello, Ignacio
  %A Greenhalgh, Joanne
  %A Anderson, Rob
  %A Briscoe, Simon
  %A Hughes, Carmel
  %A Payne, Rupert
  %A Cockcroft, Emma
  %A Harris, Jim
  %A Bramwell, Charlotte
  %A Valderas, Jose M
  %C Southampton (UK)
  %D 2021
  %I NIHR Journals Library
  %R 10.3310/hsdr09230
  %T STOPP/START interventions to improve medicines management for people aged 65 years and over: a realist synthesis
  %U https://pubmed.ncbi.nlm.nih.gov/34846830
  %X BACKGROUND: Drug-related problems and potentially inappropriate prescribing impose a huge burden on patients and the health-care system. The most widely used tools for appropriate prescription in older adults in England and in other European countries are the Screening Tool of Older People’s Prescriptions (STOPP)/Screening Tool to Alert to the Right Treatment (START) tools. STOPP/START tools support medicines optimisation for older adults. OBJECTIVES: To identify, test and refine the programme theories underlying how interventions based on the STOPP/START tools are intended to work, for whom, in what circumstances and why, as well as the resource use and cost requirements or impacts. DESIGN: A realist synthesis. SETTING: Primary care, hospital care and nursing homes. PATIENTS: Patients aged ≥ 65 years. INTERVENTIONS: Any intervention based on the use of the STOPP/START tools. REVIEW METHODS: Database and web-searching was carried out to retrieve relevant evidence to identify and test programme theories about how interventions based on the use of the STOPP/START tools work. A project reference group made up of health-care professionals, NHS decision-makers, older people, carers and members of the public was set up. In phase 1 we identified programme theories about STOPP/START interventions on how, for whom, in what contexts and why they are intended to work. We searched the peer-reviewed and grey literature to identify documents relevant to the research questions. We interviewed experts in the field in our reference group to gain input on our list of candidate context–mechanism–outcome configurations, to identify additional context–mechanism–outcome configurations and to identify additional literature and/or relevant concepts. In phase 2 we reviewed and synthesised relevant published and unpublished empirical evidence and tested the programme theories using evidence from a larger set of empirical studies. RESULTS: We developed a single logic model structured around three key mechanisms: (1) personalisation, (2) systematisation and (3) evidence implementation. Personalisation: STOPP/START-based interventions are based on shared decision-making, taking into account patient preferences, experiences and expectations (mechanisms), leading to increased patient awareness, adherence, satisfaction, empowerment and quality of life (outcomes). Systematisation: STOPP/START tools provide a standardised/systematic approach for medication reviews (mechanisms), leading to changes in professional and organisational culture and burden/costs (outcomes). Evidence implementation: delivery of STOPP/START-based interventions is based on the implementation of best evidence (mechanisms), reducing adverse outcomes through appropriate prescribing/deprescribing (outcomes). For theory testing, we identified 40 studies of the impact of STOPP/START-based interventions in hospital settings, nursing homes, primary care and community pharmacies. Most of the interventions used multiple mechanisms. We found support for the impact of the personalisation and evidence implementation mechanisms on selected outcome variables, but similar impact was achieved by interventions not relying on these mechanisms. We also observed that the impact of interventions was linked to the proximity of the selected outcomes to the intervention in the logic model, resulting in a clearer benefit for appropriateness of prescribing, adverse drug events and prescription costs. LIMITATIONS: None of the available studies had been explicitly designed for evaluating underlying causal mechanisms, and qualitative information was sparse. CONCLUSIONS: No particular configuration of the interventions is associated with a greater likelihood of improved outcomes in given settings. STUDY REGISTRATION: This study is registered as PROSPERO CRD42018110795. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 9, No. 23. See the NIHR Journals Library website for further project information.
  

2020

• 
  Exploring primary health care professionals’ perceptions about a patient feedback intervention to improve patient safety in Spanish primary health care centres: a qualitative study. Serrano-Ripoll, M. J.; Ripoll, J.; Briones-Vozmediano, E.; Llobera, J.; Fiol deRoque, M. A.; Ricci-Cabello, I. (2020). 37(6) 821–827.

  AbstractURLBibTeXEndNoteDOIBibSonomyDownload

  BACKGROUND: Patient feedback interventions are receiving increasing attention given their potential to improve health care provision. However, primary health care (PHC) professionals' acceptability and perceived utility of this type of interventions remain largely unexplored. OBJECTIVES: The aim of this study was to explore PHC professionals' perceptions, opinions and suggestions about a patient feedback intervention currently being designed to improve patient safety in Spanish PHC centres. METHODS: We conducted an exploratory qualitative study with 43 PHC professionals. Information was obtained from three semi-structured interviews and four focus groups. All data were audio-recorded, transcribed and analyzed using content analysis by three analysts. RESULTS: The patient feedback intervention was acceptable to health care professionals, who perceived it as a useful strategy to improve health care processes and activate patients. A number of factors potentially limiting the acceptability and perceived utility of the intervention were identified (low patient safety culture, low patient-centred care orientation and limited credibility of patient feedback data). Recommendations for designing and implementing the proposed intervention in the Spanish PHC centres were identified in relation to the following areas: 'collection and analysis of feedback data'; 'feedback display'; 'feedback delivery' and; 'implementation of safety improvement initiatives'. CONCLUSIONS: Although the proposed intervention was generally perceived as useful and acceptable, our study identified a number of tensions about the practical aspects of using the patient-reported data and the credibility of the data and what actions would arise from its use. The intervention has been adapted to address these tensions before its formal evaluation in a randomized clinical trial.

  @article{RN34,
  abstract = {BACKGROUND: Patient feedback interventions are receiving increasing attention given their potential to improve health care provision. However, primary health care (PHC) professionals' acceptability and perceived utility of this type of interventions remain largely unexplored. OBJECTIVES: The aim of this study was to explore PHC professionals' perceptions, opinions and suggestions about a patient feedback intervention currently being designed to improve patient safety in Spanish PHC centres. METHODS: We conducted an exploratory qualitative study with 43 PHC professionals. Information was obtained from three semi-structured interviews and four focus groups. All data were audio-recorded, transcribed and analyzed using content analysis by three analysts. RESULTS: The patient feedback intervention was acceptable to health care professionals, who perceived it as a useful strategy to improve health care processes and activate patients. A number of factors potentially limiting the acceptability and perceived utility of the intervention were identified (low patient safety culture, low patient-centred care orientation and limited credibility of patient feedback data). Recommendations for designing and implementing the proposed intervention in the Spanish PHC centres were identified in relation to the following areas: 'collection and analysis of feedback data'; 'feedback display'; 'feedback delivery' and; 'implementation of safety improvement initiatives'. CONCLUSIONS: Although the proposed intervention was generally perceived as useful and acceptable, our study identified a number of tensions about the practical aspects of using the patient-reported data and the credibility of the data and what actions would arise from its use. The intervention has been adapted to address these tensions before its formal evaluation in a randomized clinical trial.},
  author = {Serrano-Ripoll, M. J. and Ripoll, J. and Briones-Vozmediano, E. and Llobera, J. and Fiol deRoque, M. A. and Ricci-Cabello, I.},
  journal = {Fam Pract},
  keywords = {evisap grapp-caib myown},
  number = 6,
  pages = {821-827},
  title = {Exploring primary health care professionals' perceptions about a patient feedback intervention to improve patient safety in Spanish primary health care centres: a qualitative study},
  type = {Journal Article},
  volume = 37,
  year = 2020
  }
  

  %0 Journal Article
  %1 RN34
  %A Serrano-Ripoll, M. J.
  %A Ripoll, J.
  %A Briones-Vozmediano, E.
  %A Llobera, J.
  %A Fiol deRoque, M. A.
  %A Ricci-Cabello, I.
  %D 2020
  %J Fam Pract
  %N 6
  %P 821-827
  %R 10.1093/fampra/cmaa051
  %T Exploring primary health care professionals' perceptions about a patient feedback intervention to improve patient safety in Spanish primary health care centres: a qualitative study
  %U https://watermark.silverchair.com/cmaa051.pdf?token=AQECAHi208BE49Ooan9kkhW_Ercy7Dm3ZL_9Cf3qfKAc485ysgAAAsUwggLBBgkqhkiG9w0BBwagggKyMIICrgIBADCCAqcGCSqGSIb3DQEHATAeBglghkgBZQMEAS4wEQQMrlmN3H5mbo-74U36AgEQgIICeGZfR2aD_EQe0sml2ZkLauhJ8fs5OJjUoC09Em0eEMrUinPcXbeY-xPKV8ry7plrn2jxRao8oca_3IWAPE7BNCA2_Torx19HQrHNANb0fBaaho49PSJnY27tKFN78-LaU5U34nS7w7bGVTCf3fv1RJerjTyJttnFuuJIhUy4B6EB0ahrmYLQLQjDa2xpVcMR4fG1CHkrBhyELPPPC3aQM9S8iVvP1T5TAeHJRCDyXGBEI5xf4KmHec3eVg3MmTtmhJpWrd7yICKuKiYtz_MHeJAO2a6IC6niorr_j_RqTkYfsos-Lc9n_t2x5_pCcouExn6lh4IPEcg76SPHhJ2nzXA3W4Ow3ZmmwzfcOM1MNTqhyJu9gPlO1T4XhMRzaqm9wtd4phQMWUux8IZ606ziK_t3L-v7yO5bVCshZuRG3_4qrBTDM6g2T-z64-7Qi9JQMl1xeuOFyR_MKp7AvDIyhYmMaK74HDHpasfEGtpYlA4TgRm_qHUJL6YWo9BYzzWVhnbYWhw-bL5E_w5wWGGDRd73f_ygYr6u8ZyqNohnnUovKVuffBpTYL6S8LAw6WWedOXezoViHh0lPM1L_PN1yhEbqPCxE7JyEHx5aEh1t9-pHDrSwTJbQUjol9GkRoj8zF4UM7gnvXOkcNyosc5yaMxBq_NCs7PN1jLN4ztGEitY4g6Ds58H94FOpOTHR9q1KO1i_Khk1tOgAsTat6Nw9zqM8CtOtwCaNU05UKhpFyeKTn2xhxeGHxaoPhI6oeRQz-KzCHL8fPybfL4EwdzEgAUGgnjN5LS66Dg7WDET4v9EUp11ZeOqslaS5sw_rEcCf6l1Nvt6D_sS
  %V 37
  %X BACKGROUND: Patient feedback interventions are receiving increasing attention given their potential to improve health care provision. However, primary health care (PHC) professionals' acceptability and perceived utility of this type of interventions remain largely unexplored. OBJECTIVES: The aim of this study was to explore PHC professionals' perceptions, opinions and suggestions about a patient feedback intervention currently being designed to improve patient safety in Spanish PHC centres. METHODS: We conducted an exploratory qualitative study with 43 PHC professionals. Information was obtained from three semi-structured interviews and four focus groups. All data were audio-recorded, transcribed and analyzed using content analysis by three analysts. RESULTS: The patient feedback intervention was acceptable to health care professionals, who perceived it as a useful strategy to improve health care processes and activate patients. A number of factors potentially limiting the acceptability and perceived utility of the intervention were identified (low patient safety culture, low patient-centred care orientation and limited credibility of patient feedback data). Recommendations for designing and implementing the proposed intervention in the Spanish PHC centres were identified in relation to the following areas: 'collection and analysis of feedback data'; 'feedback display'; 'feedback delivery' and; 'implementation of safety improvement initiatives'. CONCLUSIONS: Although the proposed intervention was generally perceived as useful and acceptable, our study identified a number of tensions about the practical aspects of using the patient-reported data and the credibility of the data and what actions would arise from its use. The intervention has been adapted to address these tensions before its formal evaluation in a randomized clinical trial.
  

• 
  Breast Cancer Screening and Diagnosis: A Synopsis of the European Breast Guidelines. Schünemann, Holger J; Lerda, Donata; Quinn, Cecily; Follmann, Markus; Alonso-Coello, Pablo; Rossi, Paolo Giorgi; Lebeau, Annette; Nyström, Lennarth; Broeders, Mireille; Ioannidou-Mouzaka, Lydia; Duffy, Stephen W; Borisch, Bettina; Fitzpatrick, Patricia; Hofvind, Solveig; Castells, Xavier; Giordano, Livia; Canelo-Aybar, Carlos; Warman, Sue; Mansel, Robert; Sardanelli, Francesco; Parmelli, Elena; Gräwingholt, Axel; Saz-Parkinson, Zuleika; on Breast Cancer (ECIBC) Contributor Group, European Commission Initiative (2020). 172(1) 46–56.

  AbstractURLBibTeXEndNoteDOIBibSonomy

  DESCRIPTION: The European Commission Initiative for Breast Cancer Screening and Diagnosis guidelines (European Breast Guidelines) are coordinated by the European Commission's Joint Research Centre. The target audience for the guidelines includes women, health professionals, and policymakers. METHODS: An international guideline panel of 28 multidisciplinary members, including patients, developed questions and corresponding recommendations that were informed by systematic reviews of the evidence conducted between March 2016 and December 2018. GRADE (Grading of Recommendations Assessment, Development and Evaluation) Evidence to Decision frameworks were used to structure the process and minimize the influence of competing interests by enhancing transparency. Questions and recommendations, expressed as strong or conditional, focused on outcomes that matter to women and provided a rating of the certainty of evidence. RECOMMENDATIONS: This synopsis of the European Breast Guidelines provides recommendations regarding organized screening programs for women aged 40 to 75 years who are at average risk. The recommendations address digital mammography screening and the addition of hand-held ultrasonography, automated breast ultrasonography, or magnetic resonance imaging compared with mammography alone. The recommendations also discuss the frequency of screening and inform decision making for women at average risk who are recalled for suspicious lesions or who have high breast density.

  @article{schunemann2020breast,
  abstract = {DESCRIPTION: The European Commission Initiative for Breast Cancer Screening and Diagnosis guidelines (European Breast Guidelines) are coordinated by the European Commission's Joint Research Centre. The target audience for the guidelines includes women, health professionals, and policymakers. METHODS: An international guideline panel of 28 multidisciplinary members, including patients, developed questions and corresponding recommendations that were informed by systematic reviews of the evidence conducted between March 2016 and December 2018. GRADE (Grading of Recommendations Assessment, Development and Evaluation) Evidence to Decision frameworks were used to structure the process and minimize the influence of competing interests by enhancing transparency. Questions and recommendations, expressed as strong or conditional, focused on outcomes that matter to women and provided a rating of the certainty of evidence. RECOMMENDATIONS: This synopsis of the European Breast Guidelines provides recommendations regarding organized screening programs for women aged 40 to 75 years who are at average risk. The recommendations address digital mammography screening and the addition of hand-held ultrasonography, automated breast ultrasonography, or magnetic resonance imaging compared with mammography alone. The recommendations also discuss the frequency of screening and inform decision making for women at average risk who are recalled for suspicious lesions or who have high breast density.},
  address = {United States},
  author = {Schünemann, Holger J and Lerda, Donata and Quinn, Cecily and Follmann, Markus and Alonso-Coello, Pablo and Rossi, Paolo Giorgi and Lebeau, Annette and Nyström, Lennarth and Broeders, Mireille and Ioannidou-Mouzaka, Lydia and Duffy, Stephen W and Borisch, Bettina and Fitzpatrick, Patricia and Hofvind, Solveig and Castells, Xavier and Giordano, Livia and Canelo-Aybar, Carlos and Warman, Sue and Mansel, Robert and Sardanelli, Francesco and Parmelli, Elena and Gräwingholt, Axel and Saz-Parkinson, Zuleika and on Breast Cancer (ECIBC) Contributor Group, European Commission Initiative},
  journal = {Annals of internal medicine},
  keywords = {evisap},
  month = {jan},
  number = 1,
  pages = {46--56},
  title = {Breast Cancer Screening and Diagnosis: A Synopsis of the European Breast Guidelines},
  volume = 172,
  year = 2020
  }
  

  %0 Journal Article
  %1 schunemann2020breast
  %A Schünemann, Holger J
  %A Lerda, Donata
  %A Quinn, Cecily
  %A Follmann, Markus
  %A Alonso-Coello, Pablo
  %A Rossi, Paolo Giorgi
  %A Lebeau, Annette
  %A Nyström, Lennarth
  %A Broeders, Mireille
  %A Ioannidou-Mouzaka, Lydia
  %A Duffy, Stephen W
  %A Borisch, Bettina
  %A Fitzpatrick, Patricia
  %A Hofvind, Solveig
  %A Castells, Xavier
  %A Giordano, Livia
  %A Canelo-Aybar, Carlos
  %A Warman, Sue
  %A Mansel, Robert
  %A Sardanelli, Francesco
  %A Parmelli, Elena
  %A Gräwingholt, Axel
  %A Saz-Parkinson, Zuleika
  %A on Breast Cancer (ECIBC) Contributor Group, European Commission Initiative
  %C United States
  %D 2020
  %J Annals of internal medicine
  %N 1
  %P 46--56
  %R 10.7326/M19-2125
  %T Breast Cancer Screening and Diagnosis: A Synopsis of the European Breast Guidelines
  %U https://pubmed.ncbi.nlm.nih.gov/31766052
  %V 172
  %X DESCRIPTION: The European Commission Initiative for Breast Cancer Screening and Diagnosis guidelines (European Breast Guidelines) are coordinated by the European Commission's Joint Research Centre. The target audience for the guidelines includes women, health professionals, and policymakers. METHODS: An international guideline panel of 28 multidisciplinary members, including patients, developed questions and corresponding recommendations that were informed by systematic reviews of the evidence conducted between March 2016 and December 2018. GRADE (Grading of Recommendations Assessment, Development and Evaluation) Evidence to Decision frameworks were used to structure the process and minimize the influence of competing interests by enhancing transparency. Questions and recommendations, expressed as strong or conditional, focused on outcomes that matter to women and provided a rating of the certainty of evidence. RECOMMENDATIONS: This synopsis of the European Breast Guidelines provides recommendations regarding organized screening programs for women aged 40 to 75 years who are at average risk. The recommendations address digital mammography screening and the addition of hand-held ultrasonography, automated breast ultrasonography, or magnetic resonance imaging compared with mammography alone. The recommendations also discuss the frequency of screening and inform decision making for women at average risk who are recalled for suspicious lesions or who have high breast density.
  

• 
  Effectiveness and adherence of telephone-administered psychotherapy for depression: A systematic review and meta-analysis. Castro, Adoración; Gili, Margalida; Ricci-Cabello, Ignacio; Roca, Miquel; Gilbody, Simon; Perez-Ara, Maria Ángeles; Seguí, Andrea; McMillan, Dean (2020). 260 514–526.

  AbstractURLBibTeXEndNoteDOIBibSonomy

  Background The aim of this systematic review was to evaluate the effectiveness of telephone-administered psychotherapy for depression in adults when compared to control conditions or other active treatments, and to determine adherence to telephone-administered psychotherapy. Methods A bibliographic search was conducted in MEDLINE, Embase, PsycINFO, the Cochrane library, and a number of sources of grey literature. We included randomised controlled trials (RCTs) examining the impact of telephone-administered psychotherapy on depressive symptomatology. Two reviewers independently screened citations, extracted the relevant data, and assessed risk of bias using Cochrane tools. Random effects meta-analyses were used to determine the average effect of the interventions on depressive symptomatology: main analysis including randomised trials only, and several exploratory subgroup and sensitivity analyses. Results We identified ten trials. Telephone-administered psychotherapy showed beneficial effects on depression severity when compared to control conditions ((standardized mean difference [SMD]= −0.85 (95% CI −1.56 to −0.15)). When compared to active comparators, the meta-analysis showed a non-significant small effect size (SMD= −0.18 (95% CI −0.45 to 0.09)), in favour of telephone-administered psychotherapy. Total weighted mean adherence was 73%. Limitations Some of the included studies presented a small sample size. Due to variations in time points follow-ups among the studies, it was not possible to determine long term post intervention effects. Conclusions Available evidence suggests that telephone-delivered psychotherapy may be an effective strategy to reduce depression symptoms when compared to control conditions, and shows an adequate treatment adherence. Future research is needed to determine its cost-effectiveness and long-term effects.

  @article{CASTRO2020514,
  abstract = {Background The aim of this systematic review was to evaluate the effectiveness of telephone-administered psychotherapy for depression in adults when compared to control conditions or other active treatments, and to determine adherence to telephone-administered psychotherapy. Methods A bibliographic search was conducted in MEDLINE, Embase, PsycINFO, the Cochrane library, and a number of sources of grey literature. We included randomised controlled trials (RCTs) examining the impact of telephone-administered psychotherapy on depressive symptomatology. Two reviewers independently screened citations, extracted the relevant data, and assessed risk of bias using Cochrane tools. Random effects meta-analyses were used to determine the average effect of the interventions on depressive symptomatology: main analysis including randomised trials only, and several exploratory subgroup and sensitivity analyses. Results We identified ten trials. Telephone-administered psychotherapy showed beneficial effects on depression severity when compared to control conditions ((standardized mean difference [SMD]= −0.85 (95% CI −1.56 to −0.15)). When compared to active comparators, the meta-analysis showed a non-significant small effect size (SMD= −0.18 (95% CI −0.45 to 0.09)), in favour of telephone-administered psychotherapy. Total weighted mean adherence was 73%. Limitations Some of the included studies presented a small sample size. Due to variations in time points follow-ups among the studies, it was not possible to determine long term post intervention effects. Conclusions Available evidence suggests that telephone-delivered psychotherapy may be an effective strategy to reduce depression symptoms when compared to control conditions, and shows an adequate treatment adherence. Future research is needed to determine its cost-effectiveness and long-term effects.},
  author = {Castro, Adoración and Gili, Margalida and Ricci-Cabello, Ignacio and Roca, Miquel and Gilbody, Simon and Perez-Ara, Maria Ángeles and Seguí, Andrea and McMillan, Dean},
  journal = {Journal of Affective Disorders},
  keywords = {evisap grapp-caib myown},
  pages = {514-526},
  title = {Effectiveness and adherence of telephone-administered psychotherapy for depression: A systematic review and meta-analysis},
  volume = 260,
  year = 2020
  }
  

  %0 Journal Article
  %1 CASTRO2020514
  %A Castro, Adoración
  %A Gili, Margalida
  %A Ricci-Cabello, Ignacio
  %A Roca, Miquel
  %A Gilbody, Simon
  %A Perez-Ara, Maria Ángeles
  %A Seguí, Andrea
  %A McMillan, Dean
  %D 2020
  %J Journal of Affective Disorders
  %P 514-526
  %R https://doi.org/10.1016/j.jad.2019.09.023
  %T Effectiveness and adherence of telephone-administered psychotherapy for depression: A systematic review and meta-analysis
  %U https://www.sciencedirect.com/science/article/pii/S0165032719311723
  %V 260
  %X Background The aim of this systematic review was to evaluate the effectiveness of telephone-administered psychotherapy for depression in adults when compared to control conditions or other active treatments, and to determine adherence to telephone-administered psychotherapy. Methods A bibliographic search was conducted in MEDLINE, Embase, PsycINFO, the Cochrane library, and a number of sources of grey literature. We included randomised controlled trials (RCTs) examining the impact of telephone-administered psychotherapy on depressive symptomatology. Two reviewers independently screened citations, extracted the relevant data, and assessed risk of bias using Cochrane tools. Random effects meta-analyses were used to determine the average effect of the interventions on depressive symptomatology: main analysis including randomised trials only, and several exploratory subgroup and sensitivity analyses. Results We identified ten trials. Telephone-administered psychotherapy showed beneficial effects on depression severity when compared to control conditions ((standardized mean difference [SMD]= −0.85 (95% CI −1.56 to −0.15)). When compared to active comparators, the meta-analysis showed a non-significant small effect size (SMD= −0.18 (95% CI −0.45 to 0.09)), in favour of telephone-administered psychotherapy. Total weighted mean adherence was 73%. Limitations Some of the included studies presented a small sample size. Due to variations in time points follow-ups among the studies, it was not possible to determine long term post intervention effects. Conclusions Available evidence suggests that telephone-delivered psychotherapy may be an effective strategy to reduce depression symptoms when compared to control conditions, and shows an adequate treatment adherence. Future research is needed to determine its cost-effectiveness and long-term effects.
  

• 
  Mobile technologies to support healthcare provider to healthcare provider communication and management of care. Gonçalves-Bradley, D. C.; AR, J. Maria; Ricci-Cabello, I.; Villanueva, G.; Fønhus, M. S.; Glenton, C.; Lewin, S.; Henschke, N.; Buckley, B. S.; Mehl, G. L.; Tamrat, T.; Shepperd, S. (2020). 8(8) Cd012927.

  AbstractBibTeXEndNoteDOIBibSonomyDownload

  BACKGROUND: The widespread use of mobile technologies can potentially expand the use of telemedicine approaches to facilitate communication between healthcare providers, this might increase access to specialist advice and improve patient health outcomes. OBJECTIVES: To assess the effects of mobile technologies versus usual care for supporting communication and consultations between healthcare providers on healthcare providers' performance, acceptability and satisfaction, healthcare use, patient health outcomes, acceptability and satisfaction, costs, and technical difficulties. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase and three other databases from 1 January 2000 to 22 July 2019. We searched clinical trials registries, checked references of relevant systematic reviews and included studies, and contacted topic experts. SELECTION CRITERIA: Randomised trials comparing mobile technologies to support healthcare provider to healthcare provider communication and consultations compared with usual care. DATA COLLECTION AND ANALYSIS: We followed standard methodological procedures expected by Cochrane and EPOC. We used the GRADE approach to assess the certainty of the evidence. MAIN RESULTS: We included 19 trials (5766 participants when reported), most were conducted in high-income countries. The most frequently used mobile technology was a mobile phone, often accompanied by training if it was used to transfer digital images. Trials recruited participants with different conditions, and interventions varied in delivery, components, and frequency of contact. We judged most trials to have high risk of performance bias, and approximately half had a high risk of detection, attrition, and reporting biases. Two studies reported data on technical problems, reporting few difficulties. Mobile technologies used by primary care providers to consult with hospital specialists We assessed the certainty of evidence for this group of trials as moderate to low. Mobile technologies: - probably make little or no difference to primary care providers following guidelines for people with chronic kidney disease (CKD; 1 trial, 47 general practices, 3004 participants); - probably reduce the time between presentation and management of individuals with skin conditions, people with symptoms requiring an ultrasound, or being referred for an appointment with a specialist after attending primary care (4 trials, 656 participants); - may reduce referrals and clinic visits among people with some skin conditions, and increase the likelihood of receiving retinopathy screening among people with diabetes, or an ultrasound in those referred with symptoms (9 trials, 4810 participants when reported); - probably make little or no difference to patient-reported quality of life and health-related quality of life (2 trials, 622 participants) or to clinician-assessed clinical recovery (2 trials, 769 participants) among individuals with skin conditions; - may make little or no difference to healthcare provider (2 trials, 378 participants) or participant acceptability and satisfaction (4 trials, 972 participants) when primary care providers consult with dermatologists; - may make little or no difference for total or expected costs per participant for adults with some skin conditions or CKD (6 trials, 5423 participants). Mobile technologies used by emergency physicians to consult with hospital specialists about people attending the emergency department We assessed the certainty of evidence for this group of trials as moderate. Mobile technologies: - probably slightly reduce the consultation time between emergency physicians and hospital specialists (median difference -12 minutes, 95% CI -19 to -7; 1 trial, 345 participants); - probably reduce participants' length of stay in the emergency department by a few minutes (median difference -30 minutes, 95% CI -37 to -25; 1 trial, 345 participants). We did not identify trials that reported on providers' adherence, participants' health status and well-being, healthcare provider and participant acceptability and satisfaction, or costs. Mobile technologies used by community health workers or home-care workers to consult with clinic staff We assessed the certainty of evidence for this group of trials as moderate to low. Mobile technologies: - probably make little or no difference in the number of outpatient clinic and community nurse consultations for participants with diabetes or older individuals treated with home enteral nutrition (2 trials, 370 participants) or hospitalisation of older individuals treated with home enteral nutrition (1 trial, 188 participants); - may lead to little or no difference in mortality among people living with HIV (RR 0.82, 95% CI 0.55 to 1.22) or diabetes (RR 0.94, 95% CI 0.28 to 3.12) (2 trials, 1152 participants); - may make little or no difference to participants' disease activity or health-related quality of life in participants with rheumatoid arthritis (1 trial, 85 participants); - probably make little or no difference for participant acceptability and satisfaction for participants with diabetes and participants with rheumatoid arthritis (2 trials, 178 participants). We did not identify any trials that reported on providers' adherence, time between presentation and management, healthcare provider acceptability and satisfaction, or costs. AUTHORS' CONCLUSIONS: Our confidence in the effect estimates is limited. Interventions including a mobile technology component to support healthcare provider to healthcare provider communication and management of care may reduce the time between presentation and management of the health condition when primary care providers or emergency physicians use them to consult with specialists, and may increase the likelihood of receiving a clinical examination among participants with diabetes and those who required an ultrasound. They may decrease the number of people attending primary care who are referred to secondary or tertiary care in some conditions, such as some skin conditions and CKD. There was little evidence of effects on participants' health status and well-being, satisfaction, or costs.

  @article{RN38,
  abstract = {BACKGROUND: The widespread use of mobile technologies can potentially expand the use of telemedicine approaches to facilitate communication between healthcare providers, this might increase access to specialist advice and improve patient health outcomes. OBJECTIVES: To assess the effects of mobile technologies versus usual care for supporting communication and consultations between healthcare providers on healthcare providers' performance, acceptability and satisfaction, healthcare use, patient health outcomes, acceptability and satisfaction, costs, and technical difficulties. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase and three other databases from 1 January 2000 to 22 July 2019. We searched clinical trials registries, checked references of relevant systematic reviews and included studies, and contacted topic experts. SELECTION CRITERIA: Randomised trials comparing mobile technologies to support healthcare provider to healthcare provider communication and consultations compared with usual care. DATA COLLECTION AND ANALYSIS: We followed standard methodological procedures expected by Cochrane and EPOC. We used the GRADE approach to assess the certainty of the evidence. MAIN RESULTS: We included 19 trials (5766 participants when reported), most were conducted in high-income countries. The most frequently used mobile technology was a mobile phone, often accompanied by training if it was used to transfer digital images. Trials recruited participants with different conditions, and interventions varied in delivery, components, and frequency of contact. We judged most trials to have high risk of performance bias, and approximately half had a high risk of detection, attrition, and reporting biases. Two studies reported data on technical problems, reporting few difficulties. Mobile technologies used by primary care providers to consult with hospital specialists We assessed the certainty of evidence for this group of trials as moderate to low. Mobile technologies: - probably make little or no difference to primary care providers following guidelines for people with chronic kidney disease (CKD; 1 trial, 47 general practices, 3004 participants); - probably reduce the time between presentation and management of individuals with skin conditions, people with symptoms requiring an ultrasound, or being referred for an appointment with a specialist after attending primary care (4 trials, 656 participants); - may reduce referrals and clinic visits among people with some skin conditions, and increase the likelihood of receiving retinopathy screening among people with diabetes, or an ultrasound in those referred with symptoms (9 trials, 4810 participants when reported); - probably make little or no difference to patient-reported quality of life and health-related quality of life (2 trials, 622 participants) or to clinician-assessed clinical recovery (2 trials, 769 participants) among individuals with skin conditions; - may make little or no difference to healthcare provider (2 trials, 378 participants) or participant acceptability and satisfaction (4 trials, 972 participants) when primary care providers consult with dermatologists; - may make little or no difference for total or expected costs per participant for adults with some skin conditions or CKD (6 trials, 5423 participants). Mobile technologies used by emergency physicians to consult with hospital specialists about people attending the emergency department We assessed the certainty of evidence for this group of trials as moderate. Mobile technologies: - probably slightly reduce the consultation time between emergency physicians and hospital specialists (median difference -12 minutes, 95% CI -19 to -7; 1 trial, 345 participants); - probably reduce participants' length of stay in the emergency department by a few minutes (median difference -30 minutes, 95% CI -37 to -25; 1 trial, 345 participants). We did not identify trials that reported on providers' adherence, participants' health status and well-being, healthcare provider and participant acceptability and satisfaction, or costs. Mobile technologies used by community health workers or home-care workers to consult with clinic staff We assessed the certainty of evidence for this group of trials as moderate to low. Mobile technologies: - probably make little or no difference in the number of outpatient clinic and community nurse consultations for participants with diabetes or older individuals treated with home enteral nutrition (2 trials, 370 participants) or hospitalisation of older individuals treated with home enteral nutrition (1 trial, 188 participants); - may lead to little or no difference in mortality among people living with HIV (RR 0.82, 95% CI 0.55 to 1.22) or diabetes (RR 0.94, 95% CI 0.28 to 3.12) (2 trials, 1152 participants); - may make little or no difference to participants' disease activity or health-related quality of life in participants with rheumatoid arthritis (1 trial, 85 participants); - probably make little or no difference for participant acceptability and satisfaction for participants with diabetes and participants with rheumatoid arthritis (2 trials, 178 participants). We did not identify any trials that reported on providers' adherence, time between presentation and management, healthcare provider acceptability and satisfaction, or costs. AUTHORS' CONCLUSIONS: Our confidence in the effect estimates is limited. Interventions including a mobile technology component to support healthcare provider to healthcare provider communication and management of care may reduce the time between presentation and management of the health condition when primary care providers or emergency physicians use them to consult with specialists, and may increase the likelihood of receiving a clinical examination among participants with diabetes and those who required an ultrasound. They may decrease the number of people attending primary care who are referred to secondary or tertiary care in some conditions, such as some skin conditions and CKD. There was little evidence of effects on participants' health status and well-being, satisfaction, or costs.},
  author = {Gonçalves-Bradley, D. C. and AR, J. Maria and Ricci-Cabello, I. and Villanueva, G. and Fønhus, M. S. and Glenton, C. and Lewin, S. and Henschke, N. and Buckley, B. S. and Mehl, G. L. and Tamrat, T. and Shepperd, S.},
  journal = {Cochrane Database Syst Rev},
  keywords = {evisap myown},
  number = 8,
  pages = {Cd012927},
  title = {Mobile technologies to support healthcare provider to healthcare provider communication and management of care},
  type = {Journal Article},
  volume = 8,
  year = 2020
  }
  

  %0 Journal Article
  %1 RN38
  %A Gonçalves-Bradley, D. C.
  %A AR, J. Maria
  %A Ricci-Cabello, I.
  %A Villanueva, G.
  %A Fønhus, M. S.
  %A Glenton, C.
  %A Lewin, S.
  %A Henschke, N.
  %A Buckley, B. S.
  %A Mehl, G. L.
  %A Tamrat, T.
  %A Shepperd, S.
  %D 2020
  %J Cochrane Database Syst Rev
  %N 8
  %P Cd012927
  %R 10.1002/14651858.CD012927.pub2
  %T Mobile technologies to support healthcare provider to healthcare provider communication and management of care
  %V 8
  %X BACKGROUND: The widespread use of mobile technologies can potentially expand the use of telemedicine approaches to facilitate communication between healthcare providers, this might increase access to specialist advice and improve patient health outcomes. OBJECTIVES: To assess the effects of mobile technologies versus usual care for supporting communication and consultations between healthcare providers on healthcare providers' performance, acceptability and satisfaction, healthcare use, patient health outcomes, acceptability and satisfaction, costs, and technical difficulties. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase and three other databases from 1 January 2000 to 22 July 2019. We searched clinical trials registries, checked references of relevant systematic reviews and included studies, and contacted topic experts. SELECTION CRITERIA: Randomised trials comparing mobile technologies to support healthcare provider to healthcare provider communication and consultations compared with usual care. DATA COLLECTION AND ANALYSIS: We followed standard methodological procedures expected by Cochrane and EPOC. We used the GRADE approach to assess the certainty of the evidence. MAIN RESULTS: We included 19 trials (5766 participants when reported), most were conducted in high-income countries. The most frequently used mobile technology was a mobile phone, often accompanied by training if it was used to transfer digital images. Trials recruited participants with different conditions, and interventions varied in delivery, components, and frequency of contact. We judged most trials to have high risk of performance bias, and approximately half had a high risk of detection, attrition, and reporting biases. Two studies reported data on technical problems, reporting few difficulties. Mobile technologies used by primary care providers to consult with hospital specialists We assessed the certainty of evidence for this group of trials as moderate to low. Mobile technologies: - probably make little or no difference to primary care providers following guidelines for people with chronic kidney disease (CKD; 1 trial, 47 general practices, 3004 participants); - probably reduce the time between presentation and management of individuals with skin conditions, people with symptoms requiring an ultrasound, or being referred for an appointment with a specialist after attending primary care (4 trials, 656 participants); - may reduce referrals and clinic visits among people with some skin conditions, and increase the likelihood of receiving retinopathy screening among people with diabetes, or an ultrasound in those referred with symptoms (9 trials, 4810 participants when reported); - probably make little or no difference to patient-reported quality of life and health-related quality of life (2 trials, 622 participants) or to clinician-assessed clinical recovery (2 trials, 769 participants) among individuals with skin conditions; - may make little or no difference to healthcare provider (2 trials, 378 participants) or participant acceptability and satisfaction (4 trials, 972 participants) when primary care providers consult with dermatologists; - may make little or no difference for total or expected costs per participant for adults with some skin conditions or CKD (6 trials, 5423 participants). Mobile technologies used by emergency physicians to consult with hospital specialists about people attending the emergency department We assessed the certainty of evidence for this group of trials as moderate. Mobile technologies: - probably slightly reduce the consultation time between emergency physicians and hospital specialists (median difference -12 minutes, 95% CI -19 to -7; 1 trial, 345 participants); - probably reduce participants' length of stay in the emergency department by a few minutes (median difference -30 minutes, 95% CI -37 to -25; 1 trial, 345 participants). We did not identify trials that reported on providers' adherence, participants' health status and well-being, healthcare provider and participant acceptability and satisfaction, or costs. Mobile technologies used by community health workers or home-care workers to consult with clinic staff We assessed the certainty of evidence for this group of trials as moderate to low. Mobile technologies: - probably make little or no difference in the number of outpatient clinic and community nurse consultations for participants with diabetes or older individuals treated with home enteral nutrition (2 trials, 370 participants) or hospitalisation of older individuals treated with home enteral nutrition (1 trial, 188 participants); - may lead to little or no difference in mortality among people living with HIV (RR 0.82, 95% CI 0.55 to 1.22) or diabetes (RR 0.94, 95% CI 0.28 to 3.12) (2 trials, 1152 participants); - may make little or no difference to participants' disease activity or health-related quality of life in participants with rheumatoid arthritis (1 trial, 85 participants); - probably make little or no difference for participant acceptability and satisfaction for participants with diabetes and participants with rheumatoid arthritis (2 trials, 178 participants). We did not identify any trials that reported on providers' adherence, time between presentation and management, healthcare provider acceptability and satisfaction, or costs. AUTHORS' CONCLUSIONS: Our confidence in the effect estimates is limited. Interventions including a mobile technology component to support healthcare provider to healthcare provider communication and management of care may reduce the time between presentation and management of the health condition when primary care providers or emergency physicians use them to consult with specialists, and may increase the likelihood of receiving a clinical examination among participants with diabetes and those who required an ultrasound. They may decrease the number of people attending primary care who are referred to secondary or tertiary care in some conditions, such as some skin conditions and CKD. There was little evidence of effects on participants' health status and well-being, satisfaction, or costs.
  

• 
  Healthcare providers’ adherence to breast cancer guidelines in Europe: a systematic literature review. Ni~no de Guzmán, Ena; Song, Yang; Alonso-Coello, Pablo; Canelo-Aybar, Carlos; Neamtiu, Luciana; Parmelli, Elena; Pérez-Bracchiglione, Javier; Rabassa, Montserrat; Rigau, David; Parkinson, Zuleika Saz; Solà, Iván; Vásquez-Mejía, Adrián; Ricci-Cabello, Ignacio (2020). 181(3) 499–518.

  AbstractURLBibTeXEndNoteDOIBibSonomyDownload

  Clinical guidelines' (CGs) adherence supports high-quality care. However, healthcare providers do not always comply with CGs recommendations. This systematic literature review aims to assess the extent of healthcare providers' adherence to breast cancer CGs in Europe and to identify the factors that impact on healthcare providers' adherence.

  @article{NiñodeGuzmán2020,
  abstract = {Clinical guidelines' (CGs) adherence supports high-quality care. However, healthcare providers do not always comply with CGs recommendations. This systematic literature review aims to assess the extent of healthcare providers' adherence to breast cancer CGs in Europe and to identify the factors that impact on healthcare providers' adherence.},
  author = {Ni~no de Guzmán, Ena and Song, Yang and Alonso-Coello, Pablo and Canelo-Aybar, Carlos and Neamtiu, Luciana and Parmelli, Elena and Pérez-Bracchiglione, Javier and Rabassa, Montserrat and Rigau, David and Parkinson, Zuleika Saz and Solà, Iván and Vásquez-Mejía, Adrián and Ricci-Cabello, Ignacio},
  journal = {Breast Cancer Research and Treatment},
  keywords = {evisap},
  month = {jun},
  number = 3,
  pages = {499--518},
  title = {Healthcare providers' adherence to breast cancer guidelines in Europe: a systematic literature review},
  volume = 181,
  year = 2020
  }
  

  %0 Journal Article
  %1 NiñodeGuzmán2020
  %A Ni~no de Guzmán, Ena
  %A Song, Yang
  %A Alonso-Coello, Pablo
  %A Canelo-Aybar, Carlos
  %A Neamtiu, Luciana
  %A Parmelli, Elena
  %A Pérez-Bracchiglione, Javier
  %A Rabassa, Montserrat
  %A Rigau, David
  %A Parkinson, Zuleika Saz
  %A Solà, Iván
  %A Vásquez-Mejía, Adrián
  %A Ricci-Cabello, Ignacio
  %D 2020
  %J Breast Cancer Research and Treatment
  %N 3
  %P 499--518
  %R 10.1007/s10549-020-05657-8
  %T Healthcare providers' adherence to breast cancer guidelines in Europe: a systematic literature review
  %U https://doi.org/10.1007/s10549-020-05657-8
  %V 181
  %X Clinical guidelines' (CGs) adherence supports high-quality care. However, healthcare providers do not always comply with CGs recommendations. This systematic literature review aims to assess the extent of healthcare providers' adherence to breast cancer CGs in Europe and to identify the factors that impact on healthcare providers' adherence.
  

• 
  Intimate partner violence and perinatal health: a systematic review. Pastor-Moreno, G.; Ruiz-Pérez, I.; Henares-Montiel, J.; Escribà-Agüir, V.; Higueras-Callejón, C.; Ricci-Cabello, I. (2020). 127(5) 537–547.

  AbstractURLBibTeXEndNoteDOIBibSonomy

  BACKGROUND: Physical, psychological and sexual intimate partner violence (IPV) has been described in the literature as different types of IPV experienced by women during pregnancy all over the world. OBJECTIVES: To review and summarise systematically the empirical evidence on the links between IPV during pregnancy and the perinatal health of mothers and fetuses/neonates. SEARCH STRATEGY: MEDLINE (Ovid), CINAHL, Embase, Nursing@ovid (Ovid) and LILACS were searched (2008-2018). SELECTION CRITERIA: Observational studies that examined perinatal health outcomes (i.e. pre-term birth, low birthweight, miscarriage, perinatal death and premature rupture of membranes) in pregnant women exposed to IPV. DATA COLLECTION AND ANALYSIS: Information on study characteristics, type of IPV measured, study design, methodological quality and outcome variable extracted. RESULTS: Fifty studies were included. Twenty-nine analysed undifferentiated IPV (n = 25 489), 34 included physical IPV (n = 7333), 22 analysed psychological IPV (n = 7833) and 18 examined sexual IPV (n = 2388). Fifteen studies were from Asia, 12 from North America and Oceania, and 12 from Central and South America. The studies examined the association between IPV and 39 different perinatal health outcomes. The most frequent outcomes reported were pre-term birth (50%), low birthweight (46%), miscarriage (30%), perinatal death (20%) and premature rupture of membranes (20%). A significant association with perinatal health outcomes was reported by 12 of the studies analysing undifferentiated IPV, 18 physical IPV, six psychological IPV and two sexual IPV. CONCLUSIONS: The relation between IPV and perinatal health outcomes can be seen in different epidemiological designs and countries. In all, 39 different outcomes were identified and 29 were associated with IPV. TWEETABLE ABSTRACT: A variety of poor perinatal health outcomes are associated with psychological, physical and sexual IPV.

  @article{RN37,
  abstract = {BACKGROUND: Physical, psychological and sexual intimate partner violence (IPV) has been described in the literature as different types of IPV experienced by women during pregnancy all over the world. OBJECTIVES: To review and summarise systematically the empirical evidence on the links between IPV during pregnancy and the perinatal health of mothers and fetuses/neonates. SEARCH STRATEGY: MEDLINE (Ovid), CINAHL, Embase, Nursing@ovid (Ovid) and LILACS were searched (2008-2018). SELECTION CRITERIA: Observational studies that examined perinatal health outcomes (i.e. pre-term birth, low birthweight, miscarriage, perinatal death and premature rupture of membranes) in pregnant women exposed to IPV. DATA COLLECTION AND ANALYSIS: Information on study characteristics, type of IPV measured, study design, methodological quality and outcome variable extracted. RESULTS: Fifty studies were included. Twenty-nine analysed undifferentiated IPV (n = 25 489), 34 included physical IPV (n = 7333), 22 analysed psychological IPV (n = 7833) and 18 examined sexual IPV (n = 2388). Fifteen studies were from Asia, 12 from North America and Oceania, and 12 from Central and South America. The studies examined the association between IPV and 39 different perinatal health outcomes. The most frequent outcomes reported were pre-term birth (50%), low birthweight (46%), miscarriage (30%), perinatal death (20%) and premature rupture of membranes (20%). A significant association with perinatal health outcomes was reported by 12 of the studies analysing undifferentiated IPV, 18 physical IPV, six psychological IPV and two sexual IPV. CONCLUSIONS: The relation between IPV and perinatal health outcomes can be seen in different epidemiological designs and countries. In all, 39 different outcomes were identified and 29 were associated with IPV. TWEETABLE ABSTRACT: A variety of poor perinatal health outcomes are associated with psychological, physical and sexual IPV.},
  author = {Pastor-Moreno, G. and Ruiz-Pérez, I. and Henares-Montiel, J. and Escribà-Agüir, V. and Higueras-Callejón, C. and Ricci-Cabello, I.},
  journal = {Bjog},
  keywords = {evisap},
  number = 5,
  pages = {537-547},
  title = {Intimate partner violence and perinatal health: a systematic review},
  type = {Journal Article},
  volume = 127,
  year = 2020
  }
  

  %0 Journal Article
  %1 RN37
  %A Pastor-Moreno, G.
  %A Ruiz-Pérez, I.
  %A Henares-Montiel, J.
  %A Escribà-Agüir, V.
  %A Higueras-Callejón, C.
  %A Ricci-Cabello, I.
  %D 2020
  %J Bjog
  %N 5
  %P 537-547
  %R 10.1111/1471-0528.16084
  %T Intimate partner violence and perinatal health: a systematic review
  %U https://obgyn.onlinelibrary.wiley.com/doi/10.1111/1471-0528.16084
  %V 127
  %X BACKGROUND: Physical, psychological and sexual intimate partner violence (IPV) has been described in the literature as different types of IPV experienced by women during pregnancy all over the world. OBJECTIVES: To review and summarise systematically the empirical evidence on the links between IPV during pregnancy and the perinatal health of mothers and fetuses/neonates. SEARCH STRATEGY: MEDLINE (Ovid), CINAHL, Embase, Nursing@ovid (Ovid) and LILACS were searched (2008-2018). SELECTION CRITERIA: Observational studies that examined perinatal health outcomes (i.e. pre-term birth, low birthweight, miscarriage, perinatal death and premature rupture of membranes) in pregnant women exposed to IPV. DATA COLLECTION AND ANALYSIS: Information on study characteristics, type of IPV measured, study design, methodological quality and outcome variable extracted. RESULTS: Fifty studies were included. Twenty-nine analysed undifferentiated IPV (n = 25 489), 34 included physical IPV (n = 7333), 22 analysed psychological IPV (n = 7833) and 18 examined sexual IPV (n = 2388). Fifteen studies were from Asia, 12 from North America and Oceania, and 12 from Central and South America. The studies examined the association between IPV and 39 different perinatal health outcomes. The most frequent outcomes reported were pre-term birth (50%), low birthweight (46%), miscarriage (30%), perinatal death (20%) and premature rupture of membranes (20%). A significant association with perinatal health outcomes was reported by 12 of the studies analysing undifferentiated IPV, 18 physical IPV, six psychological IPV and two sexual IPV. CONCLUSIONS: The relation between IPV and perinatal health outcomes can be seen in different epidemiological designs and countries. In all, 39 different outcomes were identified and 29 were associated with IPV. TWEETABLE ABSTRACT: A variety of poor perinatal health outcomes are associated with psychological, physical and sexual IPV.
  

• 
  British South Asian Patients’ Perspectives on the Relevance and Acceptability of Mobile Health Text Messaging to Support Medication Adherence for Type 2 Diabetes: Qualitative Study. Prinjha, S.; Ricci-Cabello, I.; Newhouse, N.; Farmer, A. (2020). 8(4) e15789.

  AbstractBibTeXEndNoteDOIBibSonomyDownload

  BACKGROUND: The prevalence of type 2 diabetes (T2D) is greater in South Asian populations and health outcomes are poorer compared with other ethnic groups. British South Asians are up to six times more likely to have T2D than the general population, to develop the condition at a younger age, and to experience diabetes-related complications. Interventions to support people in managing their condition can potentially reduce debilitating complications. Evidence to support the use of digital devices in T2D management, including mobile phones, has shown positive impacts on glycemic control. There is increasing recognition that health interventions that are culturally adapted to the needs of specific groups are more likely to be relevant and acceptable, but evidence to support the effectiveness of adapted interventions is limited and inconclusive. OBJECTIVE: This formative study aimed to explore the perceptions and views of British South Asian patients with T2D on mobile health SMS text messaging to support medication adherence, aimed at the general UK population. METHODS: Eight exploratory focus groups were conducted in Leicester, the United Kingdom, between September 2017 and March 2018. A diverse sample of 67 adults took part. RESULTS: British South Asian people with T2D who use digital devices, including mobile phones, felt that short messages to support medication adherence would be acceptable and relevant, but they also wanted messages that would support other aspects of self-management too. Participants were particularly interested in content that met their information needs, including information about South Asian foods, commonly used herbs and spices, natural and herbal approaches used in the United Kingdom and in South Asia, and religious fasting. Short messages delivered in English were perceived to be acceptable, often because family members could translate for those unable to read or understand the messages. Suggestions to support patients unable to understand short messages in English included having them available in different formats, and disseminated in face-to-face groups for those who did not use digital devices. CONCLUSIONS: Exploring the views of British South Asian patients about SMS text messaging aimed at the general UK population is important in maximizing the potential of such an intervention. For such a digital system to meet the needs of UK South Asian populations, it may also have to include culturally relevant messages sent to those who opt to receive them. It is equally important to consider how to disseminate message content to patients who do not use digital devices to help reduce health inequalities.

  @article{RN41,
  abstract = {BACKGROUND: The prevalence of type 2 diabetes (T2D) is greater in South Asian populations and health outcomes are poorer compared with other ethnic groups. British South Asians are up to six times more likely to have T2D than the general population, to develop the condition at a younger age, and to experience diabetes-related complications. Interventions to support people in managing their condition can potentially reduce debilitating complications. Evidence to support the use of digital devices in T2D management, including mobile phones, has shown positive impacts on glycemic control. There is increasing recognition that health interventions that are culturally adapted to the needs of specific groups are more likely to be relevant and acceptable, but evidence to support the effectiveness of adapted interventions is limited and inconclusive. OBJECTIVE: This formative study aimed to explore the perceptions and views of British South Asian patients with T2D on mobile health SMS text messaging to support medication adherence, aimed at the general UK population. METHODS: Eight exploratory focus groups were conducted in Leicester, the United Kingdom, between September 2017 and March 2018. A diverse sample of 67 adults took part. RESULTS: British South Asian people with T2D who use digital devices, including mobile phones, felt that short messages to support medication adherence would be acceptable and relevant, but they also wanted messages that would support other aspects of self-management too. Participants were particularly interested in content that met their information needs, including information about South Asian foods, commonly used herbs and spices, natural and herbal approaches used in the United Kingdom and in South Asia, and religious fasting. Short messages delivered in English were perceived to be acceptable, often because family members could translate for those unable to read or understand the messages. Suggestions to support patients unable to understand short messages in English included having them available in different formats, and disseminated in face-to-face groups for those who did not use digital devices. CONCLUSIONS: Exploring the views of British South Asian patients about SMS text messaging aimed at the general UK population is important in maximizing the potential of such an intervention. For such a digital system to meet the needs of UK South Asian populations, it may also have to include culturally relevant messages sent to those who opt to receive them. It is equally important to consider how to disseminate message content to patients who do not use digital devices to help reduce health inequalities.},
  author = {Prinjha, S. and Ricci-Cabello, I. and Newhouse, N. and Farmer, A.},
  journal = {JMIR Mhealth Uhealth},
  keywords = {evisap},
  number = 4,
  pages = {e15789},
  title = {British South Asian Patients' Perspectives on the Relevance and Acceptability of Mobile Health Text Messaging to Support Medication Adherence for Type 2 Diabetes: Qualitative Study},
  type = {Journal Article},
  volume = 8,
  year = 2020
  }
  

  %0 Journal Article
  %1 RN41
  %A Prinjha, S.
  %A Ricci-Cabello, I.
  %A Newhouse, N.
  %A Farmer, A.
  %D 2020
  %J JMIR Mhealth Uhealth
  %N 4
  %P e15789
  %R 10.2196/15789
  %T British South Asian Patients' Perspectives on the Relevance and Acceptability of Mobile Health Text Messaging to Support Medication Adherence for Type 2 Diabetes: Qualitative Study
  %V 8
  %X BACKGROUND: The prevalence of type 2 diabetes (T2D) is greater in South Asian populations and health outcomes are poorer compared with other ethnic groups. British South Asians are up to six times more likely to have T2D than the general population, to develop the condition at a younger age, and to experience diabetes-related complications. Interventions to support people in managing their condition can potentially reduce debilitating complications. Evidence to support the use of digital devices in T2D management, including mobile phones, has shown positive impacts on glycemic control. There is increasing recognition that health interventions that are culturally adapted to the needs of specific groups are more likely to be relevant and acceptable, but evidence to support the effectiveness of adapted interventions is limited and inconclusive. OBJECTIVE: This formative study aimed to explore the perceptions and views of British South Asian patients with T2D on mobile health SMS text messaging to support medication adherence, aimed at the general UK population. METHODS: Eight exploratory focus groups were conducted in Leicester, the United Kingdom, between September 2017 and March 2018. A diverse sample of 67 adults took part. RESULTS: British South Asian people with T2D who use digital devices, including mobile phones, felt that short messages to support medication adherence would be acceptable and relevant, but they also wanted messages that would support other aspects of self-management too. Participants were particularly interested in content that met their information needs, including information about South Asian foods, commonly used herbs and spices, natural and herbal approaches used in the United Kingdom and in South Asia, and religious fasting. Short messages delivered in English were perceived to be acceptable, often because family members could translate for those unable to read or understand the messages. Suggestions to support patients unable to understand short messages in English included having them available in different formats, and disseminated in face-to-face groups for those who did not use digital devices. CONCLUSIONS: Exploring the views of British South Asian patients about SMS text messaging aimed at the general UK population is important in maximizing the potential of such an intervention. For such a digital system to meet the needs of UK South Asian populations, it may also have to include culturally relevant messages sent to those who opt to receive them. It is equally important to consider how to disseminate message content to patients who do not use digital devices to help reduce health inequalities.
  

• 
  Adherence to breast cancer guidelines is associated with better survival outcomes: a systematic review and meta-analysis of observational studies in EU countries. Ricci-Cabello, I.; Vásquez-Mejía, A.; Canelo-Aybar, C.; Niño de Guzman, E.; Pérez-Bracchiglione, J.; Rabassa, M.; Rigau, D.; Solà, I.; Song, Y.; Neamtiu, L.; Parmelli, E.; Saz-Parkinson, Z.; Alonso-Coello, P. (2020). 20(1) 920.

  AbstractURLBibTeXEndNoteDOIBibSonomyDownload

  BACKGROUND: Breast cancer (BC) clinical guidelines offer evidence-based recommendations to improve quality of healthcare for patients with or at risk of BC. Suboptimal adherence to recommendations has the potential to negatively affect population health. However, no study has systematically reviewed the impact of BC guideline adherence -as prognosis factor- on BC healthcare processes and health outcomes. The objectives are to analyse the impact of guideline adherence on health outcomes and on healthcare costs. METHODS: We searched systematic reviews and primary studies in MEDLINE and Embase, conducted in European Union (EU) countries (inception to May 2019). Eligibility assessment, data extraction, and risk of bias assessment were conducted by one author and crosschecked by a second. We used random-effects meta-analyses to examine the impact of guideline adherence on overall survival and disease-free survival, and assessed certainty of evidence using GRADE. RESULTS: We included 21 primary studies. Most were published during the last decade (90%), followed a retrospective cohort design (86%), focused on treatment guideline adherence (95%), and were at low (80%) or moderate (20%) risk of bias. Nineteen studies (95%) examined the impact of guideline adherence on health outcomes, while two (10%) on healthcare cost. Adherence to guidelines was associated with increased overall survival (HR = 0.67, 95%CI 0.59-0.76) and disease-free survival (HR = 0.35, 95%CI 0.15-0.82), representing 138 more survivors (96 more to 178 more) and 336 patients free of recurrence (73 more to 491 more) for every 1000 women receiving adherent CG treatment compared to those receiving non-adherent treatment at 5 years follow-up (moderate certainty). Adherence to treatment guidelines was associated with higher costs, but adherence to follow-up guidelines was associated with lower costs (low certainty). CONCLUSIONS: Our review of EU studies suggests that there is moderate certainty that adherence to BC guidelines is associated with an improved survival. BC guidelines should be rigorously implemented in the clinical setting. TRIAL REGISTRATION: PROSPERO ( CRD42018092884 ).

  @article{RN40,
  abstract = {BACKGROUND: Breast cancer (BC) clinical guidelines offer evidence-based recommendations to improve quality of healthcare for patients with or at risk of BC. Suboptimal adherence to recommendations has the potential to negatively affect population health. However, no study has systematically reviewed the impact of BC guideline adherence -as prognosis factor- on BC healthcare processes and health outcomes. The objectives are to analyse the impact of guideline adherence on health outcomes and on healthcare costs. METHODS: We searched systematic reviews and primary studies in MEDLINE and Embase, conducted in European Union (EU) countries (inception to May 2019). Eligibility assessment, data extraction, and risk of bias assessment were conducted by one author and crosschecked by a second. We used random-effects meta-analyses to examine the impact of guideline adherence on overall survival and disease-free survival, and assessed certainty of evidence using GRADE. RESULTS: We included 21 primary studies. Most were published during the last decade (90%), followed a retrospective cohort design (86%), focused on treatment guideline adherence (95%), and were at low (80%) or moderate (20%) risk of bias. Nineteen studies (95%) examined the impact of guideline adherence on health outcomes, while two (10%) on healthcare cost. Adherence to guidelines was associated with increased overall survival (HR = 0.67, 95%CI 0.59-0.76) and disease-free survival (HR = 0.35, 95%CI 0.15-0.82), representing 138 more survivors (96 more to 178 more) and 336 patients free of recurrence (73 more to 491 more) for every 1000 women receiving adherent CG treatment compared to those receiving non-adherent treatment at 5 years follow-up (moderate certainty). Adherence to treatment guidelines was associated with higher costs, but adherence to follow-up guidelines was associated with lower costs (low certainty). CONCLUSIONS: Our review of EU studies suggests that there is moderate certainty that adherence to BC guidelines is associated with an improved survival. BC guidelines should be rigorously implemented in the clinical setting. TRIAL REGISTRATION: PROSPERO ( CRD42018092884 ).},
  author = {Ricci-Cabello, I. and Vásquez-Mejía, A. and Canelo-Aybar, C. and Niño de Guzman, E. and Pérez-Bracchiglione, J. and Rabassa, M. and Rigau, D. and Solà, I. and Song, Y. and Neamtiu, L. and Parmelli, E. and Saz-Parkinson, Z. and Alonso-Coello, P.},
  journal = {BMC Health Serv Res},
  keywords = {evisap},
  number = 1,
  pages = 920,
  title = {Adherence to breast cancer guidelines is associated with better survival outcomes: a systematic review and meta-analysis of observational studies in EU countries},
  type = {Journal Article},
  volume = 20,
  year = 2020
  }
  

  %0 Journal Article
  %1 RN40
  %A Ricci-Cabello, I.
  %A Vásquez-Mejía, A.
  %A Canelo-Aybar, C.
  %A Niño de Guzman, E.
  %A Pérez-Bracchiglione, J.
  %A Rabassa, M.
  %A Rigau, D.
  %A Solà, I.
  %A Song, Y.
  %A Neamtiu, L.
  %A Parmelli, E.
  %A Saz-Parkinson, Z.
  %A Alonso-Coello, P.
  %D 2020
  %J BMC Health Serv Res
  %N 1
  %P 920
  %R 10.1186/s12913-020-05753-x
  %T Adherence to breast cancer guidelines is associated with better survival outcomes: a systematic review and meta-analysis of observational studies in EU countries
  %U https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7542898/pdf/12913_2020_Article_5753.pdf
  %V 20
  %X BACKGROUND: Breast cancer (BC) clinical guidelines offer evidence-based recommendations to improve quality of healthcare for patients with or at risk of BC. Suboptimal adherence to recommendations has the potential to negatively affect population health. However, no study has systematically reviewed the impact of BC guideline adherence -as prognosis factor- on BC healthcare processes and health outcomes. The objectives are to analyse the impact of guideline adherence on health outcomes and on healthcare costs. METHODS: We searched systematic reviews and primary studies in MEDLINE and Embase, conducted in European Union (EU) countries (inception to May 2019). Eligibility assessment, data extraction, and risk of bias assessment were conducted by one author and crosschecked by a second. We used random-effects meta-analyses to examine the impact of guideline adherence on overall survival and disease-free survival, and assessed certainty of evidence using GRADE. RESULTS: We included 21 primary studies. Most were published during the last decade (90%), followed a retrospective cohort design (86%), focused on treatment guideline adherence (95%), and were at low (80%) or moderate (20%) risk of bias. Nineteen studies (95%) examined the impact of guideline adherence on health outcomes, while two (10%) on healthcare cost. Adherence to guidelines was associated with increased overall survival (HR = 0.67, 95%CI 0.59-0.76) and disease-free survival (HR = 0.35, 95%CI 0.15-0.82), representing 138 more survivors (96 more to 178 more) and 336 patients free of recurrence (73 more to 491 more) for every 1000 women receiving adherent CG treatment compared to those receiving non-adherent treatment at 5 years follow-up (moderate certainty). Adherence to treatment guidelines was associated with higher costs, but adherence to follow-up guidelines was associated with lower costs (low certainty). CONCLUSIONS: Our review of EU studies suggests that there is moderate certainty that adherence to BC guidelines is associated with an improved survival. BC guidelines should be rigorously implemented in the clinical setting. TRIAL REGISTRATION: PROSPERO ( CRD42018092884 ).
  

• 
  Impact of viral epidemic outbreaks on mental health of healthcare workers: a rapid systematic review and meta-analysis. Serrano-Ripoll, Maria J.; Meneses-Echavez, Jose F.; Ricci-Cabello, Ignacio; Fraile-Navarro, David; Fiol deRoque, Maria A.; Pastor-Moreno, Guadalupe; Castro, Adoración; Ruiz-Pérez, Isabel; Zamanillo Campos, Rocío; Gonçalves-Bradley, Daniela C. (2020). 277 347–357.

  AbstractURLBibTeXEndNoteDOIBibSonomyDownload

  Background: This study aimed at examining the impact of providing healthcare during health emergencies caused by viral epidemic outbreaks on healthcare workers' (HCWs) mental health; to identify factors associated with worse impact, and; to assess the available evidence base regarding interventions to reduce such impact. Method: Rapid systematic review. We searched MEDLINE, Embase, and PsycINFO (inception to August 2020). We pooled data using random-effects meta-analyses to estimate the prevalence of specific mental health problems, and used GRADE to ascertain the certainty of evidence. Results: We included 117 studies. The pooled prevalence was higher for acute stress disorder (40% (95%CI 39 to 41%)), followed by anxiety (30%, (30 to 31%)), burnout (28% (26 to 31%)), depression (24% (24 to 25%)), and post-traumatic stress disorder (13% (13 to 14%)). We identified factors associated with the likelihood of developing those problems, including sociodemographic (younger age and female gender), social (lack of social support, stigmatization), and occupational (working in a high-risk environment, specific occupational roles, and lower levels of specialised training and job experience) factors. Four studies reported interventions for frontline HCW: two educational interventions increased confidence in pandemic self-efficacy and in interpersonal problems solving (very low certainty), whereas one multifaceted intervention improved anxiety, depression, and sleep quality (very low certainty). Limitations: We only searched three databases, and the initial screening was undertaken by a single reviewer. Conclusion: Given the very limited evidence regarding the impact of interventions to tackle mental health problems in HCWs, the risk factors identified represent important targets for future interventions.

  @article{SERRANORIPOLL2020347,
  abstract = {Background: This study aimed at examining the impact of providing healthcare during health emergencies caused by viral epidemic outbreaks on healthcare workers' (HCWs) mental health; to identify factors associated with worse impact, and; to assess the available evidence base regarding interventions to reduce such impact. Method: Rapid systematic review. We searched MEDLINE, Embase, and PsycINFO (inception to August 2020). We pooled data using random-effects meta-analyses to estimate the prevalence of specific mental health problems, and used GRADE to ascertain the certainty of evidence. Results: We included 117 studies. The pooled prevalence was higher for acute stress disorder (40% (95%CI 39 to 41%)), followed by anxiety (30%, (30 to 31%)), burnout (28% (26 to 31%)), depression (24% (24 to 25%)), and post-traumatic stress disorder (13% (13 to 14%)). We identified factors associated with the likelihood of developing those problems, including sociodemographic (younger age and female gender), social (lack of social support, stigmatization), and occupational (working in a high-risk environment, specific occupational roles, and lower levels of specialised training and job experience) factors. Four studies reported interventions for frontline HCW: two educational interventions increased confidence in pandemic self-efficacy and in interpersonal problems solving (very low certainty), whereas one multifaceted intervention improved anxiety, depression, and sleep quality (very low certainty). Limitations: We only searched three databases, and the initial screening was undertaken by a single reviewer. Conclusion: Given the very limited evidence regarding the impact of interventions to tackle mental health problems in HCWs, the risk factors identified represent important targets for future interventions.},
  author = {Serrano-Ripoll, Maria J. and Meneses-Echavez, Jose F. and Ricci-Cabello, Ignacio and Fraile-Navarro, David and Fiol deRoque, Maria A. and Pastor-Moreno, Guadalupe and Castro, Adoración and Ruiz-Pérez, Isabel and Zamanillo Campos, Rocío and Gonçalves-Bradley, Daniela C.},
  journal = {Journal of Affective Disorders},
  keywords = {evisap},
  pages = {347-357},
  title = {Impact of viral epidemic outbreaks on mental health of healthcare workers: a rapid systematic review and meta-analysis},
  volume = 277,
  year = 2020
  }
  

  %0 Journal Article
  %1 SERRANORIPOLL2020347
  %A Serrano-Ripoll, Maria J.
  %A Meneses-Echavez, Jose F.
  %A Ricci-Cabello, Ignacio
  %A Fraile-Navarro, David
  %A Fiol deRoque, Maria A.
  %A Pastor-Moreno, Guadalupe
  %A Castro, Adoración
  %A Ruiz-Pérez, Isabel
  %A Zamanillo Campos, Rocío
  %A Gonçalves-Bradley, Daniela C.
  %D 2020
  %J Journal of Affective Disorders
  %P 347-357
  %R https://doi.org/10.1016/j.jad.2020.08.034
  %T Impact of viral epidemic outbreaks on mental health of healthcare workers: a rapid systematic review and meta-analysis
  %U https://www.sciencedirect.com/science/article/pii/S0165032720326392
  %V 277
  %X Background: This study aimed at examining the impact of providing healthcare during health emergencies caused by viral epidemic outbreaks on healthcare workers' (HCWs) mental health; to identify factors associated with worse impact, and; to assess the available evidence base regarding interventions to reduce such impact. Method: Rapid systematic review. We searched MEDLINE, Embase, and PsycINFO (inception to August 2020). We pooled data using random-effects meta-analyses to estimate the prevalence of specific mental health problems, and used GRADE to ascertain the certainty of evidence. Results: We included 117 studies. The pooled prevalence was higher for acute stress disorder (40% (95%CI 39 to 41%)), followed by anxiety (30%, (30 to 31%)), burnout (28% (26 to 31%)), depression (24% (24 to 25%)), and post-traumatic stress disorder (13% (13 to 14%)). We identified factors associated with the likelihood of developing those problems, including sociodemographic (younger age and female gender), social (lack of social support, stigmatization), and occupational (working in a high-risk environment, specific occupational roles, and lower levels of specialised training and job experience) factors. Four studies reported interventions for frontline HCW: two educational interventions increased confidence in pandemic self-efficacy and in interpersonal problems solving (very low certainty), whereas one multifaceted intervention improved anxiety, depression, and sleep quality (very low certainty). Limitations: We only searched three databases, and the initial screening was undertaken by a single reviewer. Conclusion: Given the very limited evidence regarding the impact of interventions to tackle mental health problems in HCWs, the risk factors identified represent important targets for future interventions.
  

2019

• 
  Development and evaluation of an intervention based on the provision of patient feedback to improve patient safety in Spanish primary healthcare centres: study protocol. Serrano-Ripoll, Maria J; Ripoll, Joana; Llobera, Joan; Valderas, Jose Maria; Pastor-Moreno, Guadalupe; Olry de Labry Lima, Antonio; Ricci-Cabello, Ignacio (2019). 9(12)

  AbstractURLBibTeXEndNoteDOIBibSonomyDownload

  Introduction Despite the enormous potential for adverse events in primary healthcare (PHC), the knowledge about how to improve patient safety in this context is still sparse. We describe the methods for the development and evaluation of an intervention targeted at PHC professionals to improve patient safety in Spanish PHC centres.Methods and analysis The intervention will consist in using the patient reported experiences and outcomes of safety in primary care (PREOS-PC) survey to gather patient-reported experiences and outcomes concerning the safety of the healthcare patients receive in their PHC centres, and feed that information back to the PHC professionals to help them identify opportunities for safer healthcare provision. The study will involve three stages. Stage 1 (developing the intervention) will involve: (i) qualitative study with 40 PHC providers to optimise the acceptability and perceived utility of the proposed intervention; (ii) Spanish translation, cross-cultural adaptation and validation of the PREOS-PC survey; (iii) developing the intervention components; and (iv) developing an online tool to electronically administrate PREOS-PC and automatically generate feedback reports to PHC centres. Stage 2 (piloting the intervention) will involve a 3-month feasibility (one group pre-post) study in 10 PHC centres (500 patients, 260 providers). Stage 3 (evaluating the intervention) will involve: (i) a 12-month, two-arm, two-level cluster randomised controlled trial (1248 PHC professionals within 48 PHC centres; with randomisation at the centre level in a 1:1 ratio) to evaluate the impact of the intervention on patient safety culture (primary outcome), patient-reported safety experiences and outcomes (using the PREOS-PC survey), and avoidable hospitalisations; (ii) qualitative study with 20 PHC providers to evaluate the acceptability and perceived utility of the intervention and identify implementation barriers.Ethics and dissemination The study was approved by the Ethics Committee of the Balearic Islands (CEI IB: 3686/18) with the 1964 Helsinki Declaration and its later amendments. The results will be disseminated in peer-reviewed publications and national and international conferences.Trial registration number NCT03837912; pre-results.

  @article{Serrano-Ripolle031367,
  abstract = {Introduction Despite the enormous potential for adverse events in primary healthcare (PHC), the knowledge about how to improve patient safety in this context is still sparse. We describe the methods for the development and evaluation of an intervention targeted at PHC professionals to improve patient safety in Spanish PHC centres.Methods and analysis The intervention will consist in using the patient reported experiences and outcomes of safety in primary care (PREOS-PC) survey to gather patient-reported experiences and outcomes concerning the safety of the healthcare patients receive in their PHC centres, and feed that information back to the PHC professionals to help them identify opportunities for safer healthcare provision. The study will involve three stages. Stage 1 (developing the intervention) will involve: (i) qualitative study with 40 PHC providers to optimise the acceptability and perceived utility of the proposed intervention; (ii) Spanish translation, cross-cultural adaptation and validation of the PREOS-PC survey; (iii) developing the intervention components; and (iv) developing an online tool to electronically administrate PREOS-PC and automatically generate feedback reports to PHC centres. Stage 2 (piloting the intervention) will involve a 3-month feasibility (one group pre-post) study in 10 PHC centres (500 patients, 260 providers). Stage 3 (evaluating the intervention) will involve: (i) a 12-month, two-arm, two-level cluster randomised controlled trial (1248 PHC professionals within 48 PHC centres; with randomisation at the centre level in a 1:1 ratio) to evaluate the impact of the intervention on patient safety culture (primary outcome), patient-reported safety experiences and outcomes (using the PREOS-PC survey), and avoidable hospitalisations; (ii) qualitative study with 20 PHC providers to evaluate the acceptability and perceived utility of the intervention and identify implementation barriers.Ethics and dissemination The study was approved by the Ethics Committee of the Balearic Islands (CEI IB: 3686/18) with the 1964 Helsinki Declaration and its later amendments. The results will be disseminated in peer-reviewed publications and national and international conferences.Trial registration number NCT03837912; pre-results.},
  author = {Serrano-Ripoll, Maria J and Ripoll, Joana and Llobera, Joan and Valderas, Jose Maria and Pastor-Moreno, Guadalupe and Olry de Labry Lima, Antonio and Ricci-Cabello, Ignacio},
  journal = {BMJ Open},
  keywords = {evisap grapp-caib myown},
  number = 12,
  publisher = {British Medical Journal Publishing Group},
  title = {Development and evaluation of an intervention based on the provision of patient feedback to improve patient safety in Spanish primary healthcare centres: study protocol},
  volume = 9,
  year = 2019
  }
  

  %0 Journal Article
  %1 Serrano-Ripolle031367
  %A Serrano-Ripoll, Maria J
  %A Ripoll, Joana
  %A Llobera, Joan
  %A Valderas, Jose Maria
  %A Pastor-Moreno, Guadalupe
  %A Olry de Labry Lima, Antonio
  %A Ricci-Cabello, Ignacio
  %D 2019
  %I British Medical Journal Publishing Group
  %J BMJ Open
  %N 12
  %R 10.1136/bmjopen-2019-031367
  %T Development and evaluation of an intervention based on the provision of patient feedback to improve patient safety in Spanish primary healthcare centres: study protocol
  %U https://bmjopen.bmj.com/content/9/12/e031367
  %V 9
  %X Introduction Despite the enormous potential for adverse events in primary healthcare (PHC), the knowledge about how to improve patient safety in this context is still sparse. We describe the methods for the development and evaluation of an intervention targeted at PHC professionals to improve patient safety in Spanish PHC centres.Methods and analysis The intervention will consist in using the patient reported experiences and outcomes of safety in primary care (PREOS-PC) survey to gather patient-reported experiences and outcomes concerning the safety of the healthcare patients receive in their PHC centres, and feed that information back to the PHC professionals to help them identify opportunities for safer healthcare provision. The study will involve three stages. Stage 1 (developing the intervention) will involve: (i) qualitative study with 40 PHC providers to optimise the acceptability and perceived utility of the proposed intervention; (ii) Spanish translation, cross-cultural adaptation and validation of the PREOS-PC survey; (iii) developing the intervention components; and (iv) developing an online tool to electronically administrate PREOS-PC and automatically generate feedback reports to PHC centres. Stage 2 (piloting the intervention) will involve a 3-month feasibility (one group pre-post) study in 10 PHC centres (500 patients, 260 providers). Stage 3 (evaluating the intervention) will involve: (i) a 12-month, two-arm, two-level cluster randomised controlled trial (1248 PHC professionals within 48 PHC centres; with randomisation at the centre level in a 1:1 ratio) to evaluate the impact of the intervention on patient safety culture (primary outcome), patient-reported safety experiences and outcomes (using the PREOS-PC survey), and avoidable hospitalisations; (ii) qualitative study with 20 PHC providers to evaluate the acceptability and perceived utility of the intervention and identify implementation barriers.Ethics and dissemination The study was approved by the Ethics Committee of the Balearic Islands (CEI IB: 3686/18) with the 1964 Helsinki Declaration and its later amendments. The results will be disseminated in peer-reviewed publications and national and international conferences.Trial registration number NCT03837912; pre-results.
  

• 
  Methods for Development of the European Commission Initiative on Breast Cancer Guidelines. Schünemann, Holger J.; Lerda, Donata; Dimitrova, Nadya; Alonso-Coello, Pablo; Gräwingholt, Axel; Quinn, Cecily; Follmann, Markus; Mansel, Robert; Sardanelli, Francesco; Rossi, Paolo Giorgi; Lebeau, Annette; Nyström, Lennarth; Broeders, Mireille; Ioannidou-Mouzaka, Lydia; Duffy, Stephen W.; Borisch, Bettina; Fitzpatrick, Patricia; Hofvind, Solveig; Castells, Xavier; Giordano, Livia; Warman, Sue; Saz-Parkinson, Zuleika (2019). 171(4) 273.

  URLBibTeXEndNoteDOIBibSonomy

  @article{Sch_nemann_2019,
  author = {Schünemann, Holger J. and Lerda, Donata and Dimitrova, Nadya and Alonso-Coello, Pablo and Gräwingholt, Axel and Quinn, Cecily and Follmann, Markus and Mansel, Robert and Sardanelli, Francesco and Rossi, Paolo Giorgi and Lebeau, Annette and Nyström, Lennarth and Broeders, Mireille and Ioannidou-Mouzaka, Lydia and Duffy, Stephen W. and Borisch, Bettina and Fitzpatrick, Patricia and Hofvind, Solveig and Castells, Xavier and Giordano, Livia and Warman, Sue and Saz-Parkinson, Zuleika},
  journal = {Annals of Internal Medicine},
  keywords = {evisap grapp-caib myown},
  month = {jul},
  number = 4,
  pages = 273,
  publisher = {American College of Physicians},
  title = {Methods for Development of the European Commission Initiative on Breast Cancer Guidelines},
  volume = 171,
  year = 2019
  }
  

  %0 Journal Article
  %1 Sch_nemann_2019
  %A Schünemann, Holger J.
  %A Lerda, Donata
  %A Dimitrova, Nadya
  %A Alonso-Coello, Pablo
  %A Gräwingholt, Axel
  %A Quinn, Cecily
  %A Follmann, Markus
  %A Mansel, Robert
  %A Sardanelli, Francesco
  %A Rossi, Paolo Giorgi
  %A Lebeau, Annette
  %A Nyström, Lennarth
  %A Broeders, Mireille
  %A Ioannidou-Mouzaka, Lydia
  %A Duffy, Stephen W.
  %A Borisch, Bettina
  %A Fitzpatrick, Patricia
  %A Hofvind, Solveig
  %A Castells, Xavier
  %A Giordano, Livia
  %A Warman, Sue
  %A Saz-Parkinson, Zuleika
  %D 2019
  %I American College of Physicians
  %J Annals of Internal Medicine
  %N 4
  %P 273
  %R 10.7326/m18-3445
  %T Methods for Development of the European Commission Initiative on Breast Cancer Guidelines
  %U https://doi.org/10.7326%2Fm18-3445
  %V 171
  

• 
  Examining Development Processes for Text Messaging Interventions to Prevent Cardiovascular Disease: Systematic Literature Review. Ricci-Cabello, I.; Bobrow, K.; Islam, S. M. S.; Chow, C. K.; Maddison, R.; Whittaker, R.; Farmer, A. J. (2019). 7(3) e12191.

  AbstractBibTeXEndNoteDOIBibSonomyDownload

  BACKGROUND: Interventions delivered by mobile phones have the potential to prevent cardiovascular disease (CVD) by supporting behavior change toward healthier lifestyles and treatment adherence. To allow replication and adaptation of these interventions across settings, it is important to fully understand how they have been developed. However, the development processes of these interventions have not previously been systematically examined. OBJECTIVE: This study aimed to systematically describe and compare the development process of text messaging interventions identified in the Text2PreventCVD systematic review. METHODS: We extracted data about the development process of the 9 interventions identified in the Text2PreventCVD systematic review. Data extraction, which was guided by frameworks for the development of complex interventions, considered the following development stages: intervention planning, design, development, and pretesting. Following data extraction, we invited the developers of the interventions to contribute to our study by reviewing the accuracy of the extracted data and providing additional data not reported in the available publications. RESULTS: A comprehensive description of the development process was available for 5 interventions. Multiple methodologies were used for the development of each intervention. Intervention planning involved gathering information from stakeholder consultations, literature reviews, examination of relevant theory, and preliminary qualitative research. Intervention design involved the use of behavior change theories and behavior change techniques. Intervention development involved (1) generating message content based on clinical guidelines and expert opinions; (2) conducting literature reviews and primary qualitative research to inform decisions about message frequency, timing, and level of tailoring; and (3) gathering end-user feedback concerning message readability, intervention acceptability, and perceived utility. Intervention pretesting involved pilot studies with samples of 10 to 30 participants receiving messages for a period ranging from 1 to 4 weeks. CONCLUSIONS: The development process of the text messaging interventions examined was complex and comprehensive, involving multiple studies to guide decisions about the scope, content, and structure of the interventions. Additional research is needed to establish whether effective messaging systems can be adapted from work already done or whether this level of development is needed for application in other conditions and settings.

  @article{RN69,
  abstract = {BACKGROUND: Interventions delivered by mobile phones have the potential to prevent cardiovascular disease (CVD) by supporting behavior change toward healthier lifestyles and treatment adherence. To allow replication and adaptation of these interventions across settings, it is important to fully understand how they have been developed. However, the development processes of these interventions have not previously been systematically examined. OBJECTIVE: This study aimed to systematically describe and compare the development process of text messaging interventions identified in the Text2PreventCVD systematic review. METHODS: We extracted data about the development process of the 9 interventions identified in the Text2PreventCVD systematic review. Data extraction, which was guided by frameworks for the development of complex interventions, considered the following development stages: intervention planning, design, development, and pretesting. Following data extraction, we invited the developers of the interventions to contribute to our study by reviewing the accuracy of the extracted data and providing additional data not reported in the available publications. RESULTS: A comprehensive description of the development process was available for 5 interventions. Multiple methodologies were used for the development of each intervention. Intervention planning involved gathering information from stakeholder consultations, literature reviews, examination of relevant theory, and preliminary qualitative research. Intervention design involved the use of behavior change theories and behavior change techniques. Intervention development involved (1) generating message content based on clinical guidelines and expert opinions; (2) conducting literature reviews and primary qualitative research to inform decisions about message frequency, timing, and level of tailoring; and (3) gathering end-user feedback concerning message readability, intervention acceptability, and perceived utility. Intervention pretesting involved pilot studies with samples of 10 to 30 participants receiving messages for a period ranging from 1 to 4 weeks. CONCLUSIONS: The development process of the text messaging interventions examined was complex and comprehensive, involving multiple studies to guide decisions about the scope, content, and structure of the interventions. Additional research is needed to establish whether effective messaging systems can be adapted from work already done or whether this level of development is needed for application in other conditions and settings.},
  author = {Ricci-Cabello, I. and Bobrow, K. and Islam, S. M. S. and Chow, C. K. and Maddison, R. and Whittaker, R. and Farmer, A. J.},
  journal = {JMIR Mhealth Uhealth},
  keywords = {evisap grapp-caib},
  number = 3,
  pages = {e12191},
  title = {Examining Development Processes for Text Messaging Interventions to Prevent Cardiovascular Disease: Systematic Literature Review},
  type = {Journal Article},
  volume = 7,
  year = 2019
  }
  

  %0 Journal Article
  %1 RN69
  %A Ricci-Cabello, I.
  %A Bobrow, K.
  %A Islam, S. M. S.
  %A Chow, C. K.
  %A Maddison, R.
  %A Whittaker, R.
  %A Farmer, A. J.
  %D 2019
  %J JMIR Mhealth Uhealth
  %N 3
  %P e12191
  %R 10.2196/12191
  %T Examining Development Processes for Text Messaging Interventions to Prevent Cardiovascular Disease: Systematic Literature Review
  %V 7
  %X BACKGROUND: Interventions delivered by mobile phones have the potential to prevent cardiovascular disease (CVD) by supporting behavior change toward healthier lifestyles and treatment adherence. To allow replication and adaptation of these interventions across settings, it is important to fully understand how they have been developed. However, the development processes of these interventions have not previously been systematically examined. OBJECTIVE: This study aimed to systematically describe and compare the development process of text messaging interventions identified in the Text2PreventCVD systematic review. METHODS: We extracted data about the development process of the 9 interventions identified in the Text2PreventCVD systematic review. Data extraction, which was guided by frameworks for the development of complex interventions, considered the following development stages: intervention planning, design, development, and pretesting. Following data extraction, we invited the developers of the interventions to contribute to our study by reviewing the accuracy of the extracted data and providing additional data not reported in the available publications. RESULTS: A comprehensive description of the development process was available for 5 interventions. Multiple methodologies were used for the development of each intervention. Intervention planning involved gathering information from stakeholder consultations, literature reviews, examination of relevant theory, and preliminary qualitative research. Intervention design involved the use of behavior change theories and behavior change techniques. Intervention development involved (1) generating message content based on clinical guidelines and expert opinions; (2) conducting literature reviews and primary qualitative research to inform decisions about message frequency, timing, and level of tailoring; and (3) gathering end-user feedback concerning message readability, intervention acceptability, and perceived utility. Intervention pretesting involved pilot studies with samples of 10 to 30 participants receiving messages for a period ranging from 1 to 4 weeks. CONCLUSIONS: The development process of the text messaging interventions examined was complex and comprehensive, involving multiple studies to guide decisions about the scope, content, and structure of the interventions. Additional research is needed to establish whether effective messaging systems can be adapted from work already done or whether this level of development is needed for application in other conditions and settings.
  

• 
  Effectiveness of interventions to improve cardiovascular healthcare in rural areas: a systematic literature review of clinical trials. Ruiz-Pérez, Isabel; Bastos, Ángel; Serrano-Ripoll, Maria Jesús; Ricci-Cabello, Ignacio (2019). 119 132–144.

  AbstractURLBibTeXEndNoteDOIBibSonomy

  The objective of this systematic literature review is to examine the impact of interventions to improve cardiovascular disease healthcare provided to people living in rural areas. Systematic electronic searches were conducted in Medline, CINAHL, Embase, Scopus, and Web of Knowledge in July 2018. We included clinical trials assessing the effectiveness of interventions to improve cardiovascular disease healthcare in rural areas. Study eligibility assessment, data extraction, and critical appraisal were undertaken by two reviewers independently. We identified 18 trials (18 interventions). They targeted myocardial infarction (five interventions), stroke (eight), and heart failure (five). All the interventions for myocardial infarction were based on organizational changes (e.g. implementation of mobile coronary units). They consistently reduced time to treatment and decreased mortality. All the interventions for heart failure were based on the provision of patient education. They consistently improved patient knowledge and self-care behaviour, but mortality reductions were reported in only some of the trials. Among the interventions for stroke, those based on the implementation of telemedicine (tele-stroke systems or tele-consultations) improved monitoring of stroke survivors; those based on new or enhanced rehabilitation services did not consistently improve mortality or physical function; whereas educational interventions effectively improved patient knowledge and behavioural outcomes. In conclusion, a number of different strategies (based on enhancing structures and providing patient education) have been proposed to improve cardiovascular disease healthcare in rural areas. Although available evidence show that these interventions can improve healthcare processes, their impact on mortality and other important health outcomes still remains to be established.

  @article{RUIZPEREZ2019132,
  abstract = {The objective of this systematic literature review is to examine the impact of interventions to improve cardiovascular disease healthcare provided to people living in rural areas. Systematic electronic searches were conducted in Medline, CINAHL, Embase, Scopus, and Web of Knowledge in July 2018. We included clinical trials assessing the effectiveness of interventions to improve cardiovascular disease healthcare in rural areas. Study eligibility assessment, data extraction, and critical appraisal were undertaken by two reviewers independently. We identified 18 trials (18 interventions). They targeted myocardial infarction (five interventions), stroke (eight), and heart failure (five). All the interventions for myocardial infarction were based on organizational changes (e.g. implementation of mobile coronary units). They consistently reduced time to treatment and decreased mortality. All the interventions for heart failure were based on the provision of patient education. They consistently improved patient knowledge and self-care behaviour, but mortality reductions were reported in only some of the trials. Among the interventions for stroke, those based on the implementation of telemedicine (tele-stroke systems or tele-consultations) improved monitoring of stroke survivors; those based on new or enhanced rehabilitation services did not consistently improve mortality or physical function; whereas educational interventions effectively improved patient knowledge and behavioural outcomes. In conclusion, a number of different strategies (based on enhancing structures and providing patient education) have been proposed to improve cardiovascular disease healthcare in rural areas. Although available evidence show that these interventions can improve healthcare processes, their impact on mortality and other important health outcomes still remains to be established.},
  author = {Ruiz-Pérez, Isabel and Bastos, Ángel and Serrano-Ripoll, Maria Jesús and Ricci-Cabello, Ignacio},
  journal = {Preventive Medicine},
  keywords = {evisap},
  pages = {132-144},
  title = {Effectiveness of interventions to improve cardiovascular healthcare in rural areas: a systematic literature review of clinical trials},
  volume = 119,
  year = 2019
  }
  

  %0 Journal Article
  %1 RUIZPEREZ2019132
  %A Ruiz-Pérez, Isabel
  %A Bastos, Ángel
  %A Serrano-Ripoll, Maria Jesús
  %A Ricci-Cabello, Ignacio
  %D 2019
  %J Preventive Medicine
  %P 132-144
  %R https://doi.org/10.1016/j.ypmed.2018.12.012
  %T Effectiveness of interventions to improve cardiovascular healthcare in rural areas: a systematic literature review of clinical trials
  %U https://www.sciencedirect.com/science/article/pii/S0091743518303876
  %V 119
  %X The objective of this systematic literature review is to examine the impact of interventions to improve cardiovascular disease healthcare provided to people living in rural areas. Systematic electronic searches were conducted in Medline, CINAHL, Embase, Scopus, and Web of Knowledge in July 2018. We included clinical trials assessing the effectiveness of interventions to improve cardiovascular disease healthcare in rural areas. Study eligibility assessment, data extraction, and critical appraisal were undertaken by two reviewers independently. We identified 18 trials (18 interventions). They targeted myocardial infarction (five interventions), stroke (eight), and heart failure (five). All the interventions for myocardial infarction were based on organizational changes (e.g. implementation of mobile coronary units). They consistently reduced time to treatment and decreased mortality. All the interventions for heart failure were based on the provision of patient education. They consistently improved patient knowledge and self-care behaviour, but mortality reductions were reported in only some of the trials. Among the interventions for stroke, those based on the implementation of telemedicine (tele-stroke systems or tele-consultations) improved monitoring of stroke survivors; those based on new or enhanced rehabilitation services did not consistently improve mortality or physical function; whereas educational interventions effectively improved patient knowledge and behavioural outcomes. In conclusion, a number of different strategies (based on enhancing structures and providing patient education) have been proposed to improve cardiovascular disease healthcare in rural areas. Although available evidence show that these interventions can improve healthcare processes, their impact on mortality and other important health outcomes still remains to be established.
  

2018

• 
  Impact of patient and public involvement on enrolment and retention in clinical trials: systematic review and meta-analysis. Crocker, Joanna C; Ricci-Cabello, Ignacio; Parker, Adwoa; Hirst, Jennifer A; Chant, Alan; Petit-Zeman, Sophie; Evans, David; Rees, Sian (2018). 363

  AbstractURLBibTeXEndNoteDOIBibSonomyDownload

  Objective To investigate the impact of patient and public involvement (PPI) on rates of enrolment and retention in clinical trials and explore how this varies with the context and nature of PPI.Design Systematic review and meta-analysis.Data sources Ten electronic databases, including Medline, INVOLVE Evidence Library, and clinical trial registries.Eligibility criteria Experimental and observational studies quantitatively evaluating the impact of a PPI intervention, compared with no intervention or non-PPI intervention(s), on participant enrolment and/or retention rates in a clinical trial or trials. PPI interventions could include additional non-PPI components inseparable from the PPI (for example, other stakeholder involvement).Data extraction and analysis Two independent reviewers extracted data on enrolment and retention rates, as well as on the context and characteristics of PPI intervention, and assessed risk of bias. Random effects meta-analyses were used to determine the average effect of PPI interventions on enrolment and retention in clinical trials: main analysis including randomised studies only, secondary analysis adding non-randomised studies, and several exploratory subgroup and sensitivity analyses.Results 26 studies were included in the review; 19 were eligible for enrolment meta-analysis and five for retention meta-analysis. Various PPI interventions were identified with different degrees of involvement, different numbers and types of people involved, and input at different stages of the trial process. On average, PPI interventions modestly but significantly increased the odds of participant enrolment in the main analysis (odds ratio 1.16, 95\% confidence interval and prediction interval 1.01 to 1.34). Non-PPI components of interventions may have contributed to this effect. In exploratory subgroup analyses, the involvement of people with lived experience of the condition under study was significantly associated with improved enrolment (odds ratio 3.14 v 1.07; P=0.02). The findings for retention were inconclusive owing to the paucity of eligible studies (odds ratio 1.16, 95\% confidence interval 0.33 to 4.14), for main analysis).Conclusions These findings add weight to the case for PPI in clinical trials by indicating that it is likely to improve enrolment of participants, especially if it includes people with lived experience of the health condition under study. Further research is needed to assess which types of PPI work best in particular contexts, the cost effectiveness of PPI, the impact of PPI at earlier stages of trial design, and the impact of PPI interventions specifically targeting retention.Systematic review registration PROSPERO CRD42016043808.

  @article{Crockerk4738,
  abstract = {Objective To investigate the impact of patient and public involvement (PPI) on rates of enrolment and retention in clinical trials and explore how this varies with the context and nature of PPI.Design Systematic review and meta-analysis.Data sources Ten electronic databases, including Medline, INVOLVE Evidence Library, and clinical trial registries.Eligibility criteria Experimental and observational studies quantitatively evaluating the impact of a PPI intervention, compared with no intervention or non-PPI intervention(s), on participant enrolment and/or retention rates in a clinical trial or trials. PPI interventions could include additional non-PPI components inseparable from the PPI (for example, other stakeholder involvement).Data extraction and analysis Two independent reviewers extracted data on enrolment and retention rates, as well as on the context and characteristics of PPI intervention, and assessed risk of bias. Random effects meta-analyses were used to determine the average effect of PPI interventions on enrolment and retention in clinical trials: main analysis including randomised studies only, secondary analysis adding non-randomised studies, and several exploratory subgroup and sensitivity analyses.Results 26 studies were included in the review; 19 were eligible for enrolment meta-analysis and five for retention meta-analysis. Various PPI interventions were identified with different degrees of involvement, different numbers and types of people involved, and input at different stages of the trial process. On average, PPI interventions modestly but significantly increased the odds of participant enrolment in the main analysis (odds ratio 1.16, 95\% confidence interval and prediction interval 1.01 to 1.34). Non-PPI components of interventions may have contributed to this effect. In exploratory subgroup analyses, the involvement of people with lived experience of the condition under study was significantly associated with improved enrolment (odds ratio 3.14 v 1.07; P=0.02). The findings for retention were inconclusive owing to the paucity of eligible studies (odds ratio 1.16, 95\% confidence interval 0.33 to 4.14), for main analysis).Conclusions These findings add weight to the case for PPI in clinical trials by indicating that it is likely to improve enrolment of participants, especially if it includes people with lived experience of the health condition under study. Further research is needed to assess which types of PPI work best in particular contexts, the cost effectiveness of PPI, the impact of PPI at earlier stages of trial design, and the impact of PPI interventions specifically targeting retention.Systematic review registration PROSPERO CRD42016043808.},
  author = {Crocker, Joanna C and Ricci-Cabello, Ignacio and Parker, Adwoa and Hirst, Jennifer A and Chant, Alan and Petit-Zeman, Sophie and Evans, David and Rees, Sian},
  journal = {BMJ},
  keywords = {evisap grapp-caib myown},
  publisher = {BMJ Publishing Group Ltd},
  title = {Impact of patient and public involvement on enrolment and retention in clinical trials: systematic review and meta-analysis},
  volume = 363,
  year = 2018
  }
  

  %0 Journal Article
  %1 Crockerk4738
  %A Crocker, Joanna C
  %A Ricci-Cabello, Ignacio
  %A Parker, Adwoa
  %A Hirst, Jennifer A
  %A Chant, Alan
  %A Petit-Zeman, Sophie
  %A Evans, David
  %A Rees, Sian
  %D 2018
  %I BMJ Publishing Group Ltd
  %J BMJ
  %R 10.1136/bmj.k4738
  %T Impact of patient and public involvement on enrolment and retention in clinical trials: systematic review and meta-analysis
  %U https://www.bmj.com/content/363/bmj.k4738
  %V 363
  %X Objective To investigate the impact of patient and public involvement (PPI) on rates of enrolment and retention in clinical trials and explore how this varies with the context and nature of PPI.Design Systematic review and meta-analysis.Data sources Ten electronic databases, including Medline, INVOLVE Evidence Library, and clinical trial registries.Eligibility criteria Experimental and observational studies quantitatively evaluating the impact of a PPI intervention, compared with no intervention or non-PPI intervention(s), on participant enrolment and/or retention rates in a clinical trial or trials. PPI interventions could include additional non-PPI components inseparable from the PPI (for example, other stakeholder involvement).Data extraction and analysis Two independent reviewers extracted data on enrolment and retention rates, as well as on the context and characteristics of PPI intervention, and assessed risk of bias. Random effects meta-analyses were used to determine the average effect of PPI interventions on enrolment and retention in clinical trials: main analysis including randomised studies only, secondary analysis adding non-randomised studies, and several exploratory subgroup and sensitivity analyses.Results 26 studies were included in the review; 19 were eligible for enrolment meta-analysis and five for retention meta-analysis. Various PPI interventions were identified with different degrees of involvement, different numbers and types of people involved, and input at different stages of the trial process. On average, PPI interventions modestly but significantly increased the odds of participant enrolment in the main analysis (odds ratio 1.16, 95\% confidence interval and prediction interval 1.01 to 1.34). Non-PPI components of interventions may have contributed to this effect. In exploratory subgroup analyses, the involvement of people with lived experience of the condition under study was significantly associated with improved enrolment (odds ratio 3.14 v 1.07; P=0.02). The findings for retention were inconclusive owing to the paucity of eligible studies (odds ratio 1.16, 95\% confidence interval 0.33 to 4.14), for main analysis).Conclusions These findings add weight to the case for PPI in clinical trials by indicating that it is likely to improve enrolment of participants, especially if it includes people with lived experience of the health condition under study. Further research is needed to assess which types of PPI work best in particular contexts, the cost effectiveness of PPI, the impact of PPI at earlier stages of trial design, and the impact of PPI interventions specifically targeting retention.Systematic review registration PROSPERO CRD42016043808.
  

• 
  Opinions and Experiences of Primary Healthcare Providers Regarding Violence against Women: a Systematic Review of Qualitative Studies. Saletti-Cuesta, Lorena; Aizenberg, Lila; Ricci-Cabello, Ignacio (2018). 33(6) 405–420.

  AbstractURLBibTeXEndNoteDOIBibSonomy

  The aim of this systematic review of qualitative studies is to explore the opinions and experiences of primary care providers regarding violence against women. Structured searches were conducted in nine bibliographic databases (March 2016). Study identification, critical appraisal (using the CASP tool), and analyses (thematic synthesis) were conducted. 46 qualitative studies were selected. Three main themes were identified: 1) Defining violence against women and its causes; 2) Awareness of violence against women and disclosure, with subthemes: 2.1.) Barriers experienced by primary care providers; 2.2) Facilitators for providing appropriate help; 3) Actions taken by providers to help women. Violence against women was generally considered as an unacceptable act with important health consequences. Barriers to address violence against women included organizational factors, providers' subjective feelings and perceived role, and providers' perceptions about women facing violence against women. Facilitators included a trusting relationship with women, attentive non-judgmental listening, participate in the community, team-work and continuing education. Providing emotional support and offering information about resources were the main actions taken by primary care providers. Women-centred care, respecting women's decision making processes and a biopsychosocial approach may provide direction to more compassionate and supportive care while strengthening primary healthcare response.

  @article{Saletti-Cuesta2018,
  abstract = {The aim of this systematic review of qualitative studies is to explore the opinions and experiences of primary care providers regarding violence against women. Structured searches were conducted in nine bibliographic databases (March 2016). Study identification, critical appraisal (using the CASP tool), and analyses (thematic synthesis) were conducted. 46 qualitative studies were selected. Three main themes were identified: 1) Defining violence against women and its causes; 2) Awareness of violence against women and disclosure, with subthemes: 2.1.) Barriers experienced by primary care providers; 2.2) Facilitators for providing appropriate help; 3) Actions taken by providers to help women. Violence against women was generally considered as an unacceptable act with important health consequences. Barriers to address violence against women included organizational factors, providers' subjective feelings and perceived role, and providers' perceptions about women facing violence against women. Facilitators included a trusting relationship with women, attentive non-judgmental listening, participate in the community, team-work and continuing education. Providing emotional support and offering information about resources were the main actions taken by primary care providers. Women-centred care, respecting women's decision making processes and a biopsychosocial approach may provide direction to more compassionate and supportive care while strengthening primary healthcare response.},
  author = {Saletti-Cuesta, Lorena and Aizenberg, Lila and Ricci-Cabello, Ignacio},
  journal = {Journal of Family Violence},
  keywords = {evisap grapp-caib myown},
  month = {aug},
  number = 6,
  pages = {405--420},
  title = {Opinions and Experiences of Primary Healthcare Providers Regarding Violence against Women: a Systematic Review of Qualitative Studies},
  volume = 33,
  year = 2018
  }
  

  %0 Journal Article
  %1 Saletti-Cuesta2018
  %A Saletti-Cuesta, Lorena
  %A Aizenberg, Lila
  %A Ricci-Cabello, Ignacio
  %D 2018
  %J Journal of Family Violence
  %N 6
  %P 405--420
  %R 10.1007/s10896-018-9971-6
  %T Opinions and Experiences of Primary Healthcare Providers Regarding Violence against Women: a Systematic Review of Qualitative Studies
  %U https://doi.org/10.1007/s10896-018-9971-6
  %V 33
  %X The aim of this systematic review of qualitative studies is to explore the opinions and experiences of primary care providers regarding violence against women. Structured searches were conducted in nine bibliographic databases (March 2016). Study identification, critical appraisal (using the CASP tool), and analyses (thematic synthesis) were conducted. 46 qualitative studies were selected. Three main themes were identified: 1) Defining violence against women and its causes; 2) Awareness of violence against women and disclosure, with subthemes: 2.1.) Barriers experienced by primary care providers; 2.2) Facilitators for providing appropriate help; 3) Actions taken by providers to help women. Violence against women was generally considered as an unacceptable act with important health consequences. Barriers to address violence against women included organizational factors, providers' subjective feelings and perceived role, and providers' perceptions about women facing violence against women. Facilitators included a trusting relationship with women, attentive non-judgmental listening, participate in the community, team-work and continuing education. Providing emotional support and offering information about resources were the main actions taken by primary care providers. Women-centred care, respecting women's decision making processes and a biopsychosocial approach may provide direction to more compassionate and supportive care while strengthening primary healthcare response.
  

• 
  Intimate partner violence and mental disorders: Co-occurrence and gender differences in a large cross-sectional population based study in Spain. Ruiz-Pérez, Isabel; Rodríguez-Barranco, Miguel; Cervilla, Jorge A.; Ricci-Cabello, Ignacio (2018). 229 69–78.

  AbstractURLBibTeXEndNoteDOIBibSonomy

  Background Intimate partner violence (IPV) and mental disorders (MD) are important public health problems disproportionally affecting women. We aimed to study the epidemiology of IPV victimization, MD, and co-occurring IPV-MD in Spanish men and women in terms of i) prevalence, ii) association between IPV and MD, and iii) sociodemographic and clinical characteristics associated with IPV, MD, and co-occurring IPV-MD. Methods Community-based cross-sectional study with 4507 randomly selected participants. Measurement instruments (Mini International Neuropsychiatric Interview and set of validated questions about IPV during the last 12 months) were administered by trained interviewers in participants’ households. Statistical analyses included multivariate logistic regression models. Results The prevalence of IPV was 9.4%, of MD 22.3%, and of co-occurring MD-IPV 4.4%. MD was associated with higher odds of experiencing IPV (OR = 3.6; p < 0.05). Lack of social support, neuroticism, impulsivity, and family history of MD were associated with higher odds of IPV, MD, and co-occurring IPV-MD in men and women. Poor health status was associated with MD and with co-occurring IPV-MD in men and women. In women, not being married was associated with MD and with co-occurring IPV-MD; having a non-Spanish nationality was associated with IPV and co-occurring IPV-MD; and older age with IPV. In men, younger age was associated with MD. Limitations The cross-sectional nature of this study limited our ability to examine causal inferences. Conclusions MD and IPV are strongly associated. Although less frequently than in women, IPV in men is also associated with depression, post-traumatic and mood disorders, which has relevant implications for healthcare delivery.

  @article{RUIZPEREZ201869,
  abstract = {Background Intimate partner violence (IPV) and mental disorders (MD) are important public health problems disproportionally affecting women. We aimed to study the epidemiology of IPV victimization, MD, and co-occurring IPV-MD in Spanish men and women in terms of i) prevalence, ii) association between IPV and MD, and iii) sociodemographic and clinical characteristics associated with IPV, MD, and co-occurring IPV-MD. Methods Community-based cross-sectional study with 4507 randomly selected participants. Measurement instruments (Mini International Neuropsychiatric Interview and set of validated questions about IPV during the last 12 months) were administered by trained interviewers in participants’ households. Statistical analyses included multivariate logistic regression models. Results The prevalence of IPV was 9.4%, of MD 22.3%, and of co-occurring MD-IPV 4.4%. MD was associated with higher odds of experiencing IPV (OR = 3.6; p < 0.05). Lack of social support, neuroticism, impulsivity, and family history of MD were associated with higher odds of IPV, MD, and co-occurring IPV-MD in men and women. Poor health status was associated with MD and with co-occurring IPV-MD in men and women. In women, not being married was associated with MD and with co-occurring IPV-MD; having a non-Spanish nationality was associated with IPV and co-occurring IPV-MD; and older age with IPV. In men, younger age was associated with MD. Limitations The cross-sectional nature of this study limited our ability to examine causal inferences. Conclusions MD and IPV are strongly associated. Although less frequently than in women, IPV in men is also associated with depression, post-traumatic and mood disorders, which has relevant implications for healthcare delivery.},
  author = {Ruiz-Pérez, Isabel and Rodríguez-Barranco, Miguel and Cervilla, Jorge A. and Ricci-Cabello, Ignacio},
  journal = {Journal of Affective Disorders},
  keywords = {evisap grapp-caib myown},
  pages = {69-78},
  title = {Intimate partner violence and mental disorders: Co-occurrence and gender differences in a large cross-sectional population based study in Spain},
  volume = 229,
  year = 2018
  }
  

  %0 Journal Article
  %1 RUIZPEREZ201869
  %A Ruiz-Pérez, Isabel
  %A Rodríguez-Barranco, Miguel
  %A Cervilla, Jorge A.
  %A Ricci-Cabello, Ignacio
  %D 2018
  %J Journal of Affective Disorders
  %P 69-78
  %R https://doi.org/10.1016/j.jad.2017.12.032
  %T Intimate partner violence and mental disorders: Co-occurrence and gender differences in a large cross-sectional population based study in Spain
  %U https://www.sciencedirect.com/science/article/pii/S0165032717319390
  %V 229
  %X Background Intimate partner violence (IPV) and mental disorders (MD) are important public health problems disproportionally affecting women. We aimed to study the epidemiology of IPV victimization, MD, and co-occurring IPV-MD in Spanish men and women in terms of i) prevalence, ii) association between IPV and MD, and iii) sociodemographic and clinical characteristics associated with IPV, MD, and co-occurring IPV-MD. Methods Community-based cross-sectional study with 4507 randomly selected participants. Measurement instruments (Mini International Neuropsychiatric Interview and set of validated questions about IPV during the last 12 months) were administered by trained interviewers in participants’ households. Statistical analyses included multivariate logistic regression models. Results The prevalence of IPV was 9.4%, of MD 22.3%, and of co-occurring MD-IPV 4.4%. MD was associated with higher odds of experiencing IPV (OR = 3.6; p < 0.05). Lack of social support, neuroticism, impulsivity, and family history of MD were associated with higher odds of IPV, MD, and co-occurring IPV-MD in men and women. Poor health status was associated with MD and with co-occurring IPV-MD in men and women. In women, not being married was associated with MD and with co-occurring IPV-MD; having a non-Spanish nationality was associated with IPV and co-occurring IPV-MD; and older age with IPV. In men, younger age was associated with MD. Limitations The cross-sectional nature of this study limited our ability to examine causal inferences. Conclusions MD and IPV are strongly associated. Although less frequently than in women, IPV in men is also associated with depression, post-traumatic and mood disorders, which has relevant implications for healthcare delivery.
  

• 
  Identifying Primary Care Pathways from Quality of Care to Outcomes and Satisfaction Using Structural Equation Modeling. Ricci-Cabello, I.; Stevens, S.; Dalton, A. R. H.; Griffiths, R. I.; Campbell, J. L.; Valderas, J. M. (2018). 53(1) 430–449.

  AbstractBibTeXEndNoteDOIBibSonomyDownload

  OBJECTIVE: To study the relationships between the different domains of quality of primary health care for the evaluation of health system performance and for informing policy decision making. DATA SOURCES: A total of 137 quality indicators collected from 7,607 English practices between 2011 and 2012. STUDY DESIGN: Cross-sectional study at the practice level. Indicators were allocated to subdomains of processes of care ("quality assurance," "education and training," "medicine management," "access," "clinical management," and "patient-centered care"), health outcomes ("intermediate outcomes" and "patient-reported health status"), and patient satisfaction. The relationships between the subdomains were hypothesized in a conceptual model and subsequently tested using structural equation modeling. PRINCIPAL FINDINGS: The model supported two independent paths. In the first path, "access" was associated with "patient-centered care" (β = 0.63), which in turn was strongly associated with "patient satisfaction" (β = 0.88). In the second path, "education and training" was associated with "clinical management" (β = 0.32), which in turn was associated with "intermediate outcomes" (β = 0.69). "Patient-reported health status" was weakly associated with "patient-centered care" (β = -0.05) and "patient satisfaction" (β = 0.09), and not associated with "clinical management" or "intermediate outcomes." CONCLUSIONS: This is the first empirical model to simultaneously provide evidence on the independence of intermediate health care outcomes, patient satisfaction, and health status. The explanatory paths via technical quality clinical management and patient centeredness offer specific opportunities for the development of quality improvement initiatives.

  @article{RN104,
  abstract = {OBJECTIVE: To study the relationships between the different domains of quality of primary health care for the evaluation of health system performance and for informing policy decision making. DATA SOURCES: A total of 137 quality indicators collected from 7,607 English practices between 2011 and 2012. STUDY DESIGN: Cross-sectional study at the practice level. Indicators were allocated to subdomains of processes of care ("quality assurance," "education and training," "medicine management," "access," "clinical management," and "patient-centered care"), health outcomes ("intermediate outcomes" and "patient-reported health status"), and patient satisfaction. The relationships between the subdomains were hypothesized in a conceptual model and subsequently tested using structural equation modeling. PRINCIPAL FINDINGS: The model supported two independent paths. In the first path, "access" was associated with "patient-centered care" (β = 0.63), which in turn was strongly associated with "patient satisfaction" (β = 0.88). In the second path, "education and training" was associated with "clinical management" (β = 0.32), which in turn was associated with "intermediate outcomes" (β = 0.69). "Patient-reported health status" was weakly associated with "patient-centered care" (β = -0.05) and "patient satisfaction" (β = 0.09), and not associated with "clinical management" or "intermediate outcomes." CONCLUSIONS: This is the first empirical model to simultaneously provide evidence on the independence of intermediate health care outcomes, patient satisfaction, and health status. The explanatory paths via technical quality clinical management and patient centeredness offer specific opportunities for the development of quality improvement initiatives.},
  author = {Ricci-Cabello, I. and Stevens, S. and Dalton, A. R. H. and Griffiths, R. I. and Campbell, J. L. and Valderas, J. M.},
  journal = {Health Serv Res},
  keywords = {evisap grapp-caib myown},
  number = 1,
  pages = {430-449},
  title = {Identifying Primary Care Pathways from Quality of Care to Outcomes and Satisfaction Using Structural Equation Modeling},
  type = {Journal Article},
  volume = 53,
  year = 2018
  }
  

  %0 Journal Article
  %1 RN104
  %A Ricci-Cabello, I.
  %A Stevens, S.
  %A Dalton, A. R. H.
  %A Griffiths, R. I.
  %A Campbell, J. L.
  %A Valderas, J. M.
  %D 2018
  %J Health Serv Res
  %N 1
  %P 430-449
  %R 10.1111/1475-6773.12666
  %T Identifying Primary Care Pathways from Quality of Care to Outcomes and Satisfaction Using Structural Equation Modeling
  %V 53
  %X OBJECTIVE: To study the relationships between the different domains of quality of primary health care for the evaluation of health system performance and for informing policy decision making. DATA SOURCES: A total of 137 quality indicators collected from 7,607 English practices between 2011 and 2012. STUDY DESIGN: Cross-sectional study at the practice level. Indicators were allocated to subdomains of processes of care ("quality assurance," "education and training," "medicine management," "access," "clinical management," and "patient-centered care"), health outcomes ("intermediate outcomes" and "patient-reported health status"), and patient satisfaction. The relationships between the subdomains were hypothesized in a conceptual model and subsequently tested using structural equation modeling. PRINCIPAL FINDINGS: The model supported two independent paths. In the first path, "access" was associated with "patient-centered care" (β = 0.63), which in turn was strongly associated with "patient satisfaction" (β = 0.88). In the second path, "education and training" was associated with "clinical management" (β = 0.32), which in turn was associated with "intermediate outcomes" (β = 0.69). "Patient-reported health status" was weakly associated with "patient-centered care" (β = -0.05) and "patient satisfaction" (β = 0.09), and not associated with "clinical management" or "intermediate outcomes." CONCLUSIONS: This is the first empirical model to simultaneously provide evidence on the independence of intermediate health care outcomes, patient satisfaction, and health status. The explanatory paths via technical quality clinical management and patient centeredness offer specific opportunities for the development of quality improvement initiatives.
  

• 
  Historia de Violencia y Violencia de Compañero íntimo en mujeres embarazadas. Resultados en salud. Pastor-Moreno, Guadalupe; Ruiz-Pérez, Isabel; Ricci-Cabello, Ignacio (2018). 27(4) 191–195.

  AbstractURLBibTeXEndNoteBibSonomyDownload

  Objetivos: examinar la frecuencia de Historia de Violencia (HV) en mujeres embarazadas; estudiar las características sociodemográficas asociadas e identificar los resultados en salud. Metodología: estudio transversal (Andalucía, España) con 754 mujeres embarazadas con cuestionario autoadministrado, incluyendo variables sociodemográficas, estado de salud y violencia. Se calculó la prevalencia de HV y modelos de regresión logística multivariable. Resultados: el 9% refirió HV, el 4,8% Violencia de Compañero íntimo actual y el 1,9% durante su embarazo. La HV se asoció significativamente con mala percepción del estado de salud (ORa 2,54; IC95%: 1,46-4,43), morbilidad psíquica (ORa 2,82; IC95%:1,56-5,07) y uso de medicación en el embarazo (ORa 2,36 IC95%: 1,14-4,87). Conclusión principal: la HV tiene un impacto en los resultados de salud de las gestantes. Dada la alta tasa de cobertura sanitaria durante el embarazo, este se convierte en un momento idóneo para poner en marcha las recomendaciones de los protocolos.

  @article{pastormoreno2018historia,
  abstract = {Objetivos: examinar la frecuencia de Historia de Violencia (HV) en mujeres embarazadas; estudiar las características sociodemográficas asociadas e identificar los resultados en salud. Metodología: estudio transversal (Andalucía, España) con 754 mujeres embarazadas con cuestionario autoadministrado, incluyendo variables sociodemográficas, estado de salud y violencia. Se calculó la prevalencia de HV y modelos de regresión logística multivariable. Resultados: el 9% refirió HV, el 4,8% Violencia de Compañero íntimo actual y el 1,9% durante su embarazo. La HV se asoció significativamente con mala percepción del estado de salud (ORa 2,54; IC95%: 1,46-4,43), morbilidad psíquica (ORa 2,82; IC95%:1,56-5,07) y uso de medicación en el embarazo (ORa 2,36 IC95%: 1,14-4,87). Conclusión principal: la HV tiene un impacto en los resultados de salud de las gestantes. Dada la alta tasa de cobertura sanitaria durante el embarazo, este se convierte en un momento idóneo para poner en marcha las recomendaciones de los protocolos.},
  author = {Pastor-Moreno, Guadalupe and Ruiz-Pérez, Isabel and Ricci-Cabello, Ignacio},
  journal = {Index de Enfermería},
  keywords = {evisap grapp-caib myown},
  number = 4,
  pages = {191-195},
  title = {Historia de Violencia y Violencia de Compañero íntimo en mujeres embarazadas. Resultados en salud},
  type = {misc},
  volume = 27,
  year = 2018
  }
  

  %0 Journal Article
  %1 pastormoreno2018historia
  %A Pastor-Moreno, Guadalupe
  %A Ruiz-Pérez, Isabel
  %A Ricci-Cabello, Ignacio
  %D 2018
  %J Index de Enfermería
  %N 4
  %P 191-195
  %T Historia de Violencia y Violencia de Compañero íntimo en mujeres embarazadas. Resultados en salud
  %U https://scielo.isciii.es/scielo.php?script=sci_abstract&pid=S1132-12962018000300003
  %V 27
  %X Objetivos: examinar la frecuencia de Historia de Violencia (HV) en mujeres embarazadas; estudiar las características sociodemográficas asociadas e identificar los resultados en salud. Metodología: estudio transversal (Andalucía, España) con 754 mujeres embarazadas con cuestionario autoadministrado, incluyendo variables sociodemográficas, estado de salud y violencia. Se calculó la prevalencia de HV y modelos de regresión logística multivariable. Resultados: el 9% refirió HV, el 4,8% Violencia de Compañero íntimo actual y el 1,9% durante su embarazo. La HV se asoció significativamente con mala percepción del estado de salud (ORa 2,54; IC95%: 1,46-4,43), morbilidad psíquica (ORa 2,82; IC95%:1,56-5,07) y uso de medicación en el embarazo (ORa 2,36 IC95%: 1,14-4,87). Conclusión principal: la HV tiene un impacto en los resultados de salud de las gestantes. Dada la alta tasa de cobertura sanitaria durante el embarazo, este se convierte en un momento idóneo para poner en marcha las recomendaciones de los protocolos.
  

• 
  A Patient Safety Toolkit for Family Practices. Campbell, Stephen M.; Bell, Brian G.; Marsden, Kate; Spencer, Rachel; Kadam, Umesh; Perryman, Katherine; Rodgers, Sarah; Litchfield, Ian; Reeves, David; Chuter, Antony; Doos, Lucy; Ricci-Cabello, Ignacio; Gill, Paramjit; Esmail, Aneez; Greenfield, Sheila; Slight, Sarah; Middleton, Karen; Barnett, Jane; Moore, Michael; Valderas, Jose M.; Sheikh, Aziz; Avery, Anthony J. (2018). 16(3) e182-e186.

  AbstractURLBibTeXEndNoteDOIBibSonomyDownload

  OBJECTIVE: Major gaps remain in our understanding of primary care patient safety. We describe a toolkit for measuring patient safety in family practices. METHODS: Six tools were used in 46 practices. These tools were as follows: National Health Service Education for Scotland Trigger Tool, National Health Service Education for Scotland Medicines Reconciliation Tool, Primary Care Safequest, Prescribing Safety Indicators, Patient Reported Experiences and Outcomes of Safety in Primary Care, and Concise Safe Systems Checklist. RESULTS: Primary Care Safequest showed that most practices had a well-developed safety climate. However, the trigger tool revealed that a quarter of events identified were associated with moderate or substantial harm, with a third originating in primary care and avoidable. Although medicines reconciliation was undertaken within 2 days in more than 70% of cases, necessary discussions with a patient/carer did not always occur. The prescribing safety indicators identified 1435 instances of potentially hazardous prescribing or lack of recommended monitoring (from 92,649 patients). The Concise Safe Systems Checklist found that 25% of staff thought that their practice provided inadequate follow-up for vulnerable patients discharged from hospital and inadequate monitoring of noncollection of prescriptions. Most patients had a positive perception of the safety of their practice although 45% identified at least one safety problem in the past year. CONCLUSIONS: Patient safety is complex and multidimensional. The Patient Safety Toolkit is easy to use and hosted on a single platform with a collection of tools generating practical and actionable information. It enables family practices to identify safety deficits that they can review and change procedures to improve their patient safety across a key sets of patient safety issues.

  @article{Campbell_2018,
  abstract = {OBJECTIVE: Major gaps remain in our understanding of primary care patient safety. We describe a toolkit for measuring patient safety in family practices. METHODS: Six tools were used in 46 practices. These tools were as follows: National Health Service Education for Scotland Trigger Tool, National Health Service Education for Scotland Medicines Reconciliation Tool, Primary Care Safequest, Prescribing Safety Indicators, Patient Reported Experiences and Outcomes of Safety in Primary Care, and Concise Safe Systems Checklist. RESULTS: Primary Care Safequest showed that most practices had a well-developed safety climate. However, the trigger tool revealed that a quarter of events identified were associated with moderate or substantial harm, with a third originating in primary care and avoidable. Although medicines reconciliation was undertaken within 2 days in more than 70% of cases, necessary discussions with a patient/carer did not always occur. The prescribing safety indicators identified 1435 instances of potentially hazardous prescribing or lack of recommended monitoring (from 92,649 patients). The Concise Safe Systems Checklist found that 25% of staff thought that their practice provided inadequate follow-up for vulnerable patients discharged from hospital and inadequate monitoring of noncollection of prescriptions. Most patients had a positive perception of the safety of their practice although 45% identified at least one safety problem in the past year. CONCLUSIONS: Patient safety is complex and multidimensional. The Patient Safety Toolkit is easy to use and hosted on a single platform with a collection of tools generating practical and actionable information. It enables family practices to identify safety deficits that they can review and change procedures to improve their patient safety across a key sets of patient safety issues.},
  author = {Campbell, Stephen M. and Bell, Brian G. and Marsden, Kate and Spencer, Rachel and Kadam, Umesh and Perryman, Katherine and Rodgers, Sarah and Litchfield, Ian and Reeves, David and Chuter, Antony and Doos, Lucy and Ricci-Cabello, Ignacio and Gill, Paramjit and Esmail, Aneez and Greenfield, Sheila and Slight, Sarah and Middleton, Karen and Barnett, Jane and Moore, Michael and Valderas, Jose M. and Sheikh, Aziz and Avery, Anthony J.},
  journal = {Journal of Patient Safety},
  keywords = {evisap myown},
  month = {feb},
  number = 3,
  pages = {e182--e186},
  publisher = {Ovid Technologies (Wolters Kluwer Health)},
  title = {A Patient Safety Toolkit for Family Practices},
  volume = 16,
  year = 2018
  }
  

  %0 Journal Article
  %1 Campbell_2018
  %A Campbell, Stephen M.
  %A Bell, Brian G.
  %A Marsden, Kate
  %A Spencer, Rachel
  %A Kadam, Umesh
  %A Perryman, Katherine
  %A Rodgers, Sarah
  %A Litchfield, Ian
  %A Reeves, David
  %A Chuter, Antony
  %A Doos, Lucy
  %A Ricci-Cabello, Ignacio
  %A Gill, Paramjit
  %A Esmail, Aneez
  %A Greenfield, Sheila
  %A Slight, Sarah
  %A Middleton, Karen
  %A Barnett, Jane
  %A Moore, Michael
  %A Valderas, Jose M.
  %A Sheikh, Aziz
  %A Avery, Anthony J.
  %D 2018
  %I Ovid Technologies (Wolters Kluwer Health)
  %J Journal of Patient Safety
  %N 3
  %P e182--e186
  %R 10.1097/pts.0000000000000471
  %T A Patient Safety Toolkit for Family Practices
  %U https://doi.org/10.1097%2Fpts.0000000000000471
  %V 16
  %X OBJECTIVE: Major gaps remain in our understanding of primary care patient safety. We describe a toolkit for measuring patient safety in family practices. METHODS: Six tools were used in 46 practices. These tools were as follows: National Health Service Education for Scotland Trigger Tool, National Health Service Education for Scotland Medicines Reconciliation Tool, Primary Care Safequest, Prescribing Safety Indicators, Patient Reported Experiences and Outcomes of Safety in Primary Care, and Concise Safe Systems Checklist. RESULTS: Primary Care Safequest showed that most practices had a well-developed safety climate. However, the trigger tool revealed that a quarter of events identified were associated with moderate or substantial harm, with a third originating in primary care and avoidable. Although medicines reconciliation was undertaken within 2 days in more than 70% of cases, necessary discussions with a patient/carer did not always occur. The prescribing safety indicators identified 1435 instances of potentially hazardous prescribing or lack of recommended monitoring (from 92,649 patients). The Concise Safe Systems Checklist found that 25% of staff thought that their practice provided inadequate follow-up for vulnerable patients discharged from hospital and inadequate monitoring of noncollection of prescriptions. Most patients had a positive perception of the safety of their practice although 45% identified at least one safety problem in the past year. CONCLUSIONS: Patient safety is complex and multidimensional. The Patient Safety Toolkit is easy to use and hosted on a single platform with a collection of tools generating practical and actionable information. It enables family practices to identify safety deficits that they can review and change procedures to improve their patient safety across a key sets of patient safety issues.