Publications by authors named "Ignacio Ricci-Cabello"

45 Publications

Routine provision of feedback from patient-reported outcome measurements to healthcare providers and patients in clinical practice.

Cochrane Database Syst Rev 2021 Oct 12;10:CD011589. Epub 2021 Oct 12.

Health Services & Policy Research, Exeter Collaboration for Academic Primary Care (APEx), NIHR School for Primary Care Research, NIHR ARC South West Peninsula (PenARC), University of Exeter, Exeter, UK.

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.
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http://dx.doi.org/10.1002/14651858.CD011589.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8509115PMC
October 2021

Vitamin D recommendations in clinical guidelines: A systematic review, quality evaluation and analysis of potential predictors.

Int J Clin Pract 2021 Nov 15;75(11):e14805. Epub 2021 Sep 15.

Iberoamerican Cochrane Centre, Biomedical Research Institute Sant Pau (IIB-Sant Pau), Barcelona, Spain.

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.
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http://dx.doi.org/10.1111/ijcp.14805DOI Listing
November 2021

Insomnia and sleep quality in healthcare workers fighting against COVID-19: a systematic review of the literature and meta-analysis.

Actas Esp Psiquiatr 2021 Jul 1;49(4):155-179. Epub 2021 Jul 1.

Instituto de Investigación Sanitaria de las Islas Baleares (IdISBa). Carretera de Valldemossa, 79 Hospital Universitario Son Espases. Edificio S. 07120 Palma de Mallorca. Islas Baleares. España. Servicio de Salud de las Islas Baleares, Unidad de Investigación de Atención Primaria de Mallorca, Calle Escola Graduada, 3, 3o. 07002, Palma, Islas Baleares, España Ciber de Epidemiología y Salud Pública (CIBERESP), Madrid, España.

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.
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July 2021

Assessing the Impact of Multi-Morbidity and Related Constructs on Patient Reported Safety in Primary Care: Generalized Structural Equation Modelling of Observational Data.

J Clin Med 2021 Apr 20;10(8). Epub 2021 Apr 20.

Health Services & Policy Research Group, Exeter Collaboration for Academic Primary Care, NIHR School for Primary Care Research, University of Exeter, Exeter EX1 2HZ, UK.

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.
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http://dx.doi.org/10.3390/jcm10081782DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8073542PMC
April 2021

A Mobile Phone-Based Intervention to Reduce Mental Health Problems in Health Care Workers During the COVID-19 Pandemic (PsyCovidApp): Randomized Controlled Trial.

JMIR Mhealth Uhealth 2021 05 18;9(5):e27039. Epub 2021 May 18.

Health Research Institute of the Balearic Islands, Palma de Mallorca, Spain.

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.
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http://dx.doi.org/10.2196/27039DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8133164PMC
May 2021

Nurse-led telephone intervention for lifestyle changes on glycaemic control in people with prediabetes: Study protocol for a randomized controlled trial.

J Adv Nurs 2021 Jul 26;77(7):3204-3217. Epub 2021 Mar 26.

Research group on Global Health and Human Development, University of the Balearic Islands (UIB), Palma, Spain.

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.
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http://dx.doi.org/10.1111/jan.14842DOI Listing
July 2021

Effect of a mobile-based intervention on mental health in frontline healthcare workers against COVID-19: Protocol for a randomized controlled trial.

J Adv Nurs 2021 Jun 6;77(6):2898-2907. Epub 2021 Mar 6.

Health Research Institute of the Balearic Islands (IdISBa), Palma, Balearic Islands, Spain.

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.
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http://dx.doi.org/10.1111/jan.14813DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8250879PMC
June 2021

Prevalence and age patterns of depression in the United Kingdom. A population-based study.

J Affect Disord 2021 01 7;279:164-172. Epub 2020 Oct 7.

CIBER Epidemiology and Public Health (CIBERESP), Madrid, Spain; Health Services Research Group, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain; Dept. of Experimental and Health Sciences, Pompeu Fabra University (UPF), Barcelona, Spain.

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.
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http://dx.doi.org/10.1016/j.jad.2020.09.129DOI Listing
January 2021

Adherence to breast cancer guidelines is associated with better survival outcomes: a systematic review and meta-analysis of observational studies in EU countries.

BMC Health Serv Res 2020 Oct 7;20(1):920. Epub 2020 Oct 7.

CIBER de Epidemiología y Salud Pública (CIBERESP), Madrid, Spain.

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 ).
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http://dx.doi.org/10.1186/s12913-020-05753-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7542898PMC
October 2020

Impact of viral epidemic outbreaks on mental health of healthcare workers: a rapid systematic review and meta-analysis.

J Affect Disord 2020 12 23;277:347-357. Epub 2020 Aug 23.

Nuffield Department of Population Health, University of Oxford, UK.

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.
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http://dx.doi.org/10.1016/j.jad.2020.08.034DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7443314PMC
December 2020

Mobile technologies to support healthcare provider to healthcare provider communication and management of care.

Cochrane Database Syst Rev 2020 08 18;8:CD012927. Epub 2020 Aug 18.

Nuffield Department of Population Health, University of Oxford, Oxford, UK.

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.
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http://dx.doi.org/10.1002/14651858.CD012927.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7437392PMC
August 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.

Fam Pract 2020 11;37(6):821-827

Primary Care Research Unit of Mallorca, IB-Salut, Palma.

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.
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http://dx.doi.org/10.1093/fampra/cmaa051DOI Listing
November 2020

Healthcare providers' adherence to breast cancer guidelines in Europe: a systematic literature review.

Breast Cancer Res Treat 2020 Jun 6;181(3):499-518. Epub 2020 May 6.

CIBER de Epidemiología y Salud Pública (CIBERESP), Madrid, Spain.

Purpose: 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.

Methods: We searched for systematic reviews and quantitative or qualitative primary studies in MEDLINE and Embase up to May 2019. The eligibility assessment, data extraction, and risk of bias assessment were conducted by one author and cross-checked by a second author. We conducted a narrative synthesis attending to the modality of the healthcare process, methods to measure adherence, the scope of the CGs, and population characteristics.

Results: Out of 8137 references, we included 41 primary studies conducted in eight European countries. Most followed a retrospective cohort design (19/41; 46%) and were at low or moderate risk of bias. Adherence for overall breast cancer care process (from diagnosis to follow-up) ranged from 54 to 69%; for overall treatment process [including surgery, chemotherapy (CT), endocrine therapy (ET), and radiotherapy (RT)] the median adherence was 57.5% (interquartile range (IQR) 38.8-67.3%), while for systemic therapy (CT and ET) it was 76% (IQR 68-77%). The median adherence for the processes assessed individually was higher, ranging from 74% (IQR 10-80%), for the follow-up, to 90% (IQR 87-92.5%) for ET. Internal factors that potentially impact on healthcare providers' adherence were their perceptions, preferences, lack of knowledge, or intentional decisions.

Conclusions: A substantial proportion of breast cancer patients are not receiving CGs-recommended care. Healthcare providers' adherence to breast cancer CGs in Europe has room for improvement in almost all care processes. CGs development and implementation processes should address the main factors that influence healthcare providers' adherence, especially patient-related ones.

Registration: PROSPERO (CRD42018092884).
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http://dx.doi.org/10.1007/s10549-020-05657-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7220981PMC
June 2020

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.

JMIR Mhealth Uhealth 2020 04 20;8(4):e15789. Epub 2020 Apr 20.

Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.

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.
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http://dx.doi.org/10.2196/15789DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7199132PMC
April 2020

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.

J Patient Saf 2021 01;17(1):e20-e27

Health Services & Policy Research Group, Patient Centred Care, University of Exeter Collaboration for Academic Primary Care (APEx), University of Exeter Medical School, University of Exeter, Exeter, United Kingdom.

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.
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http://dx.doi.org/10.1097/PTS.0000000000000669DOI Listing
January 2021

Development and evaluation of an intervention based on the provision of patient feedback to improve patient safety in Spanish primary healthcare centres: study protocol.

BMJ Open 2019 12 23;9(12):e031367. Epub 2019 Dec 23.

Primary Care Research Unit of Mallorca, Balearic Islands Health Service, Palma, Balearic Islands, Spain

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.
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http://dx.doi.org/10.1136/bmjopen-2019-031367DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7008422PMC
December 2019

Effectiveness and adherence of telephone-administered psychotherapy for depression: A systematic review and meta-analysis.

J Affect Disord 2020 01 3;260:514-526. Epub 2019 Sep 3.

Department of Health Sciences, University of York, York, United Kingdom.

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.
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http://dx.doi.org/10.1016/j.jad.2019.09.023DOI Listing
January 2020

Examining Development Processes for Text Messaging Interventions to Prevent Cardiovascular Disease: Systematic Literature Review.

JMIR Mhealth Uhealth 2019 03 29;7(3):e12191. Epub 2019 Mar 29.

Radcliffe Observatory Quarter, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.

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.
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http://dx.doi.org/10.2196/12191DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6460311PMC
March 2019

Effectiveness of interventions to improve cardiovascular healthcare in rural areas: a systematic literature review of clinical trials.

Prev Med 2019 02 28;119:132-144. Epub 2018 Dec 28.

Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), Spain; Balearic Islands Health Research Institute (IdISBa), Spain; Atención Primaria Mallorca, IB-Salut, Spain.

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.
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http://dx.doi.org/10.1016/j.ypmed.2018.12.012DOI Listing
February 2019

Impact of patient and public involvement on enrolment and retention in clinical trials: systematic review and meta-analysis.

BMJ 2018 Nov 28;363:k4738. Epub 2018 Nov 28.

Oxford Academic Health Science Network, Oxford, UK.

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 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.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6259046PMC
http://dx.doi.org/10.1136/bmj.k4738DOI Listing
November 2018

A Patient Safety Toolkit for Family Practices.

J Patient Saf 2020 09;16(3):e182-e186

Medical School, Teviot Place, The University of Edinburgh, Midlothian, United Kingdom.

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.
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http://dx.doi.org/10.1097/PTS.0000000000000471DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7447126PMC
September 2020

Intimate partner violence and mental disorders: Co-occurrence and gender differences in a large cross-sectional population based study in Spain.

J Affect Disord 2018 03 27;229:69-78. Epub 2017 Dec 27.

Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, OX2 6GG Oxford, UK.

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.
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http://dx.doi.org/10.1016/j.jad.2017.12.032DOI Listing
March 2018

Identifying patient and practice characteristics associated with patient-reported experiences of safety problems and harm: a cross-sectional study using a multilevel modelling approach.

BMJ Qual Saf 2017 Nov 7;26(11):899-907. Epub 2017 Aug 7.

NIHR PenCLAHRC and Institute for Health Services Research, University of Exeter Medical School, University of Exeter, Exeter, UK.

Objective: To identify patient and family practice characteristics associated with patient-reported experiences of safety problems and harm.

Design: Cross-sectional study combining data from the individual postal administration of the validated Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC) questionnaire to a random sample of patients in family practices (response rate=18.4%) and practice-level data for those practices obtained from NHS Digital. We built linear multilevel multivariate regression models to model the association between patient-level (clinical and sociodemographic) and practice-level (size and case-mix, human resources, indicators of quality and safety of care, and practice safety activation) characteristics, and outcome measures.

Setting: Practices distributed across five regions in the North, Centre and South of England.

Participants: 1190 patients registered in 45 practices purposefully sampled (maximal variation in practice size and levels of deprivation).

Main Outcome Measures: Self-reported safety problems, harm and overall perception of safety.

Results: Higher self-reported levels of safety problems were associated with younger age of patients (beta coefficient 0.15) and lower levels of practice safety activation (0.44). Higher self-reported levels of harm were associated with younger age (0.13) and worse self-reported health status (0.23). Lower self-reported healthcare safety was associated with lower levels of practice safety activation (0.40). The fully adjusted models explained 4.5% of the variance in experiences of safety problems, 8.6% of the variance in harm and 4.4% of the variance in perceptions of patient safety.

Conclusions: Practices' safety activation levels and patients' age and health status are associated with patient-reported safety outcomes in English family practices. The development of interventions aimed at improving patient safety outcomes would benefit from focusing on the identified groups.
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http://dx.doi.org/10.1136/bmjqs-2016-006411DOI Listing
November 2017

Patients' evaluations of patient safety in English general practices: a cross-sectional study.

Br J Gen Pract 2017 Jul 5;67(660):e474-e482. Epub 2017 Jun 5.

Health Services and Policy Research Group, Patient Centred Care, University of Exeter Collaboration for Academic Primary Care (APEx), Exeter, UK.

Background: Description of safety problems and harm in general practices has previously relied on information from health professionals, with scarce attention paid to experiences of patients.

Aim: To examine patient-reported experiences and outcomes of patient safety in primary care.

Design And Setting: Cross-sectional study in 45 general practices across five regions in the north, centre, and south of England.

Method: A version of the Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC) questionnaire was sent to a random sample of 6736 patients. Main outcome measures included 'practice activation' (what a practice does to create a safe environment); 'patient activation' (how proactive are patients in ensuring safe healthcare delivery); 'experiences of safety events' (safety errors); 'outcomes of safety' (harm); and 'overall perception of safety' (how safe patients rate their practice).

Results: Questionnaires were returned by 1244 patients (18.4%). Scores were high for 'practice activation' (mean [standard error] = 80.4 out of 100 [2.0]) and low for 'patient activation' (26.3 out of 100 [2.6]). Of the patients, 45% reported experiencing at least one safety problem in the previous 12 months, mostly related to appointments (33%), diagnosis (17%), patient provider communication (15%), and coordination between providers (14%). Twenty-three per cent of the responders reported some degree of harm in the previous 12 months. The overall assessment of level of safety of practices was generally high (86.0 out of 100 [16.8]).

Conclusion: Priority areas for patient safety improvement in general practices in England include appointments, diagnosis, communication, coordination, and patient activation.
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http://dx.doi.org/10.3399/bjgp17X691085DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5565856PMC
July 2017

Identifying patient-centred recommendations for improving patient safety in General Practices in England: a qualitative content analysis of free-text responses using the Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC) questionnaire.

Health Expect 2017 10 28;20(5):961-972. Epub 2017 Feb 28.

Health Services and Policy Research Group, Patient Centred Care, University of Exeter Collaboration for Academic Primary Care (APEx), University of Exeter Medical School, University of Exeter, Exeter, UK.

Background: There is a growing interest in identifying strategies to achieve safer primary health-care provision. However, most of the research conducted so far in this area relies on information supplied by health-care providers, and limited attention has been paid to patients' perspectives.

Objective: To explore patients' experiences and perceptions of patient safety in English general practices with the aim of eliciting patient-centred recommendations for improving patient safety.

Methods: The Patient Reported Experiences and Outcomes of Safety in Primary Care questionnaire was sent to a random sample of 6736 primary care users registered in 45 English practices. We conducted a qualitative content analysis of responses to seven open-ended items addressing patients' experiences of safety problems, lessons learnt as a result of such experiences and recommendations for safer health care.

Results: A total of 1244 (18.4%) participants returned completed questionnaires. Of those, 678 (54.5%) responded to at least one open-ended question. Two main themes emerged as follows: (i) experiences of safety problems and (ii) good practices and recommendations to improve patient safety in primary care. Most frequent experiences of safety problems were related to appointments, coordination between providers, tests, medication and diagnosis. Patients' responses to these problems included increased patient activation (eg speaking up about concerns with their health care) and avoidance of unnecessary health care. Recommendations for safer health care included improvements in patient-centred communication, continuity of care, timely appointments, technical quality of care, active monitoring, teamwork, health records and practice environment.

Conclusion: This study identified a number of patient-centred recommendations for improving patient safety in English general practices.
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http://dx.doi.org/10.1111/hex.12537DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5600214PMC
October 2017

Identifying Primary Care Pathways from Quality of Care to Outcomes and Satisfaction Using Structural Equation Modeling.

Health Serv Res 2018 02 19;53(1):430-449. Epub 2017 Feb 19.

APEx Collaboration for Academic Primary Care, Institute for Health Services Research, University of Exeter Medical School, University of Exeter, Exeter, UK.

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.
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http://dx.doi.org/10.1111/1475-6773.12666DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5785308PMC
February 2018

Effectiveness of an intervention to improve diabetes self-management on clinical outcomes in patients with low educational level.

Gac Sanit 2017 Jan - Feb;31(1):40-47. Epub 2016 Jul 29.

CIBER en Epidemiología y Salud Pública (CIBERESP), Spain; Nuffield Department of Primary Care Health Sciences, University of Oxford, United Kingdom.

Objective: To determine whether an intervention based on patient-practitioner communication is more effective than usual care in improving diabetes self-management in patients with type 2 diabetes with low educational level.

Methods: 12-month, pragmatic cluster randomised controlled trial. Nine physicians and 184 patients registered at two practices in a deprived area of Granada (Andalusia, Spain) participated in the study. Adult patients with type 2 diabetes, low educational level and glycated haemoglobin (HbA1c) > 7% (53.01 mmol/mol) were eligible. The physicians in the intervention group received training on communication skills and the use of a tool for monitoring glycaemic control and providing feedback to patients. The control group continued standard care. The primary outcome was difference in HbA1c after 12 months. Dyslipidaemia, blood pressure, body mass index and waist circumference were also assessed as secondary outcomes. Two-level (patient and provider) regression analyses controlling for sex, social support and comorbidity were conducted.

Results: The HbA1c levels at 12 months decreased in both groups. Multilevel analysis showed a greater improvement in the intervention group (between-group HbA1c difference= 0.16; p=0.049). No statistically significant differences between groups were observed for dyslipidaemia, blood pressure, body mass index and waist circumference.

Conclusions: In this pragmatic study, a simple and inexpensive intervention delivered in primary care showed a modest benefit in glycaemic control compared with usual care, although no effect was observed in the secondary outcomes. Further research is needed to design and assess interventions to promote diabetes self-management in socially vulnerable patients.
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http://dx.doi.org/10.1016/j.gaceta.2016.05.017DOI Listing
March 2018

Framework and guidance for implementing patient-reported outcomes in clinical practice: evidence, challenges and opportunities.

J Comp Eff Res 2016 08 18;5(5):507-19. Epub 2016 Jul 18.

Health Services & Policy Research Group, Exeter Collaboration for Academic Primary Care (APEx) (Person centerd Care), University of Exeter Medical School, University of Exeter, Exeter, UK.

Patient-reported outcomes (PROs) are reports of the status of a patient's health condition that come directly from the patient. While PRO measures are a well-developed technology with robust standards in research, their use for informing healthcare decisions is still poorly understood. We review relevant examples of their application in the provision of healthcare and examine the challenges associated with implementing PROs in clinical settings. We evaluate evidence for their use and examine barriers to their uptake, and present an evidence-based framework for the successful implementation of PROs in clinical practice. We discuss current and future developments for the use of PROs in clinical practice, such as individualized measurement and computer-adaptive testing.
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http://dx.doi.org/10.2217/cer-2015-0014DOI Listing
August 2016

Patients' perceptions and experiences of patient safety in primary care in England.

Fam Pract 2016 10 16;33(5):535-42. Epub 2016 Jun 16.

Institute for Health Research, University of Exeter Collaboration for Academic Primary Care (APEx), University of Exeter Medical School, Exeter, UK.

Background: One of the most remarkable features of patient safety research in primary care is the sparse attention paid to patients' own experiences.

Objective: To explore patient's perceptions and experiences of patient safety in primary care in England.

Methods: We conducted a qualitative study in the South of England with an opportunistic sample of 27 primary care users. Information was obtained from four patient focus groups. A thematic content analysis was conducted by three analysts and consensus reached within the research team on the key themes that emerged.

Results: Participants' conceptualizations of patient safety referred to high standards of health care delivery within a relationship of trust. Participants identified four main factors that they believed could potentially affect patient safety. These included factors related to (i) the patient (attitudes, behaviours and health literacy); (ii) the health professional (attitudes, behaviours and accuracy of diagnoses); (iii) the relationship between patients and health professionals (communication and trust); and (iv) the health care system (workload, resources, care coordination, accessibility, interdisciplinary teamwork and accuracy of health care records). Confidentiality, continuity of care and treatment-related safety emerged as cross-cutting major threats to patient safety.

Conclusions: The exploration of participants' perceptions and experiences allowed the identification of a wide variety of themes that were perceived to impact on patient safety in primary care. The findings of this study could be used to enrich current frameworks that are exclusively based on professional or health care system perspectives.
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http://dx.doi.org/10.1093/fampra/cmw046DOI Listing
October 2016

Measuring Patient Safety in Primary Care: The Development and Validation of the "Patient Reported Experiences and Outcomes of Safety in Primary Care" (PREOS-PC).

Ann Fam Med 2016 05;14(3):253-61

Health Services & Policy Research Group, Patient Centred Care, University of Exeter Collaboration for Academic Primary Care (APEx), University of Exeter Medical School, University of Exeter, Exeter, United Kingdom

Purpose: We set out to develop and validate a patient-reported instrument for measuring experiences and outcomes related to patient safety in primary care.

Method: The instrument was developed in a multistage process supported by an international expert panel and informed by a systematic review of instruments, a meta-synthesis of qualitative studies, 4 patient focus groups, 18 cognitive interviews, and a pilot study. The trial version of Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC) covered 5 domains and 11 scales: practice activation (1 scale); patient activation (1 scale); experiences of patient safety events (1 scale); harm (6 scales); and general perceptions of patient safety (2 scales). The questionnaire was posted to 6,736 patients in 45 practices across England. We used "gold standard" psychometric methods to evaluate its acceptability, reliability, structural and construct validity, and ability to discriminate among practices.

Results: 1,244 completed questionnaires (18.5%) were returned. Median item-specific response rate was 91.3% (interquartile range 28.0%). No major ceiling or floor effects were observed. All 6 multi-item scales showed high internal consistency (Cronbach's α 0.75-0.96). Factor analysis, correlation between scales, and known group analyses generally supported structural and construct validity. The scales demonstrated a heterogeneous ability to discriminate between practices. The final version of PREOS-PC consisted of 5 domains, 8 scales, and 58 items.

Conclusions: PREOS-PC is a new multi-dimensional patient safety instrument for primary care developed with experts and patients. Initial testing shows its potential for use in primary care, and future developments will further address its use in actual clinical practice.
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http://dx.doi.org/10.1370/afm.1935DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4868564PMC
May 2016
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