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.

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.

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.

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).

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.

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 .

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.

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.

Clinical predictors of suicidal ideation, suicide attempts and suicide death in depressive disorder: a systematic review and meta-analysis.

Patients with depressive disorders are especially prone to suicide risk. Among the clinical predictors of suicidality, those specifically related to depressive disorders have not been accurately detailed. Our aim was to conduct a systematic review and meta-analysis of studies reporting longitudinal predictors of suicidal ideation, suicide attempts and suicide death within depression, including diagnostic subtypes, symptoms, clinical course, and assessment scales. A systematic search of the literature between 2001 and 2022 identified 4422 references, among which 19 studies providing 45 different predictors of suicidality met the inclusion criteria. Random effects meta-analyses were performed for 22 predictors, three for suicidal ideation, eleven for suicide attempts and eight for suicide death. Heterogeneity and publication bias were inspected through I2 tests and Egger's tests respectively. Meta-analysis results showed that severity of hopelessness predicted suicidal ideation and suicide attempts. History of suicide attempts, suicidal ideation, severe depression, and psychotic symptoms predicted subsequent suicide attempts and suicide death. Time to full remission and sleep disturbances were also found as relevant predictors of future suicide behaviours. This review specifies which predictors of suicidality within the clinical features of depression will help clinicians and policy makers to better prevent suicide risk in patients with depressive disorders. Further longitudinal studies are needed to reliably assess the predictive ability of our results and to analyse other possible clinical predictors to prevent suicidality, especially with regard to suicidal ideation.

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.

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.

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.

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 I2 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.

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.

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.

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.

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.

Efficacy of Different Modalities and Frequencies of Physical Exercise on Glucose Control in People with Prediabetes (GLYCEX Randomised Trial).

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.

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.

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.

Perspectives and Views of Primary Care Professionals Regarding DiabeText, a New mHealth Intervention to Support Adherence to Antidiabetic Medication in Spain: A Qualitative Study.

BACKGROUND: Antidiabetic medication is effective in preventing diabetes-related complications. However, 40% of type 2 diabetic patients do not adhere to their medication regimes adequately. Brief text messages represent a promising approach to support medication adherence. The aim of this study was to explore the perspectives of primary care professionals (PCPs) concerning the DiabeText intervention, a new text messaging intervention to be developed to support medication adherence in people with type 2 diabetes (T2D) in Mallorca, Spain. METHODS: We conducted four focus groups (n = 28) and eight semi-structured interviews with doctors and nurses. Data collection and analysis were carried out by researchers independently following Braun and Clark's methodology. RESULTS: Three main themes were identified: (1) text messaging interventions have the potential to effectively support diabetes self-management; (2) involving PCPs in the intervention would facilitate its design and implementation; (3) obtaining evidence supporting the cost-effectiveness is a key prerequisite for large-scale implementation of the intervention. PCPs identified barriers and enablers of the design and implementation of the intervention and made suggestions about the content and format of the text messages. CONCLUSION: The DiabeText intervention is perceived as useful and acceptable by PCPs provided its cost-effectiveness.

Development of 2 Short Patient-Report Questionnaires of Patient Safety in Primary Care.

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.

Feasibility of the SINERGIAPS ("Sinergias entre profesionales y pacientes para una Atención Primaria Segura") intervention for improving patient safety in primary care.

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.

Patients' Views on the Design of DiabeText, a New mHealth Intervention to Improve Adherence to Oral Antidiabetes Medication in Spain: A Qualitative Study.

BACKGROUND: Type 2 Diabetes Mellitus (T2DM) is a long-term condition affecting around 10% of people worldwide. This study aimed to explore T2DM patients' views on DiabeText, a new text messaging intervention to be developed to support adherence to diabetes medication. METHODS: A total of four focus groups were conducted with a purposive sample of people with T2DM (n = 34). The data were analysed by multiple researchers independently, and coded using thematic analysis. RESULTS: There were two main themes that emerged: (1) "patients' perspectives on unmet needs for diabetes self-management", and (2) "acceptability and perceived utility of DiabeText". The patients identified a number of barriers for diabetes self-management, including lack of appropriate information and support with diet and physical activity. Support for medication-taking was not perceived as urgently needed, although several barriers were identified (eating outside, traveling, polymedication, dispensation at the pharmacy). The participants anticipated that the proposed intervention would present high levels of patient acceptability and perceived utility as long as its content addresses the barriers that were identified, and includes specific features (short and clear messages, and personalized information). CONCLUSION: The proposed intervention has the potential to be well accepted and perceived as useful by T2DM patients who require support not only in terms of medication-taking, but more prominently of lifestyle behaviour.

Cross-Cultural Adaptation, Validation, and Piloting of the Patient Reported Experiences and Outcomes of Safety in Primary Care Questionnaire for Its Use in Spain.

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.

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.

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; I2=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.

[Impact of the COVID-19 pandemic on patient-reported patient safety in Primary Care]. / Impacto de la pandemia de COVID-19 en la seguridad del paciente percibida por los pacientes en Atención Primaria.

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.

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.