Objective: To assess the association between electrocardiogram (ECG) patterns according to the MVP ECG risk score (morphology-voltage-P-wave duration) and a diagnosis of Atrial Fibrillation (AF). Design: Prospective observational cohort study (1/01/2023-31/12/2024). Site: Primary care. Participants: Randomized sample of 150 patients aged 65-85 years without prior diagnosis of AF, stroke, or current anticoagulant treatment; high risk of future AF; CHA2DS2-VASc > 2; and ability to use the FibricheckR application (App). Measurements: At baseline, a standard ECG, MVP risk score assessment, and cardiac rhythm monitoring for 15 days using the FibricheckR R App were performed. The dependent variables were the presence of P-wave patterns on the electrocardiogram according to MVP risk score and a new diagnosis of AF. Results: The diagnosis of AF was confirmed in 14 cases (9.3%, 95% CI 5.6-15.1), 3 men and 11 women. In 3 cases, the arrhythmia was diagnosed on the baseline ECG, and in 11 cases by Holter after being reported as possible AF by the FibricheckR R App. A higher prevalence of atypical advanced interatrial block (A-AIB) (p 0.007) was detected among participants with AF, as well as the prevalence of P-wave < 0.1 mV. (p = 0.006). All new diagnoses of AF were made at scores > 4 in the MVP risk score. Conclusions: Using scales for identifying ECG patterns in high-risk subjects in primary care can facilitate the diagnosis of unknown AF. (c) 2024 The Author(s). Published by Elsevier Espana, S.L.U. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

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 (alpha > 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 .

We aim to estimate the incidence rates (IRs) of SARS-CoV-2 infections stratified by disease severity and comorbidities in pediatric population and to describe the COVID-19 vaccination coverage in children with and without comorbidities. A population-based cohort study was conducted in 6 electronic healthcare records databases from Italy, Spain, and Norway. The study lasted from 1 January 2020 to the latest databases’ available data in each site, i.e., in Italian ARS Tuscany and PEDIANET: December 2021, in Spanish BIFAP: February 2022; SIDIAP: June 2022, and VID: December 2021. Finally, in Norwegian Health Registries: December 2021. Children and adolescents were included and stratified into three age categories (< 5, 5- < 12, and 12- < 18 years old). IRs (95% confidence intervals) per 100 person-years (PY) for non-severe (positive SARS-CoV-2 test or diagnosis without hospitalization) and severe COVID-19 (hospitalization, intensive care unit admission, and death after COVID-19) are reported. The cumulative COVID-19 vaccination rollout was stratified by population with and without comorbidities. The study population comprised 5,654,040 individuals < 18 years of age (51% females) across the six European databases (median age: 6 years), with 1.4 to 8.5% of them having at least one at-risk comorbidity for severe COVID-19. Incidence rates of severe COVID-19 were low (0-1 per 100 PY) but 3 to 4 times higher among children and adolescents with comorbidities during Omicron BA.1-2 wave in December 2021-January 2022. Percentages of vaccination rollout in the general population were between 13% in PEDIANET-IT and 64% in BIFAP-ICU-ES. In ARS-IT and SIDIAP-IT, vaccination rate in children with comorbidities was slightly lower than that in the general population. CONCLUSION: Severe COVID-19 was rare across databases, but up to 3 to 4 times higher in children with comorbidities during the predominance of Omicron BA.1-2 variant in winter 2021-2022. COVID-19 vaccination coverage was slightly lower in children with comorbidities in ARS (Tuscany) and SIDIAP (Catalonia) data sources. Our findings will inform future public policies aimed to protect the pediatric population, both within these countries and globally. WHAT IS KNOWN: • Pediatric population is susceptible to SARS-CoV-2 infection. • COVID-19 severity rates in children vary across study settings and context. WHAT IS NEW: • This study confirms the low severity rates of COVID-19 in the pediatric population based on a large cohort of children and adolescents residing in Spain, Italy, and Norway. • Incidence of severe COVID-19 in children and adolescents with comorbidities was up to 3 to 4 times higher than in the general pediatric population during the SARS-CoV-2 high transmission wave of Omicron BA.1-2 variant in winter 2021-2022 in Italy and Spain.

We test the robustness of the self-controlled risk interval (SCRI) design in a setting where time between doses may introduce time-varying confounding, using both negative control outcomes (NCOs) and quantitative bias analysis (QBA). All vaccinated cases identified from 5 European databases between 1 September 2020 and end of data availability were included. Exposures were doses 1-3 of the Pfizer, Moderna, AstraZeneca, and Janssen COVID-19 vaccines; outcomes were myocarditis and otitis externa (NCO). The SCRI used a 60-day control window and dose-specific 28-day risk windows, stratified by vaccine brand and adjusted for calendar time. The QBA included two scenarios: (i) baseline probability of the confounder was higher in the control window and (ii) vice versa. The NCO was not associated with any of the COVID-19 vaccine types or doses except Moderna dose 1 (IRR = 1.09, 95%CI 1.01-1.09). The QBA suggested even the strongest literature-reported confounder (COVID-19; RRmyocarditis = 18.3) could only explain away part of the observed effect from IRR = 3 to IRR = 1.40. The SCRI seems robust to unmeasured confounding in the COVID-19 setting, although a strong unmeasured confounder could bias the observed effect upward. Replication of our findings for other safety signals would strengthen this conclusion.

Introduction ISMiHealth is a clinical decision support system, integrated as a software tool in the electronic health record system of primary care, that aims to improve the screening performance on infectious diseases and female genital mutilation (FGM) in migrants. The aim of this study is to assess the health impact of the tool and to perform a process evaluation of its feasibility and acceptability when implemented in primary care in Catalonia (Spain).Methods and analysis This study is a cluster randomised control trial where 35 primary care centres in Catalonia, Spain will be allocated into one of the two groups: intervention and control. The health professionals in the intervention centres will receive prompts, through the ISMiHealth software, with screening recommendations for infectious diseases and FGM targeting the migrant population based on an individualised risk assessment. Health professionals of the control centres will follow the current routine practice. A difference in differences analysis of the diagnostic rates for all aggregated infections and each individual condition between the intervention and control centres will be performed. Mixed-effects logistic regression models will be carried out to identify associations between the screening coverage and predictor factors. In addition, a process evaluation will be carried out using mixed methodology.Methods and analysis This study is a cluster randomised control trial where 35 primary care centres in Catalonia, Spain will be allocated into one of the two groups: intervention and control. The health professionals in the intervention centres will receive prompts, through the ISMiHealth software, with screening recommendations for infectious diseases and FGM targeting the migrant population based on an individualised risk assessment. Health professionals of the control centres will follow the current routine practice. A difference in differences analysis of the diagnostic rates for all aggregated infections and each individual condition between the intervention and control centres will be performed. Mixed-effects logistic regression models will be carried out to identify associations between the screening coverage and predictor factors. In addition, a process evaluation will be carried out using mixed methodology.Ethics and dissemination The study protocol has been approved by the institutional review boards at Hospital Cl & iacute;nic (16 June 2022, HCB/2022/0363), Clinical Research Ethics Committee of the Primary Care Research Institute IDIAPJGol (22 June 2022, 22/113-P) and the Almer & iacute;a Research Ethics Committee (27 July 2022, EMC/apg). The study will follow the tenets of the Declaration of Helsinki and Good Clinical Practice. All researchers and associates signed a collaboration agreement in which they undertake to abide by good clinical practice standards. Findings will be disseminated in peer-reviewed journals and communications to congresses.Ethics and dissemination The study protocol has been approved by the institutional review boards at Hospital Cl & iacute;nic (16 June 2022, HCB/2022/0363), Clinical Research Ethics Committee of the Primary Care Research Institute IDIAPJGol (22 June 2022, 22/113-P) and the Almer & iacute;a Research Ethics Committee (27 July 2022, EMC/apg). The study will follow the tenets of the Declaration of Helsinki and Good Clinical Practice. All researchers and associates signed a collaboration agreement in which they undertake to abide by good clinical practice standards.
Findings will be disseminated in peer-reviewed journals and communications to congresses.Trial registration number NCT05868005.

INTRODUCTION: DP-TRANSFERS is a translational lifestyle intervention project, which follows a previous protocol described in the DE-PLAN-CAT study. OBJECTIVE: Analyze the feasibility of reproducing the intensive intervention and estimating the effect of translation in real conditions of clinical practice in primary care. METHODOLOGY: Implementation of the face-to-face group intervention adjusted to 2 years. After screening, the intervention consisted of a basic module and a continuity module. Stratifying by clusters (health centers), a representative sample (centers, professionals and participants) was evaluated (FINDRISC > 11 and/or prediabetes) from 2016 to 2020. The effect of the intervention on the incidence of diabetes was analyzed. RESULTS: The intervention, feasible in 95 of 123 centers, involved 343 of 647 professionals. Of 2381 subjects screened, 1713 participated in the basic module, with 1186 participants completing the first year and 776 completing the second. 121 participants (7.06%) were diagnosed with diabetes: 77 (4.49%) during the first year; 44 (2.57%) during the second. The bivariate analysis showed that those subjects in whom diabetes affected differed in: previous glycemic status, A1c, HDL-cholesterol, FINDRISC score and adherence to the Mediterranean diet, and in the differences between the beginning and end of the study of: body weight, BMI and abdominal circumference. CONCLUSIONS: The intensive intervention substantially reduced (23.6%) the incidence of diabetes compared to that previously estimated in standardized intervention. The following acted as protective factors: a better glycemic status, lower baseline risk, elevated HDL-cholesterol, or achieving a reduction in weight or abdominal circumference during the study.