Protocol for a multicentre and prospective follow-up cohort study of early detection of atrial fibrillation, silent stroke and cognitive impairment in high-risk primary care patients: the PREFA-TE study.

BACKGROUND: Atrial fibrillation (AF) is the most common type of cardiac arrhythmia. Future estimations suggest an increase in global burden of AF greater than 60% by 2050. Numerous studies provide growing evidence that AF is not only associated with stroke but also with cognitive impairment and dementia. AIM: The main goal is to assess the impact of the combined use of cardiac rhythm monitoring devices, echocardiography, biomarkers and neuroimaging on the early diagnosis of AF, silent strokes and cognitive decline, in subjects at high risk of AF. METHODS AND ANALYSIS: Two-year follow-up of a cohort of individuals aged 65-85 years at high risk for AF, with no prior diagnosis of either stroke or dementia. The study involves baseline echocardiography, biomarkers, and neuroimaging, yearly cardiac monitoring, and semiannual clinical assessments. Different parameters from these tests will be analysed as independent variables. Throughout the study period, primary outcomes: new diagnoses of AF, stroke and cognitive impairment, along with any clinical and therapeutic changes, will be registered. A first descriptive and bivariate statistical analysis, appropriate to the types of variables, will be done. The information obtained from the data analysis will encompass adjusted risk estimates along with 95% confidence intervals. Event risk predictions will rely on multivariate Cox proportional hazards regression models. The predictive value of the model will be evaluated through the utilisation of receiver operating characteristic curves for area under the curve calculation. Additionally, time-to-event analysis will be performed using Kaplan-Meier curves. ETHICS AND DISSEMINATION: This study protocol has been reviewed and approved by the Independent Ethics Committee of the Foundation University Institute for Primary Health Care Research-IDIAP Jordi Gol (expedient file 22/090-P). The authors plan to disseminate the study results to the general public through various scientific events. Publication in open-access journals and presentations at scientific congresses, seminars and meetings is also foreseen. TRIAL REGISTRATION NUMBER: NCT05772806.

Validity of the Espiro Mobile Application in the Interpretation of Spirometric Patterns: An App Accuracy Study.

Spirometry is a pulmonary function test where correct interpretation of the results is crucial for accurate diagnosis of disease. There are online tools to assist in the interpretation of spirometry results; however, as yet none are validated. We evaluated the interpretation accuracy of the Espiro app using pulmonologist interpretations as the gold standard. This is an observational descriptive study in which 118 spirometry results were interpreted by the Espiro app, two pulmonologists, two primary care physicians, and two residents of a primary care training program. We determined the interpretation accuracy of the Espiro app and the concordance of the pattern and severity interpretation between the Espiro app and each of the observers using Cohen's kappa coefficient (k). We obtained a sensitivity and specificity for the Espiro app of 97.5% (95% confidence interval (CI): 86.8-99.9%) and 94.9% (95%CI: 87.4-98.6%) with pulmonologist 1 and 100% (95%CI: 91.6-100%) and 98.7% (95%CI: 92.9-99.9%) with pulmonologist 2. The concordance for the pattern interpretation was greater than k 0.907, representing almost perfect agreement. The concordance of the severity interpretation was greater than k 0.807, representing substantial to almost perfect agreement. We concluded that the Espiro app is a valid tool for spirometry interpretation.

[Treatment setting, symptomatology, clinical course, severity degree and case-fatality rate in 536 adults over 50 years with laboratory-confirmed COVID-19 in Tarragona, Spain, March-June 2020.] / Lugar de atención, sintomatología y curso clínico, gravedad y letalidad en 536 casos confirmados de COVID-19 en adultos mayores de 50 años en el área de Tarragona, marzo-junio de 2020.

OBJECTIVE: Population-based clinical data on COVID-19 is scarce. This study analyzed distinct clinical characteristics of COVID-19 and relationships with lethality among adults. METHODS: Retrospective cohort that included all population ≥50 years with a laboratory-confirmed COVID-19 in Tarragona, Spain, during 01/03/2020-30/06/2020. Treatment setting (outpatient/hospital/nursing-home), pre-existing comorbidities, signs/symptoms, clinical course, severity and lethality (death from any cause in-hospital or within the first 30-day after the diagnosis) were determined. Chi squared and Fisher's test were used to compare percentages. RESULTS: Of the 536 overall cases (mean age: 74 years; 43.8% male), 150 (28%) were outpatient, 179 (33.4%) were hospitalised and 207 (38.6%) happened in nursing-home/social-health centres. The most prevalent symptoms were fever (57.9%), cough (49.8%), dyspnea (41.5%), general discomfort (36.2%), fatigue (24.4%), diarrhea (19.6%), myalgias (17.3%), headache (14.6%), confusion/lethargy (14.6%), thoracic pain (10%), anosmia (9.8%), disgeusia/ageusia (8.1%) and sore throat (7.7%). Global lethality was 23.1% (1.7% in 50-64 years vs 25.5% in 65-79 years vs 38.7% in ≥80 years, p<0.001; 26.8% in men vs 20.3% in women, p=0.075; 3.3% in outpatient vs 29.6% in hospitalised vs 31.9% in nursing-home/social-health centres, p<0.001). By symptomatology, maximum lethality was observed among patients with confusion/lethargy (77.6%) and minimum among those with ageusia/disgeusia (4.8%), anosmia (3.9%) or myalgias (1.1%). By pre-existing comorbidities, greater lethality happened among patients with neurologic (36.7%), renal (35.4%) and cardiac disease (35.3%). CONCLUSIONS: There was a relatively great lethality of COVID-19 among the general population ≥50 years across the first epidemic wave in the study setting. Increasing age, male sex, nursing-home residence and several signs/symptoms and comorbidities were associated with higher mortality.

OBJETIVO: Los datos clínicos de ámbito poblacional sobre COVID-19 son escasos. Este estudio analizó distintas características de presentación de la enfermedad y su relación con letalidad en adultos de 50 años y más. METODOS: Cohorte retrospectiva que incluyó todas las personas mayores o con 50 años con diagnóstico confirmado de COVID-19 en Tarragona del 01/03/2020 al 30/06/2020 (n=536). Se valoró el lugar de atención/tratamiento (ambulatorio/hospital/residencia), las comorbilidades previas, los signos/síntomas de presentación, el curso clínico, la gravedad y la letalidad (muerte por cualquier causa en 30 días post-diagnóstico). Chi cuadrado y test exacto de Fisher se usaron para la comparación de proporciones. RESULTADOS: De los 536 casos (edad media 74 años, 43,8% varones), 150 (28%) fueron ambulatorios, 179 (33,4%) hospitalizados y 207 (38,6%) ocurrieron en residencias/sociosanitarios. Los síntomas más prevalentes fueron fiebre (57,9%), tos (49,8%), disnea (41,5%, malestar general (36,2%), fatiga (24,4%), diarrea (19,6%), mialgias (17,3%), cefalea (14,6%), confusión/letargia (14,6%), dolor torácico (10%), anosmia (9,8%), disgeusia/ageusia (8,1%) y odinofagia (7,7%). La letalidad global fue 23,1% (1,7% en 50-64 años, 25,5% en 65-79 años y 38,7% en ≥80 años, p<0,001; 26,8% en hombres vs 20,3% en mujeres, p=0,075; 3,3% en ambulatorio/domicilio vs 29,6% en hospitalizados vs 31,9% en residencias/sociosanitarios, p<0,001). Según sintomatología, la máxima letalidad se observó en pacientes con confusión/letargia (77,6%) y la mínima en aquellos con ageusia/disgeusia (4,8%), anosmia (3,9%) o mialgias (1,1%). Según la comorbilidad, la máxima letalidad apareció en pacientes con enfermedad neurológica (36,7%), renal (35,4%) y cardiaca (35,3%). CONCLUSIONES: Se constata una relativamente alta letalidad de la COVID-19 en la población general mayor o de 50 años durante la primera ola epidémica. La edad avanzada, el sexo varón, la institucionalización y la presencia de algunos signos/síntomas y/o comorbilidades se asociaron con mayor mortalidad.

Effectiveness of New Tools to Define an Up-to-Date Patient Safety Risk Map: A Primary Care Study Protocol.

BACKGROUND: Reducing incidents related to health care interventions to improve patient safety is a health policy priority. To strengthen a culture of safety, reporting incidents is essential. This study aims to define a patient safety risk map using the description and analysis of incidents within a primary care region with a prior patient safety improvement strategy organisationally developed and promoted. METHODS: The study will be conducted in two phases: (1) a cross-sectional descriptive observational study to describe reported incidents; and (2) a quasi-experimental study to compare reported incidents. The study will take place in the Camp de Tarragona Primary Care Management (Catalan Institute of Health). In Phase 1, all reactive notifications collected within one year (2018) will be analysed; during Phase 2, all proactive notifications of the second and third weeks of June 2019 will be analysed. Adverse events will also be assessed. Phases 1 and 2 will use a digital platform and the proactive tool proSP to notify and analyse incidents related to patient safety. EXPECTED RESULTS: To obtain an up-to-date, primary care patient safety risk map to prioritise strategies that result in safer practices.

Effectiveness of a Smartphone application and wearable device for weight loss in overweight or obese primary care patients: protocol for a randomised controlled trial.

BACKGROUND: To evaluate the effectiveness of an experimental intervention based on standard diet recommendations plus free Smartphone application (app) and wearable device for weight loss, compared with the standard diet intervention alone, in primary care patients aged 18 years or older who are overweight or obese. METHODS/DESIGN: Multicentre randomized, controlled clinical trial. LOCATION: Primary health care centres in the city of Tarragona and surrounding areas. SUBJECTS: 70 primary care patients, aged 18 years or older, with body mass index of 25 g/m2 or greater who wish to lose weight. Description of the intervention: 12 months of standard diet recommendations without (n = 35) or with (n = 35) assistance of a free Smartphone app that allows the participant to maintain a record of dietary intake and a bracelet monitor that records physical activity. The outcomes will be weight loss at 12 months (primary outcome), changes in physical activity and cardiometabolic risk factors, frequency of app use, and participant satisfaction after 12 months. DISCUSSION: The results of our study will offer evidence of the effectiveness of an intervention using one of the most popular free apps and wearable devices in achieving weight loss among patients who are overweight or obese. If these new technologies are proven effective in our population, they could be readily incorporated into primary care interventions promoting healthy weight. The open design and study characteristics make it impossible for the participants and researchers to be blinded to study group assignment. Researchers responsible for data analysis will be blinded to participant allocation. TRIAL REGISTRATION: Clinical Register: NCT02417623. Registered 26 March 2015.