Effectiveness and safety of drugs used for stroke prevention in a cohort of non-valvular atrial fibrillation patients from a primary care electronic database.

PURPOSE: The aim of this study was to assess effectiveness and safety of antithrombotics for stroke prevention in non-valvular atrial fibrillation in real-use conditions. METHODS: We used a population-based retrospective cohort study. Information emerges from SIDIAP, a database containing anonymized information from electronic health records from 274 primary healthcare centres of the Catalan Health Institute, Catalonia (Spain), with a reference population of 5 835 000 people. Population includes all adults with a new diagnosis of non-valvular atrial fibrillation registered in SIDIAP from 2007 to 2012. The main outcome of antithrombotics' effectiveness was stroke. The main outcomes of safety were cerebral and gastrointestinal haemorrhages. We also estimated all-cause mortality. We used multivariable Cox proportional hazard models to examine association between antithrombotic treatment and main outcomes. RESULTS: We included 22 205 subjects with non-valvular atrial fibrillation; 40.8% initiated on vitamin K antagonists (VKA), 33.4% on antiplatelets and 25.8% untreated. We found stroke-risk reduction with VKA, hazard ratio (HR) 0.72 (95% confidence interval (CI), 0.58-0.91), also seen in patients with CHADS2 ≥ 2, HR 0.65 (95%CI, 0.49-0.86), and CHA2 DS2 -VASc ≥ 2, HR 0.66 (95%CI, 0.52-0.84). We observed a higher risk of digestive bleeding with antiplatelets, HR 1.32 (95%CI, 1.01-1.73). Both VKA and antiplatelets were associated with reduction of all-cause mortality risk; HR 0.55 (95%CI, 0.49-0.62) and HR 0.89 (95%CI, 0.80-0.97), respectively. CONCLUSIONS: This study found a stroke-risk reduction associated with VKA and an increased risk of gastrointestinal bleeding associated with platelet-aggregation inhibitors in comparison with untreated patients. Both antithrombotic groups showed a reduction in all-cause mortality. Copyright © 2016 John Wiley & Sons, Ltd.

[A tool (corrected) for the critical appraisal of epidemiological cross-sectional studies]. / Instrumento para la lectura crítica y la evaluación de estudios epidemiológicos transversales.

The aim was to develop a tool for the critical appraisal of epidemiological cross-sectional studies. Several recommendations or guidelines for assessing the strength of scientific evidence provided by observational studies were reviewed, like those from the Agency for Healthcare Research and Quality, the Scottish Intercollegiate Guidelines Group, the Osteba (Basque Office for Health Technology Assessment), and the STROBE Initiative. The tool has 27 items to assess: study question or objective, participants, comparability between groups, definition and measure of main variables; analysis and confusion, results, conclusions, external validity and applicability, and conflict of interest. This tool can be used to critically appraise research papers or to rate evidence during the elaboration of systematic reviews.

Instrumento para la lectura crítica y la evaluación de estudios epidemiológicos transversales / A tool for the critical appraisal of epidemiological cross-sectional studies

El objetivo de este trabajo fue desarrollar un instrumento parala evaluación de la calidad de los estudios epidemiológicostransversales. Se tuvieron en cuenta diferentes recomendacionese instrumentos de valoración de estudios observacionales,como los de la Agency for Healthcare Research andQuality, el Scottish Intercollegiate Guidelines Group, el Osteba(Servicio de Evaluación de Tecnologías Sanitarias del PaísVasco) y la iniciativa STROBE. El instrumento consta de 27ítems para evaluar: pregunta u objetivo de investigación, participantes,comparabilidad entre los grupos estudiados, definicióny medición de las variables principales, análisis y confusión,resultados, conclusiones, validez externa y aplicabilidadde los resultados, y conflicto de interés. Este instrumento puedeutilizarse para la lectura crítica de artículos originales o en laelaboración de revisiones sistemáticas de la evidencia científica (AU)

The aim was to develop a tool for the critical appraisal of epidemiologicalcross-sectional studies. Several recommendationsor guidelines for assessing the strength of scientific evidenceprovided by observational studies were reviewed, like thosefrom the Agency for Healthcare Research and Quality, the ScottishIntercollegiate Guidelines Group, the Osteba (Basque Officefor Health Technology Assessment), and the STROBE Initiative.The tool has 27 items to assess: study question orobjective, participants, comparability between groups, definitionand measure of main variables; analysis and confusion,results, conclusions, external validity and applicability, and conflictof interest. This tool can be used to critically appraise researchpapers or to rate evidence during the elaboration ofsystematic reviews (AU)

[Portable coagulometers: a systematic review of the evidence on self-management of oral anticoagulant treatment]. / Coagulómetros portátiles: una revisión sistemática de la evidencia científica del autocontrol del tratamiento anticoagulante oral.

BACKGROUND AND OBJECTIVE: We aimed to systematically review the scientific evidence about the use of portable coagulometers for patient's self-management of oral anticoagulant treatment. MATERIAL AND METHOD: Systematic review of scientific evidence available from MEDLINE'S, DARE's, HTA-Database's, NHS-EED's and The Cochrane Library' s bibliographic databases, from their origin to March 2003. Randomized control trials (RCT) and Quasi-Experimental trials were selected provided that they compared patients in self-management with patients under usual care. The quality of scientific evidence was elicited using the Scottish Intercollegiate Guideline Network (SIGN) recommendations, whilst efficacy and security were descriptively summarized. RESULTS: Twelve (7 RCT and 5 quasi-experimental trials) articles were found, and only two of them provided grade A recommendation. Patients under self-management remained the same or more time in the therapeutic range. The incidence of adverse effects in self-management patients was the same or less than that in patients under usual care. CONCLUSIONS: The quality of the scientific evidence is heterogeneous. For selected patients, patient's self-management is at least as effective and safe as usual care. New oral anticaogulants, which have shown promising results, should be scrutinized for future changes in service provision.

Coagulómetros portátiles: una revisión sistemática de la evidencia científica del autocontrol del tratamiento anticoagulante oral / Portable coagulometers: a systematic review of the evidence on self-management of oral anticoagulant treatment

FUNDAMENTO Y OBJETIVO: Realizar una revisión sistemática de la evidencia científica acerca de luso de los coaguló metros portátiles (CP) para el control del tratamiento anticoagulante oral(TAO) en régimen de autocontrol domiciliario. MATERIAL Y MÉTODO: Revisión sistemática de la evidencia científica a partir de la consulta, desde su inicio hasta marzo de 2003, de las bases de datos bibliográficas MEDLINE, DARE, HTA-Database, NHS-EED y The Cochrane Library. Se seleccionaron los artículos originales sobre ensayos clínicos aleatorizados o estudios casi experimentales que incluían pacientes que reciben TAO y que comparaban pacientes en autocontrol domiciliario con tratamiento habitual. La calidad de la evidencia científica fue evaluada según los criterios de la Scottish Intercollegiate Guideline Network (SIGN) y se realizó un análisis descriptivo de los resultados de eficacia y seguridad. RESULTADOS: Se obtuvieron 12 publicaciones (7 ensayos clínicos aleatorizados y 5 estudios casi experimentales) de los que sólo 2 ofrecían un grado de recomendación A. Los pacientes manejados con los CP se mantenían igual o significativamente más tiempo en el margen terapéutico(MT) y tenían igual o significativamente más determinaciones en el MT. La incidencia de complicaciones en pacientes en autocontrol era igual o inferior a la del tratamiento convencional. CONCLUSIONES: La calidad de los estudios es heterogénea, pero en general es media o baja. Para poblaciones seleccionadas, el autocontrol del TAO mediante CP es al menos tan eficaz y seguro como el tratamiento habitual. Los nuevos anticoagulantes, que ya han mostrado resultados prometedores, deben ser evaluados para prever cambios en la provisión de este servicio

BACKGROUND AND OBJECTIVE:: Review the scientific evidence about the use of portable coagulometers for patient’s self-management of oral anticoagulant treatment. MATERIAL AND METHOD: Systematic review of scientific evidence available from MEDLINE’S, DA-RE’s, HTA-Database’s, NHS-EED’s and The Cochrane Library’ s bibliographic databases, from their origin to March 2003. Randomized control trials (RCT) and Quasi-Experimental trials were selected provided that they compared patients in self-management with patients under usual care. The quality of scientific evidence was elicited using the Scottish Intercollegiate Guideline Network (SIGN) recommendations, whilst efficacy and security were descriptively summarized. RESULTS: Twelve (7 RCT and 5 quasiexperimental trials) articles were found, and only two of them provided grade A recommendation. Patients under self-management remained the same or more time in the therapeutic range. The incidence of adverse effects in self-management patients was the same or less than that in patients under usual care. CONCLUSIONS: The quality of the scientific evidence is heterogeneous. For selected patients, patient’s self-management is at least as effective and safe as usual care. New oral anticaogulants, which have shown promising results, should be scrutinized for future changes in service provision