Protocol for a Systematic Review and Individual Participant Data Meta-Analysis of Randomized Trials of Screening for Atrial Fibrillation to Prevent Stroke

Area of Science:

• Cardiology
• Public Health
• Epidemiology

Background:

• Atrial fibrillation (AF) is a leading cause of stroke, with timely oral anticoagulation (OAC) preventing a significant proportion of these events.
• Ambulatory electrocardiographic (ECG) monitoring can detect undiagnosed AF in high-risk individuals.
• The impact of population-based ECG screening on stroke prevention remains uncertain due to underpowered randomized controlled trials (RCTs).

Purpose of the Study:

• To conduct a systematic review and individual participant data meta-analysis of RCTs evaluating ECG screening for AF.
• To assess the primary outcome of stroke and secondary outcomes including AF detection, OAC prescription, hospitalization, mortality, and bleeding.

Main Methods:

• The AF-SCREEN Collaboration is performing a meta-analysis of RCTs using a common data dictionary and anonymized individual participant data.
• Risk of bias will be assessed using the Cochrane Collaboration tool, and evidence quality using Grading of Recommendations Assessment, Development and Evaluation (GRADE).
• Data will be pooled using random effects models, with subgroup and meta-regression analyses to explore heterogeneity. Trial sequential meta-analyses and the SAMURAI approach will account for published and unpublished trials.

Main Results:

• Individual participant data meta-analysis will provide sufficient power to evaluate the risks and benefits of AF screening.
• Meta-regression analyses will identify patient, screening, and health system factors influencing outcomes.

Conclusions:

• This comprehensive meta-analysis aims to clarify the effectiveness of population-based ECG screening for AF in preventing stroke.
• Findings will inform clinical practice and public health strategies for AF management and stroke prevention.