TY - JOUR
T1 - Protocol for a Systematic Review and Individual Participant Data Meta-Analysis of Randomized Trials of Screening for Atrial Fibrillation to Prevent Stroke
AU - AF SCREEN
AU - AFECT-EU
A2 - Brandes, Axel
A2 - Diederichsen, Axel
A2 - Lindholt, Jes Sanddal
A2 - McIntyre, William
N1 - The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).
PY - 2023/3
Y1 - 2023/3
N2 - INTRODUCTION: Atrial fibrillation (AF) is a common cause of stroke. Timely diagnosis of AF and treatment with oral anticoagulation (OAC) can prevent up to two-thirds of AF-related strokes. Ambulatory electrocardiographic (ECG) monitoring can identify undiagnosed AF in at-risk individuals, but the impact of population-based ECG screening on stroke is uncertain, as ongoing and published randomized controlled trials (RCTs) have generally been underpowered for stroke.METHODS AND ANALYSIS: The AF-SCREEN Collaboration, with support from AFFECT-EU, have begun a systematic review and individual participant data meta-analysis of RCTs evaluating ECG screening for AF. The primary outcome is stroke. Secondary outcomes include AF detection, OAC prescription, hospitalization, mortality, and bleeding.After developing a common data dictionary, anonymized data will be collated from individual trials into a central database. We will assess risk of bias using the Cochrane Collaboration tool, and overall quality of evidence with the Grading of Recommendations Assessment, Development and Evaluation approach.We will pool data using random effects models. Prespecified subgroup and multilevel meta-regression analyses will explore heterogeneity. We will perform prespecified trial sequential meta-analyses of published trials to determine when the optimal information size has been reached, and account for unpublished trials using the SAMURAI approach.IMPACT AND DISSEMINATION: Individual participant data meta-analysis will generate adequate power to assess the risks and benefits of AF screening. Meta-regression will permit exploration of the specific patient, screening methodology, and health system factors that influence outcomes.TRIAL REGISTRATION NUMBER: PROSPERO CRD42022310308.
AB - INTRODUCTION: Atrial fibrillation (AF) is a common cause of stroke. Timely diagnosis of AF and treatment with oral anticoagulation (OAC) can prevent up to two-thirds of AF-related strokes. Ambulatory electrocardiographic (ECG) monitoring can identify undiagnosed AF in at-risk individuals, but the impact of population-based ECG screening on stroke is uncertain, as ongoing and published randomized controlled trials (RCTs) have generally been underpowered for stroke.METHODS AND ANALYSIS: The AF-SCREEN Collaboration, with support from AFFECT-EU, have begun a systematic review and individual participant data meta-analysis of RCTs evaluating ECG screening for AF. The primary outcome is stroke. Secondary outcomes include AF detection, OAC prescription, hospitalization, mortality, and bleeding.After developing a common data dictionary, anonymized data will be collated from individual trials into a central database. We will assess risk of bias using the Cochrane Collaboration tool, and overall quality of evidence with the Grading of Recommendations Assessment, Development and Evaluation approach.We will pool data using random effects models. Prespecified subgroup and multilevel meta-regression analyses will explore heterogeneity. We will perform prespecified trial sequential meta-analyses of published trials to determine when the optimal information size has been reached, and account for unpublished trials using the SAMURAI approach.IMPACT AND DISSEMINATION: Individual participant data meta-analysis will generate adequate power to assess the risks and benefits of AF screening. Meta-regression will permit exploration of the specific patient, screening methodology, and health system factors that influence outcomes.TRIAL REGISTRATION NUMBER: PROSPERO CRD42022310308.
KW - Humans
KW - Atrial Fibrillation/complications
KW - Randomized Controlled Trials as Topic
KW - Stroke/etiology
KW - Databases, Factual
KW - Electrocardiography, Ambulatory
KW - Systematic Reviews as Topic
KW - Meta-Analysis as Topic
U2 - 10.1055/s-0042-1760257
DO - 10.1055/s-0042-1760257
M3 - Journal article
C2 - 36863334
SN - 0340-6245
VL - 123
SP - 366
EP - 376
JO - Thrombosis and Haemostasis
JF - Thrombosis and Haemostasis
IS - 3
ER -