Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT): Study 18-Replication of "Risk of Myocardial infarction in Patients with Atrial Fibrillation using vitamin K antagonists, aspirin or direct acting oral anticoagulants"

Date of ISAC Approval: 
19/11/2018
Lay Summary: 
Science should be replicable. The methods section in publications describe how research is conducted. This protocol is part of the REPEAT Initiative, a project that is attempting to replicate a sample of published research studies using information provided in the publications. REPEAT is focused on studies using observational healthcare data from electronic health records or administrative claims to generate scientific evidence. The goal is to better understand what information is missing in publications that prevents replication of the published results. This project will evaluate how commonly important decisions in research process design are not clearly reported as well as how lack of transparency impacts ability to replicate study findings. Our results will inform future policies and guidelines for reporting on healthcare database research. This protocol focuses on one sampled study: "Risk of myocardial infarction in patients with atrial fibrillation using vitamin K antagonists, aspririn or direct acting oral anticoagulants" by Stolk and colleagues. The Stolk paper compared the risk of acute myocardial infarction in patients over 18 years old with atrial fibrillation (irregular or rapid heart rate) treated with direct-acting oral anticoagulants (DOACs) or vitamin K antagonists (VKAs) in the United Kingdom (UK) between 2008 and 2014. We will replicate this study based on methods reported in the publication.
Technical Summary: 
This objective of this protocol is to replicate the study: "Risk of myocardial infarction in patients with atrial fibrillation using vitamin K antagonists, aspririn or direct acting oral anticoagulants" by Stolk et al based on methods reported in the publication and appendices. We have created a checklist of specific study implementation parameters based on a comprehensive catalogue outlined in a consensus paper endorsed by the International Society of Pharmacoepidemiology and the International Society of Pharmacoeconomics and Outcomes research. We will start by reviewing the paper to identify which parameters from the catalogue are reported. We will then replicate the study population and analyses based on the study design and implementation parameters extracted during review. The Stolk paper compared the risk of AMI in patients with atrial fibrillation who initiated treatment with DOACs or to those who initiated VKAs in the UK general population between 2008 and 2014. We will focus on replicating the adjusted hazard ratio comparing the risk of AMI in atrial fibrillation patients for current users of DOACs versus current users of VKAs over this time period. Patients will be followed until the end of the study period (June 30, 2014), date of transfer of the patient out of practice, death, or the first record of AMI recorded in the CPRD, whichever occurred first.Comparative risk of AMI will be evaluated using a Cox proportional hazards model. Descriptive statistics will be calculated for users of DOACs and users of VKAs within the cohort.
Health Outcomes to be Measured: 
Occurrence of acute myocardial infarction
Collaborators: 

Dr Shirley Wang - Chief Investigator - Harvard University
Elisabetta Patorno - Collaborator - Brigham & Women's Hospital
Elizabeth Garry - Collaborator - Aetion, Inc
Jeremy Rassen - Corresponding Applicant - Aetion, Inc
Jessica Franklin - Collaborator - Brigham & Women's Hospital
Ms Krista Huybrechts - Collaborator - Brigham & Women's Hospital
Dr Sebastian Schneeweiss - Collaborator - Aetion, Inc