This protocol is part of the REPEAT Initiative, a project which samples published research studies conducted using large healthcare data (such as electronic health record or administrative claims) and replicates them by applying the publically reported methods to the same data source as the original authors. The goal is to better understand what information is missing from public reporting that prevents replication of the published results. This project will evaluate how commonly a set of specific design and analysis decisions are or are not reported in publications as well as how lack of clarity in one or more decisions 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: "Concurrent use of long-acting bronchodilators in COPD and the risk of adverse cardiovascular events." by Suissa and colleagues. The Suissa paper assesses the risk of heart attack related to use of two types of drugs to treat chronic obstructive pulmonary disorder (COPD) (long-acting Beta2-agonists (LABAs) and anticholinergics (LAMAs)) at the same time. This study used data from the CPRD between 2002 and 2012. We will replicate this study based on methods reported in the publication.
This objective of this protocol is to replicate the study: "Concurrent use of long-acting bronchodilators in COPD and the risk of adverse cardiovascular events." by Suissa 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 Suissa paper assessed the cardiovascular risk related to concurrent use of more than one bronchodilator (such as long-acting Beta2-agonists (LABAs) and anticholinergics (LAMAs)) to treat COPD compared to treatment with only one bronchodilator using CPRD data between 2002 and 2012. We will focus on replicating the cohort and baseline characteristics as well as the adjusted hazard ratio for risk of acute myocardial infarction within 1 year of follow up.
Occurrence of acute myocardial infarction
Shirley Wang - Chief Investigator - Harvard University
Elisabetta Patorno - Collaborator - Brigham & Women's Hospital
Jessica Franklin - Collaborator - Brigham & Women's Hospital
Krista Huybrechts - Collaborator - Brigham & Women's Hospital
Sebastian Schneeweiss - Collaborator - Aetion, Inc
Jeremy Rassen - Chief Investigator - Aetion, Inc
Elizabeth Garry - Collaborator - Aetion, Inc