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