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. Replicable research is a cornerstone for the scientific method and the ultimate measure of transparency. 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: "Prevalence and Burden of Breathlessness in Patients with Chronic Obstructive Pulmonary Disease Managed in Primary Care" by Mullerova and colleagues. The Mullerova paper describes the frequency of breathlessness and factors associated with it among patients with chronic obstructive pulmonary disease (COPD), a condition that makes it difficult to breathe, in the United Kingdom (UK) between 2008 and 2011. We will replicate this study based on methods reported in the publication.
This objective of this protocol is to replicate the study: "Prevalence and Burden of Breathlessness in Patients with Chronic Obstructive Pulmonary Disease Managed in Primary Care" by Mullerova 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 Mullerova paper describes the frequency of breathlessness and factors associated with it in a cohort of COPD patients managed in primary care from the CPRD database between 2008 and 2011. We will focus on replicating the outcome of the frequency of moderate-to-severe breathlessness for COPD patients managed in primary care over this time period. Moderate-to-severe dyspnoea will be assessed as Medical Research Council (MRC) dyspnoea grade greater than 3.
Prevalence and burden of breathlessness
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