This protocol is part of the REPEAT (Reproducible Evidence: Practices to Enhance and Achieve Transparency) 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 publicly 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: "Can analyses of electronic patient records be independently and externally validated? The effect of statins on the mortality of patients with ischaemic heart disease: a cohort study with nested case-control analysis" by Reeves and colleagues. This paper aimed to validate a study of the effect of statins on mortality using a different electronic health record database than CPRD. We will replicate this study based on methods reported in the publication.
This objective of this protocol is to replicate the study: "Can analyses of electronic patient records be independently and externally validated? The effect of statins on the mortality of patients with ischemic heart disease: a cohort study with nested case-control analysis" by Reeves 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 Reeves paper conducts a validation of a research study using a different electronic health record database than CPRD. We will focus on replicating the outcome of all-cause mortality of patients with ischemic heart disease on statin medication. Mortality will be identified by a record of death in the CPRD. A Cox proportional hazards model with time varying exposure to statins will be used to examine the effect of statin use on patient survival.
All-cause mortality, identified through a record of death in the CPRD.
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