Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT): Study 20 - Replication of "Risk of Death and Cardiovascular Outcomes with Thiazolidinediones: A Study with the General Practice Research Database and Secondary Care Data"

Date of ISAC Approval: 
05/12/2018
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 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 death and cardiovascular outcomes with thiazolidinediones: a study with the general practice research database and secondary care data."" by Gallagher and colleagues. The Gallagher paper describes the risks of cardiovascular events (related to the heart) and death in patients using diabetes medication in the United Kingdom (UK) between 1987 and 2007. 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 Death and Cardiovascular Outcomes with Thiazolidinediones: A Study with the General Practice Research Database and Secondary Care Data" by Gallagher 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 Gallagher paper describes the risks of cardiovascular events and mortality in patients using diabetes medication in the United Kingdom (UK) between 1987 and 2007. We will focus on replicating risks of cardiovascular events and mortality in patients using diabetes medication over this time period. Patients will be followed up to the date of censoring (transfer out of the practice, last collection from the practice, or death).
Health Outcomes to be Measured: 
Risk of cardiovascular events and mortality
Collaborators: 

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