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: "Pioglitazone use and risk of bladder cancer: population based cohort study" by Tuccori and colleagues. The Tuccori study aims to determine whether pioglitazone compared with other antidiabetic drugs is associated with an increased risk of bladder cancer in people with type 2 diabetes between 1 January 2000 and 31 July 2013 in the UK. We will replicate this study based on methods reported in the publication.
This objective of this protocol is to replicate the study: "Pioglitazone use and risk of bladder cancer: population based cohort study" by Tuccori 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 Tuccori paper compares pioglitazone with other antidiabetic drugs in association with an increased risk of bladder cancer in people with type 2 diabetes between 1 January 2000 and 31 July 2013 in the UK. We will focus on replicating the outcome of incident bladder cancer associated with pioglitazone. Cox proportional hazards models will be used to estimate adjusted hazard ratios with 95% confidence intervals of incident bladder cancer associated with pioglitazone overall and by both cumulative duration of use and cumulative dose.
Whether pioglitazone compared with other antidiabetic drugs is associated with an increased risk of bladder cancer in people with type 2 diabetes
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
Dorothee Bartels - Chief Investigator - Boehringer-Ingelheim Germany
Andrea Meyers - Collaborator - Boehringer-Ingelheim Pharmaceuticals, Inc