Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT) Study 19: Replication of "Long-term use of dipeptidyl peptidase-4 inhibitors and risk of fracture: A retrospective population-based cohort study."

Date of ISAC Approval: 
14/11/2018
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: "Long-term use of dipeptidyl peptidase-4 inhibitors and risk of fracture: A retrospective population-based cohort study." by Driessen and colleagues. The Driessen paper describes the association between long term dipeptidyl peptidase-4 inhibitors (DPP-4) inhibitor use (a treatment for diabetes) and the risk of fracture among people with type-2 diabetes in the United Kingdom (UK) between 2007 and 2015. We will replicate this study based on methods reported in the publication.
Technical Summary: 
This objective of this protocol is to replicate the study: "Long-term use of dipeptidyl peptidase-4 inhibitors and risk of fracture: A retrospective population-based cohort study." by Driessen 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 Driessen paper describes the association between long term DPP-4 inhibitor use and the risk of fracture among people with type-2 diabetes in the general population of the United Kingdom (UK) between 2007 and 2015. We will focus on replicating the outcome of risk of fracture among people with type 2 diabetes over this time period. Patients will be followed until the end of the study period, date of transfer of the patient out of practice, death, or the first record of fracture recorded in the CPRD, whichever occurred first. Comparative risk of fracture will be evaluated using a Cox proportional hazards model.
Health Outcomes to be Measured: 
Fracture
Collaborators: 

Dr Shirley Wang - Chief Investigator - Harvard University
Elisabetta Patorno - Collaborator - Brigham & Women's Hospital
Elizabeth Garry - Collaborator - Aetion, Inc
Jeremy Rassen - Collaborator - Aetion, Inc
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