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 transparency 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: Managing glycaemia in older people with type 2 diabetes: A retrospective, primary care-based cohort study, with economic assessment of patient outcomes by Gordon and colleagues. The Gordon paper compared the rate of serious cardiovascular events (e.g. heart attack) in patients with type 2 diabetes who initiated different second-line treatments for diabetes between 2008 and 2014. We will replicate this study based on methods reported in the publication.
This objective of this protocol is to replicate the study: Managing glycaemia in older people with type 2 diabetes: A retrospective, primary care-based cohort study, with economic assessment of patient outcomes by Gordon 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 Gordon paper compared the rate for major adverse cardiovascular events (MACE) in patients with type 2 diabetes who were on metformin and initiated second-line therapy with DPP-4 inhibitors versus sulfonylureas (SU) between 2008 and 2014. We will focus on replicating the multivariate adjusted incidence rate ratio. Patients were required to have at least 12 months of follow-up to be included in the total event rate analysis. Total event rates were analysed as unadjusted event incidence per 1000 person-years and in adjusted Poisson regression models.
Incidence rate ratio for MACE for metformin +DPP-4 inhibitors vs. metformin +SU defined as the composite of stroke and MI (see appendix for READ codes).
Shirley Wang - Chief Investigator - Harvard University
Shirley Wang - Corresponding Applicant - 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