Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT): Study 3 -Replication of "Non-persistence and non-adherence of patients with Type 2 Diabetes Mellitus in Therapy with GLP-1 Receptor Agonists: A Retrospective Analysis"

Date of ISAC Approval: 
11/12/2018
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 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: "Non-persistence and Non-Adherence of Patients with Type 2 Diabetes Mellitus in Therapy with GLP-1 Receptor Agonists: A Retrospective Analysis" by Wilke and colleagues. The Wilke paper compares the probability of discontinuing when prescribed twice-a-day (BID) treatment with GLP-1 receptor agonists versus once-a-day (OD) treatment with a diabetes medication in the general population of the United Kingdom (UK) between 2010 and 2012. We will replicate this study based on methods reported in the publication.
Technical Summary: 
This objective of this protocol is to replicate the study: "Non-persistence and Non-adherence of Patients with Type 2 Diabetes Mellitus in Therapy with GLP-1 Receptor Agonists: A Retrospective Analysis" by Wilke 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 Wilke paper compares the probability of discontinuing when prescribed twice-a-day (BID) treatment with GLP-1 receptor agonists versus once-a-day (OD) treatment in theUK general population between 2010 and 2012. We will focus on replicating the hazard ratio from a Cox-proportional hazard model for non-persistence between once-a-day and twice-a-day GLP-1 receptor agonist users over this time period. The reference group was considered the once-a-day users. Patients were followed for a year after their first prescription or until a treatment gap greater than 90 days at which point they were considered non-persistant. Descriptive statistics were calculated for GLP-1 receptor agonist users.
Health Outcomes to be Measured: 
Non-persistence to GLP-1 receptor agonist treatment compared between a twice-a-day (BID) treatment and an once-a-day (OD) treatment after 12 months (hazard ratio)
Collaborators: 

Ms Dorothee Bartels - Chief Investigator - Boehringer-Ingelheim Germany
Dr Andrea Meyers - Collaborator - Boehringer-Ingelheim Pharmaceuticals, 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