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: 'Drug Therapy for alcohol dependence in primary care in the UK: A Clinical Practice Research Datalink study' by Thompson and colleagues. The Thompson paper describes that those with alcohol dependence currently have limited therapeutic options. We will replicate this study based on methods reported in the publication.
This objective of this protocol is to replicate the study: 'Drug Therapy for alcohol dependence in primary care in the UK: A Clinical Practice Research Datalink study' by Thompson 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 ascertain 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 Thompson paper describes use of drug therapy for alcohol dependence within 12 months after first diagnosis in UK primary care between1990-2013. We will focus on replicating this outcome. Drug therapy for alcohol dependence was defined as prescription of acamprosate, disulfiram, naltrexone, baclofen and topiramate. Follow up was censored at the first of: 12 months following incident alcohol dependence diagnosis, the date of transfer of the patient out of the practice, the patient's death as recorded in the CPRD database, or end of study period.
Prescription of acamprosate, disulfiram, naltrexone, baclofen and topiramate.
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