Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT) Study 12 : “Quantification of the risk of liver injury associated with flucloxacillin: a UK population-based cohort study”

Date of Approval: 
2018-05-30 00:00:00
Lay Summary: 
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: “Quantification of the risk of liver injury associated with flucloxacillin: a UK population-based cohort study” by Wing and colleagues. The Wing paper examines the risk of liver injury after exposure to an antibiotic (flucloxacillin) in the general population of the United Kingdom (UK) between 2000 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: “Quantification of the risk of liver injury associated with flucloxacillin: a UK population-based cohort study” by Wing 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 Wing paper evaluates the relative and absolute risks of liver injury following exposure to flucloxacillin compared to oxytetracycline in the general population of the United Kingdom (UK) between 2000 and 2012. We will focus on replicating measures of relative and absolute risk for liver injury over this time period. We will focus on replicating the baseline cohort characteristics and the adjusted risk ratio for laboratory confirmed injury within 1-45 days of antibiotic initiation. The risk ratio will be adjusted using multivariable logistic regression.
Health Outcomes to be Measured: 
Liver injury
Application Number: 
18_119
Collaborators: 

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

Linkages: 
Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation