Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT): Study 7 - Replication of "Antibiotic treatment failure in four common infections in UK primary care 1991-2012: longitudinal analysis"

Study type
Protocol
Date of Approval
Study reference ID
18_076
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: "Antibiotic treatment failure in four common infections in UK primary care 1991-2012: longitudinal analysis" by Currie and colleagues. The Currie paper describes how frequently antibiotics fail at treating four types of infection (upper respiratory tract infection, lower respiratory tract infection, skin and soft tissue infections, ear infection) in the general population of the United Kingdom (UK) between 1991 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: "Antibiotic treatment failure in four common infections in UK primary care 1991-2012: longitudinal analysis" by Currie 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 Currie paper describes the adjusted rate of antibiotic treatment failure for four infection classes (upper respiratory tract infection, lower respiratory tract infection, skin and soft tissue infections, acute otitis media) for patients with monotherapy antibiotic treatment in the UK general population between 1991 and 2012. We will focus on replicating the outcome of rate of antibiotic treatment failure over this time period. Treatment failure was defined as a prescription of a different antibiotic drug within 30 days of the first line antibiotic; GP record of admission to hospital with an infection related diagnosis within 30 days of antibiotic initiation; GP referral to an infection related specialist service within 30 days of initiation; GP record of an emergency department visit within three days of initiation; or GP record of death with an infection related diagnostic code within 30 days of initiation. Descriptive statistics were calculated for each of the infection classes.

Health Outcomes to be Measured

Rate of antibiotic treatment failure for four infection classes

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

Former Collaborators

Jeremy Rassen - Chief Investigator - Aetion, Inc
Elizabeth Garry - Collaborator - Aetion, Inc