Core outcome set development for proximal hamstring tendinopathy (COS-PHT): a study protocol

Abstract

Background Proximal hamstring tendinopathy is a common cause of buttock pain in running based sports. A recent systematic review found outcome measures used in research studies on this condition were inconsistent, which impedes synthesis of evidence. To understand the impact tendinopathy has on patients an international collaboration (International Scientific Tendinopathy Symposium Consensus Group) agreed on nine core health domains that should be measured in research on tendinopathy. The aim of this study is to develop an outcome set for proximal hamstring tendinopathy that covers all nine tendinopathy core health domains. This protocol describes the steps taken to develop this core outcome set. Methods This mixed method study will follow two key phases. Phase one: a systematic review will produce a comprehensive list of outcome measures that have been used in studies evaluating proximal hamstring tendinopathy. Outcome measures extracted will be matched to the tendinopathy core health domains by a steering committee of clinicians and researchers. Phase two: following a Delphi process, outcome measures will be considered by experienced clinicians, researchers, and patients. Within this study, outcome measures will be screened and selected using the Outcome Measures in Rheumatology filters of truth, feasibility, and discrimination, with a threshold of 70% agreement set for consensus. Discussion This project aims to provide and disseminate a core outcome set that can be recommended for use in future studies related to proximal hamstring tendinopathy. This will have the potential to improve research quality, allow pooling of studies in meta-analysis and assist in directing future research. Trial registration Protocol registered with the Core Outcome Measures in Effectiveness Trials in May 2021 (http://www.comet-initiative.org). Key points There is no agreed set of outcomes that are consistently used when researching proximal hamstring tendinopathy This protocol outlines the methods to derive a set of outcome measures to use when researching proximal hamstring tendinopathy Researchers, clinicians and patients will participate in a process of selecting outcome measures against the nine core health domains for tendinopathy Where core health domains do not have an outcome measure recommendations for future research will be provided Consistent use of outcome measures will allow pooling of data in meta-analysis and minimise research waste