Protocol for the development of a core outcome set for lateral elbow tendinopathy (COS-LET)

BackgroundLateral elbow tendinopathy (LET) is a common condition that can cause significant disability and associated socioeconomic cost. Although it has been widely researched, outcome measures are highly variable which restricts evidence synthesis across studies. In 2019, a working group of international experts, health care professionals and patients, in the field of tendinopathy (International Scientific Tendinopathy Symposium Consensus (ICON) Group), published the results of a consensus exercise defining the nine core domains that should be measured in tendinopathy research. The aim of this study is to develop a core outcome set (COS) for LET mapping to these core domains. The primary output will provide a template for future outcome evaluation of LET. In this protocol, we detail the methodological approach to the COS-LET development.MethodsThis study will employ a three-phase approach. (1) A systematic review of studies investigating LET will produce a comprehensive list of all instruments currently employed to quantify the treatment effect or outcome. (2) Instruments will be matched to the list of nine core tendinopathy outcome domains by a Steering Committee of clinicians and researchers with a specialist interest in LET resulting in a set of candidate instruments. (3) An international three-stage Delphi study will be conducted involving experienced clinicians, researchers and patients. Within this Delphi study, candidate instruments will be selected based upon screening using the Outcome Measures in Rheumatology (OMERACT) truth, feasibility and discrimination filters with a threshold of 70% agreement set for consensus.ConclusionsThere is currently no COS for the measurement or monitoring of LET in trials or clinical practice. The output from this project will be a minimum COS recommended for use in all future English language studies related to LET. The findings will be published in a high-quality journal and disseminated widely using professional networks, social media and via presentation at international conferences.Trial registrationRegistered with the Core Outcome Measures in Effectiveness Trials (COMET) database, November 2019. https://www.comet-initiative.org/Studies/Details/1497.

Automated summary

This study aims to develop a core outcome set for lateral elbow tendinopathy (LET) based on nine core tendinopathy outcome domains identified by the ICON Group. The three-phase approach includes a systematic review, matching instruments to core domains, and conducting an international Delphi study. This project will provide a minimum COS for LET research and be registered with the COMET database.