There are currently multiple different outcome measures used in trials investigating the treatment of lateral elbow tendinopathy (Tennis Elbow). This lack of consistency prevents direct comparison of different studies and meta-analysis of data. There is a need to develop a core outcome set that aligns to the core domains agreed by the International Scientific Tendinopathy Symposium Consensus in 2019. This will allow future studies to be compared directly and improve the understanding of treatment for this common condition.Contributors
Marcus Bateman, University Hospitals of Derby & Burton NHS Trust, UK
Professor Bill Vicenzino, University of Queensland, Australia
Dr Jonathan Evans, University of Exeter Medical School, UK
Professor Adam Watts, Wrightington, Wigan & Leigh NHS Foundation Trust, UK
Mr Joideep Phadnis, Brighton & Sussex University Hospitals NHS Trust, UK
Viana Vuvan, University of Queensland, Australia
Dr Leanne Bisset, Griffith University, Australia
Valerie Jones, Sheffield Teaching Hospitals NHS Foundation Trust, UK
- COS for clinical trials or clinical research
- Recommendations for outcome measures (measurement/how)
- Consensus meeting
- Delphi process
- Systematic review
Stage 1: A systematic review and standardised comparison of English language clinical rating systems used in LET has already been completed with searches up to 2017 (Evans et al, 2019). In the original search only measures of function and disability were included. The searches will be re-run up to 2020 and all outcome measurement instruments will be extracted.
Stage 2: The Steering Group will apply the OMERACT truth and feasibility filters to map the instruments to the nine core tendinopathy domains (Vicenzino et al, 2019) and instruments failing to meet the green or amber thresholds will be excluded.
Stage 3: A two-round online Delphi survey will be conducted followed by a third-round final consensus meeting. International clinical and research experts in the field of LET will be invited to participate along with patient representatives who have experienced the condition. The Delphi Study will apply the OMERACT Truth, Feasibility and Discrimination filters to each of the instruments selected in Stage 2 resulting in an overall rating of individual instrument properties. Consensus will be determined by a 70% threshold. If agreement is <30% the instrument will be excluded. Any instruments with a 30-69% consensus will be discussed and voted on again.
Stage 4: The steering committee will prepare the final report containing the recommended minimum Core Outcome Set for Lateral Elbow Tendinopathy based upon the nine core tendinopathy domains. This will be disseminated in a high quality peer-reviewed journal and presented at international conferences.
Ethical approval has been granted by the University of Queensland, Australia (reference 2020001340).