Patient, physiotherapist and surgeon endorsement of the core domain set for total hip and total knee replacement in Germany: a study protocol for an OMERACT initiative.

INTRODUCTION

There is a lack of harmonising measures for clinical trials on total joint replacement (TJR) that would allow for results from TJR studies to be compared or pooled. The Outcome Measures in Rheumatology (OMERACT) TJR core domain set is already endorsed among patients and physicians in the USA and Australia. Physiotherapists use different types of measurements compared to orthopaedic surgeons while both make substantial contributions to research in the field of TJR. To achieve consensus on core measurements sets, patients, physiotherapists and orthopaedic surgeons need to achieve consensus on the core domains for TJR trials.

METHODS AND ANALYSIS

For this multistage study, first, the OMERACT TJR core domain set survey will be translated to German and validated according to WHO guidelines. Next, the TJR core domain set will be considered for endorsement in different German stakeholder groups including patients, physiotherapists and orthopaedic surgeons.

ETHICS AND DISSEMINATION

Ethical approval for this protocol was given by the ethics committee of the Brandenburg University of Technology Cottbus-Senftenberg (BTU-CS, EK 2019-2). This article is based on the protocol version 2.5 from 6 May 2020. Anonymous data will be presented only. We will publish the results in peer-reviewed publications and at international conferences.

TRIAL REGISTRATION NUMBER

German Clinical Trials Registry (DRKS00016015).