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.

Aim

The aim of the study is to achieve further consensus on the OMERACT TJR core domain set including three important stakeholder groups.

Contributors

Prill, R., J. A. Singh, G. H. Seeber, S. M. Nielsen, S. Goodman, S. Michel, C. Kopkow, R. Schulz, P. Choong and H. Hommel

Publication

Journal: BMJ Open
Volume: 10
Issue: 6
Pages: e035207 -
Year: 2020
DOI: 10.1136/bmjopen-2019-035207

Further Study Information

Current Stage: Completed
Date:
Funding source(s): The Parker Institute, Bispebjerg and Frederiksberg Hospital is supported by a core grant from the Oak Foundation (grant number OCAY-13-309). The Oak Foundation had no role in the study design, writing the protocol, or the decision to submit the final protocol for publication. The used funding for preparation and publishing of this project is institutional funding of the Brandenburg University of Technology Cottbus - Senftenberg and the Klinikum Märkisch Oderland GmbH. No external and especially no commercial funding has been used or will be used for this project.

Health Area

Disease Category: Rheumatology

Disease Name: Osteoarthritis

Target Population

Age Range: Unknown

Sex: Either

Nature of Intervention: Surgery

Stakeholders Involved

- Clinical experts
- Consumers (patients)

Study Type

- COS for clinical trials or clinical research

Method(s)

- N/A

In step 1; a German version of the original English core domain survey will be established and validated. Step 2; a three-armed endorsement in patients, physiotherapists and orthopaedic surgeons for outcome measures in TJR within rheumatology, to reach consensus.

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