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Protocol
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
  1. Robert Prill1,
  2. Jasvinder A Singh2,3,
  3. Gesine H Seeber4,
  4. Sabrina Mai Nielsen5,
  5. Susan Goodman6,
  6. Sven Michel1,
  7. Christian Kopkow1,
  8. Robert Schulz1,
  9. Peter Choong7,
  10. Hagen Hommel8
  1. 1Therapy Sciences, Brandenburg University of Technology Cottbus-Senftenberg, Senftenberg, Germany
  2. 2Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama, USA
  3. 3Medicine Service, Birmingham Veterans Affairs Medical Center, Birmingham, Alabama, USA
  4. 4University Hospital of Orthopedics and Trauma Surgery Pius-Hospital, Medical Campus University Oldenburg, Oldenburg, Germany
  5. 5Musculoskeletal Statistics Unit, The Parker Institute, Frederiksberg, Denmark
  6. 6Integrative Rheumatology and Orthopedics Center of Excellence, Weill Cornell Medicine, Hospital for Special Surgery, New York, New York, USA
  7. 7Department of Surgery, St. Vincent's Hospital Melbourne, The University of Melbourne, Melbourne, Victoria, Australia
  8. 8Klinik für Orthopädie, Sportmedizin und Rehabilitation, Krankenhaus Markisch-Oderland GmbH, Wriezen, Germany
  1. Correspondence to Dr Robert Prill; robert.prill{at}outlook.de

Abstract

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).

  • knee
  • hip
  • statistics & research methods
  • protocols & guidelines
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Footnotes

  • Contributors RP wrote the manuscript. He will, together with HH, coordinate the project in Germany and will recruit, together with CK, physiotherapists for the validation of the German survey and for the endorsement. JAS, SG and PC will coordinate the project worldwide and make the major methodical decisions. JAS, SG, SM, GHS, PC, SMN and CK reviewed the content of each manuscript draft critically and made substantial contributions to the writing and content. RS is writing the registration in the German trials registry and will lead contributions to the method section. SMN and JAS are responsible for data analyses of the whole project and especially for this manuscript. SG and GHS reviewed the language and writing style. SG makes substantial contributions to the consensus process. HH will recruit patients and orthopaedic surgeons for the validation of the German survey and for the endorsement and will coordinate the inclusion and data collection of those stakeholders. He is responsible for acquisition of necessary funding. All aforementioned authors are part of the expert team for discussion regarding the back translated English version of the survey to identify problems within the translation and validation process. Furthermore, all aforementioned authors will review the final version of the manuscript critically.

  • Funding 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.

  • Competing interests RP, GHS, SMN, SG, SM, CK, RS and HH do not have competing interests. JAS has received consultant fees from Crealta/Horizon, Medisys, Fidia, UBM LLC, Medscape, WebMD, Clinical Care options, Clearview healthcare partners, Putnam associates, Spherix, the National Institutes of Health and the American College of Rheumatology. JAS owns stock options in Amarin pharmaceuticals and Viking therapeutics. JAS is a member of the executive of OMERACT, an organisation that develops outcome measures in rheumatology and receives arms-length funding from 36 companies. JAS serves on the FDA Arthritis Advisory Committee. JAS is a member of the Veterans Affairs Rheumatology Field Advisory Committee. JAS is the editor and the Director of the UAB Cochrane Musculoskeletal Group Satellite Center on Network Meta-analysis. JAS previously served as a member of the following committees: member, the American College of Rheumatology's (ACR) Annual Meeting Planning Committee (AMPC) and Quality of Care Committees, the Chair of the ACR Meet-the-Professor, Workshop and Study Group Subcommittee and the cochair of the ACR Criteria and Response Criteria subcommittee. PC received institutional support from Medacta. PC also received consultancies from Johnson & Johnson and Stryker. PC received royalties from Johnson and Johnson as part of an instrument design team. PC is part of a Federal Government (Australian) funded industry led consortium (Innovative Manufacturing Cooperative Research Centre) investigating advanced manufacturing in prosthetic design and manufacture. PC is a recipient of National Health and Medical Research Council grants, as well as Australian Research Council grants.

  • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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