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

Robert Prill; Jasvinder A. Singh; Jasvinder A. Singh; Gesine H. Seeber; Sabrina Mai Nielsen; Susan Goodman; Sven Michel; Christian Kopkow; Robert Schulz; Peter Choong; Hagen Hommel

doi:10.1136/bmjopen-2019-035207

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

Robert Prill^*
, Jasvinder A. Singh
, Jasvinder A. Singh
, Gesine H. Seeber
, Sabrina Mai Nielsen
, Susan Goodman
, Sven Michel
, Christian Kopkow
, Robert Schulz
, Peter Choong
, Hagen Hommel

^*Kontaktforfatter

Brandenburg University of Technology Cottbus-Senftenberg
The University of Alabama at Birmingham
Birmingham VA Medical Center
University Hospital of Orthopedics and Trauma Surgery Pius-Hospital
Hospital for Special Surgery and Weill Cornell Medical College
University of Melbourne
Krankenhaus Markisch-Oderland GmbH
Frederiksberg Hospital

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

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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).

Originalsprog	Engelsk
Artikelnummer	035207
Tidsskrift	BMJ Open
Vol/bind	10
Udgave nummer	6
Antal sider	8
ISSN	2044-6055
DOI	https://doi.org/10.1136/bmjopen-2019-035207
Status	Udgivet - 28. jun. 2020
Udgivet eksternt	Ja

Finansiering

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.

Dokumenter og links

10.1136/bmjopen-2019-035207Licens: CC BY-NC

Open Access VersionForlagets udgivne version, 527 KBLicens: CC BY-NC

SDU link

Tjek adgangen til materialet i Syddansk Universitetsbiblioteks søgemaskine

Citationsformater

Prill, R., Singh, J. A., Singh, J. A., Seeber, G. H., Nielsen, S. M., Goodman, S., Michel, S., Kopkow, C., Schulz, R., Choong, P., & Hommel, H. (2020). 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. BMJ Open, 10(6), Artikel 035207. https://doi.org/10.1136/bmjopen-2019-035207

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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). ",

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Prill, R, Singh, JA, Singh, JA, Seeber, GH, Nielsen, SM, Goodman, S, Michel, S, Kopkow, C, Schulz, R, Choong, P & Hommel, H 2020, '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', BMJ Open, bind 10, nr. 6, 035207. https://doi.org/10.1136/bmjopen-2019-035207

TY - JOUR

T1 - Patient, physiotherapist and surgeon endorsement of the core domain set for total hip and total knee replacement in Germany

T2 - A study protocol for an OMERACT initiative

AU - Prill, Robert

AU - Singh, Jasvinder A.

AU - Seeber, Gesine H.

AU - Nielsen, Sabrina Mai

AU - Goodman, Susan

AU - Michel, Sven

AU - Kopkow, Christian

AU - Schulz, Robert

AU - Choong, Peter

AU - Hommel, Hagen

PY - 2020/6/28

Y1 - 2020/6/28

N2 - 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).

AB - 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).

KW - hip

KW - knee

KW - protocols & guidelines

KW - statistics & research methods

U2 - 10.1136/bmjopen-2019-035207

DO - 10.1136/bmjopen-2019-035207

M3 - Journal article

C2 - 32595152

SN - 2044-6055

VL - 10

JO - BMJ Open

JF - BMJ Open

IS - 6

M1 - 035207

ER -

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

Abstract

Finansiering

Dokumenter og links

SDU link

Fingeraftryk

Citationsformater