The OMERACT-OARSI core domain set for measurement in clinical trials of hip and/or knee osteoarthritis

Toby O. Smith; Gillian A. Hawker; David J. Hunter; Lyn M. March; Maarten Boers; Beverley J. Shea; Robin Christensen; Francis Guillemin; Caroline B. Terwee; Paula R. Williamson; Susanna Dodd; Ewa M. Roos; Richard F. Loeser; Thomas J. Schnitzer; Margreet Kloppenburg; Tuhina Neogi; Christoph H. Ladel; Gurdyal Kalsi; Ulrike Kaiser; Thomas W. Buttel; Anne E. Ashford; Ali Mobasheri; Nigel K. Arden; Alan Tennant; Marc C. Hochberg; Maarten De Wit; Peter Tugwell; Philip G. Conaghan

doi:10.3899/jrheum.181194

The OMERACT-OARSI core domain set for measurement in clinical trials of hip and/or knee osteoarthritis

Toby O. Smith, Gillian A. Hawker, David J. Hunter, Lyn M. March, Maarten Boers, Beverley J. Shea, Robin Christensen, Francis Guillemin, Caroline B. Terwee, Paula R. Williamson, Susanna Dodd, Ewa M. Roos, Richard F. Loeser, Thomas J. Schnitzer, Margreet Kloppenburg, Tuhina Neogi, Christoph H. Ladel, Gurdyal Kalsi, Ulrike Kaiser, Thomas W. ButtelAnne E. Ashford, Ali Mobasheri, Nigel K. Arden, Alan Tennant, Marc C. Hochberg, Maarten De Wit, Peter Tugwell, Philip G. Conaghan^*

^*Corresponding author for this work

Physical Medicine and Rehabilitation

Research output: Contribution to journal › Article › peer-review

89 Scopus citations

Abstract

Objective. To update the 1997 OMERACT-OARSI (Outcome Measures in Rheumatology-Osteoarthritis Research Society International) core domain set for clinical trials in hip and/or knee osteoarthritis (OA). Methods. An initial review of the COMET database of core outcome sets (COS) was undertaken to identify all domains reported in previous COS including individuals with hip and/or knee OA. These were presented during 5 patient and health professionals/researcher meetings in 3 continents (Europe, Australasia, North America). A 3-round international Delphi survey was then undertaken among patients, healthcare professionals, researchers, and industry representatives to gain consensus on key domains to be included in a core domain set for hip and/or knee OA. Findings were presented and discussed in small groups at OMERACT 2018, where consensus was obtained in the final plenary. Results. Four previous COS were identified. Using these, and the patient and health professionals/ researcher meetings, 50 potential domains formed the Delphi survey. There were 426 individuals from 25 different countries who contributed to the Delphi exercise. OMERACT 2018 delegates (n = 129) voted on candidate domains. Six domains gained agreement as mandatory to be measured and reported in all hip and/or knee OA clinical trials: pain, physical function, quality of life, and patient’s global assessment of the target joint, in addition to the mandated core domain of adverse events including mortality. Joint structure was agreed as mandatory in specific circumstances, i.e., depending on the intervention. Conclusion. The updated core domain set for hip and/or knee OA has been agreed upon. Work will commence to determine which outcome measurement instrument should be recommended to cover each core domain.

Original language	English (US)
Pages (from-to)	981-989
Number of pages	9
Journal	Journal of Rheumatology
Volume	46
Issue number	8
DOIs	https://doi.org/10.3899/jrheum.181194
State	Published - Aug 1 2019

Funding

Wales, Sydney, Australia; Department of Epidemiology and Biostatistics, Amsterdam University Medical Centers, location VUmc; Amsterdam University Medical Centre, Department of Medical Humanities, Amsterdam Public Health, Amsterdam; Departments of Rheumatology and Clinical Epidemiology, Leiden University Medical Centre, Leiden, the Netherlands; Musculoskeletal Statistics Unit, the Parker Institute, Bispebjerg and Frederiksberg Hospital, and Department of Rheumatology, Odense University Hospital; Center for Muscle and Joint Health, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark; Université de Lorraine, Approches Épidémiologiques et Psychologiques (APEMAC), Nancy, France; Division of Rheumatology, Allergy and Immunology, Thurston Arthritis Research Center, University of North Carolina, Chapel Hill, North Carolina; Department of Physical Medicine and Rehabilitation, Northwestern University Feinberg School of Medicine, Chicago, Illinois; Sections of Clinical Epidemiology and Rheumatology, Boston University School of Medicine, Boston, Massachusetts; TissueGene Inc., Rockville; Division of Rheumatology and Clinical Immunology, Department of Medicine and Division of Gerontology, Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland, USA; Merck Biopharma, Merck KGaA, Darmstadt; University Pain Centre, University Hospital Carl Gustav Carus, Dresden, Germany; Department of Regenerative Medicine, State Research Institute Centre for Innovative Medicine, Vilnius, Lithuania; Faculty of Humanities and Social Sciences, University of Lucerne, Lucerne, Switzerland. This research was supported by the NIHR Oxford Biomedical Research Centre (T.O. Smith) and the NIHR Leeds Biomedical Research Centre (Prof. Conaghan). The views expressed are those of the authors and not necessarily those of the UK National Health Service, the NIHR, or the Department of Health.

Keywords

Clinical trials
Hip joint
Knee joint
OMERACT
Osteoarthritis
Outcome measure

ASJC Scopus subject areas

Rheumatology
Immunology and Allergy
Immunology

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Smith, T. O., Hawker, G. A., Hunter, D. J., March, L. M., Boers, M., Shea, B. J., Christensen, R., Guillemin, F., Terwee, C. B., Williamson, P. R., Dodd, S., Roos, E. M., Loeser, R. F., Schnitzer, T. J., Kloppenburg, M., Neogi, T., Ladel, C. H., Kalsi, G., Kaiser, U., ... Conaghan, P. G. (2019). The OMERACT-OARSI core domain set for measurement in clinical trials of hip and/or knee osteoarthritis. Journal of Rheumatology, 46(8), 981-989. https://doi.org/10.3899/jrheum.181194

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abstract = "Objective. To update the 1997 OMERACT-OARSI (Outcome Measures in Rheumatology-Osteoarthritis Research Society International) core domain set for clinical trials in hip and/or knee osteoarthritis (OA). Methods. An initial review of the COMET database of core outcome sets (COS) was undertaken to identify all domains reported in previous COS including individuals with hip and/or knee OA. These were presented during 5 patient and health professionals/researcher meetings in 3 continents (Europe, Australasia, North America). A 3-round international Delphi survey was then undertaken among patients, healthcare professionals, researchers, and industry representatives to gain consensus on key domains to be included in a core domain set for hip and/or knee OA. Findings were presented and discussed in small groups at OMERACT 2018, where consensus was obtained in the final plenary. Results. Four previous COS were identified. Using these, and the patient and health professionals/ researcher meetings, 50 potential domains formed the Delphi survey. There were 426 individuals from 25 different countries who contributed to the Delphi exercise. OMERACT 2018 delegates (n = 129) voted on candidate domains. Six domains gained agreement as mandatory to be measured and reported in all hip and/or knee OA clinical trials: pain, physical function, quality of life, and patient{\textquoteright}s global assessment of the target joint, in addition to the mandated core domain of adverse events including mortality. Joint structure was agreed as mandatory in specific circumstances, i.e., depending on the intervention. Conclusion. The updated core domain set for hip and/or knee OA has been agreed upon. Work will commence to determine which outcome measurement instrument should be recommended to cover each core domain.",

keywords = "Clinical trials, Hip joint, Knee joint, OMERACT, Osteoarthritis, Outcome measure",

author = "Smith, {Toby O.} and Hawker, {Gillian A.} and Hunter, {David J.} and March, {Lyn M.} and Maarten Boers and Shea, {Beverley J.} and Robin Christensen and Francis Guillemin and Terwee, {Caroline B.} and Williamson, {Paula R.} and Susanna Dodd and Roos, {Ewa M.} and Loeser, {Richard F.} and Schnitzer, {Thomas J.} and Margreet Kloppenburg and Tuhina Neogi and Ladel, {Christoph H.} and Gurdyal Kalsi and Ulrike Kaiser and Buttel, {Thomas W.} and Ashford, {Anne E.} and Ali Mobasheri and Arden, {Nigel K.} and Alan Tennant and Hochberg, {Marc C.} and {De Wit}, Maarten and Peter Tugwell and Conaghan, {Philip G.}",

year = "2019",

month = aug,

day = "1",

doi = "10.3899/jrheum.181194",

language = "English (US)",

volume = "46",

pages = "981--989",

journal = "Journal of Rheumatology",

issn = "0315-162X",

publisher = "Journal of Rheumatology",

number = "8",

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Smith, TO, Hawker, GA, Hunter, DJ, March, LM, Boers, M, Shea, BJ, Christensen, R, Guillemin, F, Terwee, CB, Williamson, PR, Dodd, S, Roos, EM, Loeser, RF, Schnitzer, TJ, Kloppenburg, M, Neogi, T, Ladel, CH, Kalsi, G, Kaiser, U, Buttel, TW, Ashford, AE, Mobasheri, A, Arden, NK, Tennant, A, Hochberg, MC, De Wit, M, Tugwell, P & Conaghan, PG 2019, 'The OMERACT-OARSI core domain set for measurement in clinical trials of hip and/or knee osteoarthritis', Journal of Rheumatology, vol. 46, no. 8, pp. 981-989. https://doi.org/10.3899/jrheum.181194

TY - JOUR

T1 - The OMERACT-OARSI core domain set for measurement in clinical trials of hip and/or knee osteoarthritis

AU - Smith, Toby O.

AU - Hawker, Gillian A.

AU - Hunter, David J.

AU - March, Lyn M.

AU - Boers, Maarten

AU - Shea, Beverley J.

AU - Christensen, Robin

AU - Guillemin, Francis

AU - Terwee, Caroline B.

AU - Williamson, Paula R.

AU - Dodd, Susanna

AU - Roos, Ewa M.

AU - Loeser, Richard F.

AU - Schnitzer, Thomas J.

AU - Kloppenburg, Margreet

AU - Neogi, Tuhina

AU - Ladel, Christoph H.

AU - Kalsi, Gurdyal

AU - Kaiser, Ulrike

AU - Buttel, Thomas W.

AU - Ashford, Anne E.

AU - Mobasheri, Ali

AU - Arden, Nigel K.

AU - Tennant, Alan

AU - Hochberg, Marc C.

AU - De Wit, Maarten

AU - Tugwell, Peter

AU - Conaghan, Philip G.

PY - 2019/8/1

Y1 - 2019/8/1

N2 - Objective. To update the 1997 OMERACT-OARSI (Outcome Measures in Rheumatology-Osteoarthritis Research Society International) core domain set for clinical trials in hip and/or knee osteoarthritis (OA). Methods. An initial review of the COMET database of core outcome sets (COS) was undertaken to identify all domains reported in previous COS including individuals with hip and/or knee OA. These were presented during 5 patient and health professionals/researcher meetings in 3 continents (Europe, Australasia, North America). A 3-round international Delphi survey was then undertaken among patients, healthcare professionals, researchers, and industry representatives to gain consensus on key domains to be included in a core domain set for hip and/or knee OA. Findings were presented and discussed in small groups at OMERACT 2018, where consensus was obtained in the final plenary. Results. Four previous COS were identified. Using these, and the patient and health professionals/ researcher meetings, 50 potential domains formed the Delphi survey. There were 426 individuals from 25 different countries who contributed to the Delphi exercise. OMERACT 2018 delegates (n = 129) voted on candidate domains. Six domains gained agreement as mandatory to be measured and reported in all hip and/or knee OA clinical trials: pain, physical function, quality of life, and patient’s global assessment of the target joint, in addition to the mandated core domain of adverse events including mortality. Joint structure was agreed as mandatory in specific circumstances, i.e., depending on the intervention. Conclusion. The updated core domain set for hip and/or knee OA has been agreed upon. Work will commence to determine which outcome measurement instrument should be recommended to cover each core domain.

AB - Objective. To update the 1997 OMERACT-OARSI (Outcome Measures in Rheumatology-Osteoarthritis Research Society International) core domain set for clinical trials in hip and/or knee osteoarthritis (OA). Methods. An initial review of the COMET database of core outcome sets (COS) was undertaken to identify all domains reported in previous COS including individuals with hip and/or knee OA. These were presented during 5 patient and health professionals/researcher meetings in 3 continents (Europe, Australasia, North America). A 3-round international Delphi survey was then undertaken among patients, healthcare professionals, researchers, and industry representatives to gain consensus on key domains to be included in a core domain set for hip and/or knee OA. Findings were presented and discussed in small groups at OMERACT 2018, where consensus was obtained in the final plenary. Results. Four previous COS were identified. Using these, and the patient and health professionals/ researcher meetings, 50 potential domains formed the Delphi survey. There were 426 individuals from 25 different countries who contributed to the Delphi exercise. OMERACT 2018 delegates (n = 129) voted on candidate domains. Six domains gained agreement as mandatory to be measured and reported in all hip and/or knee OA clinical trials: pain, physical function, quality of life, and patient’s global assessment of the target joint, in addition to the mandated core domain of adverse events including mortality. Joint structure was agreed as mandatory in specific circumstances, i.e., depending on the intervention. Conclusion. The updated core domain set for hip and/or knee OA has been agreed upon. Work will commence to determine which outcome measurement instrument should be recommended to cover each core domain.

KW - Clinical trials

KW - Hip joint

KW - Knee joint

KW - OMERACT

KW - Osteoarthritis

KW - Outcome measure

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The OMERACT-OARSI core domain set for measurement in clinical trials of hip and/or knee osteoarthritis

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