Uptake of the OMERACT-OARSI Hip and Knee Osteoarthritis Core Outcome Set: Review of Randomized Controlled Trials from 1997 to 2017

Toby O Smith; Michael Mansfield; Gillian A Hawker; David J Hunter; Lyn M March; Maarten Boers; Beverley J Shea; Robin Christensen; Francis Guillemin; Caroline B Terwee; Paula R Williamson; 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.181066

Uptake of the OMERACT-OARSI Hip and Knee Osteoarthritis Core Outcome Set: Review of Randomized Controlled Trials from 1997 to 2017

J Rheumatol. 2019 Aug;46(8):976-980. doi: 10.3899/jrheum.181066. Epub 2019 Mar 1.

Authors

Toby O Smith^{1

2}, Michael Mansfield^{1

2}, Gillian A Hawker^{1

2}, David J Hunter^{1

2}, Lyn M March^{1

2}, Maarten Boers^{1

2}, Beverley J Shea^{1

2}, Robin Christensen^{1

2}, Francis Guillemin^{1

2}, Caroline B Terwee^{1

2}, Paula R Williamson^{1

2}, Ewa M Roos^{1

2}, Richard F Loeser^{1

2}, Thomas J Schnitzer^{1

2}, Margreet Kloppenburg^{1

2}, Tuhina Neogi^{1

2}, Christoph H Ladel^{1

2}, Gurdyal Kalsi^{1

2}, Ulrike Kaiser^{1

2}, Thomas W Buttel^{1

2}, Anne E Ashford^{1

2}, Ali Mobasheri^{1

2}, Nigel K Arden^{1

2}, Alan Tennant^{1

2}, Marc C Hochberg^{1

2}, Maarten de Wit^{1

2}, Peter Tugwell^{1

2}, Philip G Conaghan^{3

4}

Affiliations

¹ From the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford; School of Health and Social Care, London South Bank University, London; Institute of Translational Medicine, University of Liverpool, Liverpool; Faculty of Health and Medical Sciences, University of Surrey, Guildford; Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; National Institute for Health Research (NIHR) Leeds Biomedical Research Centre (BRC), Leeds, UK; Department of Medicine, Faculty of Medicine, and Institute of Health Policy, Management, and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto; Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa; Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; Institute of Bone and Joint Research, Department of Rheumatology, School of Medicine, University of Sydney and Royal North Shore Hospital, Sydney, Australia; Department of Epidemiology and Biostatistics, Amsterdam University Medical Centres, 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, 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; Sections of Clinical Epidemiology and Rheumatology, Boston University School of Medicine, Boston; 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; Inner West Psychology; Institute of Bone and Joint Research, Department of Rheumatology, School of Medicine, University of Sydney and Royal North Shore Hospital; School of Biological, Earth and Environmental Sciences, University of New South Wales, Sydney, Australia; Department of Regenerative Medicine, State Research Institute Centre for Innovative Medicine, Vilnius, Lithuania; Faculty of Humanities and Social Sciences, University of Lucerne, Lucerne, Switzerland.
² T.O. Smith, PhD, Senior Researcher in Rehabilitation, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, and NIHR Oxford BRC, John Radcliffe Hospital, Oxford; M. Mansfield, MSc, Senior Lecturer in Physiotherapy, School of Health and Social Care, London South Bank University; G.A. Hawker, PhD, Professor of Medicine, Department of Medicine, Faculty of Medicine, and Institute of Health Policy, Management, and Evaluation, Dalla Lana School of Public Health, University of Toronto; D.J. Hunter, PhD, Florance and Cope Chair of Rheumatology Chair of Institute of Bone and Joint Research Professor of Medicine, Institute of Bone and Joint Research, Florance and Cope and Professorial Department of Rheumatology, School of Medicine, University of Sydney and Royal North Shore Hospital; L.M. March, PhD, Liggins Professor of Rheumatology and Musculosketal Epidemiology Medicine, Institute of Bone and Joint Research, Florance and Cope Professorial Department of Rheumatology, School of Medicine, University of Sydney and Royal North Shore Hospital; M. Boers, PhD, Professor of Clinical Epidemiology, Department of Epidemiology and Biostatistics, Amsterdam University Medical Centers; B.J. Shea, PhD, Adjunct Professor, Ottawa Hospital Research Institute; R. Christensen, PhD, Professor of Biostatistics and Clinical Epidemiology, Musculoskeletal Statistics Unit, the Parker Institute, Bispebjerg and Frederiksberg Hospital and Department of Rheumatology, Odense University Hospital; F. Guillemin, PhD, Professor of Epidemiology and Public Health, Université de Lorraine, APEMAC; C.B. Terwee, PhD, Associate Professor in Clinimetrics, Department of Epidemiology and Biostatistics, Amsterdam University Medical Centers; P.R. Williamson, PhD, Professor of Medical Statistics, Institute of Translational Medicine, University of Liverpool; E.M. Roos, PhD, Professor, Head of Research Unit, Center for Muscle and Joint Health, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark; R.F. Loeser, MD, Herman and Louise Smith Distinguished Professor of Medicine, Division of Rheumatology, Allergy and Immunology, and Division of Rheumatology, Allergy and Immunology, Thurston Arthritis Research Center, University of North Carolina; T.J. Schnitzer, PhD, Professor of Physical Medicine and Rehabilitation, Anesthesiology and Medicine (Rheumatology), and Department of Physical Medicine and Rehabilitation, Northwestern University Feinberg School of Medicine; M. Kloppenburg, PhD, Professor in Rheumatology, Departments of Rheumatology and Clinical Epidemiology, Leiden University Medical Centre; T. Neogi, PhD, Professor, Epidemiology, Sections of Clinical Epidemiology and Rheumatology, Boston University School of Medicine; C.H. Ladel, PhD, Clinical Biomarker and Diagnostics Lead, Merck Biopharma, Merck KGaA; G. Kalsi, MD, Chief Medical Officer, Senior Vice President of Clinical Development and Regulatory and Medical Affairs, TissueGene Inc.; U. Kaiser, PhD, Principal Investigator, University Pain Centre, University Hospital Carl Gustav Carus; T.W. Buttel, MA, Psychologist, Inner West Psychology, and Institute of Bone and Joint Research, Florance and Cope Professorial Department of Rheumatology, School of Medicine, University of Sydney and Royal North Shore Hospital; A.E. Ashford, PhD, Emeritus Professor, School of Biological, Earth and Environmental Sciences, University of New South Wales; A. Mobasheri, DPhil, Professor of Musculoskeletal Physiology, Faculty of Health and Medical Sciences, University of Surrey, and Department of Regenerative Medicine, State Research Institute Centre for Innovative Medicine; N.K. Arden, MD, Professor in Rheumatic Diseases, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford; A. Tennant, PhD, Permanent Visiting Professor, Faculty of Humanities and Social Sciences, University of Lucerne; M.C. Hochberg, MD, Professor of Medicine and Epidemiology and Public Health, 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; M. de Wit, PhD, Visiting Fellow, Amsterdam University Medical Centre, Department of Medical Humanities, Amsterdam Public Health; P. Tugwell, PhD, Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, and Clinical Epidemiology Program, Ottawa Hospital Research Institute; P.G. Conaghan, PhD, Professor of Musculoskeletal Medicine, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds BRC.
³ From the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford; School of Health and Social Care, London South Bank University, London; Institute of Translational Medicine, University of Liverpool, Liverpool; Faculty of Health and Medical Sciences, University of Surrey, Guildford; Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; National Institute for Health Research (NIHR) Leeds Biomedical Research Centre (BRC), Leeds, UK; Department of Medicine, Faculty of Medicine, and Institute of Health Policy, Management, and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto; Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa; Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; Institute of Bone and Joint Research, Department of Rheumatology, School of Medicine, University of Sydney and Royal North Shore Hospital, Sydney, Australia; Department of Epidemiology and Biostatistics, Amsterdam University Medical Centres, 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, 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; Sections of Clinical Epidemiology and Rheumatology, Boston University School of Medicine, Boston; 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; Inner West Psychology; Institute of Bone and Joint Research, Department of Rheumatology, School of Medicine, University of Sydney and Royal North Shore Hospital; School of Biological, Earth and Environmental Sciences, University of New South Wales, Sydney, Australia; Department of Regenerative Medicine, State Research Institute Centre for Innovative Medicine, Vilnius, Lithuania; Faculty of Humanities and Social Sciences, University of Lucerne, Lucerne, Switzerland. p.conaghan@leeds.ac.uk.
⁴ T.O. Smith, PhD, Senior Researcher in Rehabilitation, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, and NIHR Oxford BRC, John Radcliffe Hospital, Oxford; M. Mansfield, MSc, Senior Lecturer in Physiotherapy, School of Health and Social Care, London South Bank University; G.A. Hawker, PhD, Professor of Medicine, Department of Medicine, Faculty of Medicine, and Institute of Health Policy, Management, and Evaluation, Dalla Lana School of Public Health, University of Toronto; D.J. Hunter, PhD, Florance and Cope Chair of Rheumatology Chair of Institute of Bone and Joint Research Professor of Medicine, Institute of Bone and Joint Research, Florance and Cope and Professorial Department of Rheumatology, School of Medicine, University of Sydney and Royal North Shore Hospital; L.M. March, PhD, Liggins Professor of Rheumatology and Musculosketal Epidemiology Medicine, Institute of Bone and Joint Research, Florance and Cope Professorial Department of Rheumatology, School of Medicine, University of Sydney and Royal North Shore Hospital; M. Boers, PhD, Professor of Clinical Epidemiology, Department of Epidemiology and Biostatistics, Amsterdam University Medical Centers; B.J. Shea, PhD, Adjunct Professor, Ottawa Hospital Research Institute; R. Christensen, PhD, Professor of Biostatistics and Clinical Epidemiology, Musculoskeletal Statistics Unit, the Parker Institute, Bispebjerg and Frederiksberg Hospital and Department of Rheumatology, Odense University Hospital; F. Guillemin, PhD, Professor of Epidemiology and Public Health, Université de Lorraine, APEMAC; C.B. Terwee, PhD, Associate Professor in Clinimetrics, Department of Epidemiology and Biostatistics, Amsterdam University Medical Centers; P.R. Williamson, PhD, Professor of Medical Statistics, Institute of Translational Medicine, University of Liverpool; E.M. Roos, PhD, Professor, Head of Research Unit, Center for Muscle and Joint Health, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark; R.F. Loeser, MD, Herman and Louise Smith Distinguished Professor of Medicine, Division of Rheumatology, Allergy and Immunology, and Division of Rheumatology, Allergy and Immunology, Thurston Arthritis Research Center, University of North Carolina; T.J. Schnitzer, PhD, Professor of Physical Medicine and Rehabilitation, Anesthesiology and Medicine (Rheumatology), and Department of Physical Medicine and Rehabilitation, Northwestern University Feinberg School of Medicine; M. Kloppenburg, PhD, Professor in Rheumatology, Departments of Rheumatology and Clinical Epidemiology, Leiden University Medical Centre; T. Neogi, PhD, Professor, Epidemiology, Sections of Clinical Epidemiology and Rheumatology, Boston University School of Medicine; C.H. Ladel, PhD, Clinical Biomarker and Diagnostics Lead, Merck Biopharma, Merck KGaA; G. Kalsi, MD, Chief Medical Officer, Senior Vice President of Clinical Development and Regulatory and Medical Affairs, TissueGene Inc.; U. Kaiser, PhD, Principal Investigator, University Pain Centre, University Hospital Carl Gustav Carus; T.W. Buttel, MA, Psychologist, Inner West Psychology, and Institute of Bone and Joint Research, Florance and Cope Professorial Department of Rheumatology, School of Medicine, University of Sydney and Royal North Shore Hospital; A.E. Ashford, PhD, Emeritus Professor, School of Biological, Earth and Environmental Sciences, University of New South Wales; A. Mobasheri, DPhil, Professor of Musculoskeletal Physiology, Faculty of Health and Medical Sciences, University of Surrey, and Department of Regenerative Medicine, State Research Institute Centre for Innovative Medicine; N.K. Arden, MD, Professor in Rheumatic Diseases, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford; A. Tennant, PhD, Permanent Visiting Professor, Faculty of Humanities and Social Sciences, University of Lucerne; M.C. Hochberg, MD, Professor of Medicine and Epidemiology and Public Health, 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; M. de Wit, PhD, Visiting Fellow, Amsterdam University Medical Centre, Department of Medical Humanities, Amsterdam Public Health; P. Tugwell, PhD, Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, and Clinical Epidemiology Program, Ottawa Hospital Research Institute; P.G. Conaghan, PhD, Professor of Musculoskeletal Medicine, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds BRC. p.conaghan@leeds.ac.uk.

Abstract

Objective: To assess the uptake of the OMERACT-OARSI (Outcome Measures in Rheumatology- Osteoarthritis Research Society International) core outcome set (COS) domains in hip and/or knee osteoarthritis (OA) trials.

Methods: There were 382 trials of hip and/or knee OA identified from the ClinicalTrial.gov registry from 1997 to 2017. Frequency of COS adoption was assessed by year and per 5-yearly phases.

Results: COS adoption decreased from 61% between 1997 and 2001 to 38% between 2012 and 2016. Pain (95%) and physical function (86%) were most consistently adopted. Patient's global assessment (48%) was the principal missing domain.

Conclusion: Limited adoption of the COS domains indicates that further consideration to improve uptake is required.

Keywords: ADOPTION; CORE OUTCOME SET; DOMAIN; OMERACT; TRIAL REGISTRATION.

Publication types

Research Support, Non-U.S. Gov't
Review

MeSH terms

Arthroplasty, Replacement, Hip*
Arthroplasty, Replacement, Knee*
Humans
Osteoarthritis, Hip / surgery*
Osteoarthritis, Knee / surgery*
Quality of Life*
Randomized Controlled Trials as Topic
Rheumatology
Treatment Outcome

Abstract

Publication types

MeSH terms

Grants and funding