Toby O Smith1,2, Gillian A Hawker1,2, David J Hunter1,2, Lyn M March1,2, Maarten Boers1,2, Beverley J Shea1,2, Robin Christensen1,2, Francis Guillemin1,2, Caroline B Terwee1,2, Paula R Williamson1,2, Susanna Dodd1,2, Ewa M Roos1,2, Richard F Loeser1,2, Thomas J Schnitzer1,2, Margreet Kloppenburg1,2, Tuhina Neogi1,2, Christoph H Ladel1,2, Gurdyal Kalsi1,2, Ulrike Kaiser1,2, Thomas W Buttel1,2, Anne E Ashford1,2, Ali Mobasheri1,2, Nigel K Arden1,2, Alan Tennant1,2, Marc C Hochberg1,2, Maarten de Wit1,2, Peter Tugwell1,2, Philip G Conaghan3,4. 1. From the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, and UK National Institute for Health Research (NIHR) Oxford Biomedical Research Centre, John Radcliffe Hospital, Oxford; 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; NIHR Leeds Biomedical Research Centre, 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; Inner West Psychology; School of Biological, Earth and Environmental Sciences, University of New South 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. 2. T.O. Smith, PhD, Senior Researcher in Rehabilitation, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, and NIHR Oxford Biomedical Research Centre, John Radcliffe Hospital; 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 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, location VUmc; P.R. Williamson, PhD, Professor of Medical Statistics, Institute of Translational Medicine, University of Liverpool; S. Dodd, PhD, Lecturer in Biostatistics, 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, Thurston Arthritis Research Center, University of North Carolina; T.J. Schnitzer, PhD, Professor of Physical Medicine and Rehabilitation, Anesthesiology and Medicine (Rheumatology), 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, 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, Sydney, Australia, 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, Emeritius 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 Biomedical Research Centre. 3. From the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, and UK National Institute for Health Research (NIHR) Oxford Biomedical Research Centre, John Radcliffe Hospital, Oxford; 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; NIHR Leeds Biomedical Research Centre, 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; Inner West Psychology; School of Biological, Earth and Environmental Sciences, University of New South 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. 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 Biomedical Research Centre, John Radcliffe Hospital; 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 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, location VUmc; P.R. Williamson, PhD, Professor of Medical Statistics, Institute of Translational Medicine, University of Liverpool; S. Dodd, PhD, Lecturer in Biostatistics, 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, Thurston Arthritis Research Center, University of North Carolina; T.J. Schnitzer, PhD, Professor of Physical Medicine and Rehabilitation, Anesthesiology and Medicine (Rheumatology), 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, 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, Sydney, Australia, 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, Emeritius 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 Biomedical Research Centre. p.conaghan@leeds.ac.uk.
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.
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.
Authors: Paula R Williamson; Iain A Bruce; Bilal Alkhaffaf; Jane M Blazeby; Aleksandra Metryka; Anne-Marie Glenny; Ademola Adeyeye; Paulo Matos Costa; Ismael Diez Del Val; Suzanne S Gisbertz; Ali Guner; Simon Law; Hyuk-Joon Lee; Ziyu Li; Koji Nakada; Rafael Mauricio Restrepo Nuñez; Daniel Reim; John V Reynolds; Peter Vorwald; Daniela Zanotti; William Allum; M Asif Chaudry; Ewen Griffiths Journal: Trials Date: 2021-06-21 Impact factor: 2.279
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Authors: Carolien H Teirlinck; Arianne P Verhagen; Elja A E Reijneveld; Jos Runhaar; Marienke van Middelkoop; Leontien M van Ravesteyn; Lotte Hermsen; Ingrid B de Groot; Sita M A Bierma-Zeinstra Journal: Int J Environ Res Public Health Date: 2020-10-10 Impact factor: 3.390