Margreet Kloppenburg1, Pernille Bøyesen1, A Willemien Visser1, Ida K Haugen1, Maarten Boers1, Annelies Boonen1, Philip G Conaghan1, Gillian A Hawker1, Tore K Kvien1, Robert Landewé1, Till Uhlig1, Wilma Smeets1, Elsie Greibrokk1, Désirée M van der Heijde1. 1. From the Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands; Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway; Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands; Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Center; CAPHRI Research Institute, Maastricht University, Maastricht, The Netherlands; Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and UK National Institute for Health Research (NIHR) Leeds Musculoskeletal Biomedical Research Unit, Leeds, UK; Women's College Research Institute, Women's College Hospital, and Departments of Medicine and Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada; Departments of Rheumatology and Clinical Immunology, Academic Medical Center, Amsterdam; Department of Rheumatology, Atrium Medical Center Heerlen, Heerlen, The Netherlands; National Advisory Unit on Rehabilitation in Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.M. Kloppenburg, MD, PhD, Professor in Rheumatology, Department of Rheumatology, Leiden University Medical Center; P. Bøyesen, MD, PhD, Department of Rheumatology, Diakonhjemmet Hospital; A.W. Visser, MD, Department of Rheumatology, Leiden University Medical Center; I.K. Haugen, MD, PhD, Department of Rheumatology, Diakonhjemmet Hospital; M. Boers, MSc, MD, PhD, Department of Epidemiology and Biostatistics, VU University Medical Center; A. Boonen, MD, PhD, Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Center, and CAPHRI Research Institute, Maastricht University; P.G. Conaghan, MB, BS, PhD, FRACP, FRCP, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and NIHR Leeds Musculoskeletal Biomedical Research Unit; G.A. Hawker, MD, PhD, Women's College Research Institute, Women's College Hospital, University of Toronto; Departments of Me
Abstract
OBJECTIVE: During OMERACT 12, a workshop was held with the aim to endorse a core set of domains for 3 settings: clinical trials of symptom and structure modification and observational studies. Additional goals were to endorse a core set of contextual factors for these settings, and to define preliminary instruments for each core domain. Finally, an agenda for future research in hand osteoarthritis (OA) was to be proposed. METHODS: Literature reviews of preliminary instruments for each core domain of the proposed core set for hand OA in the settings described above. Literature review of radiographic scoring methods and modern imaging in hand OA were also performed. Proposed contextual factors for a core set were identified through 2 Delphi exercises with participation of hand OA experts, patient partners, and OMERACT participants. RESULTS: Results from Delphi exercises and systematic literature reviews were presented and discussed. It was agreed that a preliminary core domain set for the setting clinical trials of symptom modification should contain at least "pain, physical function, patient global assessment, joint activity and hand strength." The settings clinical trial of structure modification and observational studies would in addition include structural damage. Preliminary instruments for the proposed domains were agreed on. A list of prioritized contextual factors was defined and endorsed for further research. A research agenda was proposed for domain instrument validation according to the OMERACT Filter 2.0. CONCLUSION: Preliminary core sets for clinical trials of symptom and structure modification and observational studies in hand osteoarthritis, including preliminary instruments and contextual factors, were agreed upon during OMERACT 12.
OBJECTIVE: During OMERACT 12, a workshop was held with the aim to endorse a core set of domains for 3 settings: clinical trials of symptom and structure modification and observational studies. Additional goals were to endorse a core set of contextual factors for these settings, and to define preliminary instruments for each core domain. Finally, an agenda for future research in hand osteoarthritis (OA) was to be proposed. METHODS: Literature reviews of preliminary instruments for each core domain of the proposed core set for hand OA in the settings described above. Literature review of radiographic scoring methods and modern imaging in hand OA were also performed. Proposed contextual factors for a core set were identified through 2 Delphi exercises with participation of hand OA experts, patient partners, and OMERACT participants. RESULTS: Results from Delphi exercises and systematic literature reviews were presented and discussed. It was agreed that a preliminary core domain set for the setting clinical trials of symptom modification should contain at least "pain, physical function, patient global assessment, joint activity and hand strength." The settings clinical trial of structure modification and observational studies would in addition include structural damage. Preliminary instruments for the proposed domains were agreed on. A list of prioritized contextual factors was defined and endorsed for further research. A research agenda was proposed for domain instrument validation according to the OMERACT Filter 2.0. CONCLUSION: Preliminary core sets for clinical trials of symptom and structure modification and observational studies in hand osteoarthritis, including preliminary instruments and contextual factors, were agreed upon during OMERACT 12.
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