RT Journal Article
SR Electronic
T1 Report from the OMERACT Hand Osteoarthritis Working Group: Set of Core Domains and Preliminary Set of Instruments for Use in Clinical Trials and Observational Studies
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP jrheum.141017
DO 10.3899/jrheum.141017
A1 Margreet Kloppenburg
A1 Pernille Bøyesen
A1 A. Willemien  Visser
A1 Ida K.  Haugen
A1 Maarten Boers
A1 Annelies Boonen
A1 Philip G.  Conaghan
A1 Gillian A.  Hawker
A1 Tore K.  Kvien
A1 Robert Landewé
A1 Till Uhlig
A1 Wilma Smeets
A1 Elsie Greibrokk
A1 Désirée M.  van der Heijde
YR 2015
UL http://www.jrheum.org/content/early/2015/06/26/jrheum.141017.abstract
AB 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.