Core outcome measurement instrument selection for physical function in hand osteoarthritis using the OMERACT Filter 2.1 process.

Physical function is one of the Outcome Measures in Rheumatology (OMERACT) core outcome domains for hand osteoarthritis studies. Our aim was to select appropriate instrument(s) to measure this domain, as part of the development of a core outcome measurement set. Following the OMERACT Filter 2.1 instrument selection process, the (function subscale of) the Australian/Canadian Hand Osteoarthritis Index (AUSCAN), Functional Index for Hand Osteoarthritis (FIHOA) and Michigan Hand Outcomes Questionnaire (MHQ) were assessed for domain match, feasibility, truth and discrimination. Data gathered from available literature, working group and patient surveys, and additional analyses in two hand osteoarthritis cohorts were used to inform a consensus process. Results were summarized in Summary of Measurements Properties tables and reviewed by the OMERACT technical advisory group. MHQ passed the assessment of domain match and feasibility by the working group and patient research partners. For AUSCAN important limitations in feasibility were noted, but domain match was good. FIHOA did not pass the assessment and was not taken through the follow-up assessment. Based on published literature, reliability and construct/longitudinal validity of both MHQ and AUSCAN fulfilled OMERACT standards. While clinical trial discrimination and thresholds of meaning were good for AUSCAN, results for MHQ were ambiguous. MHQ was provisionally endorsed as OMERACT core outcome measure for the core domain physical function. While AUSCAN may have better metric properties than MHQ, it received provisional endorsement as a second measure of function due to important feasibility issues. A research agenda to merit full endorsement was set.

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Copyright © 2021 The Author(s). Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of Competing Interest AA reports grants from AstraZeneca, Oxford Immunotech; royalties from Uptodate; consulting fees from inflazome, NGM Biopharmaceuticals; honoraria from Menarini; and support from Pfizer; all outside the submitted work. FBe reports personal fees from Boehringer, Bone Therapeutics, CellProthera, Expanscience, Galapagos, Gilead, GSK, Merck Sereno, MSD, Nordic, Novartis, Pfizer, Regulaxis, Roche, Sandoz, Sanofi, Servier, UCB, Peptinov, 4P Pharma, 4Moving Biotech, and grants from TRB Chemedica; all outside the submitted work. FBl reports grants from Abbvie, grants and personal fees from Pfizer, grants from UCB, grants from Bristol-Mayers Squibb, grants from Roche, grants from Servier, grants from Bioiberica, grants from Sanofie, grants from Grunenthal, grants from GlaxoSmithKline, grants from Lilly, grants from Janssen, grants from Regeneron, grants from Amgen, and grants from TRB Chemedica; all outside the submitted work. DB reports to be on the executive of OMERACT and Technical Advisory Group, and is involved in supporting upper limb outcome measures (none that were considered here). PC reports personal fees from Eli Lilly, personal fees from EMD Serono, personal fees from Flexion Therapeutics, personal fees from Galapagos, personal fees from Novartis, personal fees from Pfizer; all outside the submitted work. KD reports grants from the National Institute for Health Research (NIHR). TS reports personal fees from AbbVie, Sanofi Genzyme, Roche, and Takeda; all outside the submitted work. IKH reports personal fees from AbbVie, grants from Pfizer, and personal fees from Novartis; all outside the submitted work. DvdH reports personal fees from AbbVie, Amgen, Astellas, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, and UCB Pharma; all outside the submitted work; and is Director of Imaging Rheumatology BV. MK reports grants from Dutch Arthritis Association, during the conduct of the study, fee for consultancy (Abbvie, Pfizer, Levicept, GlaxoSmithKline, Merck-Serono, Kiniksa, Flexion, Galapagos, CHDR) and local investigator of industry-driven trial (Abbvie), from Wolters Kluwer (UptoDate), Springer Verlag (Reumatologie en klinische immunologie), grants from Pfizer, grants from IMI-APPROACH; all outside the submitted work. LM reports to be a paid staff member of OMERACT and helped develop the methodology applied within this manuscript. FK, CH, MI, VR, and RW have nothing to disclose.