Background:No data exist on patient participation in the selection of core domains for clinical trials of hand osteoarthritis (HOA). We aim to explore HOA patients' perspectives in the relative importance of domains.Methods: Seven domains affecting patients' lives were derived from a prior qualitative study. We recruited consecutive patients with symptomatic HOA to rate on 11point numeric rating scales for each domain, from 0 representing "not important at all" to 10 representing "most important", with consideration in two scenarios: (a) how important the domains are in affecting their current lives; and (b) how important the domains are when there are treatments for HOA (eg exercise or drugs).
Results:Forty-five patients (91% female; mean age ± standard deviation 64.3 ± 7.5 years) with mild HOA symptoms were included. Of these, 31%-42% rated current impact of HOA in various domains as highly important. Seven domains with rated scores of ≥7/10 in importance were endorsed for clinical trials in the following order: pain and HOA symptoms (endorsed by 77.8% of patients), physical function (66.7%), ability to participate in social roles (64.4%), ability to participate in social activities (62.2%), work productivity (62.2%), emotional health (60%), and appearance of fingers (55.6%).
Conclusion:The preliminary important domains as endorsed by patients with HOA for inclusion into clinical trials were explored. Apart from pain and physical function, further research is needed to refine other domains of impact, such as participation, emotional health and aesthetic concerns, as core domain sets for HOA. K E Y W O R D S core domain set development, Delphi study, hand osteoarthritis, patient participation 2046 | LEUNG Et aL. patients and clinicians. 13,14 Although there are several existing PROMs for the measurement of outcomes in HOA, 15-17 none of these PROMs were developed from patients' perspectives. Deficiencies in concepts that are relevant to patients with HOA in the existing PROMs have been recognized from qualitative studies. 18,19 According to the US Food and Drug Administration guidance to industry in supporting labeling claims, the PROMs should reflect the health status of patients without interpretation by clinicians or anyone else. 20 From the valuebased model in health care, understanding the value of health from the perspectives of patients has become indispensable. 21 The Outcome Measures in Rheumatology initiative (OMERACT) has put forward a methodological framework known as OMERACT Filter 2.0 for standardization of reporting of outcomes in clinical trials. 22 Under this framework, it is recommended that domains of concern relevant to patients are identified and prioritized to develop a "Core Domain Set" ("what to measure") before generating a "Core Outcome Measurement Set" ("how to measure") and evaluating the appropriate PROMs to measure these core domains. Different professional societies have proposed different preliminary core domain sets for HOA for purpose of use in clinical trials. The OMERACT HOA S...