Defining domains: developing consensus-based definitions for foundational domains in OMERACT core outcome sets.

To develop a set of detailed definitions for foundational domains commonly used in OMERACT (Outcome Measures in Rheumatology) core domain sets. We identified candidate domain definitions from prior OMERACT publications and websites and publications of major organizations involved in outcomes research for six domains commonly used in OMERACT Core Domain Sets: pain intensity, pain interference, physical function, fatigue, patient global assessment, and health-related quality of life. We conducted a two-round survey of OMERACT working groups, patient research partners, and then the OMERACT Technical Advisory Group to establish their preferred domain definitions. Results were presented at the OMERACT 2023 Methodology Workshop, where participants discussed their relevant lived experience and identified potential sources of variability giving the needed detail in our domain definitions. One-hundred four people responded to both rounds of the survey, and a preferred definition was established for each of the domains except for patient global assessment for which no agreement was reached. Seventy-five participants at the OMERACT 2023 Methodology Workshop provided lived experience examples, which were used to contextualise domain definition reports for each of the five domains. Using a consensus-based approach, we have created a detailed definition for five of the foundational domains in OMERACT core domain sets; patient global assessment requires further research. These definitions, although not mandatory for working groups to use, may facilitate the initial domain-match assessment step of instrument selection, and reduce the time and resources required by future OMERACT groups when developing core outcome sets.

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Déclaration de conflit d'intérêts

Declaration of competing interest COB, MB, RC, CH, CLH, SG, FK, BJS, GAW - No conflicts DEB: Member of Management team at OMERACT, co-chair of methods group and technical advisory group of OMERACT. PC: Member, OMERACT Management Committee. AB: Received research grants for Abbvie and Lilly and fees for lectures or consultations from Abbvie, UCB, Novartis, Galapagos and Pfizer, all to her department and unrelated to the topic of this manuscript. EC has received research grants from Bio-Cancer, Biogen, Novartis, Pfizer, Roche, Sanofi and UCB, consultancy from Abbvie, Amgen, Biogen, Biocon, Chugai Pharma, Eli Lilly, Fresenius Kabi, Gilead, Janssen, Merck Serono, Novartis, Pfizer, Regeneron, Roche, RPharm and Sanofi, speakers fee from Abbvie, Amgen, Bristol Myer Squibbs, Chugai Pharma, Eli Lilly, Fresenius Kai, Galapagos, Gilead, Janssen, Novartis, Pfizer, Regeneron, RPharm, Roche, Sanofi, and UCB. AD has the following relationships unrelated to the conduct of this study: Chair of the International Myositis Assessment & Clinical Studies Group (not for profit) Chair of the Radiological Society of North America (RSNA) Annual Planning Committee for Pediatric Radiology (not for profit), Co-Chair of the American College of Radiology (ACR) Pediatric Imaging Research Committee (not for profit), Chair of the Bias in Recruitment, Hiring, Promotion, Awards Committee of the Canadian Association of Radiology (not for profit), and PI of research grants from Novo Nordisk, the Terry Fox Foundation, the PSI Foundation, the Society of Pediatric Radiology, and the Garron Family Cancer Centre, unrelated to the topic of this manuscript. MADA: Grants from Abbvie, Amgen, Pfizer. Royalties or licenses from Elsevier. Consulting fees from Abbvie, Amgen, BMS, Galapagos, Novartis, Lilly, Janssen, UCB. Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Abbvie, Amgen, BMS, Galapagos, Novartis, Lilly, Janssen, UCB. Support for attending meetings and/or travel from Janssen, Novartis. BH: OMERACT 2023 conference in Colorado Springs. Paid by OMERACT to support my role a Patient Research Partner. CJ: Seed funding grants for unrelated project (pilot trial of opioids used after total joint replacement surgery) from ANZMUSC ($19,956), Arthritis Australia ($20,000) and Wiser Healthcare ($4000). Casual payments from OMERACT for hours spent creating an unrelated e-learning series (technician role) in 2022–2023. Registration, flight and accommodation costs covered by OMERACT for attendance at OMERACT Colorado Springs 2023. Current member of ECR committee of ANZMUSC SLM reports: Consultancy on behalf of her institution for Roche/Chugai, Sanofi, AbbVie, AstraZeneca, Pfizer; Investigator on clinical trials for Sanofi, GSK, Sparrow; speaking/lecturing on behalf of her institution for Roche/Chugai, Vifor, Pfizer, UCB, Novartis and AbbVie; chief investigator on STERLING-PMR trial, funded by NIHR; patron of the charity PMRGCAuk. No personal remuneration was received for any of the above activities. Support from Roche/Chugai to attend EULAR2019 in person and from Pfizer to attend ACR Convergence 2021 virtually. SLM is supported in part by the NIHR Leeds Biomedical Research Centre. The views expressed in this article are those of the authors and not necessarily those of the NIHR, the NIHR Leeds Biomedical Research Centre, the National Health Service or the UK Department of Health and Social Care. AM: Consulting fees from Sanofi, Abbvie, Amgen. Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Sobi, Sanofi, Abbvie. Registration, flight and accommodation costs covered by OMERACT for attendance at OMERACT Colorado Springs 2023. LJM is a paid staff member of OMERACT. LSS is on the Management Committee of OMERACT and is Chair, Finance Committee of OMERACT. YY (Katy)L is supported by National Medical Research Council of Singapore. AbbVie, DKSH, Janssen, Novartis and Pfizer- Speaker fee and honorarium paid to me. AbbVie, DKSH, Janssen, Novartis and Pfizer - Research sponsorship paid to institution. APLAR: Travel and accommodation to APLAR congresses. GRAPPA: Travel and accommodation to GRAPPA congresses. Co-Chair of Scientific Committee of Asia Pacific League of Associations of Rheumatology, APLAR - No payment. Education committee of Group for Research and Assessment for Psoriasis and Psoriatic Arthritis, GRAPPA -No payment. PT: Consulting Fees from Reformulary Group. An independent Committee Member for clinical trial Data Safety Monitoring Boards for FDA approved trials being conducted by: UCB Biopharma GmbH & SPRL, Parexel International, Prahealth Sciences. I am [unpaid] Chair of the Management Group of a registered non-profit independent medical research organization, OMERACT, whose goal is to improve and advance the health outcomes for patients suffering from musculoskeletal conditions. OMERACT receives arms-length funding from 11 companies: Abbvie, Astra Zenaca, Aurinia, BMS, Centrexion, GSK, Horizon Pharma Inc, Janssen, Novartis, Pfizer & Sparrow. ZT: Leadership or fiduciary role in other board, society, committee or advocacy group: Co-chair American College of Rheumatology Criteria development subcommittee.