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

Lara J Maxwell; Caitlin Jones; Clifton O Bingham; Maarten Boers; Annelies Boonen; Ernest Choy; Robin Christensen; Philip G Conaghan; Maria Antonietta D'Agostino; Andrea S Doria; Shawna Grosskleg; Catherine L Hill; Catherine Hofstetter; Ben Horgan; Féline Kroon; Ying Ying Leung; Sarah Mackie; Alexa Meara; Beverley J Shea; Lee S Simon; Zahi Touma; Peter Tugwell; George A Wells; Dorcas E Beaton

doi:10.1016/j.semarthrit.2024.152423

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

Semin Arthritis Rheum. 2024 Feb 29:66:152423. doi: 10.1016/j.semarthrit.2024.152423. Online ahead of print.

Authors

Lara J Maxwell¹, Caitlin Jones², Clifton O Bingham³, Maarten Boers⁴, Annelies Boonen⁵, Ernest Choy⁶, Robin Christensen⁷, Philip G Conaghan⁸, Maria Antonietta D'Agostino⁹, Andrea S Doria¹⁰, Shawna Grosskleg¹¹, Catherine L Hill¹², Catherine Hofstetter¹³, Ben Horgan¹⁴, Féline Kroon¹⁵, Ying Ying Leung¹⁶, Sarah Mackie¹⁷, Alexa Meara¹⁸, Beverley J Shea¹⁹, Lee S Simon²⁰, Zahi Touma²¹, Peter Tugwell²², George A Wells²³, Dorcas E Beaton²⁴

Affiliations

¹ Faculty of Medicine, University of Ottawa and Ottawa Hospital Research Institute, Centre for Practice Changing Research, 501 Smyth Rd, Ottawa, ON K1H 8L6, Canada. Electronic address: lmaxwell@uottawa.ca.
² Sydney Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, Australia.
³ Division of Rheumatology, Johns Hopkins University, Baltimore MD, USA.
⁴ Emeritus Professor of Clinical Epidemiology, Department of Epidemiology & Data Science, Amsterdam UMC, Vrije Universiteit, Amsterdam, the Netherlands.
⁵ Professor of Rheumatology, Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Center, Maastricht; Care and Public Health Research Institute Caphri, Maastricht University, Maastricht, the Netherlands.
⁶ Professor of Rheumatology, CREATE Centre, Section of Rheumatology, Division of Infection and Immunity, Cardiff University, UK.
⁷ Professor of Biostatistics, Section for Biostatistics and Evidence-Based Research, the Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, & Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Denmark.
⁸ Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds & NIHR Leeds Biomedical Research Centre, UK.
⁹ Professor of Rheumatology, Rheumatology Department, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Catholic University of Sacred Heart, Rome, Italy.
¹⁰ Department of Diagnostic Imaging and Research Institute, The Hospital for Sick Children; Department of Medical Imaging, University of Toronto, Toronto, Canada.
¹¹ OMERACT Secretariat, Ottawa, Canada.
¹² Rheumatology Unit, The Queen Elizabeth Hospital, Woodville, Australia; Discipline of Medicine, University of Adelaide, Adelaide, Australia.
¹³ Patient Research Partner, Canada.
¹⁴ Patient Research Partner, Australia.
¹⁵ Department of Rheumatology, Leiden University Medical Center (LUMC), Leiden; Rheumatology, Zuyderland Medical Centre Heerlen, Heerlen, the Netherlands.
¹⁶ Singapore General Hospital, Singapore; Duke-NUS Medical School, Singapore.
¹⁷ Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK; Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
¹⁸ Assistant Professor, Division of Rheumatology, The Ohio State University, Columbus, USA.
¹⁹ Clinical Scientist, Bruyère Research Institute, Senior Methodologist, Ottawa Hospital Research Institute, Adjunct Professor, Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada.
²⁰ SDG LLC, Cambridge, MA, USA.
²¹ Associate Professor, Division of Rheumatology, Department of Medicine, University of Toronto, Schroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital Lupus Clinic, Toronto, Canada.
²² Professor, University of Ottawa, Division of Rheumatology, Department of Medicine, Faculty of Medicine, Ottawa, Canada; Bruyère Research Institute, Ottawa, Canada; Ottawa Hospital Research Institute, Clinical Epidemiology Program, Ottawa, Canada; University of Ottawa, School of Epidemiology and Public Health, Faculty of Medicine, Ottawa, Canada; WHO Collaborating Centre for Knowledge Translation and Health Technology Assessment in Health Equity, Bruyère Research Institute, Ottawa, Canada.
²³ Director, Cardiovascular Research Methods Centre, University of Ottawa Heart Institute, Canada; Professor, School of Epidemiology and Public Health, University of Ottawa, Canada; Professor, Department of Medicine, University of Ottawa, Canada.
²⁴ Senior Scientist, Institute for Work & Health; Associate Professor, Institute Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada.

PMID: 38460282
DOI: 10.1016/j.semarthrit.2024.152423

Abstract

Objective: To develop a set of detailed definitions for foundational domains commonly used in OMERACT (Outcome Measures in Rheumatology) core domain sets.

Methods: 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.

Results: 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.

Conclusion: 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.

Keywords: Core domain set; Domains; OMERACT; Outcome methodology; Rheumatology.