Patient outcomes in longitudinal observational studies (POLOS) of rheumatoid arthritis: Determining the OMERACT core domain set

Diego Benavent; Loreto Carmona; Maria A Lopez-Olivo; Catherine L Hill; Tiffany Westrich-Robertson; Niti Goel; Vibeke Strand; Beverley Shea; Shawna Grosskleg; Amye Leong; Catherine Hofstetter; Clifton Bingham; Daniel Meyer; Deb Constien; Dorthe B Berthelsen; Grayson Schultz; Ingrid de Groot; Joan Weiner; Kate Mather; Maarten de Wit; Peter Böhm; Sam Michel Cembalo; Peter Tugwell; Sebastian Bruera; Maria E Suarez-Almazor

doi:10.1016/j.semarthrit.2023.152343

Patient outcomes in longitudinal observational studies (POLOS) of rheumatoid arthritis: Determining the OMERACT core domain set

Semin Arthritis Rheum. 2024 Feb:64:152343. doi: 10.1016/j.semarthrit.2023.152343. Epub 2023 Dec 13.

Authors

Diego Benavent¹, Loreto Carmona², Maria A Lopez-Olivo³, Catherine L Hill⁴, Tiffany Westrich-Robertson⁵, Niti Goel⁶, Vibeke Strand⁷, Beverley Shea⁸, Shawna Grosskleg⁹, Amye Leong¹⁰, Catherine Hofstetter¹¹, Clifton Bingham¹², Daniel Meyer¹³, Deb Constien¹⁴, Dorthe B Berthelsen¹⁵, Grayson Schultz¹⁴, Ingrid de Groot¹⁶, Joan Weiner¹⁴, Kate Mather¹¹, Maarten de Wit¹⁷, Peter Böhm¹⁸, Sam Michel Cembalo¹⁹, Peter Tugwell¹⁰, Sebastian Bruera²⁰, Maria E Suarez-Almazor³

Affiliations

¹ Rheumatology Department, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain. Electronic address: [email protected].
² Instituto de Salud Musculoesquelética, Madrid, Spain.
³ Section of Rheumatology and Clinical Immunology, University of Texas MD Anderson Cancer Center, Texas, USA.
⁴ Discipline of Medicine, University of Adelaide; Rheumatology Unit, The Queen Elizabeth Hospital, Woodville, Australia.
⁵ International Foundation for Autoimmune & Autoinflammatory Arthritis (AiArthritis), St. Louis, MO, USA.
⁶ Division of Rheumatology, Department of Medicine, Duke University School of Medicine, Durham, NC, USA.
⁷ Division of Immunology and Rheumatology, Stanford University School of Medicine, Palo Alto, CA, USA.
⁸ Ottawa Hospital Research Institute, School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada.
⁹ Secretariat, OMERACT, University of Ottawa, Ottawa, Ontario, Canada.
¹⁰ Department of Medicine and School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada.
¹¹ Patient Research Partner, Canada.
¹² Division of Rheumatology, Department of Medicine, Johns Hopkins University, Baltimore MD, USA.
¹³ Dartmouth Medical School, Hanover, NH, USA.
¹⁴ Patient Research Partner, USA.
¹⁵ Section for Biostatistics and Evidence-Based Research, the Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Denmark; Department of Rehabilitation, Municipality of Guldborgsund, Nykoebing F, Denmark.
¹⁶ Patient Research Partner, the Netherlands.
¹⁷ Amsterdam University Medical Centre, Department of Medical Humanities, Amsterdam Public Health.
¹⁸ Patient Research Partner, Germany.
¹⁹ Patient Research Partner, France.
²⁰ Department of Immunology, Allergy, and Rheumatology, Baylor College of Medicine, Houston, TX, USA.

PMID: 38118370
DOI: 10.1016/j.semarthrit.2023.152343

Abstract

Objective: To define and select rheumatoid arthritis (RA)-specific core domain set for Longitudinal Observational Studies (LOS) within the Outcome Measures in Rheumatology (OMERACT) framework.

Methods: A three-round online Delphi exercise, including patient research partners (PRPs) and other community partners in healthcare, was conducted. Domains scored 7-9 (i.e., critically important to include) by ≥ 70 % of participants in both groups were included. Items were consolidated in a subsequent dedicated meeting.

Results: Nineteen domains scored ≥ 70 % consensus in both groups. The focus group refined these into a list of twelve domains.

Conclusion: The achieved consensus will inform the next steps of developing the core domain set for LOS in RA.

Keywords: Core domains; Delphi; OMERACT; Rheumatoid arthritis; longitudinal observational studies.

Publication types

Observational Study

MeSH terms

Arthritis, Rheumatoid*
Consensus
Humans
Longitudinal Studies
Outcome Assessment, Health Care
Rheumatology*