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

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.

Contributors

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 Bohm, Sam Michel Cembalo, Peter Tugwell, Sebastian Bruera, Maria E. Suarez-Almazor

Publication

Journal: Seminars in Arthritis and Rheumatism
Volume: 64
Issue:
Pages: -
Year: 2024
DOI: 10.1016/j.semarthrit.2023.152343

Further Study Information

Current Stage: Completed
Date:
Funding source(s): None declared


Health Area

Disease Category: Rheumatology

Disease Name: Rheumatoid arthritis

Target Population

Age Range: Unknown

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Consumers (patients)
- Researchers
- Service providers

Study Type

- COS for clinical trials or clinical research

Method(s)

- Delphi process
- Focus group(s)

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.