Stakeholder endorsement advancing the implementation of a patient-reported domain for harms in rheumatology clinical trials: Outcome of the OMERACT Safety Working Group

Berthelsen, Dorthe B.; Simon, Lee S.; Ioannidis, John P.A.; Voshaar, Marieke; Richards, Pam; Goel, Niti; Strand, Vibeke; Nielsen, Sabrina M.; Shea, Beverly J.; Tugwell, Peter; Bartlett, Susan J.; Hazlewood, Glen S.; March, Lyn; Singh, Jasvinder A.; Suarez-Almazor, Maria E.; Boers, Maarten; Stevens, Randall M.; Furst, Daniel E.; Woodworth, Thasia; Leong, Amye; Brooks, Peter M.; Flurey, Caroline; Christensen, Robin

Abstract

Objectives: To develop an understanding of the concept of safety/harms experienced by patients involved in clinical trials for their rheumatic and musculoskeletal diseases (RMDs) and to seek input from the OMERACT community before moving forward to developing or selecting an outcome measurement instrument. Methods: OMERACT 2023 presented and discussed interview results from 34 patients indicating that up to 171 items might be important for patients’ harm-reporting. Results: Domain was defined in detail and supported by qualitative work. Participants in the Special-Interest-Group endorsed (96 %) that enough qualitative data are available to start Delphi survey(s). Conclusion: We present a definition of safety/harms that represents the patient voice (i.e., patients’ perception of safety) evaluating the symptomatic treatment-related adverse events for people with RMDs enrolled in clinical trials.

• Journal Article Type: Article
• Acceptance Date: Oct 25, 2023
• Online Publication Date: Oct 26, 2023
• Publication Date: Dec 31, 2023
• Deposit Date: Nov 19, 2023
• Publicly Available Date: Oct 27, 2024
• Journal: Seminars in Arthritis and Rheumatism
• Print ISSN: 0049-0172
• Publisher: Elsevier
• Peer Reviewed: Peer Reviewed
• Volume: 63
• Article Number: 152288
• DOI: https://doi.org/10.1016/j.semarthrit.2023.152288
• Public URL: https://uwe-repository.worktribe.com/output/11409112