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

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. OMERACT 2023 presented and discussed interview results from 34 patients indicating that up to 171 items might be important for patients' harm-reporting. 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). 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.

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Déclaration de conflit d'intérêts

Declaration of Competing Interest Dorthe B. Berthelsen: None; fellow of the OMERACT Safety Working Group. Lee S. Simon: None; co-chair of the OMERACT Safety Working Group. John P. A. Ioannidis: Part of the CONSORT Harms Group. Marieke Voshaar: None. Pam Richards: None. Niti Goel: No relevant disclosures. Vibeke Strand: Reports being a founding member of the executive committee of Outcome Measures in Rheumatology (OMERACT) [1992 – present], an international consensus organization that develops and validates outcome measures in rheumatology randomized controlled trials and longitudinal observational studies and has received arms-length funding from as many as 36 sponsors. Sabrina M. Nielsen(:) None. Beverly J. Shea: None. Peter Tugwell: None. Susan J. Bartlett: None. Glen S. Hazlewood: None. Lyn March: Has received institutional support from Janssen Australia and the Australian Government. Jasvinder A. Singh: JAS has received consultant fees from Schipher, Crealta/Horizon, Medisys, Fidia, PK Med, Two labs Inc., Adept Field Solutions, Clinical Care options, Clearview healthcare partners, Putnam associates, Focus forward, Navigant consulting, Spherix, MedIQ, Jupiter Life Science, UBM LLC, Trio Health, Medscape, WebMD, and Practice Point communications; the National Institutes of Health; and the American College of Rheumatology. JAS has received institutional research support from Biomet Holdings. JAS received food and beverage payments from Intuitive Surgical Inc./Philips Electronics North America. JAS owns stock options in Atai life sciences, Kintara therapeutics, Intelligent Biosolutions, Acumen pharmaceutical, TPT Global Tech, Vaxart pharmaceuticals, Atyu biopharma, Adaptimmune Therapeutics, GeoVax Labs, Pieris Pharmaceuticals, Enzolytics Inc., Seres Therapeutics, Tonix Pharmaceuticals Holding Corp., and Charlotte's Web Holdings, Inc. JAS previously owned stock options in Amarin, Viking and Moderna pharmaceuticals. JAS is on the speaker's bureau of Simply Speaking. JAS was a member of the executive of Outcomes Measures in Rheumatology (OMERACT), an organization that develops outcome measures in rheumatology and receives arms-length funding from 8 companies. Maria E. Suarez-Almazor: Has received consultant fees from Eli Lilly, Pfizer, Celgene and Syneos Health Maarten Boers: None. Randall M Stevens: None. Daniel E. Furst: None. Thasia Woodworth: None. Amye Leong: None. Peter M Brooks: None; co-chair of the OMERACT Safety Working Group. Caroline Flurey: None; co-chair of the OMERACT Safety Working Group. Robin Christensen: None; co-chair of the OMERACT Safety Working Group.