Stakeholder endorsement advancing the implementation of a patient-reported domain for harms in rheumatology clinical trials: Outcome of the OMERACT Safety Working Group
Authors' 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.
Study context
- Population
- Patients involved in clinical trials for their rheumatic and musculoskeletal diseases (RMDs); OMERACT community
- Participants
- 34 interviewed patients
- Outcome
- Patient-reported safety/harms domain
Methodological detailspatient interviews, OMERACT Special Interest Group, Interview results presented and discussed at OMERACT 2023
- Patient interviews
- OMERACT Special Interest Group
- Interview results presented and discussed at OMERACT 2023
Recommendations
As reported in the abstract
SIG participants endorsed that enough qualitative data are available to start Delphi survey(s)
96 %
Original publication
Stakeholder endorsement advancing the implementation of a patient-reported domain for harms in rheumatology clinical trials: Outcome of the OMERACT Safety Working Group. Semin Arthritis Rheum. Published 26 October 2023. doi:10.
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