Development of a single‑item patient‑reported measure of treatment side‑effect burden in clinical trials of rheumatic and musculoskeletal diseases using stakeholder input and large language model refinement
Authors' conclusion
We developed a novel single-item instrument.
Study context
- Population
- OMERACT community collaborators (patients, clinicians, researchers); instrument for individuals with rheumatic and musculoskeletal diseases (RMDs)OMERACT 2025 participants
- Participants
- 33 participants
- Outcome
- Approval of the merged and modified single-item side-effect bother instrument
Methodological detailsstakeholder survey and consensus voting, structured survey, large-language-model (LLM)-assisted synthesis of collaborator feedback, OMERACT 2025 consensus meeting, Six candidate instruments rated for domain match, feasibility and ranking; collaborator feedback synthesised with an LLM to refine relevance, clarity and acceptability
- Stakeholder survey and consensus voting
- Structured survey
- LLM-assisted synthesis of collaborator feedback
- OMERACT 2025 consensus meeting
- Six candidate instruments rated for domain match, feasibility and ranking; collaborator feedback synthesised with an LLM to refine relevance, clarity and acceptability
Recommendations
As reported in the abstract
Participants approving it as a reasonable approach to incorporate collaborator input
33
Rated feasible
32
97%
Voting supported advancing further assessment as exploratory outcome in RMD trials
30
91%
Original publication
Development of a single‑item patient‑reported measure of treatment side‑effect burden in clinical trials of rheumatic and musculoskeletal diseases using stakeholder input and large language model refinement. Semin Arthritis Rheum. Published 19 June 2026. doi:10.
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