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

OMERACT Safety Working Group

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.

Original languageEnglish
Article number152288
JournalSeminars in Arthritis and Rheumatism
Volume63
Pages (from-to)152288
ISSN0049-0172
DOIs
Publication statusPublished - Dec 2023

Keywords

  • Humans
  • Musculoskeletal Diseases/therapy
  • Outcome Assessment, Health Care
  • Patient Reported Outcome Measures
  • Rheumatology
  • Clinical Trials as Topic

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