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

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

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.

Aim

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.

Contributors

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

Publication

Journal: Seminars in Arthritis and Rheumatism
Volume: 63
Issue:
Pages: -
Year: 2023
DOI: 10.1016/j.semarthrit.2023.152288

Further Study Information

Current Stage: Completed
Date:
Funding source(s): Section for Biostatistics and Evidence-Based Research, the Parker Institute is supported by a core grant from the Oak Foundation (OCAY-18-774-OFIL). The Oak Foundation is a group of philanthropic organizations and, since its establishment in 1983; it has given grants to not-for-profit organizations around the world. DBB, MV, PR, SMN and RC have received a travel grant from the Erna Hamilton Foundation. The Oak Foundation and the Erna Hamilton Foundation had no role in the study design, data collection and analyses, interpretation or reporting of this work, or the decision to submit the work for publication. DBB has received PhD Scholarships from Odense University Hospital and from the Faculty of Health Sciences, University of Southern Denmark.

Health Area

Disease Category: Rheumatology

Disease Name: Musculoskeletal conditions

Target Population

Age Range: Unknown

Sex: Either

Nature of Intervention:

Stakeholders Involved

- Clinical experts
- Consumers (patients)
- Funders
- Pharmaceutical industry representatives
- Policy makers
- Researchers
- Service providers

Study Type

- Recommendations made

Method(s)

- Semi structured discussion

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