Identifying Possible Outcome Domains from Existing Outcome Measures to Inform an OMERACT Core Domain Set for Safety in Rheumatology Trials

Objective: The Outcome Measures in Rheumatology (OMERACT) Safety Working Group objective was to identify harm domains from existing outcome measurements in rheumatology.

Methods: Systematically searching the MEDLINE database on January 24, 2017, we identified full-text articles that could be used for harm outcomes in rheumatology. Domains/items from the identified instruments were described and the content synthesized to provide a preliminary framework for harm outcomes.

Results: From 435 possible references, 24 were read in full text and 9 were included: 7 measurement instruments were identified. Investigation of domains/items revealed considerable heterogeneity in the grouping and approach.

Conclusion: The ideal way to assess harm aspects from the patients' perspective has not yet been ascertained.

Contributors

Louise Klokker, Dorthe B Berthelsen, Thasia Woodworth, Kathleen M Andersen, Daniel E Furst, Dan Devoe, Paula R Williamson, Maria E Suarez-Almazor, Vibeke Strand, Amye L Leong, Niti Goel, Maarten Boers, Peter M Brooks, Lyn March, Victor S Sloan, Peter Tugwell, Lee S Simon, Robin Christensen

Publication

Journal: J Rheumatol
Volume: 46
Issue: 9
Pages: 1173 - 1178
Year: 2019
DOI: 10.3899/jrheum.190196

Further Study Information

Current Stage: Completed
Date:
Funding source(s):


Health Area

Disease Category: Rheumatology

Disease Name: Inflammatory arthritis

Target Population

Age Range: 18 - 100

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

Study Type

- Systematic review of outcome measures/measurement instruments

Method(s)

- Systematic review