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

Research output: Contribution to journalJournal articleResearchpeer-review


  • 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
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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.

Original languageEnglish
JournalJournal of Rheumatology
Issue number9
Pages (from-to)1173-1178
Number of pages6
Publication statusPublished - Sep 2019

ID: 58097603