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Improving Benefit-harm Assessment of Therapies from the Patient Perspective: OMERACT Premeeting Toward Consensus on Core Sets for Randomized Controlled Trials

Research output: Contribution to journalJournal articleResearchpeer-review


  • Kathleen M Andersen
  • Jonathan T L Cheah
  • Lyn March
  • Susan J Bartlett
  • Dorcas Beaton
  • Clifton O Bingham
  • Peter M Brooks
  • Robin Christensen
  • Philip G Conaghan
  • Maria-Antonietta D'Agostino
  • Maarten de Wit
  • Amylou C Dueck
  • Susan M Goodman
  • Shawna Grosskleg
  • Catherine L Hill
  • Martin Howell
  • Sarah L Mackie
  • Bethan Richards
  • Beverly Shea
  • Jasvinder A Singh
  • Vibeke Strand
  • Peter Tugwell
  • George A Wells
  • Lee S Simon
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OBJECTIVE: Outcome Measures in Rheumatology (OMERACT) convened a premeeting in 2018 to bring together patients, regulators, researchers, clinicians, and consumers to build upon previous OMERACT drug safety work, with patients fully engaged throughout all phases.

METHODS: Day 1 included a brief introduction to the history of OMERACT and methodology, and an overview of current efforts within and outside OMERACT to identify patient-reported medication safety concerns. On Day 2, two working groups presented results; after each, breakout groups were assembled to discuss findings.

RESULTS: Five themes pertaining to drug safety measurement emerged.

CONCLUSION: Current approaches have failed to include data from the patient's perspective. A better understanding of how individuals with rheumatic diseases view potential benefits and harms of therapies is essential.

Original languageEnglish
JournalJournal of Rheumatology
Issue number8
Pages (from-to)1053-1058
Number of pages6
Publication statusPublished - Aug 2019

ID: 57855380