Improving Benefit-harm Assessment of Therapies from the Patient Perspective: OMERACT premeeting toward consensus on core sets for randomized controlled trials

Academic Article


  • 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.
  • Authors

    Published In

    Digital Object Identifier (doi)

    Author List

  • Andersen KM; Cheah JTL; March L; Bartlett SJ; Beaton D; Bingham CO; Brooks PM; Christensen R; Conaghan PG; D’Agostino MA
  • Start Page

  • 1053
  • End Page

  • 1058
  • Volume

  • 46
  • Issue

  • 8