Abstract
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.
Publisher
The Journal of Rheumatology
Subject
Immunology,Immunology and Allergy,Rheumatology
Reference14 articles.
1. A first step to assess harm and benefit in clinical trials in one scale
2. Observations from the OMERACT Drug Safety Summit, May 2008
3. How to Ascertain Drug Safety in the Context of Benefit. Controversies and Concerns: Table 1.
4. Standardized assessment of adverse events in rheumatology clinical trials: Summary of the OMERACT 7 drug safety module update;Lassere;J Rheumatol,2005
5. Boers M Kirwan JR Tugwell P Beaton D Bingham CO III Conaghan PG . The OMERACT Handbook. [Internet. Accessed September 20, 2018.] Available from: https://omeract.org/resources
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