PT  - JOURNAL ARTICLE
AU  - Kathleen M.  Andersen
AU  - Jonathan T.L.  Cheah
AU  - Lyn March
AU  - Susan J.  Bartlett
AU  - Dorcas Beaton
AU  - Clifton O.  Bingham III
AU  - Peter M.  Brooks
AU  - Robin Christensen
AU  - Philip G.  Conaghan
AU  - Maria-Antonietta D’Agostino
AU  - Maarten de Wit
AU  - Amylou Dueck
AU  - Susan M.  Goodman
AU  - Shawna Grosskleg
AU  - Catherine L.  Hill
AU  - Martin Howell
AU  - Sarah L.  Mackie
AU  - Bethan Richards
AU  - Beverly Shea
AU  - Jasvinder A.  Singh
AU  - Vibeke Strand
AU  - Peter Tugwell
AU  - George A.  Wells
AU  - Lee S.  Simon
TI  - Improving Benefit-harm Assessment of Therapies from the Patient Perspective: OMERACT Premeeting Toward Consensus on Core Sets for Randomized Controlled Trials
AID  - 10.3899/jrheum.181123
DP  - 2019 Jan 15
TA  - The Journal of Rheumatology
PG  - jrheum.181123
4099  - http://www.jrheum.org/content/early/2019/02/12/jrheum.181123.short
4100  - http://www.jrheum.org/content/early/2019/02/12/jrheum.181123.full
AB  - 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.