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

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 SinghVibeke Strand, Peter Tugwell, George A Wells, Lee S Simon

9 Citationer (Scopus)

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.

OriginalsprogEngelsk
TidsskriftJournal of Rheumatology
Vol/bind46
Udgave nummer8
Sider (fra-til)1053-1058
Antal sider6
ISSN0315-162X
DOI
StatusUdgivet - aug. 2019

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