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

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.

Metadata

Item Type:	Article
Authors/Creators:	Andersen, KM Cheah, JTL March, L Bartlett, SJ Beaton, D Beaton, D Bingham III, CO Brooks, PM Christensen, R Conaghan, PG https://orcid.org/0000-0002-3478-5665 D'Agostino, M-A de Wit, M Dueck, A Goodman, SM Grosskleg, S Hill, CL Howell, M Mackie, SL Richards, B Shea, B Singh, JA Strand, V Tugwell, P Wells, GA Simon, LS
Copyright, Publisher and Additional Information:	© 2019 The Journal of Rheumatology. This is a pre-copyediting, author-produced PDF of an article accepted for publication in The Journal of Rheumatology following peer review. The definitive publisher-authenticated version Andersen, KM, Cheah, JTL, March, L et al. (2019) Improving Benefit-harm Assessment of Therapies from the Patient Perspective: OMERACT Premeeting Toward Consensus on Core Sets for Randomized Controlled Trials. Journal of rheumatology. ISSN 0315-162X is available online at: https://doi.org/10.3899/jrheum.181123
Keywords:	OMERACT; PATIENT SATISFACTION; CLINICAL TRIALS; DISEASE-MODIFYING ANTIRHEUMATIC DRUGS; RISK ASSESSMENT
Dates:	Accepted: 11 December 2018 Published (online): 15 January 2019 Published: 1 August 2019
Institution:	The University of Leeds
Academic Units:	The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Medicine (Leeds) > Institute of Rheumatology & Musculoskeletal Medicine (LIRMM) (Leeds) > Clinical Biomechanic & Physical Med (LIRMM) (Leeds) The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Medicine (Leeds) > Institute of Rheumatology & Musculoskeletal Medicine (LIRMM) (Leeds) > Musculoskeletal Medicine & Imaging (Leeds)
Depositing User:	Symplectic Publications
Date Deposited:	03 Apr 2019 11:12
Last Modified:	15 Jan 2020 01:39
Status:	Published
Publisher:	Journal of Rheumatology
Identification Number:	10.3899/jrheum.181123
Open Archives Initiative ID (OAI ID):	oai:eprints.whiterose.ac.uk:144436

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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

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