@article{451005d633354aaf803b5f9418c16820,
title = "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{\textquoteright}s perspective. A better understanding of how individuals with rheumatic diseases view potential benefits and harms of therapies is essential.",
keywords = "Antirheumatic Agents, Clinical trials disease-modifying antirheumatic drugs, Humans, OMERACT, Patient Satisfaction, Patient satisfaction, Randomized Controlled Trials as Topic, Rheumatic Diseases, Risk Assessment, Risk assessment, Treatment Outcome, Antirheumatic Agents, Clinical trials disease-modifying antirheumatic drugs, Humans, OMERACT, Patient Satisfaction, Patient satisfaction, Randomized Controlled Trials as Topic, Rheumatic Diseases, Risk Assessment, Risk assessment, Treatment Outcome",
author = "D'Agostino, {Maria Antonietta} and Andersen, {Kathleen M.} and Cheah, {Jonathan T.L.} and Lyn March and Bartlett, {Susan J.} and Dorcas Beaton and Bingham, {Clifton O.} and Brooks, {Peter M.} and Robin Christensen and Conaghan, {Philip G.} and Maria-Antonietta D{\textquoteright}Agostino and {De Wit}, Maarten and Dueck, {Amylou C.} and Goodman, {Susan M.} and Shawna Grosskleg and Hill, {Catherine L.} and Martin Howell and Mackie, {Sarah L.} and Bethan Richards and Beverly Shea and Singh, {Jasvinder A.} and Vibeke Strand and Peter Tugwell and Wells, {George A.} and Simon, {Lee S.}",
year = "2019",
doi = "10.3899/jrheum.181123",
language = "English",
volume = "46",
pages = "1053--1058",
journal = "Journal of Rheumatology",
issn = "0315-162X",
publisher = "Journal of Rheumatology:920 Yonge Street, Suite 115, Toronto Ontario M4W 3C7 Canada:(416)967-5155, EMAIL: jrheum@inforamp.com, INTERNET: http://jrheum.com, Fax: (416)967-7556",
}