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

J Rheumatol

From the Department of Family Medicine, and Department of Medicine, McGill University, Montreal, Quebec; Institute for Work & Health, Toronto; OMERACT; Ottawa Hospital Research Institute, Ottawa Hospital; Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa; Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa Cardiovascular Research Methods Centre, University of Ottawa Heart Institute, Ottawa, Ontario, Canada; Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen; Department of Rheumatology, Odense University Hospital, Odense, Denmark; Division of Rheumatology, Hospital for Special Surgery; Department of Medicine, Weill Cornell Medical School, New York, New York; Division of Rheumatology, Department of Medicine, Johns Hopkins University, Baltimore, Maryland; Division of Biostatistics, Department of Health Sciences Research, Mayo Clinic, Scottsdale, Arizona; Medicine Service, VA Medical Center; Department of Medicine, School of Medicine, University of Alabama at Birmingham; Division of Epidemiology, School of Public Health, University of Alabama at Birmingham, Birmingham, Alabama; Division of Immunology/Rheumatology, Stanford University, Palo Alto, California; SDG LLC, Cambridge, Massachusetts, USA; Sydney Medical School, and Sydney School of Public Health, University of Sydney; Centre for Kidney Research, The Children's Hospital at Westmead, Sydney; Institute of Bone and Joint Research, Kolling Institute, Northern Sydney Local Health District; Department of Rheumatology, Royal North Shore Hospital, Reserve Road, St Leonards; Centre for Health Policy, School of Population and Global Health, The University of Melbourne, Melbourne; Discipline of Medicine, University of Adelaide; Rheumatology Unit, The Queen Elizabeth Hospital, Woodville; Department of Rheumatology, Royal Prince Alfred Hospital, Camperdown, Australia; Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; UK National Institute for Health Research (NIHR) Leeds Biomedical Research Centre, Leeds Teaching Hospitals National Health Service (NHS) Trust; NIHR-Leeds Musculoskeletal Biomedical Research Unit, University of Leeds, Leeds, UK; Hôpital Ambroise Paré, Rheumatology Department, Boulogne-Billancourt; INSERM U1173, Laboratoire d'Excellence INFLAMEX, UFR Simone Veil, Versailles-Saint-Quentin University, Saint-Quentin en Yvelines, France; Amsterdam University Medical Centre, Department of Medical Humanities, Amsterdam Public Health, Amsterdam, the Netherlands.

Published: August 2019

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.

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Source
http://dx.doi.org/10.3899/jrheum.181123DOI Listing

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