@article{8c16900d2dc943b0b0a6c45919c0949b,
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 = "Clinical trials disease-modifying antirheumatic drugs, OMERACT, Patient satisfaction, Risk assessment",
author = "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 D{\textquoteright}Agostino, {Maria Antonietta} 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.}",
note = "Funding Information: 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{\textquoteright}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; H{\^o}pital Ambroise Par{\'e}, Rheumatology Department, Boulogne-Billancourt; INSERM U1173, Laboratoire d{\textquoteright}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. The Parker Institute, Bispebjerg and Frederiksberg Hospital (RC) is supported by a core grant from the Oak Foundation (OCAY-13-309). PGC is supported in part by the NIHR Leeds Biomedical Research Centre. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. K.M. Andersen, MSc, Department of Family Medicine, McGill University, and Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital; J.T. Cheah, MBBS, Rheumatology Fellow, Division of Rheumatology, Hospital for Special Surgery, and Fellow in Medicine, Department of Medicine, Weill Cornell Medicine; L. March, MBBS, MSc, PhD, FRACP, FAFPHM, Sydney Medical School, University of Sydney, and Institute of Bone and Joint Research, Kolling Institute, Northern Sydney Local Health District, and Department of Rheumatology, Royal North Shore Hospital; S.J. Bartlett, PhD, Professor, Department of Medicine, McGill University, and Adjunct Professor, Department of Medicine, Johns Hopkins University; D. Beaton, BscOT, PhD, Senior Scientist, Institute for Work & Health; C.O. Bingham III, MD, Division of Rheumatology, Department of Medicine, Johns Hopkins University; Funding Information: The Parker Institute, Bispebjerg and Frederiksberg Hospital (RC) is supported by a core grant from the Oak Foundation (OCAY-13-309). PGC is supported in part by the NIHR Leeds Biomedical Research Centre. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. Publisher Copyright: {\textcopyright} 2019 Journal of Rheumatology. All rights reserved.",
year = "2019",
month = aug,
day = "1",
doi = "10.3899/jrheum.181123",
language = "English (US)",
volume = "46",
pages = "1053--1058",
journal = "Journal of Rheumatology",
issn = "0315-162X",
publisher = "Journal of Rheumatology",
number = "8",
}