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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.

Authors
  • Andersen, Kathleen M1, 2
  • Cheah, Jonathan T L3, 4
  • March, Lyn3, 4
  • Bartlett, Susan J3, 4
  • Beaton, Dorcas3, 4
  • Bingham, Clifton O 3rd3, 4
  • Brooks, Peter M3, 4
  • Christensen, Robin3, 4
  • Conaghan, Philip G3, 4
  • D'Agostino, Maria-Antonietta3, 4
  • de Wit, Maarten3, 4
  • Dueck, Amylou C3, 4
  • Goodman, Susan M3, 4
  • Grosskleg, Shawna3, 4
  • Hill, Catherine L3, 4
  • Howell, Martin3, 4
  • Mackie, Sarah L3, 4
  • Richards, Bethan3, 4
  • Shea, Beverly3, 4
  • Singh, Jasvinder A3, 4
  • And 4 more
  • 1 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. [email protected] , (Australia)
  • 2 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; P.M. Brooks, MD, Centre for Health Policy, School of Population and Global Health, The University of Melbourne; R. Christensen, MSc, PhD, Professor of Biostatistics and Clinical Epidemiology, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, and Department of Rheumatology, Odense University Hospital; P.G. Conaghan, MBBS, PhD, Director, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and Deputy Director, NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust; M.A. D'Agostino, MD, PhD, APHP, Hôpital Ambroise Paré, Rheumatology Department, and INSERM U1173, Laboratoire d'Excellence INFLAMEX, UFR Simone Veil; M. de Wit, PhD, Amsterdam University Medical Centre, Department of Medical Humanities, Amsterdam Public Health; A. Dueck, PhD, Division of Biostatistics, Department of Health Sciences Research, Mayo Clinic; S.M. Goodman, MD, Professor of Clinical Medicine, Division of Rheumatology, Hospital for Special Surgery, and Professor of Clinical Medicine, Department of Medicine, Weill Cornell Medical School; S. Grosskleg, OMERACT, and University of Ottawa; C.L. Hill, MBBS, MSc, MD, FRACP, Professor, Discipline of Medicine, University of Adelaide & Rheumatology Unit, The Queen Elizabeth Hospital; M. Howell, PhD, Sydney School of Public Health, The University of Sydney, and Centre for Kidney Research, The Children's Hospital at Westmead; S.L. Mackie, MB BCh, PhD, MRCP, Associate Clinical Professor, NIHR-Leeds Musculoskeletal Biomedical Research Unit, University of Leeds; B. Richards, MBBS (Hons), MClinEpi, MSportsMed, FRACP, Department of Rheumatology, Royal Prince Alfred Hospital; B. Shea, PhD, Clinical Investigator, Ottawa Hospital Research Institute, Ottawa Hospital, and Adjunct Professor, Public Health, Faculty of Medicine, University of Ottawa; J.A. Singh, MBBS, MPH, Medicine Service, VA Medical Center, and Department of Medicine, School of Medicine, University of Alabama at Birmingham, and Division of Epidemiology, School of Public Health, University of Alabama at Birmingham; V. Strand, MD, Biopharmaceutical Consultant, Portola Valley, California, USA; P. Tugwell, MD, MSc, Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, and Clinical Epidemiology Program, Ottawa Hospital Research Institute; G.A. Wells, MSc, PhD, School of Epidemiology and Public Health, University of Ottawa, and Cardiovascular Research Methods Centre, University of Ottawa Heart Institute; L.S. Simon, MD, SDG LLC. [email protected]
  • 3 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. , (Australia)
  • 4 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; P.M. Brooks, MD, Centre for Health Policy, School of Population and Global Health, The University of Melbourne; R. Christensen, MSc, PhD, Professor of Biostatistics and Clinical Epidemiology, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, and Department of Rheumatology, Odense University Hospital; P.G. Conaghan, MBBS, PhD, Director, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and Deputy Director, NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust; M.A. D'Agostino, MD, PhD, APHP, Hôpital Ambroise Paré, Rheumatology Department, and INSERM U1173, Laboratoire d'Excellence INFLAMEX, UFR Simone Veil; M. de Wit, PhD, Amsterdam University Medical Centre, Department of Medical Humanities, Amsterdam Public Health; A. Dueck, PhD, Division of Biostatistics, Department of Health Sciences Research, Mayo Clinic; S.M. Goodman, MD, Professor of Clinical Medicine, Division of Rheumatology, Hospital for Special Surgery, and Professor of Clinical Medicine, Department of Medicine, Weill Cornell Medical School; S. Grosskleg, OMERACT, and University of Ottawa; C.L. Hill, MBBS, MSc, MD, FRACP, Professor, Discipline of Medicine, University of Adelaide & Rheumatology Unit, The Queen Elizabeth Hospital; M. Howell, PhD, Sydney School of Public Health, The University of Sydney, and Centre for Kidney Research, The Children's Hospital at Westmead; S.L. Mackie, MB BCh, PhD, MRCP, Associate Clinical Professor, NIHR-Leeds Musculoskeletal Biomedical Research Unit, University of Leeds; B. Richards, MBBS (Hons), MClinEpi, MSportsMed, FRACP, Department of Rheumatology, Royal Prince Alfred Hospital; B. Shea, PhD, Clinical Investigator, Ottawa Hospital Research Institute, Ottawa Hospital, and Adjunct Professor, Public Health, Faculty of Medicine, University of Ottawa; J.A. Singh, MBBS, MPH, Medicine Service, VA Medical Center, and Department of Medicine, School of Medicine, University of Alabama at Birmingham, and Division of Epidemiology, School of Public Health, University of Alabama at Birmingham; V. Strand, MD, Biopharmaceutical Consultant, Portola Valley, California, USA; P. Tugwell, MD, MSc, Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, and Clinical Epidemiology Program, Ottawa Hospital Research Institute; G.A. Wells, MSc, PhD, School of Epidemiology and Public Health, University of Ottawa, and Cardiovascular Research Methods Centre, University of Ottawa Heart Institute; L.S. Simon, MD, SDG LLC.
Type
Published Article
Journal
The Journal of rheumatology
Publication Date
Aug 01, 2019
Volume
46
Issue
8
Pages
1053–1058
Identifiers
DOI: 10.3899/jrheum.181123
PMID: 30647191
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

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. 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. Five themes pertaining to drug safety measurement emerged. 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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