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

Kathleen M Andersen; Jonathan T L Cheah; Lyn March; Susan J Bartlett; Dorcas Beaton; Clifton O Bingham 3rd; Peter M Brooks; Robin Christensen; Philip G Conaghan; Maria-Antonietta D'Agostino; Maarten de Wit; Amylou C Dueck; Susan M Goodman; Shawna Grosskleg; Catherine L Hill; Martin Howell; Sarah L Mackie; Bethan Richards; Beverly Shea; Jasvinder A Singh; Vibeke Strand; Peter Tugwell; George A Wells; Lee S Simon

doi:10.3899/jrheum.181123

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

J Rheumatol. 2019 Aug;46(8):1053-1058. doi: 10.3899/jrheum.181123. Epub 2019 Jan 15.

Authors

Kathleen M Andersen^{1

2}, Jonathan T L Cheah^{3

4}, Lyn March^{3

4}, Susan J Bartlett^{3

4}, Dorcas Beaton^{3

4}, Clifton O Bingham 3rd^{3

4}, Peter M Brooks^{3

4}, Robin Christensen^{3

4}, Philip G Conaghan^{3

4}, Maria-Antonietta D'Agostino^{3

4}, Maarten de Wit^{3

4}, Amylou C Dueck^{3

4}, Susan M Goodman^{3

4}, Shawna Grosskleg^{3

4}, Catherine L Hill^{3

4}, Martin Howell^{3

4}, Sarah L Mackie^{3

4}, Bethan Richards^{3

4}, Beverly Shea^{3

4}, Jasvinder A Singh^{3

4}, Vibeke Strand^{3

4}, Peter Tugwell^{3

4}, George A Wells^{3

4}, Lee S Simon^{3

4}

Affiliations

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. kathleen.andersen@mail.mcgill.ca.
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. kathleen.andersen@mail.mcgill.ca.
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.
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.

PMID: 30647191
DOI: 10.3899/jrheum.181123

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.

Keywords: CLINICAL TRIALS; DISEASE-MODIFYING ANTIRHEUMATIC DRUGS; OMERACT; PATIENT SATISFACTION; RISK ASSESSMENT.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Antirheumatic Agents / therapeutic use*
Humans
Patient Satisfaction*
Randomized Controlled Trials as Topic*
Rheumatic Diseases / drug therapy*
Risk Assessment
Treatment Outcome

Substances

Antirheumatic Agents

Abstract

Publication types

MeSH terms

Substances

Grants and funding