Patient Perspectives on DMARD Safety Concerns in Rheumatology Trials: Results from Inflammatory Arthritis Patient Focus Groups and OMERACT Attendees Discussion

Kathleen M Andersen; Ayano Kelly; Anne Lyddiatt; Clifton O Bingham 3rd; Vivian P Bykerk; Adena Batterman; Joan Westreich; Michelle K Jones; Marita Cross; Peter M Brooks; Lyn March; Beverley Shea; Peter Tugwell; Lee S Simon; Robin Christensen; Susan J Bartlett

doi:10.3899/jrheum.181185

Patient Perspectives on DMARD Safety Concerns in Rheumatology Trials: Results from Inflammatory Arthritis Patient Focus Groups and OMERACT Attendees Discussion

J Rheumatol. 2019 Sep;46(9):1168-1172. doi: 10.3899/jrheum.181185. Epub 2019 Feb 15.

Authors

Kathleen M Andersen^{1

2}, Ayano Kelly^{1

2}, Anne Lyddiatt^{1

2}, Clifton O Bingham 3rd^{1

2}, Vivian P Bykerk^{1

2}, Adena Batterman^{1

2}, Joan Westreich^{1

2}, Michelle K Jones^{1

2}, Marita Cross^{1

2}, Peter M Brooks^{1

2}, Lyn March^{1

2}, Beverley Shea^{1

2}, Peter Tugwell^{1

2}, Lee S Simon^{1

2}, Robin Christensen^{1

2}, Susan J Bartlett^{3

4}

Affiliations

¹ From the Department of Family Medicine, and the Department of Medicine, McGill University, Montreal, Quebec; 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, Ontario, Canada; Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen; Department of Rheumatology, Odense University Hospital, Odense, Denmark; Canberra Rheumatology; College of Health and Medicine, Australian National University, Canberra; Centre for Kidney Research, The Children's Hospital at Westmead; Institute of Bone and Joint Research-Kolling Institute, University of Sydney; Sydney Medical School, University of Sydney, Sydney; Department of Rheumatology, Royal North Shore Hospital; Institute of Bone and Joint Research, Kolling Institute, Northern Sydney Local Health District, St Leonards; Centre for Health Policy, School of Population and Global Health, The University of Melbourne, Melbourne; Northern Health, Epping, Australia; Division of Rheumatology, Department of Medicine, Johns Hopkins University, Baltimore, Maryland; Division of Rheumatology, Department of Medicine, Hospital for Special Surgery; Department of Social Work Programs, Hospital for Special Surgery, New York, New York; SDG LLC, Cambridge, Massachusetts, USA.
² K.M. Andersen, MSc, Department of Family Medicine, McGill University, and Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital; A. Kelly, MD, PhD student, Canberra Rheumatology, and College of Health and Medicine, Australian National University, and Centre for Kidney Research, The Children's Hospital at Westmead; A. Lyddiatt, Patient Partner; C.O. Bingham III, MD, Division of Rheumatology, Department of Medicine, Johns Hopkins University; V.P. Bykerk, MD, Division of Rheumatology, Department of Medicine, Hospital for Special Surgery; A. Batterman, MSW, Department of Social Work Programs, Hospital for Special Surgery; J. Westreich, MSW, Department of Social Work Programs, Hospital for Special Surgery; M.K. Jones, BSc, Division of Rheumatology, Department of Medicine, Johns Hopkins University; M. Cross, PhD, Institute of Bone and Joint Research-Kolling Institute, University of Sydney, and Rheumatology Department, Royal North Shore Hospital; P.M. Brooks, MD, Centre for Health Policy, School of Population and Global Health, The University of Melbourne, and Northern Health; 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, St Leonards, and Department of Rheumatology, Royal North Shore Hospital; B. Shea, PhD, Clinical Investigator, Ottawa Hospital Research Institute, Ottawa Hospital, and Adjunct Professor, School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa; 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; L.S. Simon, MD, SDG LLC; R. Christensen, PhD, Professor of Biostatistics and Clinical Epidemiology; Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, and Department of Rheumatology, Odense University Hospital; S.J. Bartlett, PhD, Professor, Department of Medicine, McGill University, and Adjunct Professor, Division of Rheumatology, Department of Medicine, Johns Hopkins University.
³ From the Department of Family Medicine, and the Department of Medicine, McGill University, Montreal, Quebec; 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, Ontario, Canada; Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen; Department of Rheumatology, Odense University Hospital, Odense, Denmark; Canberra Rheumatology; College of Health and Medicine, Australian National University, Canberra; Centre for Kidney Research, The Children's Hospital at Westmead; Institute of Bone and Joint Research-Kolling Institute, University of Sydney; Sydney Medical School, University of Sydney, Sydney; Department of Rheumatology, Royal North Shore Hospital; Institute of Bone and Joint Research, Kolling Institute, Northern Sydney Local Health District, St Leonards; Centre for Health Policy, School of Population and Global Health, The University of Melbourne, Melbourne; Northern Health, Epping, Australia; Division of Rheumatology, Department of Medicine, Johns Hopkins University, Baltimore, Maryland; Division of Rheumatology, Department of Medicine, Hospital for Special Surgery; Department of Social Work Programs, Hospital for Special Surgery, New York, New York; SDG LLC, Cambridge, Massachusetts, USA. [email protected].
⁴ K.M. Andersen, MSc, Department of Family Medicine, McGill University, and Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital; A. Kelly, MD, PhD student, Canberra Rheumatology, and College of Health and Medicine, Australian National University, and Centre for Kidney Research, The Children's Hospital at Westmead; A. Lyddiatt, Patient Partner; C.O. Bingham III, MD, Division of Rheumatology, Department of Medicine, Johns Hopkins University; V.P. Bykerk, MD, Division of Rheumatology, Department of Medicine, Hospital for Special Surgery; A. Batterman, MSW, Department of Social Work Programs, Hospital for Special Surgery; J. Westreich, MSW, Department of Social Work Programs, Hospital for Special Surgery; M.K. Jones, BSc, Division of Rheumatology, Department of Medicine, Johns Hopkins University; M. Cross, PhD, Institute of Bone and Joint Research-Kolling Institute, University of Sydney, and Rheumatology Department, Royal North Shore Hospital; P.M. Brooks, MD, Centre for Health Policy, School of Population and Global Health, The University of Melbourne, and Northern Health; 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, St Leonards, and Department of Rheumatology, Royal North Shore Hospital; B. Shea, PhD, Clinical Investigator, Ottawa Hospital Research Institute, Ottawa Hospital, and Adjunct Professor, School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa; 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; L.S. Simon, MD, SDG LLC; R. Christensen, PhD, Professor of Biostatistics and Clinical Epidemiology; Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, and Department of Rheumatology, Odense University Hospital; S.J. Bartlett, PhD, Professor, Department of Medicine, McGill University, and Adjunct Professor, Division of Rheumatology, Department of Medicine, Johns Hopkins University. [email protected].

Abstract

Objective: The Outcome Measures in Rheumatology (OMERACT) Safety Working Group is identifying core safety domains that matter most to patients with rheumatic disease.

Methods: International focus groups were held with 39 patients with inflammatory arthritis to identify disease-modifying antirheumatic drug (DMARD) experiences and concerns. Themes were identified by pragmatic thematic coding and discussed in small groups by meeting attendees.

Results: Patients view DMARD side effects as a continuum and consider the cumulative effect on day-to-day function. Disease and drug experiences, personal factors, and life circumstances influence tolerance of side effects and treatment persistence.

Conclusion: Patients weigh overall adverse effects and benefits over time in relation to experiences and life circumstances.

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

Publication types

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

MeSH terms

Adult
Antirheumatic Agents / adverse effects*
Antirheumatic Agents / therapeutic use
Arthritis, Rheumatoid / drug therapy*
Female
Focus Groups
Humans
Male
Patient Satisfaction
Rheumatology

Substances

Antirheumatic Agents

Grants and funding

P30 AR070254/AR/NIAMS NIH HHS/United States