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, Peter M. Brooks, Robin Christensen, Philip G. Conaghan, Maria Antonietta D’Agostino, Maarten De Wit, Amylou Dueck, Susan M. Goodman, Shawna Grosskleg, Catherine L. Hill, Martin Howell, Sarah L. Mackie, Bethan Richards, Beverly Shea, Jasvinder A. Singh & 4 others Vibeke Strand, Peter Tugwell, George A. Wells, Lee S. Simon

Research output: Contribution to journalArticle

3 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1053-1058
Number of pages6
JournalJournal of Rheumatology
Volume46
Issue number8
DOIs
StatePublished - Aug 1 2019

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Randomized Controlled Trials
Safety
Rheumatology
Therapeutics
Rheumatic Diseases
Pharmaceutical Preparations
History
Research Personnel
Outcome Assessment (Health Care)

Keywords

  • Clinical trials disease-modifying antirheumatic drugs
  • OMERACT
  • Patient satisfaction
  • Risk assessment

ASJC Scopus subject areas

  • Rheumatology
  • Immunology and Allergy
  • Immunology

Cite this

Improving Benefit-harm Assessment of Therapies from the Patient Perspective : OMERACT premeeting toward consensus on core sets for randomized controlled trials. / Andersen, Kathleen M.; Cheah, Jonathan T.L.; March, Lyn; Bartlett, Susan J.; Beaton, Dorcas; Bingham, Clifton O.; Brooks, Peter M.; Christensen, Robin; Conaghan, Philip G.; D’Agostino, Maria Antonietta; De Wit, Maarten; Dueck, Amylou; Goodman, Susan M.; Grosskleg, Shawna; Hill, Catherine L.; Howell, Martin; Mackie, Sarah L.; Richards, Bethan; Shea, Beverly; Singh, Jasvinder A.; Strand, Vibeke; Tugwell, Peter; Wells, George A.; Simon, Lee S.

In: Journal of Rheumatology, Vol. 46, No. 8, 01.08.2019, p. 1053-1058.

Research output: Contribution to journalArticle

Andersen, KM, Cheah, JTL, March, L, Bartlett, SJ, Beaton, D, Bingham, CO, Brooks, PM, Christensen, R, Conaghan, PG, D’Agostino, MA, De Wit, M, Dueck, A, Goodman, SM, Grosskleg, S, Hill, CL, Howell, M, Mackie, SL, Richards, B, Shea, B, Singh, JA, Strand, V, Tugwell, P, Wells, GA & Simon, LS 2019, 'Improving Benefit-harm Assessment of Therapies from the Patient Perspective: OMERACT premeeting toward consensus on core sets for randomized controlled trials', Journal of Rheumatology, vol. 46, no. 8, pp. 1053-1058. https://doi.org/10.3899/jrheum.181123
Andersen, Kathleen M. ; Cheah, Jonathan T.L. ; March, Lyn ; Bartlett, Susan J. ; Beaton, Dorcas ; Bingham, Clifton O. ; Brooks, Peter M. ; Christensen, Robin ; Conaghan, Philip G. ; D’Agostino, Maria Antonietta ; De Wit, Maarten ; Dueck, Amylou ; Goodman, Susan M. ; Grosskleg, Shawna ; Hill, Catherine L. ; Howell, Martin ; Mackie, Sarah L. ; Richards, Bethan ; Shea, Beverly ; Singh, Jasvinder A. ; Strand, Vibeke ; Tugwell, Peter ; Wells, George A. ; Simon, Lee S. / Improving Benefit-harm Assessment of Therapies from the Patient Perspective : OMERACT premeeting toward consensus on core sets for randomized controlled trials. In: Journal of Rheumatology. 2019 ; Vol. 46, No. 8. pp. 1053-1058.
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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.",
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AU - Singh, Jasvinder A.

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AU - Tugwell, Peter

AU - Wells, George A.

AU - Simon, Lee S.

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