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 journalJournal articleResearchpeer-review

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
Article number181123
JournalJournal of Rheumatology
Volume46
Issue number8
Pages (from-to)1053-1058
ISSN0315-162X
DOIs
Publication statusPublished - Aug 2019

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

Cite this

Andersen, K. M., Cheah, J. T. L., March, L., Bartlett, S. J., Beaton, D., Bingham, C. O., ... Simon, L. S. (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, 46(8), 1053-1058. [181123]. 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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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's perspective. A better understanding of how individuals with rheumatic diseases view potential benefits and harms of therapies is essential.",
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 Maria-Antonietta D'Agostino and {de Wit}, Maarten and Amylou Dueck 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}",
year = "2019",
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Andersen, KM, Cheah, JTL, March, L, Bartlett, SJ, Beaton, D, Bingham, CO, Brooks, PM, Christensen, R, Conaghan, PG, D'Agostino, M-A, 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, 181123, pp. 1053-1058. https://doi.org/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. / 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, 181123, 08.2019, p. 1053-1058.

Research output: Contribution to journalJournal articleResearchpeer-review

TY - JOUR

T1 - Improving Benefit-harm Assessment of Therapies from the Patient Perspective

T2 - OMERACT Premeeting Toward Consensus on Core Sets for Randomized Controlled Trials

AU - Andersen, Kathleen M

AU - Cheah, Jonathan T L

AU - March, Lyn

AU - Bartlett, Susan J

AU - Beaton, Dorcas

AU - Bingham, Clifton O

AU - Brooks, Peter M

AU - Christensen, Robin

AU - Conaghan, Philip G

AU - D'Agostino, Maria-Antonietta

AU - de Wit, Maarten

AU - Dueck, Amylou

AU - Goodman, Susan M

AU - Grosskleg, Shawna

AU - Hill, Catherine L

AU - Howell, Martin

AU - Mackie, Sarah L

AU - Richards, Bethan

AU - Shea, Beverly

AU - Singh, Jasvinder A

AU - Strand, Vibeke

AU - Tugwell, Peter

AU - Wells, George A

AU - Simon, Lee S

PY - 2019/8

Y1 - 2019/8

N2 - 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.

AB - 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.

U2 - 10.3899/jrheum.181123

DO - 10.3899/jrheum.181123

M3 - Journal article

VL - 46

SP - 1053

EP - 1058

JO - Journal of Rheumatology

JF - Journal of Rheumatology

SN - 0315-162X

IS - 8

M1 - 181123

ER -