Stakeholder endorsement advancing the implementation of a patient-reported domain for harms in rheumatology clinical trials: Outcome of the OMERACT Safety Working Group

OMERACT Safety Working Group

doi:10.1016/j.semarthrit.2023.152288

Stakeholder endorsement advancing the implementation of a patient-reported domain for harms in rheumatology clinical trials: Outcome of the OMERACT Safety Working Group

OMERACT Safety Working Group

The Parker Institute

3 Citations (Scopus)

Abstract

OBJECTIVES: To develop an understanding of the concept of safety/harms experienced by patients involved in clinical trials for their rheumatic and musculoskeletal diseases (RMDs) and to seek input from the OMERACT community before moving forward to developing or selecting an outcome measurement instrument.

METHODS: OMERACT 2023 presented and discussed interview results from 34 patients indicating that up to 171 items might be important for patients' harm-reporting.

RESULTS: Domain was defined in detail and supported by qualitative work. Participants in the Special-Interest-Group endorsed (96 %) that enough qualitative data are available to start Delphi survey(s).

CONCLUSION: We present a definition of safety/harms that represents the patient voice (i.e., patients' perception of safety) evaluating the symptomatic treatment-related adverse events for people with RMDs enrolled in clinical trials.

Original language	English
Article number	152288
Journal	Seminars in Arthritis and Rheumatism
Volume	63
Pages (from-to)	152288
ISSN	0049-0172
DOIs	https://doi.org/10.1016/j.semarthrit.2023.152288
Publication status	Published - Dec 2023

Keywords

Humans
Musculoskeletal Diseases/therapy
Outcome Assessment, Health Care
Patient Reported Outcome Measures
Rheumatology
Clinical Trials as Topic

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10.1016/j.semarthrit.2023.152288

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title = "Stakeholder endorsement advancing the implementation of a patient-reported domain for harms in rheumatology clinical trials: Outcome of the OMERACT Safety Working Group",

abstract = "OBJECTIVES: To develop an understanding of the concept of safety/harms experienced by patients involved in clinical trials for their rheumatic and musculoskeletal diseases (RMDs) and to seek input from the OMERACT community before moving forward to developing or selecting an outcome measurement instrument.METHODS: OMERACT 2023 presented and discussed interview results from 34 patients indicating that up to 171 items might be important for patients' harm-reporting.RESULTS: Domain was defined in detail and supported by qualitative work. Participants in the Special-Interest-Group endorsed (96 %) that enough qualitative data are available to start Delphi survey(s).CONCLUSION: We present a definition of safety/harms that represents the patient voice (i.e., patients' perception of safety) evaluating the symptomatic treatment-related adverse events for people with RMDs enrolled in clinical trials.",

keywords = "Humans, Musculoskeletal Diseases/therapy, Outcome Assessment, Health Care, Patient Reported Outcome Measures, Rheumatology, Clinical Trials as Topic",

author = "Berthelsen, {Dorthe B} and Simon, {Lee S} and Ioannidis, {John P A} and Marieke Voshaar and Pam Richards and Niti Goel and Vibeke Strand and Nielsen, {Sabrina M} and Shea, {Beverly J} and Peter Tugwell and Bartlett, {Susan J} and Hazlewood, {Glen S} and Lyn March and Singh, {Jasvinder A} and Suarez-Almazor, {Maria E} and Maarten Boers and Stevens, {Randall M} and Furst, {Daniel E} and Thasia Woodworth and Amye Leong and Brooks, {Peter M} and Caroline Flurey and Robin Christensen and {OMERACT Safety Working Group}",

year = "2023",

month = dec,

doi = "10.1016/j.semarthrit.2023.152288",

language = "English",

volume = "63",

pages = "152288",

journal = "Seminars in Arthritis and Rheumatism",

issn = "0049-0172",

publisher = "W.B. Saunders",

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TY - JOUR

T1 - Stakeholder endorsement advancing the implementation of a patient-reported domain for harms in rheumatology clinical trials

T2 - Outcome of the OMERACT Safety Working Group

AU - Berthelsen, Dorthe B

AU - Simon, Lee S

AU - Ioannidis, John P A

AU - Voshaar, Marieke

AU - Richards, Pam

AU - Goel, Niti

AU - Strand, Vibeke

AU - Nielsen, Sabrina M

AU - Shea, Beverly J

AU - Tugwell, Peter

AU - Bartlett, Susan J

AU - Hazlewood, Glen S

AU - March, Lyn

AU - Singh, Jasvinder A

AU - Suarez-Almazor, Maria E

AU - Boers, Maarten

AU - Stevens, Randall M

AU - Furst, Daniel E

AU - Woodworth, Thasia

AU - Leong, Amye

AU - Brooks, Peter M

AU - Flurey, Caroline

AU - Christensen, Robin

AU - OMERACT Safety Working Group

PY - 2023/12

Y1 - 2023/12

N2 - OBJECTIVES: To develop an understanding of the concept of safety/harms experienced by patients involved in clinical trials for their rheumatic and musculoskeletal diseases (RMDs) and to seek input from the OMERACT community before moving forward to developing or selecting an outcome measurement instrument.METHODS: OMERACT 2023 presented and discussed interview results from 34 patients indicating that up to 171 items might be important for patients' harm-reporting.RESULTS: Domain was defined in detail and supported by qualitative work. Participants in the Special-Interest-Group endorsed (96 %) that enough qualitative data are available to start Delphi survey(s).CONCLUSION: We present a definition of safety/harms that represents the patient voice (i.e., patients' perception of safety) evaluating the symptomatic treatment-related adverse events for people with RMDs enrolled in clinical trials.

AB - OBJECTIVES: To develop an understanding of the concept of safety/harms experienced by patients involved in clinical trials for their rheumatic and musculoskeletal diseases (RMDs) and to seek input from the OMERACT community before moving forward to developing or selecting an outcome measurement instrument.METHODS: OMERACT 2023 presented and discussed interview results from 34 patients indicating that up to 171 items might be important for patients' harm-reporting.RESULTS: Domain was defined in detail and supported by qualitative work. Participants in the Special-Interest-Group endorsed (96 %) that enough qualitative data are available to start Delphi survey(s).CONCLUSION: We present a definition of safety/harms that represents the patient voice (i.e., patients' perception of safety) evaluating the symptomatic treatment-related adverse events for people with RMDs enrolled in clinical trials.

KW - Humans

KW - Musculoskeletal Diseases/therapy

KW - Outcome Assessment, Health Care

KW - Patient Reported Outcome Measures

KW - Rheumatology

KW - Clinical Trials as Topic

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ER -

Stakeholder endorsement advancing the implementation of a patient-reported domain for harms in rheumatology clinical trials: Outcome of the OMERACT Safety Working Group

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Keywords

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