Improving benefit-harm assessment of glucocorticoid therapy incorporating the patient perspective: The OMERACT glucocorticoid core domain set

Joanna Tieu; Jonathan Tl Cheah; Rachel J Black; Robin Christensen; Nilasha Ghosh; Pamela Richards; Joanna Robson; Beverley Shea; Lee S Simon; Jasvinder A Singhi; Peter Tugwell; Maarten Boers; Marco A Alba Garibay; Corrado Campochiaro; Simon Decary; Maarten de Witt; Anthony P Fernandez; Helen I Keen; Lauren King; Andrea Hinojosa-Azaola; Cathie Hofstetter; Inna Gaydukova; Michael D George; Latika Gupta; Suellen Lyne; Ashima Makol; Chetan Mukhtyar; Win Min Oo; Michelle Petri; Huai Leng Pisaniello; Sebastian E Sattui; Oscar Russell; Vitor Teixeira; Karine Toupin-April; Courage Uhunmwangho; Margaret Whitstock; Kevin Yip; Sarah L Mackie; Susan M Goodman; Catherine L Hill

doi:10.1016/j.semarthrit.2021.06.010

Improving benefit-harm assessment of glucocorticoid therapy incorporating the patient perspective: The OMERACT glucocorticoid core domain set

Joanna Tieu, Jonathan Tl Cheah, Rachel J Black, Robin Christensen, Nilasha Ghosh, Pamela Richards, Joanna Robson, Beverley Shea, Lee S Simon, Jasvinder A Singhi, Peter Tugwell, Maarten Boers, Marco A Alba Garibay, Corrado Campochiaro, Simon Decary, Maarten de Witt, Anthony P Fernandez, Helen I Keen, Lauren King, Andrea Hinojosa-AzaolaCathie Hofstetter, Inna Gaydukova, Michael D George, Latika Gupta, Suellen Lyne, Ashima Makol, Chetan Mukhtyar, Win Min Oo, Michelle Petri, Huai Leng Pisaniello, Sebastian E Sattui, Oscar Russell, Vitor Teixeira, Karine Toupin-April, Courage Uhunmwangho, Margaret Whitstock, Kevin Yip, Sarah L Mackie, Susan M Goodman, Catherine L Hill

Division of Musculoskeletal & Dermatological Sciences (L5)

Research output: Contribution to journal › Article › peer-review

Abstract

OBJECTIVE: Our primary objective was to develop an Outcome Measures in Rheumatology (OMERACT) core domain set to capture the impact of glucocorticoids (GC), both positive and negative, on patients with Rheumatic conditions.

METHODS: The OMERACT Filter 2.1 was used to guide core domain selection. Systematic literature reviews, qualitative studies and quantitative surveys were conducted by the OMERACT GC Impact working group to identify candidate domains for a core domain set. A summary of prior work and Delphi exercise were presented at the OMERACT 2020 virtual GC workshop. A proposed GC Impact core domain set derived from this work was presented for discussion in facilitated breakout groups. Participants voted on the proposed GC Impact core domain set.

RESULTS: 113 people, including 23 patient research partners, participated in two virtual workshops conducted at different times on the same day. The proposed mandatory domains to be evaluated in clinical trials involving GCs were: infection, bone fragility, hypertension, diabetes, weight, fatigue, mood disturbance and death. In addition, collection of disease specific outcomes was included in the core domain set as "mandatory in specific circumstances". The proposed core domain set was endorsed by 100% (23/23) of the patient research partners and 92% (83/90) of the remaining participants, including clinicians, researchers and industry stakeholders.

CONCLUSION: A GC Impact core domain set was endorsed at the OMERACT 2020 virtual workshop. The OMERACT GC Impact working group will now progress to identify, develop and validate measurement tools to best address these domains in clinical trials.

Original language	English
Pages (from-to)	1139-1145
Number of pages	7
Journal	Seminars in arthritis and rheumatism
Volume	51
Issue number	5
DOIs	https://doi.org/10.1016/j.semarthrit.2021.06.010
Publication status	Published - Oct 2021

Keywords

Glucocorticoids/therapeutic use
Humans
Outcome Assessment, Health Care
Rheumatic Diseases/drug therapy
Rheumatology

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1016/j.semarthrit.2021.06.010

Cite this

Tieu, J., Cheah, J. T., Black, R. J., Christensen, R., Ghosh, N., Richards, P., Robson, J., Shea, B., Simon, L. S., Singhi, J. A., Tugwell, P., Boers, M., Garibay, M. A. A., Campochiaro, C., Decary, S., de Witt, M., Fernandez, A. P., Keen, H. I., King, L., ... Hill, C. L. (2021). Improving benefit-harm assessment of glucocorticoid therapy incorporating the patient perspective: The OMERACT glucocorticoid core domain set. Seminars in arthritis and rheumatism, 51(5), 1139-1145. https://doi.org/10.1016/j.semarthrit.2021.06.010

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title = "Improving benefit-harm assessment of glucocorticoid therapy incorporating the patient perspective: The OMERACT glucocorticoid core domain set",

abstract = "OBJECTIVE: Our primary objective was to develop an Outcome Measures in Rheumatology (OMERACT) core domain set to capture the impact of glucocorticoids (GC), both positive and negative, on patients with Rheumatic conditions.METHODS: The OMERACT Filter 2.1 was used to guide core domain selection. Systematic literature reviews, qualitative studies and quantitative surveys were conducted by the OMERACT GC Impact working group to identify candidate domains for a core domain set. A summary of prior work and Delphi exercise were presented at the OMERACT 2020 virtual GC workshop. A proposed GC Impact core domain set derived from this work was presented for discussion in facilitated breakout groups. Participants voted on the proposed GC Impact core domain set.RESULTS: 113 people, including 23 patient research partners, participated in two virtual workshops conducted at different times on the same day. The proposed mandatory domains to be evaluated in clinical trials involving GCs were: infection, bone fragility, hypertension, diabetes, weight, fatigue, mood disturbance and death. In addition, collection of disease specific outcomes was included in the core domain set as {"}mandatory in specific circumstances{"}. The proposed core domain set was endorsed by 100% (23/23) of the patient research partners and 92% (83/90) of the remaining participants, including clinicians, researchers and industry stakeholders.CONCLUSION: A GC Impact core domain set was endorsed at the OMERACT 2020 virtual workshop. The OMERACT GC Impact working group will now progress to identify, develop and validate measurement tools to best address these domains in clinical trials.",

keywords = "Glucocorticoids/therapeutic use, Humans, Outcome Assessment, Health Care, Rheumatic Diseases/drug therapy, Rheumatology",

author = "Joanna Tieu and Cheah, {Jonathan Tl} and Black, {Rachel J} and Robin Christensen and Nilasha Ghosh and Pamela Richards and Joanna Robson and Beverley Shea and Simon, {Lee S} and Singhi, {Jasvinder A} and Peter Tugwell and Maarten Boers and Garibay, {Marco A Alba} and Corrado Campochiaro and Simon Decary and {de Witt}, Maarten and Fernandez, {Anthony P} and Keen, {Helen I} and Lauren King and Andrea Hinojosa-Azaola and Cathie Hofstetter and Inna Gaydukova and George, {Michael D} and Latika Gupta and Suellen Lyne and Ashima Makol and Chetan Mukhtyar and Oo, {Win Min} and Michelle Petri and Pisaniello, {Huai Leng} and Sattui, {Sebastian E} and Oscar Russell and Vitor Teixeira and Karine Toupin-April and Courage Uhunmwangho and Margaret Whitstock and Kevin Yip and Mackie, {Sarah L} and Goodman, {Susan M} and Hill, {Catherine L}",

note = "Copyright {\textcopyright} 2021. Published by Elsevier Inc.",

year = "2021",

month = oct,

doi = "10.1016/j.semarthrit.2021.06.010",

language = "English",

volume = "51",

pages = "1139--1145",

journal = "Seminars in arthritis and rheumatism",

issn = "0049-0172",

publisher = "W.B. Saunders Company",

number = "5",

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Tieu, J, Cheah, JT, Black, RJ, Christensen, R, Ghosh, N, Richards, P, Robson, J, Shea, B, Simon, LS, Singhi, JA, Tugwell, P, Boers, M, Garibay, MAA, Campochiaro, C, Decary, S, de Witt, M, Fernandez, AP, Keen, HI, King, L, Hinojosa-Azaola, A, Hofstetter, C, Gaydukova, I, George, MD, Gupta, L, Lyne, S, Makol, A, Mukhtyar, C, Oo, WM, Petri, M, Pisaniello, HL, Sattui, SE, Russell, O, Teixeira, V, Toupin-April, K, Uhunmwangho, C, Whitstock, M, Yip, K, Mackie, SL, Goodman, SM & Hill, CL 2021, 'Improving benefit-harm assessment of glucocorticoid therapy incorporating the patient perspective: The OMERACT glucocorticoid core domain set', Seminars in arthritis and rheumatism, vol. 51, no. 5, pp. 1139-1145. https://doi.org/10.1016/j.semarthrit.2021.06.010

TY - JOUR

T1 - Improving benefit-harm assessment of glucocorticoid therapy incorporating the patient perspective

T2 - The OMERACT glucocorticoid core domain set

AU - Tieu, Joanna

AU - Cheah, Jonathan Tl

AU - Black, Rachel J

AU - Christensen, Robin

AU - Ghosh, Nilasha

AU - Richards, Pamela

AU - Robson, Joanna

AU - Shea, Beverley

AU - Simon, Lee S

AU - Singhi, Jasvinder A

AU - Tugwell, Peter

AU - Boers, Maarten

AU - Garibay, Marco A Alba

AU - Campochiaro, Corrado

AU - Decary, Simon

AU - de Witt, Maarten

AU - Fernandez, Anthony P

AU - Keen, Helen I

AU - King, Lauren

AU - Hinojosa-Azaola, Andrea

AU - Hofstetter, Cathie

AU - Gaydukova, Inna

AU - George, Michael D

AU - Gupta, Latika

AU - Lyne, Suellen

AU - Makol, Ashima

AU - Mukhtyar, Chetan

AU - Oo, Win Min

AU - Petri, Michelle

AU - Pisaniello, Huai Leng

AU - Sattui, Sebastian E

AU - Russell, Oscar

AU - Teixeira, Vitor

AU - Toupin-April, Karine

AU - Uhunmwangho, Courage

AU - Whitstock, Margaret

AU - Yip, Kevin

AU - Mackie, Sarah L

AU - Goodman, Susan M

AU - Hill, Catherine L

PY - 2021/10

Y1 - 2021/10

N2 - OBJECTIVE: Our primary objective was to develop an Outcome Measures in Rheumatology (OMERACT) core domain set to capture the impact of glucocorticoids (GC), both positive and negative, on patients with Rheumatic conditions.METHODS: The OMERACT Filter 2.1 was used to guide core domain selection. Systematic literature reviews, qualitative studies and quantitative surveys were conducted by the OMERACT GC Impact working group to identify candidate domains for a core domain set. A summary of prior work and Delphi exercise were presented at the OMERACT 2020 virtual GC workshop. A proposed GC Impact core domain set derived from this work was presented for discussion in facilitated breakout groups. Participants voted on the proposed GC Impact core domain set.RESULTS: 113 people, including 23 patient research partners, participated in two virtual workshops conducted at different times on the same day. The proposed mandatory domains to be evaluated in clinical trials involving GCs were: infection, bone fragility, hypertension, diabetes, weight, fatigue, mood disturbance and death. In addition, collection of disease specific outcomes was included in the core domain set as "mandatory in specific circumstances". The proposed core domain set was endorsed by 100% (23/23) of the patient research partners and 92% (83/90) of the remaining participants, including clinicians, researchers and industry stakeholders.CONCLUSION: A GC Impact core domain set was endorsed at the OMERACT 2020 virtual workshop. The OMERACT GC Impact working group will now progress to identify, develop and validate measurement tools to best address these domains in clinical trials.

AB - OBJECTIVE: Our primary objective was to develop an Outcome Measures in Rheumatology (OMERACT) core domain set to capture the impact of glucocorticoids (GC), both positive and negative, on patients with Rheumatic conditions.METHODS: The OMERACT Filter 2.1 was used to guide core domain selection. Systematic literature reviews, qualitative studies and quantitative surveys were conducted by the OMERACT GC Impact working group to identify candidate domains for a core domain set. A summary of prior work and Delphi exercise were presented at the OMERACT 2020 virtual GC workshop. A proposed GC Impact core domain set derived from this work was presented for discussion in facilitated breakout groups. Participants voted on the proposed GC Impact core domain set.RESULTS: 113 people, including 23 patient research partners, participated in two virtual workshops conducted at different times on the same day. The proposed mandatory domains to be evaluated in clinical trials involving GCs were: infection, bone fragility, hypertension, diabetes, weight, fatigue, mood disturbance and death. In addition, collection of disease specific outcomes was included in the core domain set as "mandatory in specific circumstances". The proposed core domain set was endorsed by 100% (23/23) of the patient research partners and 92% (83/90) of the remaining participants, including clinicians, researchers and industry stakeholders.CONCLUSION: A GC Impact core domain set was endorsed at the OMERACT 2020 virtual workshop. The OMERACT GC Impact working group will now progress to identify, develop and validate measurement tools to best address these domains in clinical trials.

KW - Glucocorticoids/therapeutic use

KW - Humans

KW - Outcome Assessment, Health Care

KW - Rheumatic Diseases/drug therapy

KW - Rheumatology

U2 - 10.1016/j.semarthrit.2021.06.010

DO - 10.1016/j.semarthrit.2021.06.010

M3 - Article

C2 - 34253398

SN - 0049-0172

VL - 51

SP - 1139

EP - 1145

JO - Seminars in arthritis and rheumatism

JF - Seminars in arthritis and rheumatism

IS - 5

ER -

Improving benefit-harm assessment of glucocorticoid therapy incorporating the patient perspective: The OMERACT glucocorticoid core domain set

Abstract

Keywords

UN SDGs

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