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

Tieu, Joanna, Cheah, Jonathan T. L., Black, Rachel J., Christensen, Robin, Ghosh, Nilasha, Richards, Pamela, Robson, Joanna, Shea, Beverley, Simon, Lee S., Singhi, Jasvinder A., Tugwell, Peter, Boers, Maarten, Garibay, Marco A. Alba, Campochiaro, Corrado, Decary, Simon, de Witt, Maarten, Fernandez, Anthony P., Keen, Helen I., King, Lauren, Hinojosa-Azaola, Andrea, Hofstetter, Cathie, Gaydukova, Inna, George, Michael D., Gupta, Latika, Lyne, Suellen, Makol, Ashima, Mukhtyar, Chetan, Oo, Win Min, Petri, Michelle, Pisaniello, Huai Leng, Sattui, Sebastian E., Russell, Oscar, Teixeira, Vitor, Toupin-April, Karine, Uhunmwangho, Courage, Whitstock, Margaret, Yip, Kevin, Mackie, Sarah L., Goodman, Susan M. and Hill, Catherine 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). pp. 1139-1145. ISSN 0049-0172

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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.

Item Type: Article
Additional Information: Funding Information: M Boers is principal investigator of the GLORIA trial on low-dose prednisolone or placebo in elderly RA patients, funded by the European Union's Horizon 2020 research and innovation program under the topic ‘’Personalizing Health and Care’’, grant agreement No 634886. Funding Information: MD George reports grants from Bristol-Myers Squibb and personal fees from Dysimmune Diseases Foundation outside the submitted work. Funding Information: C Hill reports research grant support from Vifor Pharmaceuticals, outside the submitted work. Funding Information: M Petri reports grants and personal fees from AstraZeneca, grants and personal fees from Eli Lilly, grants and personal fees from Exagen, grants and personal fees from GSK, grants and personal fees from Thermofisher, personal fees from Aurinia, personal fees from Abbvie, personal fees from Amgen, personal fees from Blackrock, personal fees from BMS, personal fees from Glenmark, personal fees from IQVIA, grants and personal fees from Janssen, personal fees from Merck EMD Serono, personal fees from Novartis, personal fees from Sanofi Japan, personal fees from UCB, outside the submitted work.JA Singh has received consultant fees from Crealta/Horizon, Medisys, Fidia, Two labs Inc, Adept Field Solutions, Clinical Care options, Clearview healthcare partners, Putnam associates, Focus forward, Navigant consulting, Spherix, MedIQ, UBM LLC, Trio Health, Medscape, WebMD, and Practice Point communications; and the National Institutes of Health and the American College of Rheumatology. JA Singh owns stock options in TPT Global Tech, Vaxart pharmaceuticals and Charlotte's Web Holdings, Inc. JAS previously owned stock options in Amarin, Viking and Moderna pharmaceuticals. JA Singh is on the speaker's bureau of Simply Speaking. JA Singh is a member of the executive of Outcomes Measures in Rheumatology (OMERACT), an organization that develops outcome measures in rheumatology and receives arms-length funding from 8 companies. JA Singh serves on the FDA Arthritis Advisory Committee. JAS is the chair of the Veterans Affairs Rheumatology Field Advisory Committee. JAS is the editor and the Director of the University of Alabama at Birmingham (UAB) Cochrane Musculoskeletal Group Satellite Center on Network Meta-analysis.R Christensen reports honoraria paid to the Parker institute from: Lecture- Research Methods (Pfizer, DK; 2017), GRADE Lecture (Celgene, DK; 2017), Ad Board Lecture: CAM (Orkla Health, DK; 2017), Project Grant: "GreenWhistle" (Mundipharma, 2019), Lecture: Diet in RMD (Novartis, DK; 2019), Consultancy Report: Network MA's (Biogen, DK; 2017), Ad Board Lecture: GRADE (Lilly, DK; 2017), Consultancy Report: GRADE (Celgene, 2018), Lecture: Network MA's (LEO; 2020), outside the submitted work; and Musculoskeletal Statistics Unit, The Parker Institute is grateful for the financial support received from public and private foundations, companies and private individuals over the years. The Parker Institute is supported by a core grant from the Oak Foundation. R Christensen is a founding member of the Technical Advisory Group of OMERACT, an organization that develops outcome measures in rheumatology and receives arms-length funding from 8 companies.I Gaydukova reports personal fees from Abbvie, grants and personal fees from Pfizer, grants and personal fees from MSD, grants and personal fees from Novartis, personal fees from Sandoz, personal fees from Celgen, grants and personal fees from Biocad, personal fees from Teva, outside the submitted work.A Fernandez reports personal fees and other from AbbVie, grants and personal fees from Novartis, grants and personal fees from Mallinckrodt, personal fees from BMS, personal fees from Alexion, other from Corbus, other from Pfizer, outside the submitted work.S Goodman reports research grant support from Novartis and Horizon, and consulting fees from UCB.J Tieu reports research grant support from Vifor Pharmaceuticals, outside the submitted work.C Hill reports research grant support from Vifor Pharmaceuticals, outside the submitted work.H Keen reports personal fees from Roche and Pfizer, outside the submitted work.S Mackie reports consultancy on behalf of her institution for Roche/Chugai, Sanofi, AbbVie and AstraZeneca, and received support from Roche to attend EULAR2019. SLM is supported by the Leeds Biomedical Research center.J Robson reports speaker fees from Roche and Vifor Pharma, research support from Vifor Pharma and acted as a clinical trials investigator for Chemocentryx and Novartis, outside the submitted work. Funding Information: S Goodman reports research grant support from Novartis and Horizon, and consulting fees from UCB. Funding Information: R Christensen reports honoraria paid to the Parker institute from: Lecture- Research Methods (Pfizer, DK; 2017), GRADE Lecture (Celgene, DK; 2017), Ad Board Lecture: CAM (Orkla Health, DK; 2017), Project Grant: "GreenWhistle" (Mundipharma, 2019), Lecture: Diet in RMD (Novartis, DK; 2019), Consultancy Report: Network MA's (Biogen, DK; 2017), Ad Board Lecture: GRADE (Lilly, DK; 2017), Consultancy Report: GRADE (Celgene, 2018), Lecture: Network MA's (LEO; 2020), outside the submitted work; and Musculoskeletal Statistics Unit, The Parker Institute is grateful for the financial support received from public and private foundations, companies and private individuals over the years. The Parker Institute is supported by a core grant from the Oak Foundation. R Christensen is a founding member of the Technical Advisory Group of OMERACT, an organization that develops outcome measures in rheumatology and receives arms-length funding from 8 companies. Publisher Copyright: © 2021
Uncontrolled Keywords: adverse effects,glucocorticoid,omeract,patient perspective,steroid,rheumatology,anesthesiology and pain medicine,sdg 3 - good health and well-being ,/dk/atira/pure/subjectarea/asjc/2700/2745
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Depositing User: LivePure Connector
Date Deposited: 23 Dec 2021 09:30
Last Modified: 06 Jan 2022 16:30
URI: https://ueaeprints.uea.ac.uk/id/eprint/82804
DOI: 10.1016/j.semarthrit.2021.06.010

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