Improving benefit-harm assessment of glucocorticoid therapy incorporating the patient perspective: The OMERACT glucocorticoid core domain set.
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Tieu Joanna, Cheah Jonathan Tl, 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, Hill Catherine L
Аннотация
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.