Introduction: There is no consensus amongst patients and healthcare professionals about how to measure important adverse effects of glucocorticoids (GCs) that includes the patient's perspective. The OMERACT GC Impact working group sought to identify the domains of greatest importance to both patients and healthcare professionals for use in a proposed core outcome set.
Methods: Patients and healthcare professionals participated in a Delphi consensus exercise to rate the importance of previously identified candidate domains. Those deemed critical to include by at least 70% in both groups, after three rounds of a Delphi exercise were identified as meeting consensus. All participants were asked which additional domains should be measured in all trials in a final survey; those domains selected by more than 70% of all participants were added, resulting in a final list of potential core domains.
Results: In total, 363 people (295 patients and 68 healthcare professionals) participated in the Delphi process. The final list of potential core domains included: bone fragility, diabetes, eye problems and/or changes in vision, high blood pressure, infection, osteonecrosis, mood disturbance, fatigue, sleep disturbance, weight.
Conclusion: The 10 domains identified through this exercise informed the proposed core domain set of GC effects to be considered for use in future clinical trials involving GCs. This core domain set was endorsed at the OMERACT 2020 virtual workshop.
Keywords: Adverse effects; Delphi; Glucocorticoids; Mixed methods; OMERACT; Patient perspective.
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