Abstract:Objectives:To develop a Glucocorticoid Toxicity Index (GTI) to assess glucocorticoid (GC)-related morbidity and the GC-sparing ability of other therapies. Methods:Nineteen experts on glucocorticoid use and outcome measures from 11 subspecialties participated. Ten experts were from the United States; 9 from Canada, Europe, or Australia.Group consensus methods and multi-criteria decision analysis (MCDA) were utilized.A Composite GTI and Specific List comprise the overall GTI. The Composite GTI reflects toxicity likely to change during a clinical trial. The Composite GTI toxicities occur commonly, vary with GC exposure, and are weighted and scored. Relative weights for items in the Composite GTI were derived by group consensus and MCDA. The Specific List is designed to capture GC toxicity not included in the Composite GTI. The Composite GTI was evaluated by application to paper cases by the investigators and an external group of 17 subspecialists. Results:Thirty-one toxicity items were included in the Composite GTI and 23 in the Specific List.Composite GTI evaluation showed high inter-rater agreement (investigators kappa 0.88, external raters kappa 0.90). To assess the degree to which the Composite GTI corresponds to expert clinical judgment, participants ranked 15 cases by clinical judgment in order of highest to lowest GC toxicity. Expert rankings were then compared to case ranking by the Composite GTI,

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