Karen Yee1, Daniel Serrano2, Judith Kando3, Susan L McElroy4,5. 1. Shire, a member of the Takeda group of companies, Lexington, MA, USA. karen.yee@takeda.com. 2. Pharmerit International, Bethesda, MD, USA. 3. Shire, a member of the Takeda group of companies, Lexington, MA, USA. 4. Lindner Center of HOPE, Mason, OH, USA. 5. University of Cincinnati College of Medicine, Cincinnati, OH, USA.
Abstract
PURPOSE: The Yale-Brown Obsessive Compulsive Scale modified for Binge Eating (Y-BOCS-BE) assesses the obsessiveness of binge eating thoughts and compulsiveness of binge eating behaviors. The findings of this study extend previously published Y-BOCS-BE psychometric evaluations in adults with binge eating disorder (BED). METHODS: Data from three phase 3 lisdexamfetamine dimesylate studies in adults with BED (two randomized, double-blind, placebo-controlled short-term efficacy studies; one double-blind, placebo-controlled, randomized-withdrawal maintenance-of-efficacy study) were used. Psychometric evaluations included assessment of Y-BOCS-BE dimensionality, internal consistency, convergent validity, test?retest reliability, and determinations of clinically meaningful improvement using distribution- and anchor-based methods. RESULTS: Domain specification analyses determined that the Y-BOCS-BE possessed a bifactor structure composed of a general binge eating severity domain and three subdomains (obsessive/compulsive, restraint, and control). Y-BOCS-BE internal consistency was maximized at week 12 (Cronbach?s ?, 0.95) and test?retest reliability was maximized in the 8-week retest interval from week 4 to week 12 across all no-change anchors (r?=?0.74?0.90). Likewise, convergent validity of the Y-BOCS-BE across all validators was maximized at week 12 (all r???0.66). Meaningful improvement for Y-BOCS-BE total scores was estimated to require score reductions of 12 to 17 points depending on the anchor. CONCLUSIONS: The Y-BOCS-BE is a valuable tool for assessing BED symptoms. Maximization of Y-BOCS-BE reliability and validity at later study time points may be related to both treatment effects and improved insight into BED by participants during the study.
RCT Entities:
PURPOSE: The Yale-Brown Obsessive Compulsive Scale modified for Binge Eating (Y-BOCS-BE) assesses the obsessiveness of binge eating thoughts and compulsiveness of binge eating behaviors. The findings of this study extend previously published Y-BOCS-BE psychometric evaluations in adults with binge eating disorder (BED). METHODS: Data from three phase 3 lisdexamfetamine dimesylate studies in adults with BED (two randomized, double-blind, placebo-controlled short-term efficacy studies; one double-blind, placebo-controlled, randomized-withdrawal maintenance-of-efficacy study) were used. Psychometric evaluations included assessment of Y-BOCS-BE dimensionality, internal consistency, convergent validity, test?retest reliability, and determinations of clinically meaningful improvement using distribution- and anchor-based methods. RESULTS: Domain specification analyses determined that the Y-BOCS-BE possessed a bifactor structure composed of a general binge eating severity domain and three subdomains (obsessive/compulsive, restraint, and control). Y-BOCS-BE internal consistency was maximized at week 12 (Cronbach?s ?, 0.95) and test?retest reliability was maximized in the 8-week retest interval from week 4 to week 12 across all no-change anchors (r?=?0.74?0.90). Likewise, convergent validity of the Y-BOCS-BE across all validators was maximized at week 12 (all r???0.66). Meaningful improvement for Y-BOCS-BE total scores was estimated to require score reductions of 12 to 17 points depending on the anchor. CONCLUSIONS: The Y-BOCS-BE is a valuable tool for assessing BED symptoms. Maximization of Y-BOCS-BE reliability and validity at later study time points may be related to both treatment effects and improved insight into BED by participants during the study.
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