Karen S Yee1, Robin Pokrzywinski2, Asha Hareendran3, Shannon Shaffer2, David V Sheehan4. 1. Shire, a Member of the Takeda Group of Companies, Cambridge, Massachusetts, USA. 2. Patient-Centered Research, Evidera, Bethesda, Maryland, USA. 3. Patient-Centered Research, Evidera, London, UK. 4. University of South Florida College of Medicine, Tampa, Florida, USA.
Abstract
OBJECTIVES: This study examined Sheehan Disability Scale (SDS) performance in binge eating disorder (BED) and explored relationships between SDS and BED outcomes using data from three placebo-controlled lisdexamfetamine (LDX) studies (two short-term, dose-optimized studies and one double-blind, randomized-withdrawal study) in adults with Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision (DSM-IV-TR)-defined BED. METHODS: Analyses evaluated the psychometric properties of the SDS. RESULTS: Confirmatory factor analysis supported a unidimensional total score in the short-term studies, with internal consistency (Cronbach's α) being 0.878. Total score exhibited good construct validity, with moderate and statistically significant correlations observed with Yale-Brown Obsessive Compulsive Scale modified for binge eating, Binge Eating Scale (BES), and EuroQol Group 5-Dimension 5-Level health status index scores. Known-groups validity analysis for the short-term studies demonstrated a significantly lower total score at end of study in participants considered "not ill" versus "ill" based on Clinical Global Impressions-Severity scores. SDS total score changes in the short-term studies were greater in responders than nonresponders based on binge eating abstinence or BES score. In the randomized-withdrawal study, SDS scores increased relative to baseline to a greater extent in participants randomized to placebo than LDX. CONCLUSIONS: These analyses support the reliability, validity, and responsiveness to change of the SDS in individuals with BED.
RCT Entities:
OBJECTIVES: This study examined Sheehan Disability Scale (SDS) performance in binge eating disorder (BED) and explored relationships between SDS and BED outcomes using data from three placebo-controlled lisdexamfetamine (LDX) studies (two short-term, dose-optimized studies and one double-blind, randomized-withdrawal study) in adults with Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision (DSM-IV-TR)-defined BED. METHODS: Analyses evaluated the psychometric properties of the SDS. RESULTS: Confirmatory factor analysis supported a unidimensional total score in the short-term studies, with internal consistency (Cronbach's α) being 0.878. Total score exhibited good construct validity, with moderate and statistically significant correlations observed with Yale-Brown Obsessive Compulsive Scale modified for binge eating, Binge Eating Scale (BES), and EuroQol Group 5-Dimension 5-Level health status index scores. Known-groups validity analysis for the short-term studies demonstrated a significantly lower total score at end of study in participants considered "not ill" versus "ill" based on Clinical Global Impressions-Severity scores. SDS total score changes in the short-term studies were greater in responders than nonresponders based on binge eating abstinence or BES score. In the randomized-withdrawal study, SDS scores increased relative to baseline to a greater extent in participants randomized to placebo than LDX. CONCLUSIONS: These analyses support the reliability, validity, and responsiveness to change of the SDS in individuals with BED.
Authors: Jose C Appolinario; Rosely Sichieri; Claudia S Lopes; Carlos E Moraes; Gloria V da Veiga; Silvia Freitas; Maria A A Nunes; Yuan-Pang Wang; Phillipa Hay Journal: Soc Psychiatry Psychiatr Epidemiol Date: 2022-01-19 Impact factor: 4.519