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T 07: Strong Considerations for Self-Reporting Prospective Suicidal Ideation Using the eC-SSRS
ERT United States
This report examines the self-reported eC-SSRS (Columbia Suicide Severity Rating Scale) alternative for prospective suicide ideation and compares it to the rater-reported C-SSRS.
A review of current global regulatory guidelines was conducted, centering on the 2012 Revised Draft of the FDA Guidance on Suicide Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials.
Current literature reveals significant evidence of equivalence between self-reported and rater-reported suicide ideation, including preferences by youth and adult subjects. This report found significant mapping equivalence to all 11 C-CASA categories for both the self-reported eC-SSRS and the C-SSRS; and equivalence between the IVR and Tablet eC-SSRS. Literature confirms the eC-SSRS as …’an alternative approach to obtaining data on suicidal ideation and behavior.’
The self-reported eC-SSRS is equivalent and viable alternative to the rater-version of the C-SSRS. Two to four times more suicidal ideation events are reported with self-reporting vs a clinical interview, with youth more likely to endorse on a self-report than on an interview. In addition to regulatory and literature support, the self-reported eC-SSRS may provide additional conveniences to clinical sites.