Innovations In Clinical Neuroscience

SEP-OCT 2014

A peer-reviewed, evidence-based journal for clinicians in the field of neuroscience

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Innovations in CLINICAL NEUROSCIENCE [ V O L U M E 1 1 , N U M B E R 9 – 1 0 , S E P T E M B E R – O C T O B E R 2 0 1 4 ] 172 ABSTRACT Objective: The United States Food and Drug Administration's newest classification system for suicidality assessment anchors suicidal ideation to various combinations of passive suicidal ideation, active suicidal ideation, method, intent, and plan. This is based upon the suicidal ideation categories in the Columbia–Suicide Severity Rating Scale. Although there are 32 possible combinations of these suicidal ideation phenomena, the Food and Drug Administration's 2012 system and the Columbia–Suicide Severity Rating Scale accommodate six combinations. We use a case study to explore the impact of possible type II errors on suicidality classification posed by not including remaining 26 possible categories. Methods: A suicidal subject kept detailed daily records of her experience of suicidality over two separate intervals of eight- months' and nine-months' duration. These records permitted classification of individual events into each of the possible 32 suicidal ideation combinations. Results: Although only a small percentage of all events of suicidality from either collection period fell outside of the Food and Drug Administration's classification system and the Columbia –Suicide Severity Rating Scale categories, those that were not so categorized constituted a FUNDING: There was no funding for the development and writing of this article. FINANCIAL DISCLOSURES: J. Giddens is the author and copyright holder of the Suicide Plan Tracking Scale (SPTS) and is a named consultant on the Sheehan-Suicidality Tracking Scale (S-STS), the Sheehan- Suicidality Tracking Scale Clinically Meaningful Change Measure Version (S- STS CMCM), the Pediatric versions of the S-STS, and the Suicidality Modifiers Scale; Dr. D. Sheehan is the author and copyright holder of the S-STS, the S-STS CMCM, the Pediatric versions of the S-STS, the Sheehan Disability Scale (SDS), and the Suicidality Modifiers Scale, is a co-author of the SPTS, and owns stock in Medical Outcomes Systems, which has computerized the S-STS. ADDRESS CORRESPONDENCE TO: David V. Sheehan, MD, MBA; E-mail: dsheehan@health.usf.edu KEY WORDS: Suicide scale, suicide assessment, suicide risk, suicide attempt, suicide, suicidal ideation, suicidal behavior, suicidality, C–SSRS, FDA 2012 Draft Guidance Document [ C A S E S T U D Y ] Do the Five Combinations of Suicidal Ideation in the FDA 2012 Draft Guidance Document and the C–SSRS Adequately Cover All Suicidal Ideation Combinations in Practice? A Case Study by JENNIFER M. GIDDENS and DAVID V. SHEEHAN, MD, MBA J. Giddens is Co-founder of the Tampa Center for Research on Suicidality, Tampa, Florida; and Dr. Sheehan is Distinguished University Health Professor Emeritus, University of South Florida College of Medicine, Tampa, Florida. Innov Clin Neurosci. 2014;11(9–10):172–178

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