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 ] 54 ABSTRACT Objective: Standard international classification criteria require that classification categories be comprehensive to avoid type II error. Categories should be mutually exclusive and definitions should be clear and unambiguous (to avoid type I and type II errors). In addition, the classification system should be robust enough to last over time and provide comparability between data collections. This article was designed to evaluate the extent to which the classification system contained in the United States Food and Drug Administration 2012 Draft Guidance for the prospective assessment and classification of suicidal ideation and behavior in clinical trials meets these criteria. Method: A critical review is used to assess the extent to which the proposed categories contained in the Food and Drug Administration 2012 Draft Guidance are comprehensive, unambiguous, and robust. Assumptions that underlie the classification system are also explored. Results: The Food and Drug Administration classification system FUNDING: There was no funding for the development and writing of this article. FINANCIAL DISCLOSURES: Dr. D. Sheehan is the author and copyright holder of 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, the Sheehan Disability Scale (SDS), and the Suicidality Modifiers Scale, is a co-author of the Suicide Plan Tracking Scale (SPTS), and owns stock in Medical Outcomes Systems, which has computerized the S- STS; J. Giddens is the author and copyright holder of the SPTS and is a named consultant on the S-STS, the S-STS CMCM, the Pediatric versions of the S-STS, and the Suicidality Modifiers Scale; and Dr. K. Sheehan is the spouse of Dr. D. Sheehan, who is the author and copyright holder of the S-STS, the S-STS CMCM, the Pediatric versions of the S-STS, the 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. She has no other conflicts to report. 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, suicidal classification [ C R I T I C A L R E V I E W ] Current Assessment and Classification of Suicidal Phenomena using the FDA 2012 Draft Guidance Document on Suicide Assessment: A Critical Review by DAVID V. SHEEHAN, MD, MBA; JENNIFER M. GIDDENS; and KATHY HARNETT SHEEHAN, PhD Dr. D. Sheehan is Distinguished University Health Professor Emeritus at the University of South Florida College of Medicine, Tampa, Florida; J. Giddens is the Co-founder of the Tampa Center for Research on Suicidality, Tampa, Florida; and Dr. K. Sheehan is Associate Professor Emeritus at the University of South Florida College of Medicine, Tampa, Florida. Innov Clin Neurosci. 2014;11(9–10):54–65

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