Innovations In Clinical Neuroscience

SEP-OCT 2014

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

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who were blind to the ratings on the other scales. Results: The Sheehan-Suicidality Tracking Scale and the InterSePT Scale for Suicidal Thinking- Plus show acceptable agreement with the Columbia–Suicide Severity Rating Scale in detecting the presence or absence of the 2012 Food and Drug Administration-Classification Algorithm of Suicide Assessment categories 1, 5, 6, 10, and 11 (passive ideation; active ideation with method, intent, and plan; completed suicide; preparatory actions; and self-injurious behavior) but not of categories 2, 3, and 4 (3 other active suicidal ideation combination categories) or to 8 and 9 (aborted and interrupted attempt). Despite the significant disagreement between the Columbia–Suicide Severity Rating Scale on the one side and the InterSePT Scale for Suicidal Thinking-Plus and the Sheehan-Suicidality Tracking Scale on the other in the ability to accurately map to the 2012 Food and Drug Administration-Classification Algorithm of Suicide Assessment categories on some items, there was close agreement between the InterSePT Scale for Suicidal Thinking-Plus and the Sheehan-Suicidality Tracking Scale on these categories. Conclusion: The results of this exploratory study invite discussion and debate about the validity of the Columbia–Suicide Severity Rating Scale and its ability to accurately assess key active suicidal ideation categories, since it disagrees so much with the other two standardized scales that agree so closely with each other. Simple Measures of Hopelessness and Impulsivity are Associated with Acute Suicidal Ideation and Attempts in Patients in Psychiatric Crisis..................................47 ABSTRACT: Objective: To explore the authors' predictions 1) that hopelessness would positively correlate with suicidal ideation and that impulsivity (either transient urges to self-harm or impulsive acting out) would positively correlate with suicidal behavior, and 2) that the recent or long-standing nature of the traits will have corresponding effects on reported histories of suicidal ideation and behavior. Design: Questionnaire validation trial in which each subject received every measure in counterbalanced fashion. Setting: Inpatient and outpatient psychiatric settings associated with a medium-sized medical school in the southeastern United States. Participants: Forty-five subjects presenting with varying levels of suicidal ideation and behavior completed measures providing information about their histories of suicidal ideation and behavior, recent feelings of hopelessness, feelings of general hopelessness, recent feelings of difficulty controlling urges to self-harm, and feeling about general levels of impulsivity. Measurements: The InterSePT Scale for Suicidal Thinking–Plus, the Sheehan- Suicidality Tracking Scale, the Columbia–Suicide Severity Rating Scale, and six additional questions to assess hopelessness and impulsivity. Results: Recent and trait hopelessness correlated positively with suicidal ideation. Patients who reported any suicide attempt endorsed higher levels of general impulsivity than those who did not report a history of at least one suicide attempt. Those enrolled in the study secondary to a very recent suicide attempt reported more difficulties with recent suicidal impulses. Conclusion: Simple measures of hopelessness and impulsivity are associated with suicidal ideation and attempts and may add to determination of suicide risk. CRITICAL REVIEWS Current Assessment and Classification of Suicidal Phenomena using the FDA 2012 Draft Guidance Document on Suicide Assessment: A Critical Review ...............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 contained in the 2012 Draft Guidance does not capture the full range of suicidal ideation and behavior (type II error). Definitions, moreover, are frequently ambiguous (susceptible to multiple interpretations), and the potential for misclassification (type I and type II errors) is compounded by frequent mismatches in category titles and definitions. These issues have the potential to compromise data comparability within clinical trial sites, across sites, and over time. Conclusion: These problems need to be remedied because of the potential for flawed data output and consequent threats to public health, to research on the safety of medications, and to the search for effective medication treatments for suicidality. The Columbia–Suicide Severity Rating Scale (C–SSRS): Has the "Gold Standard" Become a Liability? ..................................66 ABSTRACT: Objective: The Columbia– Suicide Severity Rating Scale has become the gold standard for the assessment of suicidal ideation and behavior in clinical trials. Criticism of the instrument has been mounting. We examine whether the instrument meets widely accepted psychometric standards and maps to the United States Food and Drug Administration's most recent 2012 algorithm for assessment of suicidal phenomena. Our goal is to determine if the Columbia–Suicide Severity Rating Scale should be retained as the preferred instrument for assessment of suicidal ideation and behavior. Method: Standard psychometric criteria dictate that categorizations to avoid type I and type II errors should be comprehensive and address the full spectrum (i.e., all dimensions) of a phenomenon. The criteria should also be well defined and consistent, and the wording throughout should be unambiguous. We examine the Columbia–Suicide Severity Rating Scale in terms of these criteria. Results: The Columbia–Suicide Severity Rating Scale does not address the full spectrum of suicidal ideation or behavior. As a result, it has the potential to miss many combinations of suicidal ideation and behavior that present to clinicians in practice (type II error). Potential misclassifications (type I [ 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 ] Innovations in CLINICAL NEUROSCIENCE 7 A N N O T A T E D T A B L E O F C O N T E N T S

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