Innovations In Clinical Neuroscience

SEP-OCT 2014

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

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[ 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 33 recruited from inpatient, outpatient, and emergency room settings. Each patient was interviewed using all three scales (InterSePT Scale for Suicidal T hinking-Plus, the Sheehan-Suicidality Tracking Scale, and the Columbia–Suicide Severity Rating Scale) on the same day. The scales were administered in a random sequence by three independent raters 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. INTRODUCTION What if two test instruments do not line up with a reference or gold standard? Does this mean that the test instruments are flawed or could it be that the reference itself is limited and the test instruments tap i nto a more accurate reality? These are quandaries we address in this article describing our efforts to validate two suicidality assessment scales against the gold standard scale. The study was developed in the context of increasing calls for standardized instruments to assess suicidal ideation and behavior (SIB) in central nervous system (CNS) trials. To understand the purposes of the study, it is helpful to give some background. In 2010, the United States Food and Drug Administration (FDA) in its "Draft Guidance for Industry on the Prospective Assessment of Occurrence of Suicidality in Clinical Trials" 1 (FDA 2010 Draft Guidance) introduced and recommended the Columbia Classification Algorithm of Suicide Assessment (C-CASA), a classification algorithm developed at Columbia University that classifies various types of suicidal and non- suicidal events into nine categories. 2 In 2012, the FDA introduced a second, modified version of the C- CASA for public comment (referred to here as the FDA-CASA 2012). 3 This classification system changed the number of FDA required categories to the 11 used in the Columbia–Suicide Severity Rating Scale (C–SSRS), a rating scale that is now widely used in clinical trials. 4 In addition, the FDA 2012 Draft Guidance designated the C–SSRS as the standard for the assessment of SIB for United States regulatory data collection, stipulating further that while it would consider other suicidality assessment scales as alternatives to the C–SSRS, any such new scale must map to the new FDA- CASA 2012 categories and should provide validity and reliability study data comparing itself to the C–SSRS. These decisions were not without controversy. Some observers felt that the C–SSRS required more testing before it should be conferred gold standard status. 5,6 Concern has also been voiced that C–SSRS categories do not line up with the FDA-CASA 2012 categories when the titles, d efinitions, and probe questions are carefully scrutinized. 7,8 The phenomenology of SIB is complex, and alternative approaches to collecting information that address needs that cannot be fully addressed with the C–SSRS would be valuable. 9,10 Two alternative suicidality scales that do map to both the 2010 C-CASA and the 2012 FDA-CASA are the InterSePT Scale for Suicidal Thinking–Plus (ISST-Plus) and the Sheehan-Suicidality Tracking Scale (S-STS). 11–13 The ISST-Plus is an iterative evolution of the original ISST scale used as the primary outcome measure in the InterSePT study that was the basis for the regulatory approval of clozapine as a treatment for suicidal behaviors in schizophrenia and schizoaffective disorder. 14 The original ISST was developed long before the development of the C-CASA, and it did not map to C-CASA categories. Its authors modified it into the ISST- Plus to permit mapping to the C- CASA. Following publication of the FDA 2012 Draft Guidance, a mapping table was developed to show how the ISST-Plus could be mapped to the FDA-CASA 2012 categories. The current S-STS is an iterative evolution of the original 2009 S-STS scale. 11 It has also been adapted to map to the 2010 C-CASA and the FDA-CASA 2012. STUDY OBJECTIVES The primary objectives of the analyses in this exploratory study were to evaluate the concordance between the ISST-Plus and the C–SSRS and the concordances between each version of the S-STS (clinician version, patient version, and reconciled patient/clinician version) and the C–SSRS in mapping symptoms of suicidal ideation, self-harm, and suicidal behavior using FDA-CASA 2012 categories. Secondary objectives included

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