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 67 algorithm for suicidal ideation and behavior. Conclusion: The evidence suggests that the Columbia–Suicide S everity Rating Scale is conceptually and psychometrically flawed and does not map to the Food and Drug Administration's new standards. A new gold standard for assessment of suicidality may be warranted. INTRODUCTION In 2012, the United States Food and Drug Administration (FDA) made the Columbia–Suicide Severity Rating Scale (C–SSRS) 1 the preferred instrument—the "gold standard"—for measuring suicidal ideation and behavior in clinical trials going forward. But has the gold standard become a liability? In this paper, we trace the making of the C– SSRS into a gold standard. We then evaluate the instrument in the context of widely accepted psychometric criteria and the FDA's own most recent algorithm for classifying suicidal ideation and behavior. BACKGROUND: THE MAKING OF A GOLD STANDARD The C–SSRS was developed for a National Institute of Mental Health study of adolescent suicide attempters reported in 2007. 2 From the outset, the scale adopted definitions from the Columbia Suicide History Form (CSHF), 3 an instrument originally designed as a chart extraction tool. The scale was also tied to the Columbia Classification Algorithm of Suicide Assessment (C–CASA), an algorithm commissioned by the FDA in 2007 for retrospective study of adverse events related to use of antidepressants. 4 In 2010, the FDA sanctioned the use of the nine- category C–CASA and, by extension, approved the C–SSRS as the basis for mapping suicidal ideation and behavior in trials falling under its authority. 5 More recently, in 2012, the FDA conferred gold standard status on the C–SSRS by labeling it the preferred instrument for measuring suicidal ideation and behavior in clinical trials going forward. 6 But was this gold standard status j ustified? And to what extent does the C–SSRS map to the more recent 2012 classification system the FDA now endorses for monitoring suicidal ideation and behavior? 6 These are important questions since how suicidal ideation and behavior are measured in clinical trials has serious ramifications. On one level, whatever instrument is chosen as the preferred instrument will determine who is included or excluded in a particular trial. On another level, instrument choice influences whether suicidal ideation and/or behavior are connected to a particular drug (e.g., as an adverse effect). In other words, the choice has serious safety implications. In the normal course of events, gold standard status is achieved slowly over time. According to Martin Roth, "it took more than a decade" before the Hamilton Rating Scale for Depression (HRSD) was even recognized as a worthy contribution to practice. 7 It took more than two decades before the HRSD was endorsed by the World Health Organization (WHO) and the FDA, and this only occurred after it had been subjected to enormous scrutiny that included hundreds of studies by clinicians and researchers in the field, as opposed to "top down" endorsement by regulatory agencies and government authorities. 8 Why was the C–SSRS so quickly endorsed by the FDA? After all, the C–SSRS was not the only suicide rating scale in use at the time. In fact, there were and are numerous other scales in use, including Harkavy-Asnis Suicide Survey, 9 the InterSePT Scale for Suicidal Thinking (ISST-Plus), 10 the Suicidal Behaviors Questionnaire–Revised, 11 the Beck Scale for Suicidal Ideation (BSI or BSS), 12 and the Sheehan-Suicidality Tracking Scale (S-STS) 13 to name a few. One explanation is that suicide was much in the news, and the FDA needed to identify a scale as rapidly as possible to be able to show the public that it was on top of this lethal problem. The C–SSRS would have b een convenient since the FDA had already adopted the C-CASA for classificatory purposes. In addition, as the FDA 2012 Draft Guidance specifically notes, the C–SSRS definitions had by then been adopted by the United States Center for Disease Control and Prevention (CDC), 1 4 and there was evidence from the Columbia University website that the C–SSRS was frequently requested by national and international agencies, including various branches of the United States Military, the Israeli Defense Force, Health Canada, Japanese National Institute of Mental Health, Korean Association for Suicide Prevention, the United States Department of Education, the CDC, the FDA, and the WHO. 15 But is "top-down" recognition by government authorities equal to rigorous scientific scrutiny? MINIMAL SCRUTINY Despite its gold standard conferral, the C–SSRS has been relatively under scrutinized. As Chappell et al 1 6 observed, published papers on the reliability and validity of the scale have "lagged behind" its widespread acceptance. Moreover, what published data do exist have been inconsistent for inter-rater reliability 17,18 and limited for validity. 19 Although two validation reports have been published, 1,18 one is a retrospective analysis of data from three clinical trials that were not specifically designed as tests of the psychometric properties of the instrument and neither was prospectively designed to compare C–SSRS with alternative suicide assessment tools. Additionally, both studies are limited by small sample sizes and both have been deemed by at least one government expert as "low quality studies (level III- evidence)." 20 Gutierrez from the Military Suicide Research Consortium in evaluating the existing

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