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 ] 96 suicidal ideation events; preparatory acts; suicide attempt events; non- suicidal self-injury events; and usual, most, and least amount of time in suicidal ideation, impulses, or behavior can also be calculated from the standard S-STS. The CMCM version generates all of the same scores and counts. In addition, it can be used to generate total risk and total protective factor scores, a total clinically meaningful impairment score, a functional impairment score, and a global severity score. Mapping to FDA algorithms. The S-STS accommodates the definitions used in the Columbia Classification Algorithm of Suicide Assessment (C- C ASA) 1 4 a nd adopted by the FDA in its 2010 Draft Guidance for assessment of suicidal ideation in clinical trials. 1 It also maps to the expanded classification algorithm for suicide assessment adopted by the FDA in its updated Draft Guidance issued in 2012 (referred to as FDA-CASA 2012). 2 (The mapping tables of the S-STS to the FDA 2010 and 2012 Draft Guidance categories are in Appendices F and G.) Linguistic validation in other languages. The S-STS has been linguistically validated in over 20 languages by Mapi Group (www.mapigroup.com). This is expected to increase to up to 70 languages in the near future. Changes in S-STS items from 2011 to 2013. The 2009 version of S-STS had 10 items. In 2011, the method item was disaggregated to improve sensitivity into two items: one for method (how) and one for means (with what). In 2012, we realized that this version was missing something that was captured in global suicide severity ratings and that its sensitivity could still be improved. By disaggregating one additional planning item into two questions—one for the location and another for the timing of plan—we were able to improve the relationship between the S-STS total score and the global severity of suicidality, making it more sensitive as a research tool in detecting efficacy and safety signals. As shown in Figure 1, there was a direct ascending linear relationship between S-STS total score and the global suicidality severity rating (R 2 =0.6997) for the 14-item 2013 version. The relationship was less clear (R 2 =0.4434) for the 10-item 2011 version (Figure 2) over exactly the same concurrent timeframe. VALIDITY AND RELIABILITY TESTING Evidence of validity. Coric et al 13 incorporated the self-rated S-STS into a multicenter, randomized, double- blind, placebo-controlled, and active FIGURE 1. Relationship between the S-STS total score (2013 14-question version) and the CMCM global measure of suicidality from a single subject Source: Weekly self-ratings of the 14-item 2013 S-STS total score and CMCM Global Severity score over a 15-week period. S-STS: Sheehan-Suicidality Tracking Scale; CMCM: Clinically Meaningful Change Measure FIGURE 2. Relationship between the S-STS Total score (2011 10-question version) and the CMCM global measure of suicidality from a single subject Source: Weekly self-ratings of 10-item 2011 S-STS total score and CMCM Global Severity score over a 15-week period. S-STS: Sheehan-Suicidality Tracking Scale; CMCM: Clinically Meaningful Change Measure

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