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 ] 78 C–SSRS, it is not present in some other versions (C–SSRS Lifetime/Recent Version, C–SSRS Screen Version, C–SSRS Risk A ssessment Version, and C–SSRS Baseline Version). Moreover, the category, when it is present, is not defined, leaving clinicians to assume but not be entirely sure that the FDA-CASA 2012 definition for a completed suicide is what the authors intended. 5. Are versions of the C–SSRS consistent? There are several inconsistencies between versions of the C–SSRS. Some versions, for example, do not include a "Completed Suicide" category. There are also version control problems. For example, during the months of December 2013 and January 2014, we carefully monitored the Columbia University website for different C– SSRS versions and found that the versions changed repeatedly (sometimes daily) and remained inconsistent with each other and with the earlier 1/14/09 version, and yet they all retained the 1/14/09 version date. We observed that problems with the 1/14/09 version we had identified a few months earlier were gone but new problems were introduced—all under the same version date. This lack of version control does not meet regulatory requirements for translation and linguistic validation. 36 Another inconsistency in versions is that the instruction, "Answer for actual attempts only," 1 placed above the "Actual Lethality/Medical Damage" section, is missing in the Lifetime/Recent Version and Risk Assessment Version of the scale. This omission could lead to inconsistencies in the way lethality/medical damage is rated. For the versions without the instruction, the rater might reasonably include damage from non-suicidal self- injurious behavior as well damage from actual attempts. After all, the probe for non-suicidal self-injurious behavior is placed in the "Suicidal Behavior" section just above the "Actual Lethality/Medical Damage" section. For the versions with the instruction, however, damage from non-suicidal behavior would not be allowed. These differences have the p otential to create inflation of lethality/medical damage in some versions but not others. The C–SSRS dated June 17, 2007, 37 had a broad range of six passive suicidal ideation questions (including "Better Off Dead"), while the current versions have eliminated most of these questions and substituted others that were not in the 2007 version into this category. Is it justifiable to integrate as one, into the same FDA database, questions that are worded differently? Problems going forward. The inconsistencies outlined above make the C–SSRS incompatible with the updated FDA-CASA 2012 and incompatible with the S-STS and the ISST-Plus. This situation poses a dilemma. Revising the C–SSRS to correct all the flaws identified here would make a new corrected C–SSRS incompatible with the current versions, rendering it impossible to merge current data for a particular drug or research study with new data going forward. Indeed, the argument could be made that any findings resulting from application of the current C–SSRS should be re- evaluated in light of the flaws identified above and the FDA's 2012 revised, more exacting draft guidance standards. These incompatibilities cannot be remedied by retroactive reanalyses and correction in existing datasets. In addition, in accordance with regulatory standards, any newly corrected C–SSRS along the lines above would then need to be properly re-validated. CONCLUSIONS The C–SSRS has been endorsed by the FDA as the gold standard for assessment of suicidal ideation and behavior in clinical trials. While the instrument makes an effort to provide standardized categories and definitions, it falls short of widely accepted standards. Its psychometric properties, moreover, have only been evaluated in a limited way to date. The most serious criticisms we have o f the scale are as follows: 1) it is not comprehensive, which can lead to over-endorsements; 2) it does not cover the range of suicidal ideation or behavior; 3) the categories are not well defined, and wording in many cases is ambiguous and imprecise; and 4) many titles, definitions, and probes do not align with the updated FDA-CASA 2012 as documented in 2012 Draft Guidance. We see these flaws as having the potential to lead to endless arrays of type I and type II errors. These findings suggest that C–SSRS, at the very least, requires substantial revision and reconstruction. What are internal review board members, data safety monitoring board members, and peer reviewers for journal articles and grants to do if they are aware of these flaws in the C–SSRS and they have to adjudicate approval for use for funding or for publication? In its current form, we believe the C–SSRS is a liability. In our opinion, the field of suicide assessment cannot scientifically move forward until these issues are resolved. We leave the reader with these unanswered questions and dilemmas. We believe we all have a responsibility to our suicidal patients to fix these problems and to resolve these dilemmas. How best to do this remains unresolved. REFERENCES 1. Posner K, Brown GK, Stanley B, The Columbia–Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011; 168:1266–1277. 2. Brent, DA, Greenhill L, Compton S, et al. The Treatment of Adolescent Suicide Attempters study (TASA): predictors of suicidal events in an open treatment trial. J Am Acad Child Adolesc Psychiatry. 2009;

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