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 61 ideation or behavior on two different days, each with the same number of suicidal events. 14 Since the FDA 2012 Draft Guidance does not require that t he amount of time be tracked, the clinician may miss the increase in time spent experiencing suicidality and, more importantly, miss the impact this change has in the life of the patient. 14 Misalignment of category titles and category definitions. More often than not, the category titles in the FDA-CASA 2012 do not align with the definitions below them, and all too often definitions are ambiguous, which can create confusion. Misalignment of title and definition (Table 3) is a critical problem since some clinicians will only use the title to classify individual patients, others will only use the definition, a third group may try to use the title plus the definition, and a fourth group may cherry pick using unique combinations of the above. SPECIFIC PROBLEMS RELATED TO FDA-CASA 2012 CATEGORIES "Suicide attempt." This category definition requires the suicide attempt to be "a potentially self-injurious behavior" (line 513). 4 This is a limited definition of a suicide attempt and does not allow for a full range of suicide attempt behavior phenomena. For example, after watching the movie Snow White with his family, a young child is teased by his older brother. The older brother offers the child an apple that the older brother claims is poisoned like the one in the movie. Assuming it will make him sleep forever, the child eats the apple. Because the child thinks that eating the apple will kill him, just as it put Snow White into the "sleeping death," this event should count as a suicide attempt. However the category definition for "Suicide attempt" in FDA-CASA 2012 does not allow this event to be coded as a suicide attempt and thereby misses what could be argued to be a clear suicide attempt. This is because the definition assumes that everyone making a suicide attempt has a clear understanding of what behaviors truly are potentially self-injurious. T his same issue is present in the "Interrupted suicide attempt" and "Aborted suicide attempt" categories. "Interrupted suicide attempt" and "Aborted suicide attempt." In both cases, the definitions require the patient to have refrained from engaging in the potentially self- injurious or self destructive act. These definitions are problematic for two reasons. First, it is misleading to classify the defined behavior as a suicide attempt since the attempt by definition never started. Second, there is a safety issue. Starting a self- injurious action that is then interrupted or aborted is more worrisome than engaging in preparatory behavior. To the extent that such started actions are excluded, per FDA-CASA 2012 definition, true incidents of interrupted or aborted attempts will be missed. It is more appropriate to use language that accurately describes the phenomenon than to mislabel something as a suicide attempt, when it is not a suicide attempt but is a preparatory behavior. A further problem with the FDA- CASA 2012 category "Interrupted suicide attempt" is contained in its definition stating that "if not for that [the interruption], [an] actual attempt would have occurred" (line 521). 4 The problem here is that the clinician is required to know what the future would have been, if not for the interruption. It is quite possible that the patient would have aborted the attempt if the interruption had not occurred, but there is no way to know if the attempt would have been aborted or not because the interruption did occur. This wording presents serious challenges in reasonably coding any event as an "Interrupted suicide attempt" based upon the category definition. "Preparatory acts toward imminent suicidal behaviors." Again, this category has a title that does not match the definition below it. Specifically, the title contains the word "imminent," but the definition does not require the preparatory actions to be connected to any i mminent suicidal behavior. 4 Moreover, the word "imminent" is not defined. Does it refer to a time span of a week, four weeks, four months, one year, or some other time frame? Without specification, clinicians may apply wildly different timeframes to determine if a preparatory behavior fits into the category or not. This can result in inconsistency. There is also the potential to miss important behaviors if the time frame applied is short. In fact, some patients make preparatory behaviors months or even years in advance of an attempt. These patients may not require additional preparations just prior to an attempt. In sum, using the qualifier "imminent" is ambiguous and may result in a clinician completely missing or dismissing preparatory behavior because the behavior did not occur within a subjective period of time (e.g., consider the patient who purchased a gun and bullets over a year ago and wrote suicide letters to loved ones months ago). The clinician may not ask about all of the steps the patient has taken in the past and by not doing so will have a much more difficult time helping to keep the patient safe. The definition under this category is problematic in another way. In identifying relevant behavior, the definition (lines 533–534) 4 refers to "assembling a specific method (e.g., buying pills, purchasing a gun)." Most of us would consider these examples as gathering "means" or tools, not assembling methods. The clinician reading this definition, however, may interpret the wording to include "planning the way" for a suicide, causing further complications in the interpretation of FDA-CASA 2012 by raters or clinicians. "Self-Injurious Behavior Without Suicidal Intent." According to the definition, this category is specifically intended

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