Innovations In Clinical Neuroscience

SEP-OCT 2014

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

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Page 61 of 201

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 ] 62 "purely for other reasons, either to relieve distress […] or to effect change in others or the environment" (lines 539–541). 4 Unfortunately, that e xcludes a wide range of self- injurious behaviors. Take the example of a car accident while the patient is driving or other types of accidents patients might have. In the blind- rater, case-history, narrative reviews for the FDA in its investigation on the effect of antidepressants on suicidality in adults, there were many cases of accidents in depressed patients that required adjudication in drug trials. The first author of this article (D.S.), who served as a blind rater in these adjudications recalls a typical narrative: This depressed study patient crashed into a tree and suffered severe injuries while skiing. Could this event have been a suicide attempt? Many examples of such accidents need careful investigation and coding and are too frequent to ignore. And what about the patient who engages in self-injurious behavior for reasons other than those specified? For example, the category definition here precludes such behavior for religious purposes, such as Tatbir, which is the ritual act of mourning performed by some Shi'a Muslims where they strike themselves on the head with a sword in order to cause blood flow in an act of remembrance. It also precludes classifying anyone engaging in self- injury strictly for the purposes of sadomasochism (S & M), such as a submissive being instructed by a dominant to self-flagellate or cut. 15 We have seen such behaviors labeled as suicide attempts in emergency rooms, especially when the patient admitted to having some recent suicidal ideation, although the suicidal ideation was not related to the sadomasochistic acts that resulted in the self-injury needing medical treatment in the emergency room. If this definition for this category was broadened to cover self- injurious behaviors such as those described above, it may avoid their being incorrectly labeled as suicide attempts. "Active suicidal ideation: nonspecific (no method, intent, or plan)." This FDA-CASA 2012 category requires, in part, active s uicidal ideation "without general thoughts of ways to kill oneself/associated methods, intent, or plan during the assessment period" (lines 478–479). 4 The clinician might interpret this to mean without general thoughts of ways to kill oneself, as stated by the definition, or might interpret it to mean without general thoughts but with specific thoughts of associated methods, intent, or plan. To avoid ambiguity, the definition might be better worded to read "without general thoughts of ways to kill oneself and without any associated methods, intent, or plan during the assessment period." Otherwise the existing wording could be interpreted to allow inclusion of those with specific methods, intent, or plan while allowing exclusion of those with general ideation, general thoughts about method, general intent, and general plan, even though this was probably not the intent of the FDA wording. The wording and the unclear use of the "/" is a potential source of confusion because the title and the first part of the definition, "general nonspecific thoughts" 4 clearly indicate that this category is for nonspecific active suicidal ideation, but the second part of the definition can be interpreted to also include specific active suicidal ideation. While the reader may regard some of these interpretations of definitions as overly literal, we raise them because the experience of the first author of this article (D.S.) in doing clinical trials is that the exact FDA-CASA 2012 wording is often used to adjudicate disputes between study investigators, scale raters, clinical monitors, contract research organizations (CROs), and rater training agencies when item responses on rating scales could be interpreted in different ways. "Active suicidal ideation: method, but no intent or plan." For this FDA-CASA 2012 category, the definition is that the "patient […] has thought of at least one method during the assessment period" (lines 4 83–484) 4 [ italics ours]. However, we then read, "This situation is different than a specific plan with time, place, or method details worked out" (lines 484–485) 4 [italics ours]. The presence of a method is necessary based on the category title and on the first sentence of the definition. However, the qualifying phrase "or method details worked out" in the following sentence indicates that if the patient HAS worked out the details of the method, the patient no longer qualifies for this category. What is the demarcation line for the amount of detail about the method necessary to meet or not meet criteria for this category? For example, consider the patient who says, "I have thought about hanging myself with a rope, but I have not worked out the rest of the details of the plan on carrying it out." In this case, the patient has a specific method in mind. It is not clear whether the patient does or does not meet criteria for this category. This ambiguity can be interpreted in different ways by different readers and by different raters, with little guidance on how to disentangle this ambiguity or how to precisely operationalize classifying to this category in practice. Such ambiguity contributes to inter-rater unreliability. "Active suicidal ideation: method and intent, but no plan." The current definition wording is as follows: "Active suicidal thoughts of killing oneself, and patient reports having some intent to act on such thoughts, as opposed to 'I have the thoughts but I definitely will not do anything about them'" (lines 492–494). 4 For this category, the title suggests that the patient has suicidal intent, but the definition wording could be interpreted to erroneously include a patient without intent. The problem is the instruction in the definition wording not to include

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