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 ] 70 commit suicide with a gun that same day at home. The patient does not fit the criteria for passive ideation. A "wish to be dead," 1 after all, implies a d egree of willfulness. The patient cannot be said to have "active non- specific ideation." 1 In fact, the patient's ideation is highly specific. On the other hand, you could say the patient has a deadly method in mind and, insofar as several of the "details are worked out," 1 the patient has a plan (combination #13), but this case too will not be recognized on the C– SSRS. This is an issue with the navigation instructions for suicidal ideation in the C–SSRS (see Section 2 on flawed navigation instructions). The above cases are not unique, nor are they trivial. Indeed, the consequences of not considering them are broad. One consequence is the real possibility that patients who are at risk for suicide are included in studies when, per exclusion criteria, they should be excluded. An example is someone who decided a year ago that he intends to kill himself when his parents die, but not sooner. He has not thought about suicide in the past week or month, but this intent is unchanged and is only at the back of his mind, not overtly thought about during the investigation timeframe. What if his parents are killed in a car crash next week? This would then pose an immediate safety threat not readily detected by the C–SSRS. Another concern is that worsening suicidality associated with a study treatment can be missed by the C–SSRS. Consider the patient who is entered into a study and has some suicidal ideation at baseline. However, at Week 4 he reports an increased need to act on the suicidal thoughts sooner rather than later (increased urgency). Such a treatment- emergent change goes easily undetected by the C–SSRS. The C–SSRS misses some types of passive suicidal ideation. For example, it does not detect "the thought that you would be better off dead." 30 The importance of including a question about this type of passive suicidal ideation is supported by the findings of Preti et al, 31 who found that the question "Did you think you would be better off dead or wish you w ere dead?" had a 0.774 loading on a unidimensional model fit for the S- STS. Furthermore, thoughts of being better off dead can be an immediate antecedent to impulsive suicidality and is associated with functional impairment in work, social life, family life, and quality of life impacted by suicidality. 3 2 Suicidal patients have conveyed to us that this is a suicidal phenomenon worthy of note. 2. Are instructions, definitions, and probes well-defined and clear? Another aspect of scale development and acceptance is that instructions need to be clear and should not pose a burden on the reader. Here we will examine whether the navigation instructions in the C–SSRS meet these criteria. "Suicidal Ideation." Consider the instructions under "Suicidal Ideation." 1 The rater is told to ask questions 1 and 2: if the patient has a "wish to be dead" and if the patient has "non-specific active suicidal thoughts." 1 The rater is then instructed as follows: "If both are negative, proceed to 'Suicidal Behavior' section. If the answer to question 2 is 'yes,' ask questions 3, 4 and 5. If the answer to question 1 and/or 2 is 'yes', [sic] complete 'Intensity of Ideation' section below." 1 This was extracted from the Lifetime/Recent Version 1/14/09 and Baseline/Screening Version of the C–SSRS—is the same on most versions of C-SSRS, except Screen Version that is now filed under Scales for Clinical Practice. There are no directions on what to do if the answer to question 1 is yes and to question 2 is no. Given this ambiguity, different raters could handle this in different ways, leading to inter-rater unreliability. Apart from the unclear nature of this instruction (e.g., there are 3 different "ifs" and 3 different paths to consider), the rater confronting a suicidal patient is faced with an immediate dilemma. Let's say the response to question 2 (non-specific active suicidal thoughts) is no, precisely because the patient has very specific active suicidal ideation. I n fact, at this moment, the patient has a specific method, plan, and intent, but no non-specific active suicidal ideation. Specifically, the patient plans to take a fatal overdose at home this evening after work. The rater, however, is instructed to only ask about method, plan, and intent if the patient endorses non-specific active ideation. In effect, the rater has to choose between two undesirable options. The rater can opt to follow the instructions explicitly and skip over the questions about method, intent, and plan. In this scenario, ideation that includes method, intent, or plan will be missed (type II error). Alternately, to err on the side of safety and be able to document method, intent, and/or plan, the rater can violate the instructions by incorrectly responding yes to question 2, thereby endorsing a nonexistent "non-specific active suicidal thought" (type I error). In either scenario, the resulting data will be incorrect. That is, in the second scenario, there will be an invalid inflation (over-identification) of non-specific active ideation. We have made several patient-rater videos associated with this flawed navigation instruction that document precisely how this plays out in practice. Additionally, the rater may be forced once again to violate the navigation instructions by indicating the patient experienced one of the combinations in C–SSRS probe questions 3, 4, or 5 when the patient really experienced another combination (e.g., combination #10). The FDA-CASA 2012 validation study 29 identifies and highlights this over-inflation of endorsements by the C–SSRS on non-specific suicidal ideation compared to the comparable items on both the S-STS and the ISST-Plus. The S-STS and the ISST- Plus are concordant with each other on this finding and discordant with the C–SSRS. 29

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