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 ] 74 the rater's interpretation of this question. "Preparatory Acts or Behavior." According to the definition, p reparatory acts or behavior are "acts or preparation towards imminently making a suicide attempt." 1 Use of the qualifier "imminently" is ambiguous because it lends itself to multiple interpretations. One rater may take it to mean "in the next 24 hours," another may take it to mean "in the next week," while a third may feel it can be interpreted as "in the next month." Without an explicit definition of "imminent," individual raters may select very different time frames—causing many type I and type II errors, depending on one's own time frame reference, within a trial. As a further complication, neither the title or the probe use the word "imminent." As a result some raters may simply ignore it. "Interrupted Attempt." This type of attempt is defined as follows: "When the person is interrupted (by an outside circumstance) from starting the potentially self-injurious act (if not for that, actual attempt would have occurred)." 1 The wording here can be confusing to raters and patients. What is "a circumstance" in this context? And what is meant by "if not for that?" Does "that" refer to the intervening circumstance or the self-injurious act? The point here is that the rater has to stop because the wording is ambiguous. Some of the illustrations under this category are also problematic. For example, a person with a noose around his neck could be engaged in autoerotic asphyxiation with no intent to die. Classifying this case as an interrupted attempt would be an error. "Aborted" or "Self-Interrupted Attempt." This category is defined as one in which the patient "begins to take steps toward making a suicide attempt, but stops themselves before they actually have engaged in any self-destructive behavior." 1 Use of the plural (e.g., they and themselves) is not simply poor grammar; it suggests that more than one person has to be involved—as in a suicide pact. For an obsessional rater, it could be interpreted to exclude situations when only one person makes an a ttempt, posing yet another classification error. We, the authors of this paper, have seen examples of this interpretation by patients. Use of "he/she." On one version of the C–SSRS, the timeframe for the questions references the time "he/she felt most suicidal." Use of gender- specific language such as this can cause problems if the person is intersex (e.g., Klinefelter's or Turner's syndrome) or gender neutral. The standard today is gender neutrality in rating scales, a standard the S-STS and ISST-Plus have both consciously adopted. 4. Does the C–SSRS map to the FDA 2012 classification algorithm? Since the FDA-CASA 2012 adopted category titles and definitions that were similar to the C–SSRS, one would expect to see compatibility going forward of data collected through years of use of the C–SSRS. Unfortunately, this is not the case since the FDA Draft Guidance document, in its update of 2012, actually made the C–SSRS incompatible with several of the 2012 FDA classification categories. The FDA 2012 Draft Guidance document states on page 6, lines 217–218, "Direct classification into the 11 preferred terms (see Appendix A): Use of the C–SSRS instrument accomplishes this goal directly" and on page 5, lines 177–179, "The direct classification of information collected in the C–SSRS interview into these 11 categories, along with integration of information about the event from other sources, renders it unnecessary to conduct any other classification step." 6 Unfortunately these statements are factually inaccurate in substantial measure. As shown in Table 3, there are numerous inconsistencies between the C-SSRS and the FDA-CASA 2012. Category titles are consistent across the C–SSRS and FDA-CASA 2012 for only four of the 11 categories (36%). Definitions are consistent for eight of the 10 categories where the C–SSRS provides definitions (80%). However, probes tend to be inconsistent, m atching FDA-CASA 2012 definitions for only two of the 10 categories where probes are used (20%). When the mismatches in Table 3 are applied to the possible combinations in Table 1, the result is Table 4. The last column of Table 4 illustrates where the FDA-CASA 2012 titles and definitions and the C–SSRS titles, definitions, and questions all capture the same combination number. Four (12.5%) were captured, 25 (78.125%) were not captured, and three (9.375%) were overlooked and not considered as options. Specific incompatibilities. Some of the specific incompatibilities and how they have the potential to increase error in classification, depending on whether the rater uses the C–SSRS title, definition, or probe or some combination of the three, are further detailed below. "Wish to Be Dead." This C–SSRS category should align with the FDA- CASA 2012 category "Passive suicidal ideation: wish to be dead." 6 The C– SSRS and FDA definitions are similar, both addressing wishes to be dead or not alive anymore or to fall asleep and not wake up. 1,6 The C–SSRS probe question, however, does not inquire into the potential of a patient experiencing "a wish to be [...] not alive anymore." 1 This omission might seem like a small detail, but it has the potential to narrow the application of this category resulting in under- identification (type II error) on the C– SSRS. " Non-Specific Active Suicidal Thoughts." This C–SSRS category should match the FDA-CASA 2012 category "Active suicidal ideation: non-specific (no method, intent or plan)." 6 The C–SSRS probe, however, is not limited to the kind of suicidal phenomena described in the FDA definition. In fact, the probe, "Have you actually had any thoughts of killing yourself?" [1] could refer to specific as well as non-specific

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