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 70 of 201

[ 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 71 The intent and directive in implementing this navigation instruction is explicit in a paper by Mundt et al 18 on the computer a utomated C-SSRS. It is also captured at 48:06 minutes in a video that was made of an October 2011 Grand Rounds at the Child Center of New York University and was online and accessed by the authors on November 30, 2012. 33 The experience of the second two authors of this paper (K.S. and D.S.) is that the SOP (standard operating procedures) of pharmaceutical companies, clinical research organizations, and rater training companies conducting clinical trials reflect this C–SSRS instruction and they implement it assertively in monitoring clinical trials. "Intensity of Ideation." In the Lifetime/Baseline Version of C–SSRS, under "Intensity of Ideation," the rater is told the following: "The following features should be rated with respect to the most severe type of ideation (i.e., 1–5 from above, with 1 being the least severe and 5 being the most severe). Ask about time he/she was feeling the most suicidal." 1 The second part of this instruction indicates that the rater should ask about the time the patient felt "most suicidal." However, the first part indicates that the rater should only provide intensity ratings for the "most severe" type of ideation, defined in terms of the five categories above the instruction. What if a patient reports feeling "most suicidal" when only having passive ideation (C–SSRS category #1)? After all, this ideation went on for hours and it was frightening to the patient. What if, in addition, the patient reports that the experienced active ideation with a plan and intent (C–SSRS category #5) passed quickly and troubled the patient less? That is, from the patient's viewpoint, it was much less severe and much less troublesome. This type of scenario is not uncommon. In fact, the active type of ideation may be less frightening to the patient than the passive ideation. At the least, the rater is faced with another dilemma. Should the ratings be provided for the time when the p atient felt "most suicidal" (following the second part of the instruction) or or should the ratings be provided for the time when the patient met criteria for the most severe category (following the first part of the instruction)? And what are the implications for the answers to specific questions regarding such things as frequency and duration if the rater makes one choice instead of the other? Clearly, if different raters make different choices, the integrity of the data will suffer. In our view, this issue creates inconsistencies across the different versions of C–SSRS. "Suicidal Behavior." In the "Suicidal Behavior" section of the C– SSRS, the rater is told the following: "Check all that apply, so long as these are separate events; must ask about all types." We find this contradictory. The first part ("check all that apply") indicates that the rater should only rate those types of suicidal behavior that apply (i.e., check "yes" or "no") if they are "separate events." In other words, the rater can safely ignore questions about preparatory acts or behavior or other types of events if the patient reports a single "interrupted attempt." On the other hand, the second part ("must ask about all types") suggests that questions should be asked about all five types of suicidal behavior shown in this section. Does this mean that the rater should leave all the other the yes/no boxes blank? Or, following the second part of the instruction, should the rater place checkmarks in the "no" boxes for the other types? What if the patient did engage in preparatory acts or behavior before an interrupted or actual attempt? Which type of behavior trumps here? We may assume that attempts should trump preparatory acts, but the instructions are not explicit. In many cases, a confused rater, to be safe, may just check all types that apply whether or not they are separate. This scenario undoubtedly leads to inflation of some types of behavior in the results (type I error). I n our experience, patients and raters are confused when the term "interrupted attempt" is used to describe an interrupted preparatory behavior and patients are told this attempt is not a suicide attempt. The use of this ambiguous term led to discrepancies between the C–SSRS on one side and the ISST-Plus and the S-STS on the other side in the validation study of all three. 29 The S- STS does not use the term "interrupted attempt," thus avoiding this confusion. Use of this term also leads to many problems in translations to other languages thereby causing linguistic invalidation. In many languages, the term "interrupted attempt" cannot be translated in a way that makes sense in the end language without the addition of the word suicide (as in "interrupted suicide attempt") [Personal communication to the third author (D.S.) in 2010, 2011, 2012, 2013, 2014 from MAPI Group, a leading international translation and linguistic validation agency involved in translating psychiatry scales and structured interviews]. When asked for clarification on what this term means, the scale author is required to explain that an "interrupted attempt" is not a suicide attempt at all (per C–SSRS definition), but is classified as a preparatory behavior. The third author of this paper (D.S.) has repeatedly faced this challenge in the translation of the S-STS and the MINI suicidality module into many languages with MAPI. The only satisfactory way to avoid this confusion in all languages, including English, is to avoid using the word attempt for either "interrupted attempt" or "aborted attempt." 34 Some of the navigation problems may relate to the use of a Guttman Scale-like procedure in the design of the C–SSRS. Guttman scaling is used when the responses can be ranked in an order so that agreement with one item implies agreement with a lower

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