Innovations In Clinical Neuroscience

Summit 2017

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

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for all indications, but we see the i mmediate need for those within the CNS realm. Results: Assessing the outcome measures will begin with tracking multiple areas: 1) creating a designated " warm" line for call centers and sites to transfer individuals with potential suicidal ideations. The number of calls can be tracked and calculated; and 2) Call centers and sites can also complete a suicide assessment questionnaire, which can be tracked and calculated. STARR911 can do periotic follow ups and receive feedback from call center operators and sites. Conclusion: Research can be a part of the solution to suicide prevention. Progressive initiatives are key for re- search to be considered a part of the healthcare community and to gain credibility for drug development. Validity and retest-reliability of sleep measurements using a simple, self- applicable device Presenters: Dorffner G 1,2 , Gruber G 1 , Parapatics S 1 , Loretz E 1 , Kemethofer M 1 , Simeoni M 2 , Rainer L 2 Affiliations: 1 The Siesta Group; 2 Medical University of Vienna, Section for Artificial Intelligence and Decision Support, Vienna, Austria Background/Objective: Portable solutions for sleep measurement (polysomnography [PSG]) in clinical trials are gaining interest. However, most such solutions still require involvement of highly skilled personnel, thus limiting the potential scope of those instruments. Recently, we presented a new method of sleep staging based on a reduced setting using only two electrooculography (EOG) channels. The aim of this prospective study was to explore further the reliability and validity of this reduction. Design: Twenty healthy subjects (aged 20–29 years) participated in the study. A reduced recording setup was used for five consecutive nights using an Actiwave miniature recorder (Camntech, Cambridge UK). During the first night, a full PSG according to standard criteria was recorded simultaneously. All 120 recordings were analyzed, either using a validated computer-assisted scoring system for t he standard PSGs or a modified version adapted for the reduced two-channel setup. Results: Data loss was minimal in the two-channel recorder. The number of e pochs not scoreable was 1.3 percent in the portable device. In general, the differences of target variables between reduced and standard setup were marginal in absolute terms: Sleep efficiency: -0.47 percent (SD=2.6), Wake after Sleep Onset: -3.2 minutes (SD= 9.05), Percentage of stage N1: - 0.24 percent (SD=4.57), N2: -0.61 percent (SD=7.36), N3: -0.52 percent (SD=7.17), and R: +1.44 (SD=4.5). No significant differences were found in a paired samples t-test in any variable. All sleep parameters turned out to be very stable during the five nights. Analysis of variance (ANOVA) for repeated measurements as well as Kruskal-Wallis H-tests did not reveal any significant differences in any variable. Effect sizes of internight differences evaluated by Cohen's d were below 0.2 (very small to no effect) for the vast majority of pairwise comparisons. Conclusion: The results provide further evidence that, with appropriate computer-supported sleep scoring, data obtained by means of a two-channel portable device lead to sleep measurements similar to a full PSG. Disclosures/funding: Georg Dorffner is an employee and shareholder of The Siesta Group GmbH. PATIENT ASSESSMENT AND ADHERENCE Criteria satisfied on diagnostic instrument often not confirmed on severity ratings Presenters: Sachs G, Reksoprodjo P, Roy M, Kott K, and Busner J Affiliations: Bracket Global Background/Objective: Entry criteria for randomized, acute depression studies typically include both a categorical requirement (meeting Diagnostic and Statistical Manual of Mental Disorders [DSM] criteria for major depressive episode [MDE]) and a threshold score on a continuous severity measure. When these distinct assessment techniques produce i ncongruent results, the diagnosis might be unreliable. We interrogated blinded data sets from recent acute depressions studies to determine the frequency of this potential unreliable diagnosis. D esign: Data from eight double-blind, randomized acute major depressive disorder (MDD) studies were analyzed. We considered Montgomery-Asberg Depression Scale (MADRS) items clinically significant if for scores of 4 or higher. Subjects were classified as Insufficient Gating Criteria if three MADRS items—Apparent Sadness, Reported Sadness and Inability to Feel— were all rated below the clinically significant range, and as Insufficient Pychopathology for MDE if the corresponding MADRS items fewer than four DSM criteria were rated 4 or higher. Unreliable diagnosis was defined as meeting DSM criteria by a diagnostic instrument but lacking gating criteria or having insufficient psychopathology for a MDE diagnosis. Results: Among 3,256 subjects with screening and baseline assessments, 3,091 (95%) were randomized. Of these, 667 (21.6%) met operational criteria for unreliable diagnosis, 124 (4%) lacked gating criteria n=124 (4%), and 660 (21.4%) had insufficient psychopathology for MDE. The proportion of unreliable diagnosis varied widely across studies (9.2–37.7% (c 2 (8)=153.5;p<0.001). Conclusion: Our analysis found high rates of unreliable diagnostic assessment, and supports the use of diagnostic validation procedures in clinical trials. Further analysis will assess signal detection these subjects. Data quality concerns associated with PANSS negative items: an exploratory analysis Presenters: Kott A, Daniel DG Affiliations: Bracket Global, LLC Background/Objective: Within the Positive and Negative Syndrome Scale (PANSS), errors are frequent and are associated with increased response to placebo. Most of the currently available data checks focus on positive and some general psychopathology items. We have recently developed a battery of data ICNS Innovations in Clinical Neuroscience • November–December 2017 • Volume 14 • Number 11–12 • Supplement S11

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