Innovations In Clinical Neuroscience

Summit 2017

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

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The SAGE-SR: item development and i nitial validation of a DSM-5 and SCID- based self-report diagnostic assessment. Presenters: Brodey BB, Zweede EA Affiliations: TeleSage, Inc., 201 E. R osemary St., Chapel Hill, NC 27514 USA Background/Objective: Our objective was to develop and validate a rigorous self-report diagnostic assessment based on DSM-5 and ICD-10 diagnostic criteria that can be used to accurately identify any of 31 standard behavioral health diagnoses and to facilitate screening people for eligibility to participate in FDA clinical trials. Design: The item development and validation process included an expert panel, four clinical sites, and a control population. An expert panel iteratively developed items based on the exact individual symptoms, time-frames, and clustering described in the DSM-5 and the Structured Clinical Interview for DSM-5 Disorders (SCID-5). Items were tested using cognitive interviewing (CI) with a total of 50 participants in three rounds. Items that gave rise to any confusion were re-written and re-tested iteratively with CI until all items were clearly understood in the final round of CI. Items were placed into a computer adaptive instrument in sequential order based on the SCID-5, and a branching pattern was developed to eliminate non- contributory items during each assessment. The resulting SAGE-SR was administered to 44 public sector clinical participants and to 84 nonclinical controls. Results: We successfully developed and validated 661 items covering the exact symptoms, time frames, and clustering criteria for the 31 most common DSM-5 diagnoses. The resulting computer adaptive program ran smoothly and was well liked by study participants. A clinical report was successfully generated after each assessment. The assessment took 14 minutes (SD=6.8) and 24 minutes (SD=12.5) to administer to clinical controls and public sector participants respectively. Conclusion: The SAGE-SR is a brief self-report diagnostic assessment that can be used to efficiently screen large p opulations in order to identify individuals who might be appropriate for participation in specific clinical trials. The SAGE-SR also provides a detailed exportable symptom database that can b e used to identify sub-populations that have a robust response to a clinical intervention. Disclosures/funding: This research was supported in part by a grant from the National Institutes of Mental Health, which was awarded to TeleSage, Inc. Dr. Brodey is Chief Executive Officer of TeleSage, Inc., and Dr. Zweede is employed by the company as a clinical research specialist. Subjects' knowledge of symptoms that can occur during seizures Presenters: Ly JJ, Yamamoto RT, Khurana L, Gerzon M, Dias NR, Durand EM, Gary ST, Tuller JM, and Dallabrida SM Affiliations: ERT, Boston, MA Background/Objective: The aim of this study was to assess subjects' knowledge and recognition of common symptoms that can occur during various types of generalized and partial focal seizures. Design: Participants (N=645) completed an online survey asking them to endorse, in a checklist format, 10 common symptoms that can happen during seizures. All participants reported that they did not have a history of seizures. Demographic information were also recorded. Results: Most participants endorsed symptoms associated with clonic-tonic seizures including loss of consciousness and falling to the ground while shaking on both sides of the body (82% and 91%, respectively) as symptoms that can occur during seizures. Fewer participants identified symptoms associated with tonic (muscles become tense or rigid, 78%), clonic (twitching in one arm or leg, 72%), absence (staring into space, 65%; rapid eye blink, 61%; eyes rolling back, 86%), and atonic seizures (muscles become weak or limp, 54%). Many of the respondents did not endorse symptoms associated with complex partial (repeated movements like clapping, lip-smacking, or walking, 44%) and simple partial seizures (change in how things look, smell, feel, taste, or s ound, 51%). Conclusion: Clinical trials for epilepsy often involve seizure frequency as a primary endpoint. Findings have shown that caregivers often underreport seizure f requency. Our results suggest that caregivers might have difficulty identifying many symptoms that can occur during seizures, especially partial focal and atonic seizures. Training caregivers might be beneficial in improving the accuracy of seizure frequency. Disclosures/funding: All authors are employees of ERT. Training, above all other motivators, is preferred by subjects with CNS disorders for motivating them to complete daily questionnaires Presenters: Yamamoto RT, Ly JJ, Dias N, Durand EM, Gary ST, Gerzon M, Khurana L, Tuller JM, and Dallabrida SM Affiliations: eResearch Technology Background/Objective: We aimed to determine what would most motivate clinical trial subjects with CNS-related diagnoses to complete daily questionnaires, as well as how much time they would be willing to commit to training. Design: There were 273 patients (26% of which had previously participated in a clinical trial) with at least one CNS-related diagnosis who responded to an online survey. Respondents were 18 to 79 years old (74% female). In addition to demographics and diagnoses, patients reported what would most motivate them to complete study questionnaires on a daily basis and, if they were provided educational information in a clinical trial, how much time would they be willing to spend training. Results: Fifty-six percent of those respondents who had previously participated in a clinical trial and 64% of those who had not previously participated in a clinical trial reported that they would be motivated by training, selecting either A) "If I were trained on the importance of my role and what to expect in the study," (B) If I were trained about the purpose and importance of the questionnaires, or both (A) and (B). Of ICNS Innovations in Clinical Neuroscience • November–December 2017 • Volume 14 • Number 11–12 • Supplement S13

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