Innovations In Clinical Neuroscience

MAR-APR 2017

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 4 , N U M B E R 3 – 4 , M A R C H – A P R I L 2 0 1 7 ] 19 to be eligible, staff requested that the attending physician allow the project coordinator to approach the patient regarding participation. The project coordinator then met with the patient to describe the study details and respond to any questions and concerns. All chart reviews and other screening activities were completed in accordance with Health Insurance Portability and Accountability Act of 1996 (HIPAA) guidelines. At the beginning of the testing session, participants were instructed on the use of the ePRO instruments. Following randomization, the participant completed the first eC-SSRS assessment (lifetime assessment, version 2.0) using either the IVR or a text-based (tablet) solution. Following this, participants completed a lexical decision task and were given a refreshment break. The total time for lexical decision task and the break was 20 to 25 minutes. Participants then completed the second eC-SSRS assessment using the other modality (IVR or text-based), and this was followed by another 20- to 25- minute lexical decision task and refreshment break. Participants subsequently completed the third eC- SSRS assessment using the same modality as the first period. Assessments. All assessments were presented in English. eC-SSRS. The tablet and IVR versions (provided by ERT, Inc., Philadelphia, Pennsylvania) were derived from the baseline/lifetime version of the CSSRS with recency assessment of six months for suicidal ideation and two years for suicidal behavior. 4,6 Lexical decision (word recognition) task. The lexical decision (word recognition) task was presented as a distractor test between eC-SSRS administrations; the data were not included in analysis. A list of pairs of word stimuli was printed on paper. Each pair consisted of a word and a nonword, and the subject identified which one was the real word. Two lists were used, with the words matched for frequency between the lists. Technology/preference scale. A questionnaire asking about users' experience with the telephone and tablet modes was completed at the end of the session. Data management and analysis. Demographic and clinical information were summarized using descriptive statistics. The eC-SSRS includes ratings of SIB. Suicidal ideation ratings were coded as 1) passive; 2) active: nonspecific, with no method, intent or plan; 3) active: method, but no intent or plan; 4) active: method and intent, but no plan; and 5) active: method, intent, and plan. Suicidal behavior reports were coded as 1) completed suicide (not applicable in this study); 2) suicide attempt; 3) interrupted attempt; 4) aborted attempt; 5) preparatory actions toward imminent suicidal behaviors; and 6) non-suicidal, self-injurious behavior. The following scores were derived from the SIB reports on the eC-SSRS: • Most severe lifetime ideation (0–5) • Most severe ideation in past six months (0 –5) • Lifetime presence of each type of suicidal behavior (Yes/No) • Presence of each type of behavior in past two years (Yes/No) • Number of lifetime suicide attempts (continuous variable). The objective of the analysis was to evaluate the level of agreement (i.e., equivalence) across the IVR and text- based modes. For the ideation variables, which are on an ordinal scale, this included calculation of Kendall's Tau-b and intraclass correlation coefficients 12 (ICC; using 2, 1 form from Shrout and Fleiss 12 ). Kappa statistics were calculated for the suicidal behavior binary variables. Equivalence analyses compared the first and second assessments. The target value for "good" agreement is 0.5 or greater for Tau-b (tb), 0.7 or greater for ICC, and 0.6 or greater for kappa. 13–15 For comparison purposes, the test-retest reliability of the modes was examined by calculating the ICC for the first and third administrations (ideation only). Known-groups validity was examined by comparing scores on the two modes from the inpatients and hospital workers. It was expected that the inpatients would report significantly greater ideation and behavior than the hospital workers and that the mode of administration would not moderate this effect. Scores from the first administration of the eC-SSRS (either tablet or IVR) were used in analyses. ANOVA with terms for group and mode and the group x mode interaction were used for ordinal variables. Chi-square tests, including tests for all modes, IVR, and tablet were used for categorical variables. RESULTS Participant characteristics. There were 115 participants enrolled in the study. However, data for 25 patients were excluded from analysis due to violations of the assessment randomization protocol. Another four patients were excluded because they were asked about their SIB "since the last assessment" (a variant that is often TABLE 1. Overview of study design PERIODS SEQUENCE A SEQUENCE B Period 1 Tablet IVR 5 minute distractor task followed by 20 minute refreshment break Period 2 IVR Tablet 5 minute distractor task followed by 20 minute refreshment break Period 3 Tablet IVR Technology/ease of use/preference scale

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