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 ] 17 ABSTRACT Objectives: Our study objective was to compare the equivalence of a new version of the electronic Columbia-Suicide Severity Rating Scale that was administered on a tablet device with the existing interactive voice response version in order to support the prospective monitoring of suicidal ideation and behavior in clinical trials and clinical practice. Design: This was a randomized, crossover-equivalence study with no treatment intervention. Setting: The study setting was a psychiatric hospital. Participants: Fifty-eight recently admitted psychiatric inpatients and 28 employees of the hospital site were included in the study. Mean age was 41.0 years (standard deviation=12.5), and 59 percent were female. Measurements: Participants completed both tablet and interactive voice response versions in randomized order, with a 25- minute break between administrations. Finally, participants completed a second administration of the first administered version. Intraclass correlation coefficients (ICCs) and Kappa coefficients were used to evaluate agreement across modalities. Results: High levels of agreement were observed for most severe lifetime (ICC=0.88) and recent (ICC=0.79) ideation, occurrence of actual lifetime (Kappa=0.81) and recent (Kappa=0.73) suicide attempts, and occurrence of lifetime interrupted attempts (Kappa=0.78), aborted attempts (Kappa=0.54), and preparatory behaviors (Kappa=0.77), as well as non-suicidal self- injurious behavior (Kappa=0.73). Scores from both modes significantly differentiated psychiatric patients and hospital employee controls, and the test- retest reliability of both modes was excellent. Conclusions: These results support the validity and reliability of the new tablet- based electronic Columbia-Suicide Severity Rating Scale. This will allow the inclusion of the electronic Columbia-Suicide Severity Rating Scale in a wider range of clinical studies, particularly where a tablet is also being used to collect other study data. INTRODUCTION Prospective assessment of suicidal ideation and behavior (SIB) is a critical step in many clinical trials. The United States Food and Drug Administration (FDA) mandates prospective SIB in "all by CHAD GWALTNEY, PhD; JAMES C MUNDT, PhD; JOHN H. GREIST, MD; JEAN PATY, PhD; and BRIAN TIPLADY, PhD Dr. Gwaltney is with Gwaltney Consulting, Westerly, Rhode Island (with ERT Inc. during the time of this study); Dr. Mundt is with ePRO Research Consulting, LLC, Sauk City, Wisconsin; Dr. Greist is Professor Emeritus of Psychiatry, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin; Dr. Paty is with Quintiles Advisory Services at QuintilesIMS, Pittsburgh, Pennsylvania; and Dr. Tiplady is an honorary fellow at Edinburgh University Medical School, Scotland, UK (with ERT Inc. during the time of this study). Innov Clin Neurosci. 2017;14(3–4):17–23 FUNDING: This study was sponsored by ERT, Inc., Philadelphia, Pennsylvania. FINANCIAL DISCLOSURES: Dr. Gwaltney was an employee of ERT Inc., Philadelpia, Pennsylvania, at the time of this study. Drs. Mundt and Greist are shareholders in Healthcare Technology Systems, Madison, Wisconsin,which receives royalty payments for licensing of the eC-SSRS; Dr. Tiplady was an employee of eResearch Technology, Ltd., Petersborough, UK at the time of this study and is a holder of AstraZeneca stock. ADDRESS CORRESPONDENCE TO: Dr. Brian Tiplady; Phone: +44 (0)131 447 2171; E-mail: KEY WORDS: Suicidal ideation and behavior, Columbia-Suicide Severity Rating Scale, C-SSR, electronic patient-reported outcomes, interactive voice response, tablet computer, equivalence O R I G I N A L R E S E A R C H Interactive Voice Response and Text-based Self-report Versions of the Electronic Columbia- Suicide Severity Rating Scale Are Equivalent

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