Citation

Gwaltney C, Mundt JC, Greist JH, Paty J, Tiplady B. Innov. Clin. Neurosci. 2017; 14(3-4): 17-23.

Affiliation

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).

Copyright

(Copyright © 2017, Matrix Medical Communications)

DOI

unavailable

PMID

28584693

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.

Language: en

Keywords

C-SSR; Columbia-Suicide Severity Rating Scale; Suicidal ideation and behavior; electronic patient-reported outcomes; equivalence; interactive voice response; tablet computer