Implementation of the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS™) Across Four Phase IIIb Clinical Trials in HIV-infected Individuals (ARIA, STRIIVING, DAWNING and INSPIRING).

ABSTRACT

Objective: Increased rates of suicidal ideation/behavior have been reported in individuals with human immunodeficiency virus infection/acquired immunodeficiency syndrome. The electronic Columbia-Suicidality Severity Rating Scale (eC-SSRS™) is a validated tool for assessment of suicidal risk. The objective of this study was to assess the site perspectives on implementation of the eC-SSRS used in Phase IIIb studies of dolutegravir. Methods: We developed and validated the ViiV eC-SSRS Metrics and Perspectives Site Questionnaire (VEQ). Topics included ease of eC-SSRS administration, agreement with clinical assessment, unreported risk, and confidence in utility of the eC-SSRS. Results: Clinical data from two Phase IIIb studies were reviewed for correlation with the eC-SSRS results. The overall VEQ response rate was 83%. A total of 85% of respondents administered the eC-SSRS by phone, and 34% reported their patients would be unable to complete a web survey. First-time eC-SSRS users made up 64% of the responders; 85% of repeat administrators said implementation became easier over time. One-half said the eC-SSRS accurately predicted risk, and 14% said the eC-SSRS identified previously unreported risk. A total of 65% were somewhat/very confident their patients are being assessed accurately for suicide risk. Conclusion: Results of the eC-SSRS from ARIA and STRIIVING were consistent with the clinical data. The eC-SSRS identified previous unreported risk for suicidality and provided physicians opportunity for follow-up. Respondents felt the eC-SSRS helps them manage suicide risk, and they reported that its administration became easier with experience. Thus, the eC-SSRS is considered a useful tool in this setting.