Metrics and perspectives on implementation of the electronic Columbia Suicide Severity Rating scale (eC-SSRs)™ across four Phase IIIB/IV clinical trials (ARIA, STRIIVING, DAWNING and INSPIRING)

Background: Increased rates of suicidal ideation/behavior have been reported in individuals with HIV/AIDS. FDA guidance endorses routine monitoring for suicidality in clinical trials of HIV. The electronic Columbia Suicidality Severity Rating scale (eC SSRs) is recommended as a validated tool for prospective assessment of suicidal risk in clinical trials. We evaluated the perception of the eC-SSRs by investigators/site staff in active clinical studies, and determined if the eC-SSRs results correlated with the clinical assessment. This is the first assessment by ViiV of site perspectives on implementation of the e-CSSRs.

Methods: The self-reported eC-SSRs administered by EResearch Technology (ERT) was included in four Phase IIIb/IV studies of dolutegravir. Administration was by telephone (2 studies) and by telephone or internet (2 studies). ViiV administered the “eC-SSRs Metrics and Perspectives Site Questionnaire” (VEQ) as a web-based survey to sites enrolling at least one subject. Topics included ease of eC-SSRs administration, first time use, agreement with clinical assessment, unreported risk, and confidence in utility of the eC-SSRs. Clinical assessment data from ARIA and STRIIVING were reviewed for correlation with the eC-SSRs results.

Results: Overall VEQ response rate was 83% (181/218) from 13 countries. Approximately 1/3 of respondents were investigators. 85% of respondents administered the eC-SSRs by phone, and 34% reported their patients would be unable to complete a web survey. 64% were first time eC-SSRs users; among these, 85% said implementation became easier over time. Half of respondents said the eC-SSRs accurately predicted the risk for suicidality and 14% said the eC-SSRs identified a previously unreported risk. 65% of respondents were somewhat/very confident their patients are being assessed accurately for suicidal risk and the eC-SSRs helps manage this risk appropriately. EC-SSRs results from ARIA and STRIIVING were consistent with the clinical assessment data.

Conclusion: The eC-SSRs identified previous unreported risk for suicidality and provided physicians opportunity for follow up. Overall, respondents feel the eC-SSRs helps them manage suicide risk. The eC-SSRs is considered a useful tool in this setting.