Innovations In Clinical Neuroscience

SEP-OCT 2014

A peer-reviewed, evidence-based journal for clinicians in the field of neuroscience

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[ V O L U M E 1 1 , N U M B E R 9 – 1 0 , S E P T E M B E R – O C T O B E R 2 0 1 4 ] Innovations in CLINICAL NEUROSCIENCE 43 the magnitude of the discrepancies calls into question the validity of the gold standard if it disagrees so much with the two other s tandardized instruments that agree so closely with each other. Modification of the C-SSRS to address the problems raised by Giddens et al 8 and to capture the additional missing combinations might significantly narrow these discrepancies. However such modifications would be considerable and consequently would require that the C-SSRS so modified be revalidated against some other standard. The lack of agreement on these categories should not be taken to mean that the ISST-Plus and S-STS are weak and the C–SSRS is strong. Rather it invites debate and discussion over whether these alternative instruments better tap into the full spectrum of suicidal phenomena that exist and whether the C–SSRS in its existing form should continue to be the reference standard. ACKNOWLEDGMENTS The authors acknowledge Samantha White, BS; Courtney Blair MA; and Jaymee Nelson, MD for their work as raters in this study and Kathy Harnett Sheehan, PhD; Jennifer M. Giddens, Sheena Hunt, PhD; and Matthew Grzywacz, PhD for providing editorial assistance. REFERENCES 1. United States Food and Drug Administration, United States Department of Health and Human Services. Guidance for Industry: Suicidality: Prospective Assessment of Occurrence in Clinical Trials, Draft Guidance. September 2010. https://www.federalregister.gov/artic les/2010/09/09/2010-22404/draft- guidance-for-industry-on- suicidality-prospective-assessment- of-occurrence-in-clinical-trials. Accessed October 1, 2014. 2. Posner K, Oquendo, MA, Gould, et al. Columbia Classification Algorithm of Suicide Assessment (C-CASA): classification of suicidal events in the FDA's pediatric suicidal risk analysis of antidepressants, Am J Psychiatry. 2007;164:1035–1043. 3. United States Food and Drug Administration, United States Department of Health and Human Services. Guidance for Industry: Suicidality: Prospective Assessment of Occurrence in Clinical Trials, Draft Guidance. August 2012. Revision 1. http://www.fda.gov/downloads/Drug s/Guidances/UCM225130.pdf. Accessed October 1, 2014. 4. Posner K, Brown GK, Stanley B, et.al. The Columbia–Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011;168:1266–1277. 5. Gutierrez PM. Evaluation of existing psychometric data on the Columbia–Suicide Severity Rating Scale (C-SSRS). Working paper for the Military Suicide Research Consortium. Florida State University. December 6, 2011. https://msrc.fsu.edu/ sites/default/files/MSRC_C-SSRS_ evaluation.pdf. Accessed October 1, 2014. 6. Vandepeer M. Health Policy Advisory Committee on Technology, Technology Brief, Columbia–Suicide Severity Rating Scale, HealthPact Emerging Health Technology. State of Queensland, Australia. August 2012. http://www.health.qld.gov.au/health pact/docs/briefs/WP114.pdf. Accessed October 1, 2014. 7. Sheehan DV, Giddens JM, Sheehan KH. Current assessment and classification of suicidal phenomena using the FDA 2012 Draft Guidance document on suicide assessment: a critical review. Innov Clin Neurosci. 2014;11(9–10):54–65. 8. Giddens JM, Sheehan KH, Sheehan DV. The Columbia–Suicide Severity FIGURE 8. Percentage agreement between the clinician-rated version of the S-STS and the ISST-Plus based on FDA-CASA 2012 categories. Notes: Since categories #6, #12, #13 and #14 on the FDA-CASA 2012 (shown as red bars) (completed suicide; self-injurious behavior intent unknown; fatal, not enough information; non-fatal, not enough information) did not occur in the subjects surveyed, there is 100% agreement. ISST-Plus: InterSePT Scale for Suicidal Thinking-Plus; S-STS (Clinician): Sheehan- Suicidality Tracking Scale clinician-rated version; C–SSRS: Columbia–Suicide Severity Rating Scale

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