title: Comparative Validation of the S-STS, the ISST-Plus, and the C-SSRS for Assessing the Suicidal Thinking and Behavior FDA 2012 Suicidality Categories.
abstract: OBJECTIVE
  This exploratory study examines the concurrent validity for mapping symptoms of suicidal ideation, self-harm, and suicidal behavior as recorded on the InterSePT Scale for Suicidal Thinking-Plus, the Sheehan-Suicidality Tracking Scale (clinician- and patient-rated and reconciled patient/clinician versions), and the Columbia-Suicide Severity Rating Scale to the 11 United States Food and Drug Administration-Classification Algorithm of Suicide Assessment (September 2012) categories.
  
  
  METHODS
  Forty subjects with varying degrees of suicidal ideation and behavior severity (from not present to extremely severe) were recruited from inpatient, outpatient, and emergency room settings. Each patient was interviewed using all three scales (InterSePT Scale for Suicidal Thinking-Plus, the Sheehan-Suicidality Tracking Scale, and the Columbia-Suicide Severity Rating Scale) on the same day. The scales were administered in a random sequence by three independent raters who were blind to the ratings on the other scales.
  
  
  RESULTS
  The Sheehan-Suicidality Tracking Scale and the InterSePT Scale for Suicidal Thinking-Plus show acceptable agreement with the Columbia-Suicide Severity Rating Scale in detecting the presence or absence of the 2012 Food and Drug Administration-Classification Algorithm of Suicide Assessment categories 1, 5, 6, 10, and 11 (passive ideation; active ideation with method, intent, and plan; completed suicide; preparatory actions; and self-injurious behavior) but not of categories 2, 3, and 4 (3 other active suicidal ideation combination categories) or to 8 and 9 (aborted and interrupted attempt). Despite the significant disagreement between the Columbia-Suicide Severity Rating Scale on the one side and the InterSePT Scale for Suicidal Thinking-Plus and the Sheehan-Suicidality Tracking Scale on the other in the ability to accurately map to the 2012 Food and Drug Administration-Classification Algorithm of Suicide Assessment categories on some items, there was close agreement between the InterSePT Scale for Suicidal Thinking-Plus and the Sheehan-Suicidality Tracking Scale on these categories.
  
  
  CONCLUSIONS
  The results of this exploratory study invite discussion and debate about the validity of the Columbia-Suicide Severity Rating Scale and its ability to accurately assess key active suicidal ideation categories, since it disagrees so much with the other two standardized scales that agree so closely with each other.
authors.affiliation: Dr. Sheehan is Distinguished University Health Professor Emeritus, University of South Florida College of Medicine, Tampa, Florida; Dr. Alphs is with Janssen Medical Affairs, LLC, Titusville, New Jersey; Dr. Mao is with Janssen Research & Development, LLC, Titusville, New Jersey; Mr. Q. Li is Director, Statistical Programming, Regeneron Pharmaceuticals, Inc., Basking Ridge, New Jersey; Ms. May is with the University of Alabama, Birmingham, Alabama; Ms Bruer is with the University of Alabama, Department of Psychiatry and Behavioral Neurobiology, Birmingham, Alabama; Dr. McCullumsmith is with the University of Cincinnati Department of Psychiatry and Behavioral Neuroscience, Cincinnati, Ohio; Mr. Gray is with Medical Outcomes Systems, Jacksonville, Florida; Mr. X. Li is with St. Vincent East Hospital, St. Vincent Health System, Birmingham, Alabama; and Dr. Williamson is with the University of South Alabama College of Medicine, Departments of Psychiatry and Neurology, Birmingham, Alabama, and Janssen Medical Affairs, LLC, Titusville, New Jersey.
authors.forename: David V
authors.initials: DV
authors.lastname: Sheehan
authors.affiliation: Dr. Sheehan is Distinguished University Health Professor Emeritus, University of South Florida College of Medicine, Tampa, Florida; Dr. Alphs is with Janssen Medical Affairs, LLC, Titusville, New Jersey; Dr. Mao is with Janssen Research & Development, LLC, Titusville, New Jersey; Mr. Q. Li is Director, Statistical Programming, Regeneron Pharmaceuticals, Inc., Basking Ridge, New Jersey; Ms. May is with the University of Alabama, Birmingham, Alabama; Ms Bruer is with the University of Alabama, Department of Psychiatry and Behavioral Neurobiology, Birmingham, Alabama; Dr. McCullumsmith is with the University of Cincinnati Department of Psychiatry and Behavioral Neuroscience, Cincinnati, Ohio; Mr. Gray is with Medical Outcomes Systems, Jacksonville, Florida; Mr. X. Li is with St. Vincent East Hospital, St. Vincent Health System, Birmingham, Alabama; and Dr. Williamson is with the University of South Alabama College of Medicine, Departments of Psychiatry and Neurology, Birmingham, Alabama, and Janssen Medical Affairs, LLC, Titusville, New Jersey.
authors.forename: Larry D
authors.initials: LD
authors.lastname: Alphs
authors.affiliation: Dr. Sheehan is Distinguished University Health Professor Emeritus, University of South Florida College of Medicine, Tampa, Florida; Dr. Alphs is with Janssen Medical Affairs, LLC, Titusville, New Jersey; Dr. Mao is with Janssen Research & Development, LLC, Titusville, New Jersey; Mr. Q. Li is Director, Statistical Programming, Regeneron Pharmaceuticals, Inc., Basking Ridge, New Jersey; Ms. May is with the University of Alabama, Birmingham, Alabama; Ms Bruer is with the University of Alabama, Department of Psychiatry and Behavioral Neurobiology, Birmingham, Alabama; Dr. McCullumsmith is with the University of Cincinnati Department of Psychiatry and Behavioral Neuroscience, Cincinnati, Ohio; Mr. Gray is with Medical Outcomes Systems, Jacksonville, Florida; Mr. X. Li is with St. Vincent East Hospital, St. Vincent Health System, Birmingham, Alabama; and Dr. Williamson is with the University of South Alabama College of Medicine, Departments of Psychiatry and Neurology, Birmingham, Alabama, and Janssen Medical Affairs, LLC, Titusville, New Jersey.
authors.forename: Lian
authors.initials: L
authors.lastname: Mao
authors.affiliation: Dr. Sheehan is Distinguished University Health Professor Emeritus, University of South Florida College of Medicine, Tampa, Florida; Dr. Alphs is with Janssen Medical Affairs, LLC, Titusville, New Jersey; Dr. Mao is with Janssen Research & Development, LLC, Titusville, New Jersey; Mr. Q. Li is Director, Statistical Programming, Regeneron Pharmaceuticals, Inc., Basking Ridge, New Jersey; Ms. May is with the University of Alabama, Birmingham, Alabama; Ms Bruer is with the University of Alabama, Department of Psychiatry and Behavioral Neurobiology, Birmingham, Alabama; Dr. McCullumsmith is with the University of Cincinnati Department of Psychiatry and Behavioral Neuroscience, Cincinnati, Ohio; Mr. Gray is with Medical Outcomes Systems, Jacksonville, Florida; Mr. X. Li is with St. Vincent East Hospital, St. Vincent Health System, Birmingham, Alabama; and Dr. Williamson is with the University of South Alabama College of Medicine, Departments of Psychiatry and Neurology, Birmingham, Alabama, and Janssen Medical Affairs, LLC, Titusville, New Jersey.
authors.forename: Qin
authors.initials: Q
authors.lastname: Li
authors.affiliation: Dr. Sheehan is Distinguished University Health Professor Emeritus, University of South Florida College of Medicine, Tampa, Florida; Dr. Alphs is with Janssen Medical Affairs, LLC, Titusville, New Jersey; Dr. Mao is with Janssen Research & Development, LLC, Titusville, New Jersey; Mr. Q. Li is Director, Statistical Programming, Regeneron Pharmaceuticals, Inc., Basking Ridge, New Jersey; Ms. May is with the University of Alabama, Birmingham, Alabama; Ms Bruer is with the University of Alabama, Department of Psychiatry and Behavioral Neurobiology, Birmingham, Alabama; Dr. McCullumsmith is with the University of Cincinnati Department of Psychiatry and Behavioral Neuroscience, Cincinnati, Ohio; Mr. Gray is with Medical Outcomes Systems, Jacksonville, Florida; Mr. X. Li is with St. Vincent East Hospital, St. Vincent Health System, Birmingham, Alabama; and Dr. Williamson is with the University of South Alabama College of Medicine, Departments of Psychiatry and Neurology, Birmingham, Alabama, and Janssen Medical Affairs, LLC, Titusville, New Jersey.
authors.forename: Roberta S
authors.initials: RS
authors.lastname: May
authors.affiliation: Dr. Sheehan is Distinguished University Health Professor Emeritus, University of South Florida College of Medicine, Tampa, Florida; Dr. Alphs is with Janssen Medical Affairs, LLC, Titusville, New Jersey; Dr. Mao is with Janssen Research & Development, LLC, Titusville, New Jersey; Mr. Q. Li is Director, Statistical Programming, Regeneron Pharmaceuticals, Inc., Basking Ridge, New Jersey; Ms. May is with the University of Alabama, Birmingham, Alabama; Ms Bruer is with the University of Alabama, Department of Psychiatry and Behavioral Neurobiology, Birmingham, Alabama; Dr. McCullumsmith is with the University of Cincinnati Department of Psychiatry and Behavioral Neuroscience, Cincinnati, Ohio; Mr. Gray is with Medical Outcomes Systems, Jacksonville, Florida; Mr. X. Li is with St. Vincent East Hospital, St. Vincent Health System, Birmingham, Alabama; and Dr. Williamson is with the University of South Alabama College of Medicine, Departments of Psychiatry and Neurology, Birmingham, Alabama, and Janssen Medical Affairs, LLC, Titusville, New Jersey.
authors.forename: Emily H
authors.initials: EH
authors.lastname: Bruer
authors.affiliation: Dr. Sheehan is Distinguished University Health Professor Emeritus, University of South Florida College of Medicine, Tampa, Florida; Dr. Alphs is with Janssen Medical Affairs, LLC, Titusville, New Jersey; Dr. Mao is with Janssen Research & Development, LLC, Titusville, New Jersey; Mr. Q. Li is Director, Statistical Programming, Regeneron Pharmaceuticals, Inc., Basking Ridge, New Jersey; Ms. May is with the University of Alabama, Birmingham, Alabama; Ms Bruer is with the University of Alabama, Department of Psychiatry and Behavioral Neurobiology, Birmingham, Alabama; Dr. McCullumsmith is with the University of Cincinnati Department of Psychiatry and Behavioral Neuroscience, Cincinnati, Ohio; Mr. Gray is with Medical Outcomes Systems, Jacksonville, Florida; Mr. X. Li is with St. Vincent East Hospital, St. Vincent Health System, Birmingham, Alabama; and Dr. Williamson is with the University of South Alabama College of Medicine, Departments of Psychiatry and Neurology, Birmingham, Alabama, and Janssen Medical Affairs, LLC, Titusville, New Jersey.
authors.forename: Cheryl B
authors.initials: CB
authors.lastname: Mccullumsmith
authors.affiliation: Dr. Sheehan is Distinguished University Health Professor Emeritus, University of South Florida College of Medicine, Tampa, Florida; Dr. Alphs is with Janssen Medical Affairs, LLC, Titusville, New Jersey; Dr. Mao is with Janssen Research & Development, LLC, Titusville, New Jersey; Mr. Q. Li is Director, Statistical Programming, Regeneron Pharmaceuticals, Inc., Basking Ridge, New Jersey; Ms. May is with the University of Alabama, Birmingham, Alabama; Ms Bruer is with the University of Alabama, Department of Psychiatry and Behavioral Neurobiology, Birmingham, Alabama; Dr. McCullumsmith is with the University of Cincinnati Department of Psychiatry and Behavioral Neuroscience, Cincinnati, Ohio; Mr. Gray is with Medical Outcomes Systems, Jacksonville, Florida; Mr. X. Li is with St. Vincent East Hospital, St. Vincent Health System, Birmingham, Alabama; and Dr. Williamson is with the University of South Alabama College of Medicine, Departments of Psychiatry and Neurology, Birmingham, Alabama, and Janssen Medical Affairs, LLC, Titusville, New Jersey.
authors.forename: Christopher R
authors.initials: CR
authors.lastname: Gray
authors.affiliation: Dr. Sheehan is Distinguished University Health Professor Emeritus, University of South Florida College of Medicine, Tampa, Florida; Dr. Alphs is with Janssen Medical Affairs, LLC, Titusville, New Jersey; Dr. Mao is with Janssen Research & Development, LLC, Titusville, New Jersey; Mr. Q. Li is Director, Statistical Programming, Regeneron Pharmaceuticals, Inc., Basking Ridge, New Jersey; Ms. May is with the University of Alabama, Birmingham, Alabama; Ms Bruer is with the University of Alabama, Department of Psychiatry and Behavioral Neurobiology, Birmingham, Alabama; Dr. McCullumsmith is with the University of Cincinnati Department of Psychiatry and Behavioral Neuroscience, Cincinnati, Ohio; Mr. Gray is with Medical Outcomes Systems, Jacksonville, Florida; Mr. X. Li is with St. Vincent East Hospital, St. Vincent Health System, Birmingham, Alabama; and Dr. Williamson is with the University of South Alabama College of Medicine, Departments of Psychiatry and Neurology, Birmingham, Alabama, and Janssen Medical Affairs, LLC, Titusville, New Jersey.
authors.forename: Xiaohua
authors.initials: X
authors.lastname: Li
authors.affiliation: Dr. Sheehan is Distinguished University Health Professor Emeritus, University of South Florida College of Medicine, Tampa, Florida; Dr. Alphs is with Janssen Medical Affairs, LLC, Titusville, New Jersey; Dr. Mao is with Janssen Research & Development, LLC, Titusville, New Jersey; Mr. Q. Li is Director, Statistical Programming, Regeneron Pharmaceuticals, Inc., Basking Ridge, New Jersey; Ms. May is with the University of Alabama, Birmingham, Alabama; Ms Bruer is with the University of Alabama, Department of Psychiatry and Behavioral Neurobiology, Birmingham, Alabama; Dr. McCullumsmith is with the University of Cincinnati Department of Psychiatry and Behavioral Neuroscience, Cincinnati, Ohio; Mr. Gray is with Medical Outcomes Systems, Jacksonville, Florida; Mr. X. Li is with St. Vincent East Hospital, St. Vincent Health System, Birmingham, Alabama; and Dr. Williamson is with the University of South Alabama College of Medicine, Departments of Psychiatry and Neurology, Birmingham, Alabama, and Janssen Medical Affairs, LLC, Titusville, New Jersey.
authors.forename: David J
authors.initials: DJ
authors.lastname: Williamson
keywords: C-CASA; C-SSRS; FDA 2012 Draft Guidance Document; ISST-Plus; S-STS; Suicide scale; concurrent validity; suicidal behavior; suicidal ideation; suicidality; suicide; suicide assessment; suicide attempt; suicide risk; validation