title: Do the Five Combinations of Suicidal Ideation in the FDA 2012 Draft Guidance Document and the C-SSRS Adequately Cover All Suicidal Ideation Combinations in Practice? A Case Study.
abstract: OBJECTIVE
  The United States Food and Drug Administration's newest classification system for suicidality assessment anchors suicidal ideation to various combinations of passive suicidal ideation, active suicidal ideation, method, intent, and plan. This is based upon the suicidal ideation categories in the Columbia-Suicide Severity Rating Scale. Although there are 32 possible combinations of these suicidal ideation phenomena, the Food and Drug Administration's 2012 system and the Columbia-Suicide Severity Rating Scale accommodate six combinations. We use a case study to explore the impact of possible type II errors on suicidality classification posed by not including remaining 26 possible categories.
  
  
  METHODS
  A suicidal subject kept detailed daily records of her experience of suicidality over two separate intervals of eight-months' and nine-months' duration. These records permitted classification of individual events into each of the possible 32 suicidal ideation combinations.
  
  
  RESULTS
  Although only a small percentage of all events of suicidality from either collection period fell outside of the Food and Drug Administration's classification system and the Columbia -Suicide Severity Rating Scale categories, those that were not so categorized constituted a large percentage of the time this subject experienced suicidality. When these two timeframes were aggregated, more than half of the subject's time spent experiencing suicidality fell into the suicidal ideation combinations not captured by the Food and Drug Administration's classification system and the Columbia-Suicide Severity Rating Scale categories.
  
  
  CONCLUSIONS
  This case study suggests that type II errors in the Food and Drug Administration's classification system and in the Columbia-Suicide Severity Rating Scale categories for suicidal ideation may represent important omissions.
authors.affiliation: J. Giddens is Co-founder of the Tampa Center for Research on Suicidality, Tampa, Florida; and Dr. Sheehan is Distinguished University Health Professor Emeritus, University of South Florida College of Medicine, Tampa, Florida.
authors.forename: Jennifer M
authors.initials: JM
authors.lastname: Giddens
authors.affiliation: J. Giddens is Co-founder of the Tampa Center for Research on Suicidality, Tampa, Florida; and Dr. Sheehan is Distinguished University Health Professor Emeritus, University of South Florida College of Medicine, Tampa, Florida.
authors.forename: David V
authors.initials: DV
authors.lastname: Sheehan
keywords: C–SSRS; FDA 2012 Draft Guidance Document; Suicide scale; suicidal behavior; suicidal ideation; suicidality; suicide; suicide assessment; suicide attempt; suicide risk