Literature DB >> 25520895

Do the Five Combinations of Suicidal Ideation in the FDA 2012 Draft Guidance Document and the C-SSRS Adequately Cover All Suicidal Ideation Combinations in Practice?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.

Jennifer M Giddens1, David V Sheehan1.   

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.
CONCLUSION: 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.

Keywords:  C–SSRS; FDA 2012 Draft Guidance Document; Suicide scale; suicidal behavior; suicidal ideation; suicidality; suicide; suicide assessment; suicide attempt; suicide risk

Year:  2014        PMID: 25520895      PMCID: PMC4267792     

Source DB:  PubMed          Journal:  Innov Clin Neurosci        ISSN: 2158-8333


  3 in total

1.  Columbia Classification Algorithm of Suicide Assessment (C-CASA): classification of suicidal events in the FDA's pediatric suicidal risk analysis of antidepressants.

Authors:  Kelly Posner; Maria A Oquendo; Madelyn Gould; Barbara Stanley; Mark Davies
Journal:  Am J Psychiatry       Date:  2007-07       Impact factor: 18.112

2.  Status Update on the Sheehan-Suicidality Tracking Scale (S-STS) 2014.

Authors:  David V Sheehan; Jennifer M Giddens; Ivan Sascha Sheehan
Journal:  Innov Clin Neurosci       Date:  2014-09

3.  The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults.

Authors:  Kelly Posner; Gregory K Brown; Barbara Stanley; David A Brent; Kseniya V Yershova; Maria A Oquendo; Glenn W Currier; Glenn A Melvin; Laurence Greenhill; Sa Shen; J John Mann
Journal:  Am J Psychiatry       Date:  2011-12       Impact factor: 18.112

  3 in total
  2 in total

1.  The Columbia-Suicide Severity Rating Scale (C-SSRS): Has the "Gold Standard" Become a Liability?

Authors:  Jennifer M Giddens; Kathy Harnett Sheehan; David V Sheehan
Journal:  Innov Clin Neurosci       Date:  2014-09

2.  Current Assessment and Classification of Suicidal Phenomena using the FDA 2012 Draft Guidance Document on Suicide Assessment: A Critical Review.

Authors:  David V Sheehan; Jennifer M Giddens; Kathy Harnett Sheehan
Journal:  Innov Clin Neurosci       Date:  2014-09
  2 in total

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