Do the Five Combinations of Suicidal Ideation in the FDA 2012 Draft Guidance Document and the C–SSRS Adequately Cover All Suicidal Ideation Combinations in Practice?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

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...

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Publicado en:Innovations in Clinical Neuroscience Vol. 11; no. 9/10; pp. 172 - 179
Autores principales: GIDDENS, JENNIFER M., SHEEHAN, DAVID V.
Formato: case study pictorial research Journal Article
Publicado: Matrix Medical Communications, LLC Sep/Oct2014
Acceso en línea:Ver este registro en EBSCOhost
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      dt: Sep/Oct2014
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      pub: Matrix Medical Communications, LLC
      place: West Chester, Pennsylvania
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        atl: Do the Five Combinations of Suicidal Ideation in the FDA 2012 Draft Guidance Document and the C–SSRS Adequately Cover All Suicidal Ideation Combinations in Practice?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.
      aug:
        au:
          GIDDENS, JENNIFER M.
          SHEEHAN, DAVID V.
        affil: Co-founder, Tampa Center for Research on Suicidality, Tampa, Florida.
      sug:
        subj:
          Suicidal Ideation Classification
          United States Food and Drug Administration
          Female
          Type II Error
          Scales
          Diaries
          Adult
          Depression Complications
          Pervasive Developmental Disorder-Not Otherwise Specified Diagnosis
          Asperger Syndrome Diagnosis
          Algorithms
          Human
          Adult: 19-44 years
          Female
      ab: 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.
      pubtype: Academic Journal
      doctype:
        case study
        pictorial
        research
        Journal Article
      ougenre: Article
    language: English
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