Current Assessment and Classification of Suicidal Phenomena using the FDA 2012 Draft Guidance Document on Suicide Assessment: A Critical Review.
Objective: Standard international classification criteria require that classification categories be comprehensive to avoid type II error. Categories should be mutually exclusive and definitions should be clear and unambiguous (to avoid type I and type II errors). In addition, the classification syst...
| Publicado en: | Innovations in Clinical Neuroscience Vol. 11; no. 9/10; pp. 54 - 66 |
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| Autores principales: | , , |
| Formato: | pictorial review tables/charts Journal Article |
| Publicado: |
Matrix Medical Communications, LLC
Sep/Oct2014
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=100084064&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 100084064 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 21588333 DAD5 jtl: Innovations in Clinical Neuroscience issn: 21588333 maglogo: N pubinfo: dt: Sep/Oct2014 vid: 11 iid: 9/10 pid: 33670 pub: Matrix Medical Communications, LLC place: West Chester, Pennsylvania artinfo: ui: 100084064 100084064 103863071 100084064 ppf: 54 ppct: 12 formats: fmt: @attributes: type: P tig: atl: Current Assessment and Classification of Suicidal Phenomena using the FDA 2012 Draft Guidance Document on Suicide Assessment: A Critical Review. aug: au: SHEEHAN, DAVID V. GIDDENS, JENNIFER M. HARNETT SHEEHAN, KATHY affil: Distinguished University Health Professor Emeritus, University of South Florida College of Medicine, Tampa, Florida. sug: subj: Suicide Prevention Patient Assessment United States Food and Drug Administration Suicidal Ideation Classification Suicide Risk Factors Algorithms Type II Error Instrument Validation Suicide, Attempted Self-Injurious Behavior ab: Objective: Standard international classification criteria require that classification categories be comprehensive to avoid type II error. Categories should be mutually exclusive and definitions should be clear and unambiguous (to avoid type I and type II errors). In addition, the classification system should be robust enough to last over time and provide comparability between data collections. This article was designed to evaluate the extent to which the classification system contained in the United States Food and Drug Administration 2012 Draft Guidance for the prospective assessment and classification of suicidal ideation and behavior in clinical trials meets these criteria. Method: A critical review is used to assess the extent to which the proposed categories contained in the Food and Drug Administration 2012 Draft Guidance are comprehensive, unambiguous, and robust. Assumptions that underlie the classification system are also explored. Results: The Food and Drug Administration classification system contained in the 2012 Draft Guidance does not capture the full range of suicidal ideation and behavior (type II error). Definitions, moreover, are frequently ambiguous (susceptible to multiple interpretations), and the potential for misclassification (type I and type II errors) is compounded by frequent mismatches in category titles and definitions. These issues have the potential to compromise data comparability within clinical trial sites, across sites, and over time. Conclusion: These problems need to be remedied because of the potential for flawed data output and consequent threats to public health, to research on the safety of medications, and to the search for effective medication treatments for suicidality. pubtype: Academic Journal doctype: pictorial review tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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