Document Detail

The probability of inevitability: the inherent impossibility of validating criteria for brain death or 'irreversibility' through clinical studies.
MedLine Citation:
PMID:  3659664     Owner:  NLM     Status:  MEDLINE    
A great need persists for diagnostic criteria for both brain death in young children and irreversible loss of consciousness at all ages. This article examines the inferences derived from a hypothetical confirmatory study in which all of the N patients who fulfilled the criterion did in fact experience brain death (irreversibility). A Bayesian methodology proves that, for N in the range of a large clinical study, estimations of prior probabilities are, for all practical purposes, irrelevant to the calculation of the posterior probabilities. The risk of a false positive diagnosis for the next patient who meets the criterion is approximately 1/(N + 2). The chance of at least one false positive diagnosis among the next (N + 1) patients who meet the criterion is around 50 per cent. Thus, achievement of the requisite moral certainty of a declaration of death (irreversibility) necessitates an impossibly large N for the study. This does not mean that one cannot diagnose death, but rather that the validity of the diagnostic criteria must be self-evident on a priori grounds, and that confirmatory studies are necessarily either inadequate or superfluous.
D A Shewmon
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Statistics in medicine     Volume:  6     ISSN:  0277-6715     ISO Abbreviation:  Stat Med     Publication Date:    1987 Jul-Aug
Date Detail:
Created Date:  1987-11-05     Completed Date:  1987-11-05     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  8215016     Medline TA:  Stat Med     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  535-53     Citation Subset:  IM    
Department of Pediatrics, UCLA Medical Center 90024.
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MeSH Terms
Bayes Theorem*
Brain Death / diagnosis*
Child, Preschool
Coma / diagnosis
Diagnosis, Differential
Infant, Newborn
Predictive Value of Tests

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