Document Detail

Premature stopping and informed consent in AMI trials.
MedLine Citation:
PMID:  12042406     Owner:  NLM     Status:  MEDLINE    
Clinical trials give rise to ethical dilemmas, especially in the acutely ill, but we take issue with two points raised in a recent comment on a specific acute myocardial infarction (AMI) trial. The commentators judged that the trial most likely could, and therefore should, have been terminated much earlier. By analysing the problem statistically we arrive at results that go against their intuitive judgment-they also see it as mandatory to update the patient Information sheet as trial results accrue and trends begin to emerge. In our view, interpreting subtle trends and borderline p-values must rest with data monitoring boards, not patients. Moreover, patients with AMI or in other medical emergencies need very simple instructions. Empirical studies of the consent process confirm that the idea of a genuinely informed consent is problematic in such cases.
J Hilden; A Gammelgaard
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Publication Detail:
Type:  Comment; Comparative Study; Journal Article    
Journal Detail:
Title:  Journal of medical ethics     Volume:  28     ISSN:  0306-6800     ISO Abbreviation:  J Med Ethics     Publication Date:  2002 Jun 
Date Detail:
Created Date:  2002-06-03     Completed Date:  2002-07-24     Revised Date:  2009-11-18    
Medline Journal Info:
Nlm Unique ID:  7513619     Medline TA:  J Med Ethics     Country:  England    
Other Details:
Languages:  eng     Pagination:  188-9; discussion 190-1     Citation Subset:  E; IM    
Department of Biostatistics, University of Copenhagen, Copenhagen, Denmark.
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MeSH Terms
Coronary Care Units / standards
Data Interpretation, Statistical
Ethics, Clinical*
Informed Consent*
Myocardial Infarction / mortality,  therapy*
Patient Selection
Randomized Controlled Trials as Topic / standards*
Thrombolytic Therapy*
Comment On:
J Med Ethics. 2001 Jun;27(3):177-8   [PMID:  11417025 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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