Document Detail

Application of a stopping rule based on total treatment failures: the postoperative Crohn's disease trial.
MedLine Citation:
PMID:  1588355     Owner:  NLM     Status:  MEDLINE    
The Postoperative Crohn's Disease Trial (PCDT), a placebo-controlled randomized trial of Rowasa I in the prevention of postoperative recurrence of Crohn's disease, is used as an example of how a stopping rule based on total endpoint occurrences can provide considerable advantage over standard fixed sample size methods. It can be used when the primary outcome is occurrence or time to occurrence and does not raise the troublesome issues regarding the unblinding of group differences that other sequential methods create. The main advantage of the total endpoint stopping rule is that it provides set power. Standard fixed sample size designs provide a given power only on average. The power actually achieved in a particular fixed sample size trial is largely determined by the overall observed rate of endpoint occurrences. This claim about the total endpoint stopping rule is well established in the statistical literature and, as well as outlining the mathematical details in an Appendix, we use computer simulation of the PCDT to demonstrate that use of the stopping rule will allow termination of the trial while maintaining power and type I error at a predetermined level.
A H Steinhart; K O'Rourke; B G Wolff; R S McLeod
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of clinical epidemiology     Volume:  45     ISSN:  0895-4356     ISO Abbreviation:  J Clin Epidemiol     Publication Date:  1992 May 
Date Detail:
Created Date:  1992-06-19     Completed Date:  1992-06-19     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  8801383     Medline TA:  J Clin Epidemiol     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  495-504     Citation Subset:  IM    
Department of Medicine, University of Toronto, Ontario, Canada.
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MeSH Terms
Aminosalicylic Acids / therapeutic use*
Computer Simulation
Crohn Disease / prevention & control*,  surgery
Double-Blind Method
Multicenter Studies as Topic
Randomized Controlled Trials as Topic / economics,  methods*
Risk Factors
Time Factors
Reg. No./Substance:
0/Aminosalicylic Acids; 89-57-6/Mesalamine

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

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