Document Detail

Random treatment assignment using mathematical equipoise for comparative effectiveness trials.
MedLine Citation:
PMID:  21348950     Owner:  NLM     Status:  MEDLINE    
In controlled clinical trials, random assignment of treatment is appropriate only when there is equipoise, that is, no clear preference among treatment options. However, even when equipoise appears absent because prior trials show, on average, one treatment yields superior outcomes, random assignment still may be appropriate for some patients and circumstances. In such cases, enrollment into trials may be assisted by real-time patient-specific predictions of treatment outcomes, to determine whether there is equipoise to justify randomization. The percutaneous coronary intervention thrombolytic predictive instrument (PCI-TPI) computes probabilities of 30-day mortality for patients having ST elevation myocardial infarction (STEMI), if treated with thrombolytic therapy (TT), and if treated with PCI. We estimated uncertainty around differences in their respective predicted benefits using the estimated uncertainty of the model coefficients. Using the 2,781-patient PCI-TPI development dataset, we evaluated the distribution of predicted benefits for each patient. For three typical clinical situations, randomization was potentially warranted for 70%, 93%, and 80% of patients. Predictive models may allow real-time patient-specific determination of whether there is equipoise that justifies trial enrollment for a given patient. This approach may have utility for comparative effectiveness trials and for application of trial results to clinical practice.
Harry P Selker; Robin Ruthazer; Norma Terrin; John L Griffith; Thomas Concannon; David M Kent
Publication Detail:
Type:  Comparative Study; Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Clinical and translational science     Volume:  4     ISSN:  1752-8062     ISO Abbreviation:  Clin Transl Sci     Publication Date:  2011 Feb 
Date Detail:
Created Date:  2011-02-25     Completed Date:  2011-06-06     Revised Date:  2013-12-19    
Medline Journal Info:
Nlm Unique ID:  101474067     Medline TA:  Clin Transl Sci     Country:  United States    
Other Details:
Languages:  eng     Pagination:  10-6     Citation Subset:  IM    
Copyright Information:
© 2011 Wiley Periodicals, Inc.
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MeSH Terms
Angioplasty, Balloon, Coronary
Comparative Effectiveness Research / methods*
Myocardial Infarction / mortality,  therapy
Random Allocation
Randomized Controlled Trials as Topic / methods*
Survival Analysis
Therapeutic Equipoise*
Grant Support
KL 2RR025751-01A1/RR/NCRR NIH HHS; R01 HS 10280/HS/AHRQ HHS; U01 HL077821/HL/NHLBI NIH HHS; U01 HL077821/HL/NHLBI NIH HHS; U01 HL077821-01/HL/NHLBI NIH HHS; UL1 RR025752/RR/NCRR NIH HHS; UL1 RR025752-01/RR/NCRR NIH HHS

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

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