Document Detail

Statistical issues in the design and analysis of expertise-based randomized clinical trials.
MedLine Citation:
PMID:  18837074     Owner:  NLM     Status:  MEDLINE    
In order to avoid certain difficulties with the conventional randomized clinical trial design, the expertise-based design has been proposed as an alternative. In the expertise-based design, patients are randomized to clinicians (e.g. surgeons), who then treat all their patients with their preferred intervention. This design recognizes individual clinical preferences and so may reduce the rates of procedural crossovers compared with the conventional design. It may also facilitate recruitment of clinicians, because they are always allowed to deliver their therapy of choice, a feature that may also be attractive to patients.The expertise-based design avoids the possibility of so-called differential expertise bias. If a standard treatment is generally more familiar to clinicians than a new experimental treatment, then in the conventional design, more patients randomized to the standard treatment will have an expert clinician, compared with patients randomized to the experimental treatment. If expertise affects the study outcome, then a biased comparison of the treatment groups will occur.We examined the relative efficiency of estimating the treatment effect in the expertise-based and conventional designs. We recognize that expected patient outcomes may be better in the expertise-based design, which in turn may modify the estimated treatment effect. In particular, a larger treatment effect in the expertise-based design can sometimes offset a higher standard error arising from the confounding of clinician effects with treatments.These concepts are illustrated with data taken from a randomized trial of two alternative surgical techniques for tibial fractures.
S D Walter; A S Ismaila; P J Devereaux;
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Statistics in medicine     Volume:  27     ISSN:  0277-6715     ISO Abbreviation:  Stat Med     Publication Date:  2008 Dec 
Date Detail:
Created Date:  2008-11-25     Completed Date:  2009-03-31     Revised Date:  2013-06-05    
Medline Journal Info:
Nlm Unique ID:  8215016     Medline TA:  Stat Med     Country:  England    
Other Details:
Languages:  eng     Pagination:  6583-96     Citation Subset:  IM    
Copyright Information:
Copyright 2008 John Wiley & Sons, Ltd.
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ont., Canada L8N 3Z5.
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MeSH Terms
Bone Nails
Clinical Competence
Fracture Fixation, Intramedullary / methods*
Randomized Controlled Trials as Topic / statistics & numerical data*
Research Design*
Statistics as Topic*
Tibial Fractures / surgery*
Grant Support
38140//Canadian Institutes of Health Research

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

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