Document Detail

Establishing equivalence of two treatments and sample size requirements in matched-pairs design.
MedLine Citation:
PMID:  9423257     Owner:  NLM     Status:  MEDLINE    
Statistical methods for testing the null hypothesis of a nonzero difference between two treatments and the sample size determination for matched-pairs studies are investigated. A Wald-type test proposed by Lu and Bean (1995, Statistics in Medicine 14, 1831-1839) is anticonservative, i.e., its false positive error rate is greater than specified. Score method and normal deviate based on a restricted maximum likelihood estimation are presented. These two test statistics are shown to be algebraically equal. Their actual type I error probabilities are satisfactorily close to a nominal level. Numerical examinations demonstrate that the sample size formulas using these alternative methods are reasonable while that by Lu and Bean is not. The efficiency of matching in equivalence studies is positively related to intercorrelation or the kappa coefficient of agreements. We recommend the score or ML methods to establish equivalence of two treatments for individually matched samples.
J M Nam
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Publication Detail:
Type:  Comparative Study; Journal Article    
Journal Detail:
Title:  Biometrics     Volume:  53     ISSN:  0006-341X     ISO Abbreviation:  Biometrics     Publication Date:  1997 Dec 
Date Detail:
Created Date:  1998-02-04     Completed Date:  1998-02-04     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  0370625     Medline TA:  Biometrics     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  1422-30     Citation Subset:  IM    
Biostatistics Branch, National Cancer Institute, Rockville, Maryland 20892-7368, USA.
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MeSH Terms
Biometry / methods
Controlled Clinical Trials as Topic / methods*
Liver / pathology,  radiography
Liver Diseases / pathology,  radiography
Models, Statistical
Reproducibility of Results
Research Design*

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