The effects of outcome misclassification and measurement error on the design and analysis of therapeutic equivalence trials

Statistics in Medicine

Volumn 20, Issue 14, 2001, Pages 2065-2078

  Kim, Mimi Y ^a   Goldberg, Judith D ^a  

^a NEW YORK UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTICAL ERROR; ARTICLE; CLASSIFICATION; CLINICAL STUDY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIAGNOSTIC ERROR; DIAGNOSTIC PROCEDURE; HUMAN; LABORATORY TEST; MEASUREMENT; METHODOLOGY; OUTCOMES RESEARCH; STATISTICAL ANALYSIS; STATISTICAL PARAMETERS; TREATMENT OUTCOME;

ESTROGEN REPLACEMENT THERAPY; FEMALE; HUMANS; LUPUS ERYTHEMATOSUS, SYSTEMIC; MIDDLE AGED; MULTICENTER STUDIES; RANDOMIZED CONTROLLED TRIALS; THERAPEUTIC EQUIVALENCY; TREATMENT OUTCOME;

EID: 0035974236     PISSN: 02776715     EISSN: None     Source Type: Journal    
DOI: 10.1002/sim.847     Document Type: Article

References (21)

1. Trials to assess equivalence: The importance of rigorous methods
2. Practical issues in equivalence trials
3. Therapeutic equivalence investigations: Statistical considerations
4. Clinical and statistical issues in therapeutic equivalence trials
5. Designs of clinical trials: Active control (equivalence trials)
6. Misclassification in 2 × 2 tables
7. The effects of misclassification on the bias in the difference between two proportions and the relative odds in the fourfold table
8. Bias due to misclassification in the estimation of relative risk
9. The effects of exposure misclassification on estimates of relative risk
10. Effects of measurement error on relative risk regressions
11. Proving the null hypothesis in clinical trials
12. Significance testing to establish equivalence between treatments, with special reference to data in the form of 2 × 2 tables
13. Sample size requirements for evaluating a conservative therapy
14. Exposure measurement error: Influence on exposure-disease relationships and methods of correction
15. A review of methods for misclassified categorical data in epidemiology
16. Use of the positive predictive value to correct for disease misclassification in epidemiologic studies
17. Variance estimates for epidemiologic effect estimates under misclassification
18. Comment to: The statistical precision of medical screening procedures: Application to polygraph and AIDS antibodies test data
19. Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference or non-unity relative risk
20. Effects of mismodelling and mismeasuring explanatory variables on tests of their association with a response variable