On the non-inferiority of a diagnostic test based on paired observations

Statistics in Medicine

Volumn 22, Issue 19, 2003, Pages 3029-3044

  Lu, Ying ^a   Jin, Hua ^a,b   Genant, Harry K ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b SOUTH CHINA NORMAL UNIVERSITY   (China)

Author keywords

Intersection union test; Non inferiority of diagnostic tests; Sample size; Sensitivity; Specificity

Indexed keywords

ANALYTICAL ERROR; ARTICLE; COST BENEFIT ANALYSIS; DIAGNOSTIC TEST; DUAL ENERGY X RAY ABSORPTIOMETRY; FEMALE; FRAGILITY FRACTURE; HUMAN; MEDICAL RESEARCH; SAMPLE SIZE; SENSITIVITY AND SPECIFICITY; SIMULATION; STANDARDIZATION; STATISTICAL ANALYSIS; SURGICAL TECHNIQUE;

CLINICAL TRIALS; DIAGNOSTIC TESTS, ROUTINE; HUMANS; OSTEOPOROSIS; SENSITIVITY AND SPECIFICITY;

EID: 0141815720     PISSN: 02776715     EISSN: None     Source Type: Journal    
DOI: 10.1002/sim.1569     Document Type: Article

References (24)

1. Lui K, Cumberland W. Sample size determination for equivalence test using rate ratio of sensitivity and specificity in paired sample data. Controlled Clinical Trials 2001; 22(4):373-389.
2. Liu JP, Hsueh HM, Hsieh E, Chen JJ. Tests for equivalence or non-inferiority for paired binary data. Statistics in Medicine 2002; 21(1):231-245.
3. Food and Drug Administration HHS. International Conference on Harmonisation; choice of control group and related issues in clinical trials; availability. Notice. FEDERAL REGISTER 2001, 14 May 2001: 24390.
4. Lu Y, Bean JA. On the sample size for studies of bioequivalence based upon McNemar's test. Statistics in Medicine 1995; 14(16):1831-1839.
5. Morikawa T, Yishida M. A useful testing strategy in phase II trials: combined test of superiority and test of equivalence. Journal of Biopharmaceutical Statistics 1995; 5:297-306.
6. Nam JM. Establishing equivalence of two treatments and sample size requirements in matched-pairs design. Biometrics 1997; 53(4):1422-1430.
7. Tango T. Equivalence test and confidence interval for the difference in proportions for the paired-sample design. Statistics in Medicine 1998; 17(8):891-908.
8. Lachenbruch P, Lynch C. Assessing screening tests: extensions of McNemar's test. Statistics in Medicine 1998; 17(19):2207-2217.
9. Nam JM, Blackwelder C. Analysis of the ratio of marginal probabilities in a matched-pair setting. Statistics in Medicine 2002; 21:689-699.
10. Berger RL, Hsu JC. Bioequivalence trials, intersection-union tests and equivalence confidence sets. Statistical Science 1996; 11(4):283-319.
11. Kinkel K, Kaji Y, Yu KK, Segal MR, Lu Y, Powell CB, Hricak H. Radiologic staging in patients with endometrial cancer: a meta-analysis. Radiology 1999; 212:711-718.
12. NOF. Osteoporosis: review of the evidence for prevention, diagnosis, and treatment and cost-effectiveness analysis. Status report. Osteoporosis International 1998; 8(Suppl 4):S3-S80.
13. WHO. Assessment of fracture risk and its application to screening for postmenopausal osteoporosis: report of a WHO study group. WHO Technical Report Series. World Health Organization: Geneva, 1994. Report No. 843.
14. Lu Y, Mathur A, Genant H. Which site, which method? dilemmas in bone densitometry. In Bone Densitometry and Osteoporosis, Genant H, Guglielmi G, Jergas M (eds). Springer-Verlag: Berlin, 1997; 449-460.
15. Faulkner K, von Stetten E, Steiger P, Miller P. Discrepancies in osteoporosis prevalence at different skeletal sites: impact on the WHO criteria. Bone 1998; 23(5 Suppl):S194.
16. Faulkner K, von Stetten E, Miller P. Discordance in patient classification using T-scores. Journal of Clinical Densitometry 1999; 2(3):343-350.
17. Miller PD. Controversies in bone mineral density diagnostic classifications (editorial). Clacified Tissue International 2000; 66(5):317-319.
18. Lu Y, Genant HK, Shepherd J, Zhao S, Mathur A, Fuerst TP, Cummings SR. Classification of osteoporosis based on bone mineral densities. Journal of Bone and Mineral Research 2001; 16(5):901-910.
19. Swets JA. Sensitivities and specificities of diagnostic tests. Journal of the American Medical Association 1982; 248(5):548-549.
20. Hanley J. Receiver operating characteristic (ROC) methodology: the state of the art. Critical Reviews of Diagnostic Imaging 1989; 29:307-335.
21. Quan H, Bolognese J, Yuan W. Assessment of equivalence on multiple endpoints. Statistics in Medicine 2001; 20:3159-3173.
22. Wiens BL. Choosing an equivalence limit for noninferiority or equivalence studies. Controlled Clinical Trials 2002; 23(1):2-14.
23. Thornbury JR. Clinical efficacy of diagnostic imaging: love it or leave it. American Journal of Roentgenology 1994; 162:1-8.
24. Gastsonis C. Design of evaluations of imaging technologies: development of a paradigm. Academic Radiology 2000; 7:681-683.