Overview of agreement statistics for medical devices

Journal of Biopharmaceutical Statistics

Volumn 18, Issue 1, 2008, Pages 126-144

  Lin, Lawrence ^a  

^a BAXTER HEALTHCARE CORPORATION   (United States)

Author keywords

Accuracy; CCC; CP; ICC; Kappa; MSD; Precision; TDI

Indexed keywords

ACCURACY; ARTICLE; CALIBRATION; DEVICE; ERROR; IMMUNOASSAY; INSTRUMENTATION; LABORATORY; METHODOLOGY; PRIORITY JOURNAL; SAMPLE SIZE; STATISTICAL ANALYSIS; STATISTICS; VALIDATION PROCESS;

EQUIPMENT AND SUPPLIES; MODELS, STATISTICAL; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY;

EID: 37549041727     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543400701668290     Document Type: Article

References (41)

1. Agresti, A. (1996). An Introduction to Categorical Data Analysis. New York: Wiley.
2. Barko, J. J. (1966). The intraclass correlation coefficient as a measure of reliability. Psychol. Rep. 19:3-11.
3. Barnhart, H. X., Williamson, J. M. (2001). Modeling concordance correlation via GEE to evaluate reproducibility. Biometrics 57:931-940.
4. Barnhart, H. X., Haber, M., Song, J. (2002). Overall concordance correlation for evaluating agreement among multiple observers. Biometrics 58:1020-1027.
5. Barnhart, H. X., Song, J., Haber, M. (2005). Assessing intra, inter, and total agreement with replicated readings. Stat. Med. 24:1371-1384.
6. Bland, J. M., Altman, D. G. (1986). Statistical methods for assessing agreement between two methods of clinical measurement. Lancet i 307-310.
7. Brennen, R. L. (2001). Generalizability Theory. Springer Verlag.
8. Bross, I. D. (1985). Reader viewpoint: Why proof of safety is much more difficult than proof of hazard. Biometrics 41:785-793.
9. Carrasco, J. L., Jover, L. (2003). Estimating the generalized concordance correlation coefficient through variance components. Biometrics 59:849-858.
10. Chinchilli, V. M., Martel, J. K., Kumanyka, S., Lloyd, T. (1996) A weighted concordance correlation coefficient for repeated measurement designs. Biometrics 52:341-353.
11. Christensen, R. (1997). Log-Linear Models and Logistic Regression. New York: Springer.
12. CLIA Final Rules (2003). U.S. Department of Health and Human Services. Medicare, Medicaid and CLIA Programs: Laboratory Requirements Relating to Quality Systems and Certain Personnel Qualifications. Final rule. Fed Regist 2003; 68:3640-3714 (Available at http://www.phppo.cdc.gov/clia/pdf/CMS-2226-F. pdf).
13. Cohen, J. (1960). A coefficient of agreement for nominal scales. Educ. Psychol. Measure. 20:37-46.
14. Cohen, J. (1968). Weighted kappa: Nominal scale agreement with provision for scaled disagreement or partial credit. Psychol. Bull. 70:213-220.
15. Cox, D. R., Snell, E. (1989). Analysis of Binary Data. London: Chapman & Hall.
16. Dunnett, C. W., Gent, M. (1977). Significance testing to establish equivalence between treatments, with special reference to data in the form of 2 x 2 tables. Biometrics 33:593-602.
17. Fisher, R. A. (1925). Statistical Methods for Research Workers. Edinburgh: Oliver & Boyd.
18. Fleiss, J. L. (1981). Statistics Methods for Rates and Proportions. New York: Wiley.
19. Fleiss, J. L. (1986). Reliability of Measurement. The Design and Analysis of Clinical Experiments. New York: Wiley.
20. Fleiss, J. L., Cohen, J. (1973). The equivalence of weighted kappa and the intraclass correlation coefficient as measure of reliability. Educ. Psychol. Measure. 33:613-619.
21. Fleiss, J. L., Cohen, J., Everitt, B. (1969). Large sample standard errors of kappa and weighted kappa. Psychol. Bull. 72:323-327.
22. Grant, E. L., Leavenworth, R. S. (1972). Statistical Quality Control. New York: McGraw-Hill.
23. Haberman, S. J. (1974). Analysis of Frequency Data. Chicago, IL: University of Chicago Press.
24. King, T. S., Chinchilli, V. M. (2001). A generalized concordance correlation coefficient for continuous and categorical data. Stat. Med. 20:2131-2147.
25. King, T. S., Chinchilli, V. M. (2002). Robust estimators of the concordance correlation coefficient. J. Biopharm. Stat. 11:83-105.
26. Li, R., Chow, M. (2004). Evaluation of reproducibility for paired functional data. J. Multivariate Anal. 93:81-101.
27. Lin, L. I. (1989). A concordance correlation coefficient to evaluate reproducibility. Biometrics 45:255-268.
28. Lin, L. I. (1992). Assay validation using the concordance correlation coefficient. Biometrics 48:599-604.
29. Lin, L. I. (2000). Total deviation index for measuring individual agreement: with application in lab performance and bioequivalence. Stat. Med. 19:255-270.
30. Lin, L. I., (2003). Measuring Agreement. Encyclopedia of Biopharmaceutical Statistics. New York: Marcel Dekker, Inc., pp. 561-567.
31. Lin, L. I., Vonesh, E. F. (1989). An empirical nonlinear data-fitting approach for transforming data to normality. Am. Stat. 43:237-243.
32. Lin, L. I., Chinchilli, V. M. (1997). Rejoinder to the letter to the editor from Atkinson and Nevill. Biometrics 53:777-778.
33. Lin, L. I., Torbeck, L. D. (1998). Coefficient of accuracy and concordance correlation coefficient: new statistics for method comparison. J. Pharm. Sci. Technol. 52:55-59.
34. Lin, L. I., Hedayat, A. S., Sinha, B., Yang, M. (2002). Statistical methods in assessing agreement: models, issues, and tools. J. Am. Stat. Assoc. 97:257-270.
35. Lin, L. I., Hedayat, A. S., Wu, W. (2007). A unified approach for assessing agreement. special issue on agreement assessment. J. Biopharm. Stat. 17(4):629-652.
36. Neter, J., Kutner, M. H., Nachtsheim, C. J., Wasserman, W. (1996). Applied Linear Statistics Models. Chicago: Irwin.
37. Robieson, W. Z. (1999). On Weighted Kappa and Concordance Correlation Coefficient. Ph.D. Thesis, Chicago: Graduate College, University of Illinois.
38. Rodary, C., Com-Noughe, C., Tournade, M. F. (1989). How to establish equivalence between treatments: A one-sided clinical trial in pediatric oncology. Stat. Med. 8:593-598.
39. Shuster, C. (2001). Kappa as a parameter of symmetric model for rater agreement. J. Educ. Behav. Stat. 26:331-342.
40. Shrout, P., Fleiss, J. (1979). Intraclass correlations: uses in rater reliability. Psychol. Bull. 86:420-428.
41. Williamson, J. M., Manatunga, A. K., Lipsitz, S. R. (2000). Modeling kappa for measuring dependent categorical agreement data. Biostatistics 1:191-202.