An appraisal of statistical procedures used in derivation of reference intervals

Clinical Chemistry and Laboratory Medicine

Volumn 48, Issue 11, 2010, Pages 1537-1551

  Ichihara, Kiyoshi ^a   Boyd, James C ^b  

^a YAMAGUCHI UNIVERSITY   (Japan)

^b UNIVERSITY OF VIRGINIA HEALTH SYSTEM   (United States)

Author keywords

Modified Box Cox formula; Multiple regression analysis; Nested ANOVA; Partitioning criteria; Percentile; Power transformation

Indexed keywords

ANALYSIS OF VARIANCE; ARTICLE; CONFIDENCE INTERVAL; MULTICENTER STUDY (TOPIC); MULTIPLE REGRESSION; MULTIVARIATE ANALYSIS; PARAMETRIC TEST; PRIORITY JOURNAL; REFERENCE VALUE; SAMPLE SIZE; STATISTICAL ANALYSIS; STATISTICS; UNIVARIATE ANALYSIS;

ANALYSIS OF VARIANCE; DATA INTERPRETATION, STATISTICAL; HUMANS; REFERENCE VALUES; REGRESSION ANALYSIS; SAMPLE SIZE; STATISTICS, NONPARAMETRIC;

EID: 78751612244     PISSN: 14346621     EISSN: 14374331     Source Type: Journal    
DOI: 10.1515/CCLM.2010.319     Document Type: Article

References (29)

1. Harris EK, Boyd JC. Statistical basis of reference values in laboratory medicine. New York: Marcel Dekker, 1995.
2. Horn PS, Pesce AJ. Reference intervals. A user's guide. Washington, DC: AACC Press, 2005.
3. CLSI. Defining, establishing, and verifying reference intervals in the clinical laboratory; approved guideline, 3rd ed. CLSI document C28-A3. Clinical and Laboratory Standards Institute, Wayne, PA, USA, 2008.
4. Ichihara K, Kawai T. Determination of reference intervals for 13 plasma proteins based on IFCC international reference preparation (CRM470) and NCCLS proposed guideline (C28-P, 1992): a strategy for partitioning reference individuals with validation based on multivariate analysis. J Clin Lab Anal 1997;11:117-24.
5. Sokal RR, Rohlf FJ. Biometry, 3rd ed. New York: W. H. Frieman, 1995:272-320.
6. Ichihara K, Itoh Y, Lam CW, Poon PM, Kim JH, Kyono H, et al. Sources of variation of commonly measured serum analytes among 6 Asian cities and consideration of common reference intervals. Clin Chem 2008;54:356-65.
7. Harris EK, Boyd JC. On dividing reference data into subgroups to produce separate reference ranges. Clin Chem 1990;36:265-70.
8. Lahti A, Petersen PH, Boyd JC, Rustad P, Laake P, Solberg HE. Partitioning of non-Gaussian-distributed biochemical reference data into subgroups. Clin Chem 2004;50:891-900.
9. Lahti A. Are the common reference intervals truly common? Case studies on stratifying biochemical reference data by countries using two partitioning methods. Scand J Clin Lab Invest 2004;64:407-30.
10. Fraser CG, Hyltoft Petersen P, Libeer JC, Ricos C. Proposals for setting generally applicable quality goals solefly based on biology. Ann Clin Biochem 1997;24:8-12.
11. Horn PS, Feng L, Li Y, Pesce AJ. Effect of outliers and nonhealthy individuals on reference interval estimation. Clin Chem 2001;47:2137-45.
12. Solberg HE, Lahti A. Detection of outliers in reference distributions: performance of Horn's algorithm. Clin Chem 2005;51:2326-32.
13. Dixon WJ. Processing data for outliers. Biometrics 1953;9:74-89.
14. Smirnov NV. On the estimation of the maximum term in a series of observations win Russianx. Dokl Akad Nauk SSSR, 1941;33:346-9.
15. Healy MJ. Outliers in clinical chemistry quality-control schemes. Clin Chem 1979;25:675-7.
16. Ichihara K, Kawai T. An iterative method for improved estimation of the mean of peer-group distributions in proficiency testing. Clin Chem Lab Med 2005;43:412-21.
17. Kratzsch J, Fiedler GM, Leichtle A, Brügel M, Buchbinder S, Otto L, et al. New reference intervals for thyrotropin and thyroid hormones based on National Academy of Clinical Biochemistry criteria and regular ultrasonography of the thyroid. Clin Chem 2005;51:1480-6.
18. Ichihara K, Kawai T. Determination of reference intervals for 13 plasma proteins based on IFCC international reference preparation (CRM470) and NCCLS proposed guideline (C28-P, 1992): trial to select reference individuals by results of screening tests and application of maximal likelihood method. J Clin Lab Anal 1996;10:110-7.
19. Ichihara K, Itoh Y, Min WK, Yap SF, Lam CW, Kong XT, et al. Diagnostic and epidemiological implications of regional differences in serum concentrations of proteins observed in six Asian cities. Clin Chem Lab Med 2004;42:800-9.
20. Ichihara K, Saito K, Itoh Y. Sources of variation and reference intervals for serum cystatin C in a healthy Japanese adult population. Clin Chem Lab Med 2007;45:1232-6.
21. Tamechika Y, Iwatani Y, Tohyama K, Ichihara K. Insufficient filling of vacuum tubes as a cause of microhemolysis and elevated serum lactate dehydrogenase levels. Use of a data-mining technique in evaluation of questionable laboratory test results. Clin Chem Lab Med 2006;44:657-61.
22. Matsubara A, Ichihara K, Fukutani S. Determination of reference intervals for 26 commonly measured biochemical analytes with consideration of long-term within-individual variation. Clin Chem Lab Med 2008;46:691-8.
23. Grossi E, Colombo R, Cavuto S, Franzini C. The REALAB project: a new method for the formulation of reference intervals based on current data. Clin Chem 2005;51:1232-40.
24. Solberg HE. Approved recommendation (1987) on the theory of reference values. Part 5. Statistical treatment of collected reference values. Determination of reference limits. J Clin Chem Clin Biochem 1987;25:645-56.
25. Pryce JD. Level of haemoglobin in whole blood and red bloodcells, and proposed convention for defining normality. Lancet 1960;2:333-6.
26. Hoffman RG. Statistics in the practice of medicine. J Am Med Assoc 1963;185:864-73.
27. Amador E, Hsi BP. Indirect methods for estimating the normal range. Am J Clin Pathol 1969;52:538-46.
28. Elveback LR, Guiller CL, Keating FR Jr. Health, normality, and the ghost of Gauss. J Am Med Assoc 1970;211:69-75.
29. Linnet K. Non-parametric estimation of reference intervals by simple and bootstrap-based procedures. Clin Chem 2000;46:867-9.