Abstract
Objectives
The aim of this study was to harmonize the criteria for the Bhattacharya indirect method Microsoft Excel Spreadsheet for reference intervals calculation to reduce between-user variability and use these criteria to calculate and evaluate reference intervals for eight analytes in two different years.
Methods
Anonymized laboratory test results from outpatients were extracted from January 1st 2018 to December 31st 2019. To assure data quality, we examined the monthly results from an external quality control program. Reference intervals were determined by the Bhattacharya method with the St Vincent’s hospital Spreadsheet firstly using original criteria and then using additional harmonized criteria defined in this study. Consensus reference intervals using the additional harmonized criteria were calculated as the mean of four users’ lower and upper reference interval results. To further test the operation criteria and robustness of the obtained reference intervals, an external user validated the Spreadsheet procedure.
Results
The extracted test results for all selected laboratory tests fulfilled the quality criteria and were included in the present study. Differences between users in calculated reference intervals were frequent when using the Spreadsheet. Therefore, additional criteria for the Spreadsheet were proposed and applied by independent users, such as: to set central bin as the mean of all the data, bin size as small as possible, at least three consecutive bins and a high proportion of bins within the curve.
Conclusions
The proposed criteria contributed to the harmonization of reference interval calculation between users of the Bhattacharya indirect method Spreadsheet.
Acknowledgments
We thank Dr. Raymond Noordam for the R script to design the figures for the moving averages analysis.
-
Research funding: None declared.
-
Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
-
Competing interests: Authors state no conflict of interest.
-
Informed consent: Not applicable.
-
Ethical approval: Not applicable.
References
1. Siest, G, Henny, J, Gräsbeck, R, Wilding, P, Petitclerc, C, Queraltó, JM, et al.. The theory of reference values: an unfinished symphony. Clin Chem Lab Med 2013;51:47–64. https://doi.org/10.1515/cclm-2012-0682.Search in Google Scholar PubMed
2. Sikaris, KA. Physiology and its importance for reference intervals. Clin Biochem Rev 2014;35:3–14.Search in Google Scholar
3. Placzkowska, S, Terpinska, M, Piwowar, A. The importance of establishing reference intervals – is it still a current problem for laboratory and doctors? Clin Lab 2020;1:1429–38. https://doi.org/10.7754/clin.lab.2020.191120.Search in Google Scholar PubMed
4. Committee, S, Section, C, Petitclerc, C, Biochimie, SD, Montreal, HD. International Federation of Clinical Chemistry (IFCC) 1), 2) approved recommendation (1987); on the theory of reference values part 2. Selection of individuals for the production of reference values International Federation of Clinical Chemistry. J Clin Chem Clin Biochem 1987;25:2–30.Search in Google Scholar
5. Martinez-Sanchez, L, Marques-Garcia, F, Ozarda, Y, Blanco, A, Brouwer, N, Canalias, F, et al.. Big data and reference intervals: rationale, current practices, harmonization and standardization prerequisites and future perspectives of indirect determination of reference intervals using routine data. Adv Lab Med/Av en Med Lab 2020;0:9–16. https://doi.org/10.1515/almed-2020-0034.Search in Google Scholar
6. Poole, S, Schroeder, LF, Shah, N. An unsupervised learning method to identify reference intervals from a clinical database. J Biomed Inform Elsevier Inc 2016;59:276–84. https://doi.org/10.1016/j.jbi.2015.12.010.Search in Google Scholar PubMed PubMed Central
7. Lykkeboe, S, Nielsen, CG, Christensen, PA. Indirect method for validating transference of reference intervals. Clin Chem Lab Med 2018;56:463–70. https://doi.org/10.1515/cclm-2017-0574.Search in Google Scholar PubMed
8. Den Elzen, WPJ, Brouwer, N, Thelen, MH, Le Cessie, S, Haagen, IA, Cobbaert, CM. NUMBER: standardized reference intervals in The Netherlands using a “big data” approach. Clin Chem Lab Med 2019;57:42–56. https://doi.org/10.1515/cclm-2018-0462.Search in Google Scholar PubMed
9. Clerico, A, Trenti, T, Aloe, R, Dittadi, R, Rizzardi, S, Migliardi, M, et al.. A multicenter study for the evaluation of the reference interval for TSH in Italy (ELAS TSH Italian Study). Clin Chem Lab Med 2019;57:259–67. https://doi.org/10.1515/cclm-2018-0541.Search in Google Scholar PubMed
10. Shaw, JLV, Cohen, A, Konforte, D, Binesh-Marvasti, T, Colantonio, DA, Adeli, K. Validity of establishing pediatric reference intervals based on hospital patient data: a comparison of the modified Hoffmann approach to CALIPER reference intervals obtained in healthy children. Clin Biochem The Canadian Society of Clinical Chemists 2014;47:166–72. https://doi.org/10.1016/j.clinbiochem.2013.11.008.Search in Google Scholar PubMed
11. Jones, GRD, Haeckel, R, Loh, TP, Sikaris, K, Streichert, T, Katayev, A, et al.. Indirect methods for reference interval determination – review and recommendations. Clin Chem Lab Med 2019;57:20–9. https://doi.org/10.1515/cclm-2018-0073.Search in Google Scholar PubMed
12. Hoffmann, RG. Statistics in the practice of medicine. JAMA, J Am Med Assoc 1963;185:864–73. https://doi.org/10.1001/jama.1963.03060110068020.Search in Google Scholar PubMed
13. Pryce, JD, Lond, MD. Level of haemoglobin in whole blood and red blood-cells, and proposed convention for defining normality. Lancet 1960;2:333–6.10.1016/S0140-6736(60)91480-XSearch in Google Scholar
14. Bhattacharya, CG. A simple method of resolution of a distribution into Gaussian components. Biometrics 1967;23:115. https://doi.org/10.2307/2528285.Search in Google Scholar
15. Zierk, J, Arzideh, F, Kapsner, LA, Prokosch, HU, Metzler, M, Rauh, M. Reference interval estimation from mixed distributions using truncation points and the Kolmogorov-Smirnov distance (kosmic). Sci Rep 2020;10:1704. https://doi.org/10.1038/s41598-020-58749-2.Search in Google Scholar PubMed PubMed Central
16. Wosniok, W, Haeckel, R. A new indirect estimation of reference intervals: truncated minimum chi-square (TMC) approach. Clin Chem Lab Med 2019;57:1933–47. https://doi.org/10.1515/cclm-2018-1341.Search in Google Scholar PubMed
17. Baadenhuijsen, H, Smit, JC. Indirect estimation of clinical chemical reference intervals from total hospital patient data: application of a modified Bhattacharya procedure. Clin Chem Lab Med 1985;23:829–40. https://doi.org/10.1515/cclm.1985.23.12.829.Search in Google Scholar PubMed
18. Oosterhuis, WP, Modderman, TA, Pronk, C. Reference values: Bhattacharya or the method proposed by the IFCC? Ann Clin Biochem 1990;27:359–65. https://doi.org/10.1177/000456329002700413.Search in Google Scholar PubMed
19. Sikaris, KA. Separating disease and health for indirect reference intervals. J Lab Med 2021;45:55–68. https://doi.org/10.1515/labmed-2020-0157.Search in Google Scholar
20. Martinez-Sanchez, L, Cobbaert, CM, Noordam, R, Brouwer, N, Blanco-Grau, A, Villena-Ortiz, Y, et al.. Indirect determination of biochemistry reference intervals using outpatient data. PLoS One 2022;17:e0268522. https://doi.org/10.1371/journal.pone.0268522.Search in Google Scholar PubMed PubMed Central
21. Fraser, CG, Harris, EK. Generation and application of data on biological variation in clinical chemistry. Crit Rev Clin Lab Sci 1989;27:409–37. https://doi.org/10.3109/10408368909106595.Search in Google Scholar PubMed
22. Aarsand, AK, Fernandez-Calle, P, Webster, C, Coskun, A, Gonzales-Lao, E, Diaz-Garzon, J, et al.. The European Federation of Clinical Chemistry and Laboratory Medicine (EFLM). [cited 2022 Sep 25]. Available from: https://biologicalvariation.eu/.Search in Google Scholar
23. Davis, KR, Crook, MA. Seasonal factitious increase in serum potassium: still a problem and should be recognised. Clin Biochem 2014;47:283–6. https://doi.org/10.1016/j.clinbiochem.2014.08.019.Search in Google Scholar PubMed
24. Hemel, JB, Hindriks, FR, Van Der Slik, W. Critical discussion on a method for derivation of reference limits in clinical chemistry from a patient population. J Automat Chem 1985;7:20–30.10.1155/S1463924685000062Search in Google Scholar PubMed PubMed Central
25. Farrell, CL, Nguyen, L. Indirect reference intervals: harnessing the power of stored laboratory data. Clin Biochem Rev 2019;40:99–111.10.33176/AACB-19-00022Search in Google Scholar PubMed PubMed Central
26. Wayne, P., establishing, and verifying reference intervals in the clinical laboratory; approved guideline, 3rd ed. CLSI document EP28-A3c; Wayne, PA: Clinical and Laboratory Standards Institute; 2008. C28–A3.Search in Google Scholar
27. Adeli, K, Higgins, V, Nieuwesteeg, M, Raizman, JE, Chen, Y, Wong, SL, et al.. Biochemical marker reference values across pediatric, adult, and geriatric ages: establishment of robust pediatric and adult reference intervals on the basis of the Canadian Health Measures Survey. Clin Chem 2015;61:1049–62. https://doi.org/10.1373/clinchem.2015.240515.Search in Google Scholar PubMed
28. Tate, JR, Sikaris, KA, Jones, GR, Yen, T, Koerbin, G, Ryan, J, et al.. Harmonising adult and paediatric reference intervals in Australia and New Zealand: an evidence-based approach for establishing a first panel of chemistry analytes. Clin Biochem Rev 2014;35:213–35.Search in Google Scholar
29. Rustad, P, Felding, P, Franzson, L, Kairisto, V, Lahti, A, Mårtensson, A, et al.. The Nordic Reference Interval Project 2000: recommended reference intervals for 25 common biochemical properties. Scand J Clin Lab Invest 2004;64:271–84. https://doi.org/10.1080/00365510410006324.Search in Google Scholar PubMed
30. Jansen, RTP, Cobbaert, CM, Weykamp, C, Thelen, M. The quest for equivalence of test results: the pilgrimage of the Dutch Calibration 2.000 program for metrological traceability. Clin Chem Lab Med 2018;56:1673–84. https://doi.org/10.1515/cclm-2017-0796.Search in Google Scholar PubMed
Supplementary Material
The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2022-0439).
© 2022 Walter de Gruyter GmbH, Berlin/Boston