Use of patient data in calculation of reference intervals for complete blood count parameters; how reliable?

Abstract

Calculation of reference intervals (RI) for each quantitative test for the population served is mandatory in clinical care. Standard method of calculation of RI is costly and tedious. Literature show success in using patient data in calculating RI for some tests but, those related to complete blood count (CBC) are sparse. Therefore, this study was conducted to assess the applicability of stored patient data of CBC in calculating RI as a less costly and reliable method. A retrospective cross-sectional study was performed using a large database of CBC reports of adults (18–60 years) in a hospital laboratory. Data were grouped in to patients and routine health checkup category and then partitioned according to gender. Data were refined using clinically relevant criteria and statistical tools to harness reference data sets for each parameter. RI were calculated using standard statistical methods. Obtained values were compared with those in the literature and of the manufacturer. All data sets showed Gaussian distribution. The RI calculated using patient data showed no clinically significant differences when compared with those of the healthy subjects, manufacturer and literature. When appropriate selection criteria and statistical tools are applied, large patient databases can be used to calculate RI for CBC parameters.

Keywords:

• Complete blood count
• haematology parameters
• indirect method
• reference intervals
• stored data

Ethical consideration

No human subjects were included in the study. Only the data available in a hospital database were accessed. No personal identification data were collected during data collection. Confidentiality of the collected information was maintained throughout the study. Only grouped data will be presented in scientific meetings and in scientific journals. The authenticity of the results was strictly maintained so that no funding agency can influence. The available data are password protected in a personal database and cannot be accessed without the permission of the authors.

Ethics approval and consent to participate

Ethics approval was obtained from the Ethical Review Committee of Faculty of Allied Health Sciences, University of Ruhuna, Sri Lanka.

The consent of participants was not a requirement since the data were obtained from the existing database.

Institutional permission and approval were obtained to retrieve data which were mandatory to obtain ethical clearance.

Acknowledgements

We acknowledge the administrative team of Ruhunu Hospitals Galle Sri Lanka, Head Laboratories Ruhunu Hospitals Diagnostics, Galle, Sri Lanka (RHD) for giving permission to carry out this study, Nirosha B.T.T (technical officer) of RHD for assisting retrieval of data and all the technical officers in Haematology laboratory, RHD for carrying out routine tests and quality management.

Author contributions

The first author designed the work, collected and interpreted data, verified the analytical method, and critically revised the final manuscript with important intellectual content. The second author performed the computations and analysis, took the lead in writing the manuscript. Both the authors discussed the results and contributed to the final manuscript.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Data availability statement

The data that support the findings of this study are available on request from the corresponding author, Wickramaratne KAC.