Current status and challenges in establishing reference intervals based on real-world data.

Reference intervals (RIs) are the cornerstone for evaluation of test results in clinical practice and are invaluable in judging patient health and making clinical decisions. Establishing RIs based on clinical laboratory data is a branch of real-world data mining research. Compared to the traditional...

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Published in:Critical Reviews in Clinical Laboratory Sciences Vol. 60; no. 6; pp. 427 - 442
Main Authors: Ma, Sijia, Yu, Juntong, Qin, Xiaosong, Liu, Jianhua
Format: review tables/charts Journal Article
Published: Taylor & Francis Ltd Sep2023
Online Access:View this record in EBSCOhost
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      dt: Sep2023
      vid: 60
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      pub: Taylor & Francis Ltd
      place: Philadelphia, Pennsylvania
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        10.1080/10408363.2023.2195496
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        atl: Current status and challenges in establishing reference intervals based on real-world data.
      aug:
        au:
          Ma, Sijia
          Yu, Juntong
          Qin, Xiaosong
          Liu, Jianhua
        affil: Department of Laboratory Medicine, Shengjing Hospital of China Medical University, Liaoning Clinical Research Center for Laboratory Medicine, Shenyang, P.R. China
      sug:
        subj:
          Clinical Laboratories
          Reference Values
          Diagnosis, Laboratory
          Analysis of Variance
          Decision Making, Clinical
          Data Mining
          Health Status
          Age Factors
          Sensitivity and Specificity
      ab: Reference intervals (RIs) are the cornerstone for evaluation of test results in clinical practice and are invaluable in judging patient health and making clinical decisions. Establishing RIs based on clinical laboratory data is a branch of real-world data mining research. Compared to the traditional direct method, this indirect approach is highly practical, widely applicable, and low-cost. Improving the accuracy of RIs requires not only the collection of sufficient data and the use of correct statistical methods, but also proper stratification of heterogeneous subpopulations. This includes the establishment of age-specific RIs and taking into account other characteristics of reference individuals. Although there are many studies on establishing RIs by indirect methods, it is still very difficult for laboratories to select appropriate statistical methods due to the lack of formal guidelines. This review describes the application of real-world data and an approach for establishing indirect reference intervals (iRIs). We summarize the processes for establishing iRIs using real-world data and analyze the principle and applicable scope of the indirect method model in detail. Moreover, we compare different methods for constructing growth curves to establish age-specific RIs, in hopes of providing laboratories with a reference for establishing specific iRIs and giving new insight into clinical laboratory RI research. (201 words)
      pubtype: Academic Journal
      doctype:
        review
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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