BACKGROUND While many studies have established reference intervals (RIs) for thyroid hormones using patient data, this approach has not been validated. Therefore, in this study, we aimed to validate an approach for establishing RIs for thyroid hormones only using patient data from clinical laboratories. METHODS We established two derived databases: derived database* and derived database#. Reference individuals in derived database* were selected using strict exclusion criteria, and the RIs established by the database were considered standard RIs (RIs*). Individuals in derived database# were the physical examination population, whose information was downloaded directly from the Laboratory Information System, and RIs established from this database were evaluated (RIs#). The comparative confidence interval (CI) method and consistency of the decision results based on external databases were used to compare RIs* and RIs#. RESULTS RIs# and RIs* for the thyroid hormones tested were similar. The 90% CIs of the upper and lower limits of RIs for most thyroid hormones overlapped between RIs# and RIs*, and the limit of RIs# was within the 90% CI of RIs*. The consistency rates for the results of the RIs* and RIs# in the external database were greater than 98% for all thyroid hormones tested. CONCLUSION It was possible to establish RIs for thyroid hormones using only patient data from clinical laboratories after adopting appropriate statistical methods.

中文翻译：

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验证仅使用来自临床实验室的患者大数据来建立基于数据挖掘的甲状腺激素参考区间的方法。

背景技术尽管许多研究已经使用患者数据建立了甲状腺激素的参考区间（RIs），但该方法尚未得到验证。因此，在这项研究中，我们旨在验证仅使用临床实验室的患者数据为甲状腺激素建立RI的方法。方法我们建立了两个派生数据库：派生数据库*和派生数据库＃。使用严格的排除标准选择派生数据库*中的参考个人，并将数据库建立的RI视为标准RI（RI *）。派生数据库中的个人是体检人群，其信息直接从实验室信息系统下载，并评估了从该数据库中建立的RI（RIs＃）。使用比较置信区间（CI）方法和基于外部数据库的决策结果的一致性来比较RIs *和RIs＃。结果甲状腺激素的RIs＃和RIs *相似。大多数甲状腺激素的RIs上限和下限的90％CI重叠在RIs＃和RIs *之间，并且RIs＃的限制在RIs *的90％CI之内。对于所有测试的甲状腺激素，外部数据库中RIs *和RIs＃结果的一致性率均大于98％。结论采用适当的统计方法后，仅使用来自临床实验室的患者数据就可以建立甲状腺激素的RI。大多数甲状腺激素的RIs上限和下限的90％CI重叠在RIs＃和RIs *之间，并且RIs＃的限制在RIs *的90％CI之内。对于所有测试的甲状腺激素，外部数据库中RIs *和RIs＃结果的一致性率均大于98％。结论采用适当的统计方法后，仅使用来自临床实验室的患者数据就可以建立甲状腺激素的RI。大多数甲状腺激素的RIs上限和下限的90％CI重叠在RIs＃和RIs *之间，并且RIs＃的限制在RIs *的90％CI之内。对于所有测试的甲状腺激素，外部数据库中RIs *和RIs＃结果的一致性率均大于98％。结论采用适当的统计方法后，仅使用来自临床实验室的患者数据就可以建立甲状腺激素的RI。