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日本医学信息数据库网络(MID-NET)中胃肠道穿孔病例的检测算法。

Detection Algorithms for Gastrointestinal Perforation Cases in the Medical Information Database Network (MID-NET) in Japan.

机构信息

Clinical Research Support Center, Kagawa University Hospital, 1750-1 Ikenobe, Miki-Cho, Kita-Gun, Kagawa, 761-0793, Japan.

Office of Medical Informatics and Epidemiology, Pharmaceutical and Medical Devices Agency, Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan.

出版信息

Ther Innov Regul Sci. 2024 Jul;58(4):746-755. doi: 10.1007/s43441-024-00619-4. Epub 2024 Apr 21.

Abstract

BACKGROUND

The Medical Information Database Network (MID-NET) in Japan is a vast repository providing an essential pharmacovigilance tool. Gastrointestinal perforation (GIP) is a critical adverse drug event, yet no well-established GIP identification algorithm exists in MID-NET.

METHODS

This study evaluated 12 identification algorithms by combining ICD-10 codes with GIP therapeutic procedures. Two sites contributed 200 inpatients with GIP-suggestive ICD-10 codes (100 inpatients each), while a third site contributed 165 inpatients with GIP-suggestive ICD-10 codes and antimicrobial prescriptions. The positive predictive values (PPVs) of the algorithms were determined, and the relative sensitivity (rSn) among the 165 inpatients at the third institution was evaluated.

RESULTS

A trade-off between PPV and rSn was observed. For instance, ICD-10 code-based definitions yielded PPVs of 59.5%, whereas ICD-10 codes with CT scan and antimicrobial information gave PPVs of 56.0% and an rSn of 97.0%, and ICD-10 codes with CT scan and antimicrobial information as well as three types of operation codes produced PPVs of 84.2% and an rSn of 24.2%. The same algorithms produced statistically significant differences in PPVs among the three institutions. Combining diagnostic and procedure codes improved the PPVs. The algorithm combining ICD-10 codes with CT scan and antimicrobial information and 80 different operation codes offered the optimal balance (PPV: 61.6%, rSn: 92.4%).

CONCLUSION

This study developed valuable GIP identification algorithms for MID-NET, revealing the trade-offs between accuracy and sensitivity. The algorithm with the most reasonable balance was determined. These findings enhance pharmacovigilance efforts and facilitate further research to optimize adverse event detection algorithms.

摘要

背景

日本的医疗信息数据库网络(MID-NET)是一个庞大的存储库,提供了一个重要的药物警戒工具。胃肠道穿孔(GIP)是一种严重的药物不良反应事件,但在 MID-NET 中尚未建立完善的 GIP 识别算法。

方法

本研究通过结合 ICD-10 代码和 GIP 治疗程序,评估了 12 种识别算法。两个站点分别贡献了 200 例具有 GIP 提示性 ICD-10 代码的住院患者(各 100 例),而第三个站点贡献了 165 例具有 GIP 提示性 ICD-10 代码和抗菌药物处方的住院患者。确定了算法的阳性预测值(PPV),并评估了第三个机构的 165 例住院患者之间的相对灵敏度(rSn)。

结果

观察到 PPV 和 rSn 之间存在权衡。例如,基于 ICD-10 代码的定义的 PPV 为 59.5%,而 CT 扫描和抗菌信息的 ICD-10 代码的 PPV 为 56.0%,rSn 为 97.0%,CT 扫描和抗菌信息以及三种手术代码的 ICD-10 代码的 PPV 为 84.2%,rSn 为 24.2%。相同的算法在三个机构之间产生了 PPV 的统计学显著差异。结合诊断和程序代码提高了 PPV。结合 ICD-10 代码、CT 扫描和抗菌信息以及 80 种不同手术代码的算法提供了最佳平衡(PPV:61.6%,rSn:92.4%)。

结论

本研究为 MID-NET 开发了有价值的 GIP 识别算法,揭示了准确性和敏感性之间的权衡。确定了具有最合理平衡的算法。这些发现增强了药物警戒工作,并促进了进一步研究以优化不良事件检测算法。

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