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