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

Autor: Tanigawa M; Clinical Research Support Center, Kagawa University Hospital, 1750-1 Ikenobe, Miki-Cho, Kita-Gun, Kagawa, 761-0793, Japan. tanigawa.masatoshi.k6@kagawa-u.ac.jp., Kohama M; Office of Medical Informatics and Epidemiology, Pharmaceutical and Medical Devices Agency, Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan., Hirata K; Office of Medical Informatics and Epidemiology, Pharmaceutical and Medical Devices Agency, Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan., Izukura R; Social Medicine, Department of Basic Medicine, Faculty of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan., Kandabashi T; Medical Information Center, Kyushu University Hospital, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan., Kataoka Y; Clinical Research Support Center, Kagawa University Hospital, 1750-1 Ikenobe, Miki-Cho, Kita-Gun, Kagawa, 761-0793, Japan., Nakashima N; Medical Information Center, Kyushu University Hospital, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan., Kimura M; Department of Medical Informatics, Hamamatsu University Hospital, 1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, 431-3192, Japan., Uyama Y; Office of Medical Informatics and Epidemiology, Pharmaceutical and Medical Devices Agency, Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan., Yokoi H; Department of Medical Informatics, Kagawa University Hospital, 1750-1 Ikenobe, Miki-Cho, Kita-Gun, Kagawa, 761-0793, Japan.
Jazyk: angličtina
Zdroj: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2024 Jul; Vol. 58 (4), pp. 746-755. Date of Electronic Publication: 2024 Apr 21.
DOI: 10.1007/s43441-024-00619-4
Abstrakt: 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.
(© 2024. The Author(s), under exclusive licence to The Drug Information Association, Inc.)
Databáze: MEDLINE
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