Validation Study of Algorithms to Identify Malignant Tumors and Serious Infections in a Japanese Administrative Healthcare Database

Author:

Nishikawa Atsushi1,Yoshinaga Eiko1,Nakamura Masaki2,Suzuki Masayoshi2,Kido Keiji1,Tsujimoto Naoto1,Ishii Taeko1,Koide Daisuke3

Affiliation:

1. Eli Lilly Japan K.K.

2. Medical Data Vision Co., Ltd.

3. Department of Biostatistics and Bioinformatics, Graduate School of Medicine, University of Tokyo

Publisher

Society for Clinical Epidemiology

Reference21 articles.

1. 1. Hirano Y, Asami Y, Kuribayashi K, Kitazaki S, Yamamoto Y, Fujimoto Y. Possibility of database research as a means of pharmacovigilance in Japan based on a comparison with sertraline postmarketing surveillance. Value Health Reg Issues 2018;15:1–5.

2. 2. Pharmaceuticals and Medical Devices Agency. Revision of the Ministerial Ordinance on Good Post-marketing Study Practice (GPSP Ordinance). Pharmaceuticals and Medical Devices Safety Information, No 355. 2018. https://www.pmda.go.jp/files/000225335.pdf. Accessed Nov 20, 2020.

3. 3. Pharmaceuticals and Medical Devices Agency. Basic concepts for validating outcome definitions used in post-marketing database surveillance, PSEHB/PED, PSEHB/SD Notice. CRS Notification No 0731001, CPE Notification No 0731001. Accessed Nov 20, 2020 (In Japanese).

4. 4. Ono Y, Taneda Y, Takeshima T, Iwasaki K, Yasui A. Validity of claims diagnosis codes for cardiovascular diseases in diabetes patients in Japanese administrative database. Clin Epidemiol 2020;12:367–375.

5. 5. Koram N, Delgado M, Stark JH, Setoguchi S, de Luise C. Validation studies of claims data in the Asia-Pacific region: a comprehensive review. Pharmacoepidemiol Drug Saf 2019;28:156–170.

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