Task Force Report on the Validation of Diagnosis Codes and Other Outcome Definitions in the Japanese Receipt Data

Masao Iwagami; Kotonari Aoki; Manabu Akazawa; Chieko Ishiguro; Shinobu Imai; Nobuhiro Ooba; Makiko Kusama; Daisuke Koide; Atsushi Goto; Norihiro Kobayashi; Izumi Sato; Sayuri Nakane; Makoto Miyazaki; Kiyoshi Kubota

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Task Force Report on the Validation of Diagnosis Codes and Other Outcome Definitions in the Japanese Receipt Data

VernacularTitle:⌈日本における傷病名を中心とするレセプト情報から得られる指標のバリデーションに関するタスクフォース⌋ 報告書
Author: Masao IWAGAMI ¹ ; Kotonari AOKI ² ; Manabu AKAZAWA ³ ; Chieko ISHIGURO ⁴ ; Shinobu IMAI ⁵ ; Nobuhiro OOBA ⁶ ; Makiko KUSAMA ⁷ ; Daisuke KOIDE ⁸ ; Atsushi GOTO ⁹ ; Norihiro KOBAYASHI ¹⁰ ; Izumi SATO ¹¹ ; Sayuri NAKANE ¹² ; Makoto MIYAZAKI ² ; Kiyoshi KUBOTA ¹³
Author Information

1. London School of Hygiene and Tropical Medicine
2. Real World Data Science Dept., Drug Safety Div., Chugai Pharmaceutical Co.Ltd.
3. Department of Public Health and Epidemiology, Meiji Pharmaceutical University
4. Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency
5. Department of Clinical Data Management and Research, Clinical Research Center, National Hospital Organization Headquarters
6. Nihon University School of Pharmacy
7. Graduate School of Pharmaceutical Sciences, The University of Tokyo
8. Current address：Japan Agency for Medical Research and Development（AMED)
9. Graduate School of Medicine, The University of Tokyo
10. Epidemiology and Prevention Group, Center for Public Health Sciences, National Cancer Center
11. Digital Intelligence Department, Corporate Strategy Division, Shionogi & Co., Ltd.
12. Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University
13. Risk Assessment & Pharmacoepidemiology, MSD K.K.
Keywords: validation studies; outcome assessment; sensitivity and specificity; predictive values
From:Japanese Journal of Pharmacoepidemiology 2018;23(2):95-123
CountryJapan
Language:Japanese
Abstract: Although the recent revision of the ministerial ordinance on Good Post-marketing Study Practice (GPSP) included the utilization of medical information databases for post-marketing surveillance, there has been limited research on the validity of diagnosis codes and other outcome definitions in Japanese databases such as administrative claims (“receipt”) database. This task force proposed how to conduct good validations studies, based on the narrative review on around 100 published papers around the world. The established check list consists of ： (ⅰ) understanding the type of the database (e.g. administrative claims data, electronic health records, disease registry) ； (ii) understanding the setting of the validation study (e.g. “population-based” or not) ； (iii) defining the study outcome ； (iv) determining the way of linkage between databases ； (v) defining the gold standard ； (vi) selecting the sampling method (e.g. using the information of all patients in the database or a hospital, random sampling from all patients, random sampling from patients satisfying the outcome definition, random sampling from patients satisfying and not satisfying the outcome definition, “all possible cases” method) and sample size ； (vii) calculating the measures of validity (e.g. sensitivity, specificity, positive predictive value, negative predictive value) ； and (viii) discussing how to use the result for future studies. In current Japan, where the linkage between databases is logistically and legally difficult, most validation studies would to be conducted on a hospital basis. In such a situation, detailed description of hospital and patient characteristics is important to discuss the generalizability of the validation study result to the entire database. This report is expected to encourage and help to conduct appropriate validation studies.