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

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  • IWAGAMI Masao
    London School of Hygiene and Tropical Medicine
  • AOKI Kotonari
    Real World Data Science Dept., Drug Safety Div., Chugai Pharmaceutical Co.Ltd.
  • AKAZAWA Manabu
    Department of Public Health and Epidemiology, Meiji Pharmaceutical University
  • ISHIGURO Chieko
    Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency
  • IMAI Shinobu
    Department of Clinical Data Management and Research, Clinical Research Center, National Hospital Organization Headquarters
  • OOBA Nobuhiro
    Nihon University School of Pharmacy
  • KUSAMA Makiko
    Graduate School of Pharmaceutical Sciences, The University of Tokyo Current address：Japan Agency for Medical Research and Development（AMED)
  • KOIDE Daisuke
    Graduate School of Medicine, The University of Tokyo
  • GOTO Atsushi
    Epidemiology and Prevention Group, Center for Public Health Sciences, National Cancer Center
  • KOBAYASHI Norihiro
    Digital Intelligence Department, Corporate Strategy Division, Shionogi & Co., Ltd.
  • SATO Izumi
    Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University
  • NAKANE Sayuri
    Real World Data Science Dept., Drug Safety Div., Chugai Pharmaceutical Co.Ltd.
  • MIYAZAKI Makoto
    Risk Assessment & Pharmacoepidemiology, MSD K.K.
  • KUBOTA Kiyoshi
    NPO Drug Safety Research Unit Japan

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Other Title
  • <b>⌈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 </b>
  • 「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
  • 「 ニホン ニ オケル ショウビョウメイ オ チュウシン ト スル レセプト ジョウホウ カラ エラレル シヒョウ ノ バリデーション ニ カンスル タスクフォース 」 ホウコクショ
  • Task force report on the validation of diagnosis codes and other outcome definitions in the Japanese receipt data (in Japanese)

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Abstract

<p>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.</p>

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