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Japanese Journal of Pharmacoepidemiology ; : 95-123, 2018.
Article in Japanese | WPRIM | ID: wpr-688487


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.