Trends in the use of validated claims-based algorithms in Japanese post-marketing database studies.

ABSTRACT:

Background

In pharmacoepidemiological research, misclassification is a concern with claims-based algorithms (also called computable phenotypes). Validating them is crucial, particularly within regulatory settings. However, the extent of their application remains unclear globally.

Objectives

This study aimed to investigate the frequency and trends of validated claims-based algorithms use in post-marketing database studies.

Method

We reviewed all Japanese risk management plans published until January 2023, identifying four issue types [Effectiveness Issues (EI), Important Identified Risks (IIR), Important Potential Risks (IPR), and Important Missing Information (IMI)] that were planned to use a claims-based algorithm in post-marketing database studies. We then calculate

SUBMITTER: Ishiguro C 

PROVIDER: S-EPMC12436343 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature