Chinese Journal of Pharmacovigilance ›› 2019, Vol. 16 ›› Issue (3): 144-148.

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Interpretation of the Guidance for Reporting of Pharmacoepidemiology Studies Conducted Using Observational Routinely Collected Health Data: RECORD-PE Statement

HU Fangyuan, YE Xiaofei, XU Jinfang, GUO Xiaojing, HE Jia*   

  1. Department of Medical Statistics, Faculty of Medical Services, Second Military Medical University, Shanghai 200433, China
  • Received:2019-02-21 Revised:2020-06-28 Online:2019-03-20 Published:2019-04-17

Abstract: Routinely collected data plays more and more important role in pharmacoepidemiology studies. Current available guidance for routinely collected data is the REporting of studies Conducted using Observational Routinely collected health data(RECORD) statement based on Strengthing the Reporting of OBservational studies in Epidemiology(STROBE) statement, but the RECORD statement is not fully suitable for pharmacoepidemiology studies. This study interprets each of the new items of the RECORD-PE (RECORD for Pharmacoepidemiology research) statement extended from the RECORD statement using related examples. We hope this interpretation will give scholars a better understanding and use of the RECORD-PE statement.

Key words: routinely collected health data, pharmacoepidemiology, RECORD-PE statement, guidelines

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