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Perinatal pharmacoepidemiology: How often are key methodological elements reported in publications?

Andrea V Margulis1, Alison T Kawai2, Mary S Anthony3

  • 1Department of Epidemiology, RTI Health Solutions, Barcelona, Spain.

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|September 9, 2021
PubMed
Summary

Reporting in perinatal pharmacoepidemiology studies often lacks completeness. A standardized checklist is recommended to improve transparency and understanding of pregnancy-related research findings.

Keywords:
epidemiologyobservationalpharmacoepidemiologypregnancyreproductive

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Area of Science:

  • Perinatal Pharmacoepidemiology
  • Reproductive Health Research
  • Medical Product Safety

Background:

  • Publications are vital for clinicians, researchers, and patients.
  • Transparency in reporting methodological elements is crucial for understanding research.
  • Perinatal pharmacoepidemiology studies require specific methodological details for accurate interpretation.

Purpose of the Study:

  • To identify key methodological elements for understanding perinatal pharmacoepidemiology research.
  • To quantify the reporting completeness of these elements in published studies.
  • To assess the transparency of pregnancy-related pharmacoepidemiology publications.

Main Methods:

  • Identified key methodological elements from guidelines and literature.
  • Conducted a literature review of recent observational studies on medical product use/safety in pregnancy.
  • Sampled 100 publications and extracted data on the reporting of identified elements.

Main Results:

  • Reporting completeness varied significantly across methodological elements.
  • Pregnancy start source reported in 43%, multifetal pregnancies in 57%, and non-live births in 93%.
  • Mother-infant linkage process described in 35% and success rate in 21% of applicable studies.

Conclusions:

  • Completeness of reporting in perinatal pharmacoepidemiology publications can be improved.
  • A pregnancy-specific checklist is proposed to enhance transparency.
  • Improved reporting will facilitate better understanding and utilization of study results.