Reporting bias in retrospective ascertainment of drug-induced embryopathy

Lancet. 1999 Nov 13;354(9191):1700-1. doi: 10.1016/s0140-6736(99)04411-6.

Abstract

The rate of congenital malformations after first-trimester exposure to itraconazole was four times higher when ascertained retrospectively than prospectively (13.0 vs 3.2%, p=0.006). Reporting bias in retrospective studies should be acknowledged in interpretation of such data.

Publication types

  • Comparative Study
  • Letter

MeSH terms

  • Abnormalities, Drug-Induced / epidemiology*
  • Antifungal Agents / adverse effects*
  • Antifungal Agents / therapeutic use
  • Belgium
  • Bias
  • Cohort Studies
  • Data Collection / statistics & numerical data*
  • Female
  • Humans
  • Infant, Newborn
  • Itraconazole / adverse effects*
  • Itraconazole / therapeutic use
  • Male
  • Pregnancy
  • Pregnancy Outcome
  • Pregnancy Trimester, First
  • Prospective Studies
  • Retrospective Studies

Substances

  • Antifungal Agents
  • Itraconazole