Reporting bias in retrospective ascertainment of drug-induced embryopathy.
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.
Bar-Oz
B
B
Moretti
M E
ME
Mareels
G
G
Van Tittelboom
T
T
Koren
G
G
D000014:Abnormalities, Drug-Induced / Q000453:epidemiology*; D000935:Antifungal Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001530:Belgium; D015982:Bias; D015331:Cohort Studies; D003625:Data Collection / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D017964:Itraconazole / Q000009:adverse effects* / Q000627:therapeutic use; D008297:Male; D011247:Pregnancy; D011256:Pregnancy Outcome; D011261:Pregnancy Trimester, First; D011446:Prospective Studies; D012189:Retrospective Studies
D000935:Antifungal Agents; D017964:Itraconazole