Background: Any use of data not primarily collected for research purposes requires their prior
validation. A large pharmacoepidemiological database was created in Germany, which
contains records of ˜14 mill insurants from four statutory health insurances covering
whole Germany (17% of the German population). The aim of the current analysis was
to validate the birth and birth outcome information in GePaRD by comparing it to official
statistics. Methods: We estimated the crude birth rate (number of newborns per 100,000 population), the
fertility rate (number of newborns per 1,000 women in reproductive age range (15–44)),
the percentage of twins and higher order births and percentage of stillbirths stratified
by federal state in 2004 to 2006. We compared our results with the data from birth
registration from federal health monitoring. Results: The crude birth rate agreed with the official statistics within 2% (2004: 873 vs.
855, 2005: 834 vs. 832 and 2006: 806 vs. 817). The fertility rate showed an average
underestimation of 9% (2004: 39 vs. 42, 2005: 38 vs. 41 and 2006: 38 vs. 41), in line
with the slight underrepresentation of younger women in reproductive age in the GePaRD
compared to the German population. As expected, regional variation in fertility indicators
from official statistics in Germany was better reproduced by the database estimates
for the fertility rate than for crude birth rate. Twins and higher order births were
recorded in 1.5% of all births in our database and in 1.6% in the official statistics
for the years 2004–2006. During the same time period, 3.3% of births in the database
were stillbirths, in agreement with the official statistics where 3.6% of the deliveries
were stillbirths. Conclusion: Our results show a good agreement of the database with official statistics for Germany
for birth and birth outcomes providing a basis of further evaluation.
