Results from the National Perinatal Patient Safety Program in Sweden: the challenge of evaluation.

Abstract

We studied the effects of the national Perinatal Patient Safety Program in Sweden, addressing local improvement measures, changes in the proportion of low Apgar score and the number of settled injury claims due to asphyxia. Final reports on achieved improvements from all Swedish obstetric units were analyzed and categories of the improvement measures taken in perinatal risk areas were established. Data on all term newborns during 2006-12 were obtained from the Medical Birth Registry. Incidence of 5-min Apgar score <7 was analyzed before, during and after the intervention. The odds ratio for low Apgar score in period ÍII vs. period I was calculated. Patient injury claims from The Swedish National Patient Insurance Company (LÖF) were analyzed. Numerous local improvement initiatives were reported. The incidence of 5-min Apgar score <7 on a national level remained unchanged during the study periods. The units with the highest rate of Apgar score <7 showed a significant decrease in Apgar score of 4-6 after the intervention, whereas units with the lowest rate of Apgar score <7 showed a significant increase in Apgar score <7 after the intervention. A decline in settled claims due to substandard care was observed (7.5%, 2012-14; p for trend 0.049). The national incidence of low Apgar score remained unchanged but a reduction of settled claims of severely asphyxiated neonates was observed. The study highlights the need for robust designs when evaluating large-scale initiatives for improving patient safety at delivery, along with the difficulties in performing them.