title: Results from the National Perinatal Patient Safety Program in Sweden: the challenge of evaluation.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Obstetrics and Gynecology, Södersjukhuset Hospital, Stockholm, Sweden.|Department of Clinical Science and Education and Department of Obstetrics and Gynecology, Karolinska Institute, Södersjukhuset Hospital, Stockholm, Sweden.
authors.forename: Charlotte
authors.identifier: http://orcid.org/0000-0002-9181-7299
authors.initials: C
authors.lastname: Millde Luthander
authors.affiliation: Division of Occupational and Environmental Medicine, Institute of Laboratory Medicine, Lund University, Lund, Sweden.
authors.forename: Karin
authors.identifier: http://orcid.org/0000-0001-5765-2630
authors.initials: K
authors.lastname: Källen
authors.affiliation: Department of Learning, Informatics, Management and Ethics, Medical Management Centre, Karolinska Institute, Stockholm, Sweden.|Department of Public Health and Clinical Medicine, Epidemiology and Global Health, Umeå University, Umeå, Sweden.
authors.forename: Monica E
authors.identifier: http://orcid.org/0000-0003-2281-4622
authors.initials: ME
authors.lastname: Nyström
authors.affiliation: Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.
authors.forename: Ulf
authors.identifier: http://orcid.org/0000-0002-2121-7511
authors.initials: U
authors.lastname: Högberg
authors.affiliation: Department of Clinical Sciences/Pediatrics, Umeå University, Umeå, Sweden.
authors.forename: Stellan
authors.identifier: http://orcid.org/0000-0002-2395-809X
authors.initials: S
authors.lastname: Håkansson
authors.affiliation: Department of Learning, Informatics, Management and Ethics, Medical Management Centre, Karolinska Institute, Stockholm, Sweden.|Astrid Lindgren's Children's Hospital, Karolinska University Hospital, Stockholm, Sweden.
authors.forename: Karin P
authors.identifier: http://orcid.org/0000-0002-5502-2237
authors.initials: KP
authors.lastname: Härenstam
authors.affiliation: Department of Obstetrics and Gynecology, Karolinska University Hospital, Stockholm, Sweden.|Department of Women's and Children's Health, Karolinska Institute, Stockholm, Sweden.
authors.forename: Charlotta
authors.identifier: http://orcid.org/0000-0001-8290-5441
authors.initials: C
authors.lastname: Grunewald
mesh_terms: D001034:Apgar Score; D001238:Asphyxia Neonatorum / Q000453:epidemiology / Q000517:prevention & control; D017598:Efficiency, Organizational; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D017063:Outcome Assessment, Health Care; D061214:Patient Safety / Q000592:standards / Q000706:statistics & numerical data; D018743:Perinatal Care / Q000379:methods / Q000592:standards; D011247:Pregnancy; D058996:Quality Improvement; D017751:Safety Management / Q000458:organization & administration*; D013548:Sweden / Q000453:epidemiology
keywords: Cardiotocogram; delivery; education; fetal monitoring; injury claims