title: Early comprehensive care of preterm infants-effects on quality of life, childhood development, and healthcare utilization: study protocol for a cohort study linking administrative healthcare data with patient reported primary data.
abstract: About 9 % of all children in Germany are born preterm. Despite significant improvements of medical care, preterm infants are at a greater risk to develop short and long term health complications. Negative consequences of preterm birth include neurodevelopmental disabilities, behavioral problems or learning disorders. Most data on effects of prematurity are derived from single or multi-center studies and not population-based. Since some of the long term problems of preterm delivery are associated with a disturbed parent-child interaction originating in the neonatal period, several intervention programs became available aiming to strengthen the early parent-child relationship. However, there is insufficient knowledge regarding the psychosocial and socioeconomic impact of these interventions. Prior to introducing them into routine care, those effects have to be rigorously evaluated. The population-based cohort study EcoCare-PIn (Early comprehensive Care of Preterm Infants-effects on quality of life, childhood development, and healthcare utilization) will investigate the following primary research questions: 1) What are the short- and long-term consequences of preterm birth with regard to parental stress, parent-child relationship, childhood development, quality of life and healthcare utilization including costs? 2) Does early family-centered psychosocial care prevent the hypothesized negative consequences of preterm birth on the above mentioned outcomes?
  
  
  
  EcoCare-PIn examines the research questions by means of a linkage of a) pseudonymized administrative individual-level claims data from the German statutory health insurance AOK PLUS on approximately 140,000 children born between 2007 and 2013 in Saxony, and b) primary data collected from the parents/caregivers of all very low birth weight (<1,500 g; n = 1,000) and low birth weight infants (1,500 to 2,500 g; n = 5,500) and a matched sample of infants above 2,500 g birth weight (n = 10,000).
  
  
  
  In Saxony, approximately 50 % of all individuals are insured at the AOK PLUS. The linkage of patient-level administrative and primary data is a novel approach in neonatal research and probably the only way to overcome shortcomings of studies solely relying on one data source. The study results are based on an observation period of up to 8 years and will directly inform perinatal healthcare provision in Saxony and Germany as a whole.
authors.affiliation: Center for Evidence-based Healthcare, University Hospital and Medical Faculty Carl Gustav Carus, TU Dresden, Fetscherstr. 74, 01307, Dresden, Germany.
authors.forename: Jochen
authors.initials: J
authors.lastname: Schmitt
authors.affiliation: Center for Evidence-based Healthcare, University Hospital and Medical Faculty Carl Gustav Carus, TU Dresden, Fetscherstr. 74, 01307, Dresden, Germany.
authors.forename: Katrin
authors.initials: K
authors.lastname: Arnold
authors.affiliation: Center for Evidence-based Healthcare, University Hospital and Medical Faculty Carl Gustav Carus, TU Dresden, Fetscherstr. 74, 01307, Dresden, Germany. Diana.Druschke@uniklinikum-dresden.de.
authors.forename: Diana
authors.initials: D
authors.lastname: Druschke
authors.affiliation: Institute of Social Medicine and Health Economics (ISMG), Faculty of Medicine, Otto-von-Guericke-University Magdeburg, Leipziger Str. 44, 39120, Magdeburg, Germany.
authors.forename: Enno
authors.initials: E
authors.lastname: Swart
authors.affiliation: Coordination Centre for Clinical Trials, Medical Faculty Carl Gustav Carus, TU Dresden, Fetscherstr. 74, 01307, Dresden, Germany.
authors.forename: Xina
authors.initials: X
authors.lastname: Grählert
authors.affiliation: AOK PLUS, Sternplatz 7, 01067, Dresden, Germany.
authors.forename: Ulf
authors.initials: U
authors.lastname: Maywald
authors.affiliation: AOK PLUS, Sternplatz 7, 01067, Dresden, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Fuchs
authors.affiliation: AOK PLUS, Sternplatz 7, 01067, Dresden, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Werblow
authors.affiliation: AOK PLUS, Sternplatz 7, 01067, Dresden, Germany.
authors.forename: Maryan
authors.initials: M
authors.lastname: Schemken
authors.affiliation: Department for Neonatology and Pediatric Intensive Care, University Hospital Carl Gustav Carus, TU Dresden, Fetscherstr. 74, 01307, Dresden, Germany.
authors.forename: Jörg
authors.initials: J
authors.lastname: Reichert
authors.affiliation: Department for Neonatology and Pediatric Intensive Care, University Hospital Carl Gustav Carus, TU Dresden, Fetscherstr. 74, 01307, Dresden, Germany.
authors.forename: Mario
authors.initials: M
authors.lastname: Rüdiger
mesh_terms: D002648:Child; D002657:Child Development; D002675:Child, Preschool; D002985:Clinical Protocols; D003191:Comprehensive Health Care / Q000191:economics / Q000379:methods*; D016208:Databases, Factual; D005260:Female; D005858:Germany; D006296:Health Services / Q000191:economics / Q000706:statistics & numerical data*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007234:Infant, Premature; D016247:Information Storage and Retrieval; D015931:Intensive Care, Neonatal / Q000191:economics / Q000379:methods*; D016014:Linear Models; D016015:Logistic Models; D008297:Male; D010287:Parent-Child Relations; D011788:Quality of Life; D013315:Stress, Psychological / Q000191:economics / Q000209:etiology / Q000517:prevention & control
keywords: Claims data; Cohort study; Data linkage; Early comprehensive care; Preterm infants; Quality of life