title: Structure, Process, and Culture Differences of Pediatric Trauma Centers Participating in an International Comparative Effectiveness Study of Children with Severe Traumatic Brain Injury.
abstract: Traumatic brain injury (TBI) is an important worldwide cause of death and disability for children. The Approaches and Decisions for Acute Pediatric TBI (ADAPT) Trial is an observational, cohort study to compare the effectiveness of six aspects of TBI care. Understanding the differences between clinical sites-including their structure, clinical processes, and culture differences-will be necessary to assess differences in outcome from the study and can inform the overall community regarding differences across academic centers.
  
  
  
  We developed a survey and queried ADAPT site principal investigators with a focus on six domains: (i) hospital, (ii) pediatric intensive care unit (PICU), (iii) medical staff characteristics, (iv) quality of care, (v) medication safety, and (vi) safety culture. Summary statistics were used to describe differences between centers.
  
  
  
  ADAPT clinical sites that enrolled a subject within the first year (32 US-based, 11 international) were studied. A wide variation in site characteristics was observed in hospital and ICU characteristics, including an almost sevenfold range in ICU size (8-55 beds) and more than fivefold range of overall ICU admissions (537-2623). Nursing staffing (predominantly 1:1 or 1:2) and the presence of pharmacists within the ICU (79 %) were less variable, and most sites "strongly agreed" or "agreed" that Neurosurgery and Critical Care teams worked well together (81.4 %). However, a minority of sites (46 %) used an explicit protocol for treatment of children with severe TBI care.
  
  
  
  We found a variety of inter-center structure, process, and culture differences. These intrinsic differences between sites may begin to explain why interventional studies have failed to prove efficacy of experimental therapies. Understanding these differences may be an important factor in analyzing future ADAPT trial results and in determining best practices for pediatric severe TBI.
authors.affiliation: Departments of Pediatrics, University of Utah, Salt Lake City, UT, USA.
authors.forename: Gitte Y
authors.initials: GY
authors.lastname: Larsen
authors.affiliation: Departments of Pediatrics, University of Utah, Salt Lake City, UT, USA.
authors.forename: Michelle
authors.initials: M
authors.lastname: Schober
authors.affiliation: Departments of Epidemiology, University of Pittsburgh, Pittsburgh, PA, USA.
authors.forename: Anthony
authors.initials: A
authors.lastname: Fabio
authors.affiliation: Departments of Epidemiology, University of Pittsburgh, Pittsburgh, PA, USA.
authors.forename: Stephen R
authors.initials: SR
authors.lastname: Wisniewski
authors.affiliation: Departments of Nursing, University of Utah, Salt Lake City, UT, USA.
authors.forename: Mary Jo C
authors.initials: MJ
authors.lastname: Grant
authors.affiliation: Department of Pediatrics, University of Tennessee, Memphis, TN, USA.
authors.forename: Nadeem
authors.initials: N
authors.lastname: Shafi
authors.affiliation: Department of Pediatrics, University of Colorado, Aurora, CO, USA.
authors.forename: Tellen D
authors.initials: TD
authors.lastname: Bennett
authors.affiliation: Division of Extramural Research, National Institute of Neurological Disorders and Stroke, Bethesda, MD, USA.
authors.forename: Deborah
authors.initials: D
authors.lastname: Hirtz
authors.affiliation: Department Critical Care Medicine, Neurological Surgery and Pediatrics, University of Pittsburgh, 3434 Fifth Avenue, Pittsburgh, PA, 15260, USA. bellmj4@upmc.edu.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Bell
mesh_terms: D000070642:Brain Injuries, Traumatic / Q000628:therapy*; D002648:Child; D015331:Cohort Studies; D057186:Comparative Effectiveness Research / Q000706:statistics & numerical data*; D006801:Humans; D015278:Intensive Care Units, Pediatric / Q000706:statistics & numerical data*; D008505:Medical Staff, Hospital / Q000706:statistics & numerical data*; D015279:Organizational Culture; D061214:Patient Safety / Q000706:statistics & numerical data*; D011787:Quality of Health Care / Q000706:statistics & numerical data*; D014193:Trauma Centers / Q000706:statistics & numerical data*
keywords: Comparative effectiveness research; Pediatric neurocritical care; Pediatric traumatic brain injury; Quality of care; Secondary injuries