title: A prospective observational study of human factors, adverse events, and patient outcomes in surgery for pediatric cardiac disease.
abstract: OBJECTIVE
  To explore the impact of human factors on intraoperative adverse events and compensation mechanisms in pediatric cardiac surgery.
  
  
  METHODS
  Prospective observations of pediatric cardiac surgical procedures were conducted. Patient complexity scores were calculated and outcomes recorded. The process of care was divided into epochs. Events were extracted and coded into compensated or uncompensated major and minor adverse events. Linear regression and analysis of variance were used to analyze the relationships between epochs, complexity, adverse events, and outcome. Patient-specific and procedure-specific variables were tested in a forward stepwise logistic regression as predictors of cases with 1 or more major adverse events.
  
  
  RESULTS
  One hundred two patients undergoing pediatric cardiac surgery were observed. An average of 1.2 (range 0-6) major adverse events occurred per case. The most common type of major adverse event was cardiovascular, and most occurred during the surgery/postbypass epoch. Cognitive compensation was the most common compensation mechanism for major adverse events. An average of 15.3 minor adverse events occurred per case. Minor adverse events occurred frequently during the surgery/bypass epoch and related to communication and coordination failures. Higher case complexity, longer surgery duration, and higher number of major adverse events per patient correlated with death compared with other outcome groups (P < .01). Case complexity (P < .01) and surgery duration (P < .05) were both significant predictors of major adverse events.
  
  
  CONCLUSIONS
  Pediatric cardiac surgery is an ideal model to study the coordinated efforts of team members in a complex organizational structure. Adverse events occurred routinely during pediatric cardiac surgery and were mostly compensated. Case complexity was a significant predictor of major adverse events. The number of major adverse events per patient correlated with clinical outcomes.
authors.affiliation: Department of Anesthesia, Utrecht Medical Center, Utrecht, The Netherlands.
authors.forename: Paul
authors.initials: P
authors.lastname: Barach
authors.forename: Julie K
authors.initials: JK
authors.lastname: Johnson
authors.forename: Asima
authors.initials: A
authors.lastname: Ahmad
authors.forename: Cynthia
authors.initials: C
authors.lastname: Galvan
authors.forename: Agnes
authors.initials: A
authors.lastname: Bognar
authors.forename: Robert
authors.initials: R
authors.lastname: Duncan
authors.forename: Joanne P
authors.initials: JP
authors.lastname: Starr
authors.forename: Emile A
authors.initials: EA
authors.lastname: Bacha
mesh_terms: D000293:Adolescent; D006348:Cardiac Surgical Procedures / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D006330:Heart Defects, Congenital / Q000601:surgery*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007362:Intensive Care Units / Q000458:organization & administration; D007431:Intraoperative Complications / Q000209:etiology*; D009873:Operating Rooms / Q000458:organization & administration; D010348:Patient Care Team / Q000458:organization & administration; D011446:Prospective Studies; D018570:Risk Assessment; D016896:Treatment Outcome