title: An Assessment of Publication Status of Pediatric Liver Transplantation Studies.
abstract: BACKGROUND
  Pediatric liver transplantation is a highly specialized, challenging field. Selective reporting may introduce bias into evidence based clinical decision making, but the precise extent of unpublished data in pediatric liver transplantation is unknown today. We therefore assessed the public availability of completed clinical trials in pediatric liver transplantation.
  
  
  METHODS
  We determined the proportion of published and unpublished pre-registered, completed pediatric liver transplantation studies on ClinicalTrials.gov. The major trial and literature databases, i.e., clinicaltrials.gov, Pubmed, and Google Scholar were searched for publications. In addition, principal investigators or sponsors were contacted directly. STROBE criteria were applied for the descriptive analysis.
  
  
  RESULTS
  Out of N = 33 studies focusing on pediatric liver transplantation registered as completed until March 2014 on clinicaltrials.gov, N = 19 (58%) studies were published until February 2015, whereas N = 14 (42%) studies remained unpublished. The unpublished trials contain data from N = 2105 (35%) patients out of a total population of N = 6044 study participants. Median time-to-publication, i.e., the period from completion of the trial until public availability of the data was 23 IQR 10 to 28 months. Most pertinent key questions in pediatric liver transplantation, i.e., surgical procedures, immunosuppression, concomitant infections, and graft rejection were addressed in 48% of studies (N = 16/33), half of which were published.
  
  
  CONCLUSIONS
  Half of the clinical trials in pediatric liver transplantation focused on key questions such as surgical procedures, immunosuppression, concomitant infections, and graft rejection. There is still a considerable amount of unpublished studies results in pediatric liver transplantation. Time from study completion to publication was almost twice as long as the 12 months mandatory FDAAA-timeline with a trend towards acceleration over time. The data should serve as a baseline for future progress in the field. More stringent publication of completed trials and focused multicenter research should be encouraged.
authors.affiliation: Pediatric Gastroenterology and Hepatology, Center for Pediatric and Adolescent Medicine, Heidelberg University Hospital, Heidelberg, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Breil
authors.affiliation: Pediatric Gastroenterology and Hepatology, Center for Pediatric and Adolescent Medicine, Heidelberg University Hospital, Heidelberg, Germany.
authors.forename: Daniel
authors.initials: D
authors.lastname: Wenning
authors.affiliation: Pediatric Gastroenterology and Hepatology, Center for Pediatric and Adolescent Medicine, Heidelberg University Hospital, Heidelberg, Germany.
authors.forename: Ulrike
authors.initials: U
authors.lastname: Teufel
authors.affiliation: Pediatric Gastroenterology and Hepatology, Center for Pediatric and Adolescent Medicine, Heidelberg University Hospital, Heidelberg, Germany.|Pediatric Neurology and Metabolic Medicine, Center for Pediatric and Adolescent Medicine, Heidelberg University Hospital, Heidelberg, Germany.
authors.forename: Georg F
authors.initials: GF
authors.lastname: Hoffmann
authors.affiliation: Pediatric Neurology and Metabolic Medicine, Center for Pediatric and Adolescent Medicine, Heidelberg University Hospital, Heidelberg, Germany.
authors.forename: Markus
authors.identifier: http://orcid.org/0000-0002-5054-5741
authors.initials: M
authors.lastname: Ries
mesh_terms: D022126:Access to Information; D002648:Child; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D016031:Liver Transplantation / Q000706:statistics & numerical data*; D008297:Male; D011643:Publishing / Q000706:statistics & numerical data*