title: Significant differences between local reporting and central assessment of radiological complications in a prospective, multicenter study about locking plate fixation of proximal humerus fractures.
abstract: OBJECTIVE
  To compare radiological complication reporting outcomes undertaken by an independent review board and the responsible on-site study personnel in a multicenter study about locking plate fixation of proximal humeral fractures.
  
  
  METHODS
  prospective, multicenter study SETTING:: Level I trauma centers PATIENTS:: One-hundred and fifty patients with a radiological confirmed, closed, displaced proximal humeral fracture fixed with a locking plate and aged between fifty and ninety years.
  
  
  METHODS
  Re-evaluation of all radiological data according to pre-defined criteria after finished collection of all study radiographs by an independent review board.
  
  
  METHODS
  Differences in outcomes between the review board and the sites assessment were tested with a paired t-test. Inter-rater agreements between the central review board and sites assessments were estimated by means of kappa statistics.
  
  
  RESULTS
  The review board revealed significant more radiological complications than the sites assessment (p = 0.006), except for the complication 'head necrosis'. The inter-rater agreement was slight to moderate in all calculated categories.
  
  
  CONCLUSIONS
  To prevent underreporting of radiological complications by on-site assessment, the implementation of a complication review board, using pre-defined criteria, is recommended for clinical studies that focus on radiological complications.
authors.affiliation: 1Department of Trauma Surgery and Sports Medicine, Medical University of Innsbruck, Austria 2Clinical Investigation and Documentation, AO Foundation, Dübendorf, Switzerland 3Institute for Biomechanics at ETH Zurich, Switzerland.
authors.forename: Susanne
authors.initials: S
authors.lastname: Kathrein
authors.forename: Alexander
authors.initials: A
authors.lastname: Joeris
authors.forename: Franz
authors.initials: F
authors.lastname: Kralinger
authors.forename: Michael
authors.initials: M
authors.lastname: Blauth
authors.forename: Joerg
authors.initials: J
authors.lastname: Goldhahn