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Significant differences between local reporting and central assessment of radiological complications in a
Susanne Kathrein1, Alexander Joeris, Franz Kralinger
11Department 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.
Objectives:
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.
Design:
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.
Intervention:
Re-evaluation of all radiological data according to pre-defined criteria after finished collection of all study radiographs by an independent review board.
Main Outcome Measurements:
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.
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