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Significant Differences Between Local Reporting and Central Assessment of Radiographic Complications in a
Susanne Kathrein1, Alexander Joeris, Franz Kralinger
1*Department of Trauma Surgery and Sports Medicine, Medical University of Innsbruck, Innsbruck, Austria;†Clinical Investigation and Documentation, AO Foundation, Dübendorf, Switzerland; and‡Institute for Biomechanics at ETH Zurich, Zurich, Switzerland.
Objectives:
To compare reporting outcomes of radiographic complications conducted 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: 9 level I trauma centers.
Patients:
One hundred fifty patients (age 50-90) with a radiographically confirmed displaced proximal humeral fracture fixed with a locking plate were included in the study.
Intervention:
All radiographic data were reevaluated by an independent review board according to predefined criteria.
Main Outcome Measurements:
Differences in outcomes between the review board and the on-site assessment were analyzed with a paired t test. Interrater agreements between the central review board and on-site assessments were estimated by means of kappa statistics.
Results:
The review board revealed significantly more radiographic complications than the on-site assessment (P = 0.006), except for the complication "head necrosis." The interrater agreement was slight to moderate in all calculated categories.
Conclusions:
Implementation of a complication review board using predefined criteria is recommended for clinical studies to prevent underreporting of radiographic complications by on-site assessment.
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