Significant Differences Between Local Reporting and Central Assessment of Radiographic Complications in a Prospective, Multicenter Study About Locking Plate Fixation of Proximal Humerus Fractures

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Abstract

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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