title: Percentage of inadequate phlebograms and observer agreement in thromboprophylactic multicenter trials using standardized methodology and central assessment.
abstract: This study examines inadequacy rates for phlebography in two multicenter trials for the prevention of post-operative DVT and determines inter-and intra-observer variability in evaluating phlebograms. A total of 991 (I) and 385 (II) patients underwent bilateral phlebography in two studies of thromboprophylaxis. Phlebography was performed using a standard method designed to visualize and assess all deep veins. Each vein was scored as normal, DVT or inadequate by both local and central assessment. The study showed low inadequacy rates for phlebograms of 12.2% (121/991) and 6.5% (25/385). Inter-observer agreement (local vs. central assessment) was moderate in both studies (I: 74.8%, Kappa-value 0.41; II: 82.6%, Kappa-value 0.51). Good intra-observer agreement (within the central assessment group) was observed (I:88.8%, Kappa-value 0.75). This study demonstrates low inadequacy rates for phlebograms using a standardized methodology and superior intra-observer agreement compared to inter-observer agreement and supports the importance of central assessment of phlebograms in thromboprophylactic multicenter trials to reduce observer variability.
authors.affiliation: Department of Radiology, University of Göteborg, Sweden.
authors.forename: P
authors.initials: P
authors.lastname: Kälebo
authors.forename: S
authors.initials: S
authors.lastname: Ekman
authors.forename: S
authors.initials: S
authors.lastname: Lindbratt
authors.forename: B I
authors.initials: BI
authors.lastname: Eriksson
authors.forename: U
authors.initials: U
authors.lastname: Pauli
authors.forename: B E
authors.initials: BE
authors.lastname: Zachrisson
authors.forename: P
authors.initials: P
authors.lastname: Close
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D006801:Humans; D015337:Multicenter Studies as Topic / Q000592:standards; D015588:Observer Variation; D010690:Phlebography / Q000379:methods / Q000592:standards*; D011237:Predictive Value of Tests; D013927:Thrombosis / Q000517:prevention & control*