Percentage of Inadequate Phlebograms and Observer Agreement in Thromboprophylactic Multicenter Trials Using Standardized Methodology and Central Assessment

P Kälebo; S Ekman; S Lindbratt; B I Eriksson; U Pauli; B E Zachrisson; P Close

doi:10.1055/s-0038-1650682

Thrombosis and Haemostasis, Inhaltsverzeichnis

Thromb Haemost 1996; 76(06): 0893-0896
DOI: 10.1055/s-0038-1650682

Original Article

Schattauer GmbH Stuttgart

Percentage of Inadequate Phlebograms and Observer Agreement in Thromboprophylactic Multicenter Trials Using Standardized Methodology and Central Assessment

P Kälebo

¹The Department of Radiology, University of Göteborg, Sweden

,

S Ekman

²Ciba-Geigy Ltd, Basel, Switzerland

,

S Lindbratt

³The Department of Ciba-Geigy AB, V. Frölunda, Sweden

,

B I Eriksson

⁴The Department of Orthopaedic Surgery, University of Göteborg, Sweden

,

U Pauli

³The Department of Ciba-Geigy AB, V. Frölunda, Sweden

,

B E Zachrisson

¹The Department of Radiology, University of Göteborg, Sweden

,

P Close

²Ciba-Geigy Ltd, Basel, Switzerland

› Institutsangaben

Abstract

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Summary

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 (1:74.8%, Kappa-value 0.41; II: 82.6%, Kappa-value 0.51). Good intraobserver 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.

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Referenzen

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