Reliability of phlebography in the assessment of venous thrombosis in a clinical trial.
In the frame of a multicenter controlled study comparing the efficacy of low-molecular-weight heparin to standard heparin in the prevention of postsurgical thrombosis, 94 phlebograms were centrally evaluated by two independent radiologists. Three months after the first central evaluation, a new reading was performed with the same radiologists, and discrepancies were adjudicated by a senior radiologist. The number of discrepancies between the first and the second evaluation was high: 33 interpretations (35%) had a least one difference, including 14 (14.9%) discrepancies regarding the main issue, i.e. the presence of venous thrombosis. After the adjudication by the senior radiologist, this number decreased but was still large: 22 films (23.4%) with at least one discrepant item in all and 11 related to the presence of venous thrombosis. This report shows that venous thrombosis assessed by phlebography, which is usually considered as a golden standard in clinical trials, deserves a thorough quality control procedure.
Picolet
H
H
Clinical Pharmacology Unit, Claude Bernard University, Lyon, France.
Leizorovicz
A
A
Revel
D
D
Chirossel
P
P
Amiel
M
M
Boissel
J P
JP
D004311:Double-Blind Method; D005069:Evaluation Studies as Topic; D006493:Heparin / Q000627:therapeutic use*; D006495:Heparin, Low-Molecular-Weight / Q000627:therapeutic use*; D006801:Humans; D015588:Observer Variation; D010690:Phlebography / Q000187:drug effects; D015203:Reproducibility of Results; D013924:Thrombophlebitis / Q000000981:diagnostic imaging / Q000517:prevention & control*
D006495:Heparin, Low-Molecular-Weight; D006493:Heparin