Key result
Phlebography interpretation of 94 films showed a 35% discrepancy rate between first and second evaluations, highlighting the need for quality control procedures in clinical trials.
Why the study?
What is the reliability of phlebography interpretation for assessing venous thrombosis in a clinical trial setting?
Population
94 phlebograms from a multicenter controlled study comparing low-molecular-weight heparin to standard…
Comparison
Second reading of phlebograms by the same two… vs First central evaluation by the two independent…
Design
Other, two independent radiologists
Follow-up
3 months between evaluations
Authors
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Variable phlebography readings threaten trial endpoint validity; mandates standardized adjudication protocols in venous thrombosis RCTs.
Observational (n=94)
Yes
What is the reliability of phlebography interpretation for assessing venous thrombosis in a clinical trial setting?
Phlebography interpretation for venous thrombosis has a high rate of discrepancies, highlighting the need for thorough quality control procedures in clinical trials.
Picolet et al. (2009) conducted an observational in Venous thrombosis (n=94). Phlebography interpretation was evaluated on Discrepancies between first and second evaluation. Phlebography interpretation of 94 films showed a 35% discrepancy rate between first and second evaluations, highlighting the need for quality control procedures in clinical trials.
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