Water displacement leg volumetry in clinical studies - A discussion of error sources
1 Department of Dermatology of the University of Bonn, Sigmund-Freud-Strasse 25, 53229 Bonn, Germany
2 Department of Dermatology of the University of Bochum, Gudrunstrasse 56, 44791 Bochum, Germany
3 Ottillinger Life Sciences, Foehrenstrasse 12, 85649 Hofolding, Germany
BMC Medical Research Methodology 2010, 10:5 doi:10.1186/1471-2288-10-5Published: 13 January 2010
Water displacement leg volumetry is a highly reproducible method, allowing the confirmation of efficacy of vasoactive substances. Nevertheless errors of its execution and the selection of unsuitable patients are likely to negatively affect the outcome of clinical studies in chronic venous insufficiency (CVI).
Placebo controlled double-blind drug studies in CVI were searched (Cochrane Review 2005, MedLine Search until December 2007) and assessed with regard to efficacy (volume reduction of the leg), patient characteristics, and potential methodological error sources. Almost every second study reported only small drug effects (≤ 30 mL volume reduction). As the most relevant error source the conduct of volumetry was identified. Because the practical use of available equipment varies, volume differences of more than 300 mL - which is a multifold of a potential treatment effect - have been reported between consecutive measurements. Other potential error sources were insufficient patient guidance or difficulties with the transition from the Widmer CVI classification to the CEAP (Clinical Etiological Anatomical Pathophysiological) grading.
Patients should be properly diagnosed with CVI and selected for stable oedema and further clinical symptoms relevant for the specific study. Centres require a thorough training on the use of the volumeter and on patient guidance. Volumetry should be performed under constant conditions. The reproducibility of short term repeat measurements has to be ensured.