Heterogeneity of wound outcome measures in RCTs of treatments for VLUs: a systematic review

Abstract

Objective: Venous leg ulcers (VLUs) affect up to 4% of the population aged over 65 years. Outcomes of randomised controlled trials (RCTs) in VLUs are important to guide clinical and resource decision making. Our objective was to identify what endpoints and wound bed outcomes were assessed in RCTs in VLUs; how these were assessed and what reference was made to validity and reliability of methods used.

Method: A systematic review of all full text RCTs, published in English, from 1998-2013.

Results: Our criteria were met by 102 studies. There were 78 different endpoints recorded, the majority (n=34) related to healing and were evaluated at 12 different times points. Size was the most frequently reported outcome measure (n=99), with photographs, tissue type, exudate, odour and pain also recorded. There was poor reporting of methods used to assess outcomes. Visual analogue scales predominated as a method of assessment, but 95% of studies made no reference to the validity or reliability of assessment methods.

Conclusion: Future research in VLUs requires standards for measuring outcomes with acceptable inter-rater reliability and validated measures of patient-reported outcomes.

Keywords: leg ulcer; randomised controlled trial (RCT); varicose ulcer; venous stasis ulcer; venous ulcer.