A systematic review of wound bed outcomes in RCTs of treatment interventions in Venous Leg Ulceration

Background: venous leg ulcers (VLU) affect up to 2% of the population . The outcomes of RCTs in VLU are important to guide clinical and resource decision making. Purpose: to identify what endpoints and wound bed outcomes were... [ view full abstract ]

Background: venous leg ulcers (VLU) affect up to 2% of the population . The outcomes of RCTs in VLU are important to guide clinical and resource decision making.
Purpose: to identify what endpoints and wound bed outcomes were assessed in RCTs of interventions in VLU; how these were assessed and what reference was made to the validity and reliability of methods used.
Methods: Systematic Review.
Inclusion criteria: (i) primary research with full text available of RCTs of VLU treatment interventions (ii) published from January 1998 – March 2013, (iii) wound bed must have been evaluated (iv) English language only.
Data extraction: Each citation was reviewed independently by two researchers and filtered through three screening levels: (i) titles screening; (ii) title and abstract screening and (iii) full-text screening.
Results: 10,990 patients were represented in 102 studies meeting our criteria. 50% of trials enrolled < 83 patients. 78 different endpoints were recorded, the majority (n=34) of which related to healing and were evaluated at 12 different times points. 40% did not state the study outcome in the methods section. 62% did not provide a definition of healing and of those who did, seven different definitions were provided. Size was the most frequently reported outcome measure (n=99). Visual analogue scales predominated as a method of outcome assessment across all domains. 95% of studies made no reference to the validity or reliability of assessment methods.
Conclusions: A wide diversity of outcomes across different time points were identified. Lack of validated methods of assessment were apparent. In the field of VLU treatment the widespread use of invalidated outcome measures and lack of consensus derived definitions can weaken the value of research results. Identification of future research needs in VLU treatments calls for standards for measuring outcomes with acceptable IRR and validated measures of patient-reported outcomes.