Systematic review assessing the measurement properties of patient-reported outcomes for venous leg ulcers

Background: A variety of instruments have been used to assess outcomes for patients with venous leg ulcers. This study sought to identify, evaluate and recommend the most appropriate patient reported outcomes (PROMs) for English-speaking patients with venous leg ulcers (VLUs). Method: This systematic review used a two-staged approach. Electronic searches of major databases including MEDLINE were completed in October 2015 and then updated in July 2016. Additional studies were identified from citation checking. Study selection, data extraction and quality assessment were undertaken independently by at least two reviewers. Evaluation and summary of measurement properties of identified PROMs were undertaken using standard and adapted study-relevant criteria. Results: Ten studies with data for three generic PROMS and six condition-specific measures were identified. No generic PROM showed adequate content and criterion validity; however the EQ-5D, Nottingham Health Profile (NHP) and 12-item Health Survey Short-Form had good acceptability with scores ranging from 80% to 91%. In general, the EQ-5D showed poor responsiveness in patients with VLUs. Condition-specific PROMs demonstrated poor criterion and construct validity. Overall, good internal consistency was demonstrated for the Venous Leg Ulcer Quality of Life (VLU-QOL) and the Sheffield Preference-based Venous Ulcer questionnaire (SPVU-5D). Test re-test reliability was also satisfactory for SPVU-5D and VeLUSET measures. Conclusions: The NHP and VLU-QOL seemed the most suitable PROMs for use by clinicians. A valid condition-specific PROM is still required.