Systematic Review of Patient-Reported Outcome Measures in Patients With Varicose Veins

Varicose veins can affect a patient's quality of life. Patient-reported outcome measures (PROMs) provide a direct report from the patient's perspective. The aim of this study was to examine the quality of the psychometric evidence for PROMs used in patients with varicose veins. A systematic review was undertaken to identify studies that reported the psychometric properties of generic and disease-specific PROMs in patients with varicose veins. A literature search was conducted in databases, including MEDLINE, up to July 2016. The psychometric criteria used to assess these studies were adapted from published recommendations in accordance with US Food and Drug Administration guidance. Of 3870 articles found, nine studies were included which reported on aspects of the development and/or validation of one generic (36-Item Short Form Health Survey, SF-36) and three disease-specific (Aberdeen Varicose Vein Questionnaire, AVVQ; Varicose Veins Symptoms Questionnaire, VVSymQ; Specific Quality-of-life and Outcome Response – Venous, SQOR-V) PROMs. The studies were generally small to moderate size (40-1700 patients) and included >50% women. Follow-up was short (immediately after treatment) to 12 months. Reliability is the ability to produce the same results when repeated in populations with similar characteristics as assessed by reproducibility (test-retest) and internal consistency (Cronbach's a score). Validity measures how well the PROM measures what it intends to measure (content validity, construct validity, criterion validity). Responsiveness is the ability to detect important change over time, if true change exists. Assessment of acceptability and floor or ceiling effect measures the completeness of the data. This review identified only one generic measure (SF-36) and three disease-specific instruments (AVVQ, VVSymQ, SQOPR-V) that have undergone psychometric assessment in patients with varicose veins. The evidence suggests that the SF-36 exhibits good internal consistency and acceptability among patients with varicose veins, with some evidence of construct validity and responsiveness. It is the only generic PROM with evidence to support its use in patients with varicose veins. The AVVQ had good test–retest reliability, construct and criterion validity, and responsiveness. However, the evidence for the content validity was weak, and clinicians and researchers generated the items with limited input from patients; the weighting of the items was based on the judgement of two clinicians. However, it was the most evaluated PROM with five studies examining its psychometric validity. The detailed methods of analysis are well explained in the manuscript text.