Validation and comparison of quality‐of‐life measures for topical 5‐fluorouracil treatment: results from a randomized controlled trial

Summary Background Topical 5‐fluorouracil (5‐FU) is commonly used for high‐risk patients with keratinocyte carcinoma (KC). Skindex and Skin Cancer Index (SCI) are validated instruments to measure quality of life (QoL) of patients with KC and those who have had surgical treatment of KCs. Aim To validate Skindex and SCI for topical 5‐fluorouracil (5‐FU) application and to compare the two QoL instruments. Methods We randomized 932 veterans at high risk for developing a KC to either topical 5‐FU or vehicle control cream applied to the face and ears for up to 1 month. We collected their Skindex‐29 and SCI scores at baseline and follow‐up visits. Results Compared with controls, 5‐FU reduced QoL, measured by the Skindex symptom, Skindex function and SCI social subscales (P