BACKGROUND: Health-related quality of Life in patients with chronic urticaria is evaluated by mean of generic instruments or questionnaire designed for skin diseases. No disease-specific tool is now available for the assessment of chronic urticaria impact from patients' viewpoint. OBJECTIVE: The aim of our study is to develop and validate a new questionnaire specifically designed for the assessment of quality of life in chronic urticaria (Chronic Urticaria Quality of Life Questionnaire -- CU-Q(2)oL). METHODS: In the development phase of CU-Q(2)oL an initial list of items of 37 items was compiled and given to 80 patients with chronic urticaria; the 23 most significant items were selected and converted into questions evaluating the answers on a Likert scale of five steps. The validation procedure involved 125 patients (86 F and 39 M) (age 42.17 +/- 9.24 years). RESULTS: Following a statistical analysis, CU-Q(2)oL showed a six-dimensional structure and good levels of internal consistency for the extracted factors: Pruritus (0.79), Swelling (0.65), Impact on life activities (0.83), Sleep problems (0.77), Looks (0.83) and Limits (0.74). In stable conditions CU-Q(2)oL showed a good reliability, ranged between 0.64 and 0.92. Responsiveness to clinical changes was accomplished. DISCUSSION: These results provide evidence that CU-Q(2)oL has specificity enough for being a valid tool for detecting the relative burden of CU on subjective wellbeing, and for obtaining a global evaluation both of CU impact and of treatments, taking into account the patient's point of view. The CU-Q(2)oL was easily and quickly filled up and well accepted by the patients.
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Baiardini et al. (2005) studied this question.
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