• disease specific questionnaire;
  • quality of life;
  • urticaria;
  • validation

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-Q2oL)

Methods:  In the development phase of CU-Q2oL 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-Q2oL 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-Q2oL showed a good reliability, ranged between 0.64 and 0.92. Responsiveness to clinical changes was accomplished.

Discussion:  These results provide evidence that CU-Q2oL 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-Q2oL was easily and quickly filled up and well accepted by the patients.