Development of a daily diary for patients with chronic idiopathic urticaria.

BACKGROUND: Chronic idiopathic urticaria (CIU) is a disease characterized by itching and skin hives or wheals of unknown cause that vary in size and last for at least 6 weeks. The criterion standard for measuring disease activity is the urticaria activity score (UAS). However, content validity of the UAS has not been previously reported.
OBJECTIVES: To identify outcomes important to patients with CIU, create an urticaria patient daily diary based on the UAS and input from patients, and assess its content validity.
METHODS: A qualitative research study was conducted in 2 stages using one-on-one telephone interviews of patients with CIU. In stage 1, patients were asked to discuss the impact of CIU on aspects of their life and to evaluate the content of the UAS. On the basis of this information, a patient daily diary, including UAS items, was developed. In stage 2, patients were interviewed to determine whether the urticaria patient daily diary was comprehensive and easily understood.
RESULTS: Stage 1 interviews showed that CIU has an extensive impact on patients, from the primary symptoms of itching, hives, and angioedema to the broader aspects of sleep and health-related quality of life. Stage 2 interviews demonstrated the content validity of the urticaria patient daily diary and resulted in minor modifications to the diary. When the urticaria patient daily diary was administered in conjunction with the Dermatology Life Quality Index and Medical Outcomes Study Sleep Scale, patients considered the assessment to be comprehensive, although some recommendations were made to include more items on emotional issues and other aspects of angioedema.
CONCLUSIONS: The final urticaria patient daily diary is an easy-to-administer, comprehensive assessment of symptoms for CIU patients. Future research is needed to establish its additional psychometric properties. Copyright 2010. Published by Elsevier Inc.