Development and Validation of the Cholinergic Urticaria Quality of Life Questionnaire: CholU-QoL

Abstract

Background

Cholinergic urticaria (CholU), a common form of chronic inducible urticaria, is characterized by itchy wheals that occur in response to physical exercise or passive warming. CholU patients frequently exhibit a high burden of disease. As of yet, no specific instrument is available to assess their disease-related quality of life (QoL) impairment.

Objective

The aim of this study was to develop and validate the first disease specific QoL instrument for CholU patients, the Cholinergic Urticaria Quality of Life Questionnaire (CholU-QoL).

Methods

Using a combined approach of literature search, semi-structured patient interviews and expert opinion we developed 96 potential CholU-QoL items. Subsequent item selection was performed by means of impact analysis complemented by an expert review for face validity. The resulting final CholU-QoL was then tested for levels of validity, reliability and influence factors in 88 CholU patients. In parallel, an US American-Canadian English version of the CholU-QoL was developed.

Results

The final 28-item CholU-QoL was found to have a 5-domain structure ('symptoms', 'functional life', 'social interaction', 'therapy', 'emotions') with excellent internal consistency. The CholU-QoL also showed a valid total score, and good levels of convergent validity, known-groups validity, as well as test-retest reliability. Multiple regression analysis found no significant drivers of the CholU-QoL total score.

Conclusions & Clinical Relevance

The CholU-QoL is the first disease specific QoL instrument for CholU and also the first specific QoL measure in the field of chronic inducible urticarias. It may serve as a valuable tool for clinical trials and improve routine patient management.

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