Publications

Background: Cholinergic urticaria (CholU), a common form of chronic inducible urticaria, is characterized by itchy weals that occur in response to physical exercise or passive warming. CholU patients frequently exhibit a high burden of disease. As ofyet, 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-LifeQuestionnaire (CholU-QoL).

Methods: Using a combined approach of the literature search, semistructured patient interviews and expert opinion, we developed 96 potential CholU-QoL items. Subse-quent item selection was performed by means of impact analysis complemented by anexpert review for face validity. The resulting final CholU-QoL was then tested forlevels of validity, reliability and influence factors in 88 CholU patients. In parallel, anUS 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 excel-lent internal consistency. The CholU-QoL also showed a valid total score, and goodlevels 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 and Clinical Relevance: The CholU-QoL is the first disease-specificQoL 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 andimprove routine patient management.