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Development and validation of the Cholinergic Urticaria Quality‐of‐Life Questionnaire (CholU‐QoL)
Author(s) -
Ruft J.,
Asady A.,
Staubach P.,
Casale T.,
Sussmann G.,
Zuberbier T.,
Maurer M.,
Weller K.,
Altrichter S.
Publication year - 2018
Publication title -
clinical and experimental allergy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.462
H-Index - 154
eISSN - 1365-2222
pISSN - 0954-7894
DOI - 10.1111/cea.13102
Subject(s) - quality of life (healthcare) , medicine , face validity , reliability (semiconductor) , convergent validity , physical therapy , disease , psychometrics , internal consistency , clinical psychology , power (physics) , physics , nursing , quantum mechanics
Summary 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 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 the literature search, semistructured 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 and 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.