J Ruft1, A Asady1, P Staubach2, T Casale3, G Sussmann4, T Zuberbier1, M Maurer1, K Weller1, S Altrichter1. 1. Department of Dermatology and Allergy, Urticaria Center of Reference and Excellence (UCARE), Charité-Universitätsmedizin Berlin, Berlin, Germany. 2. Department of Dermatology, Urticaria Center of Reference and Excellence (UCARE), University Medical Center Mainz, Mainz, RP, Germany. 3. Division of Allergy and Immunology, University of South Florida, Tampa, FL, USA. 4. Division of Clinical Immunology and Allergy, Urticaria Center of Reference and Excellence (UCARE), University of Toronto, Toronto, ON, Canada.
Abstract
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.
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. CholUpatients 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 CholUpatients, 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 CholUpatients. 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.
Authors: Pavel Kolkhir; Ana M Giménez-Arnau; Kanokvalai Kulthanan; Jonny Peter; Martin Metz; Marcus Maurer Journal: Nat Rev Dis Primers Date: 2022-09-15 Impact factor: 65.038
Authors: Marcus Maurer; Kilian Eyerich; Stefanie Eyerich; Marta Ferrer; Jan Gutermuth; Karin Hartmann; Thilo Jakob; Alexander Kapp; Pavel Kolkhir; Désirée Larenas-Linnemann; Hae-Sim Park; Gunnar Pejler; Mario Sánchez-Borges; Knut Schäkel; Dagmar Simon; Hans-Uwe Simon; Karsten Weller; Torsten Zuberbier; Martin Metz Journal: Int Arch Allergy Immunol Date: 2020-03-30 Impact factor: 2.749