Development and validation of the Cholinergic Urticaria Quality-of-Life Questionnaire (CholU-QoL)

Area of Science:

• Dermatology
• Quality of Life Research
• Clinical Psychology

Background:

• Cholinergic urticaria (CholU) is a common inducible urticaria causing significant disease burden.
• Existing assessment tools do not adequately capture the disease-specific quality-of-life (QoL) impairment in CholU patients.

Purpose of the Study:

• To develop and validate the first disease-specific QoL instrument for CholU patients, the Cholinergic Urticaria Quality-of-Life Questionnaire (CholU-QoL).

Main Methods:

• A 96-item questionnaire was developed using literature, patient interviews, and expert opinion.
• Item selection involved impact analysis and expert review for face validity.
• The final 28-item CholU-QoL was validated in 88 CholU patients for reliability and validity.

Main Results:

• The CholU-QoL demonstrated a 5-domain structure (symptoms, functional life, social interaction, therapy, emotions) with excellent internal consistency.
• The questionnaire showed valid total scores, good convergent and known-groups validity, and reliable test-retest results.
• No significant drivers of the total CholU-QoL score were identified through regression analysis.

Conclusions:

• The CholU-QoL is the first disease-specific QoL instrument for CholU and chronic inducible urticarias.
• This validated tool can enhance clinical trials and improve routine management of CholU patients.
• The CholU-QoL provides a crucial measure for assessing the comprehensive impact of CholU on patient well-being.