Development and validation of a questionnaire measuring quality of life in primary caregivers of children with atopic dermatitis (QPCAD)

Abstract

Background: Disease-specific health-related quality of life (HRQoL) instruments for primary caregivers of children with atopic dermatitis are useful in evaluating the efficacy of treatment in clinical practice and study. However, no such scale has been available in Japan.

Objectives: To develop and validate a self-administered instrument specifically designed to measure quality of life in primary caregivers of children with atopic dermatitis (QPCAD).

Methods: This study consisted of three successive phases: the item generation phase, pilot test phase and validation phase. In the item generation phase, questionnaire items were derived from 33 qualitative interviews with primary caregivers. In the pilot test phase, the face and content validity of the preliminary scale were assessed (n = 33). In the validation phase, the questionnaire was finalized and assessed in terms of statistical performance (n = 416).

Results: The QPCAD included 19 items in the following categories: 'exhaustion', 'worry about atopic dermatitis', 'family cooperation' and 'achievement'. The reliability of internal consistency was fair (Cronbach's alpha coefficients 0.66-0.87). The QPCAD subscales and total score were significantly correlated with psychological health, physical health, anxiety, depression and severity score, with mild to moderate correlation coefficients. Test-retest reliability and responsiveness to change in severity were also satisfactory.

Conclusions: The QPCAD is an appropriate tool for assessing HRQoL of primary caregivers of children with atopic dermatitis in clinical practice and clinical trials.