Background: Previous studies on coeliac disease (CD)-related quality of life (QOL) have been limited by their use of a 'generic' rather than coeliac disease-specific assessment instruments.
Aim: To develop and psychometrically validate a new coeliac disease-specific instrument, the CD-QOL.
Methods: Through a series of focus groups, we elicited items from patients that related to the specific nature of their disease and its impact on their basic needs. Through expert review, cognitive debriefing with patients and pilot testing, a scale was developed, refined and administered to 387 patients on a gluten-free diet from both community-based support groups and a tertiary care referral centre. Finally, a formal validation study was conducted to assess the psychometric properties of the CD-QOL.
Results: The final CD-QOL has 20 items across four clinically relevant subscales (Limitations, Dysphoria, Health Concerns, and Inadequate Treatment). The CD-QOL has high internal consistency, reliability, and psychometric validation indicates both convergent and discriminate validity.
Conclusions: The CD-QOL is a reliable and valid measure of coeliac disease related QOL. As a new disease-specific instrument, it is likely to be a useful tool for evaluating patients with this disorder.