Development of a head and neck lymphoedema specific quality of life tool: The Comprehensive Assessment of Lymphoedema Impact in the Head and Neck

Purpose To develop a head and neck lymphoedema (HNL) specific quality of life (QoL) instrument to assess physical, functional, and social/emotional impacts of HNL. Methods Instrument candidate items were reviewed by patients with HNL and clinicians and rated for importance, clarity, and invasiveness. The Content Validity Ratio was applied for item reduction. Three‐step cognitive interviews were conducted with HNL patients to validate the items, survey format, and instructions. Results Initially, 130 candidate questions were developed. Following item reduction, 52 items progressed to three‐step cognitive interviews. Following cognitive interviews, the Comprehensive Assessment of Lymphoedema Impact in Head and Neck (CALI‐HaN) included 33 items; 1 global, 10 physical, 7 functional, and 15 emotional. Conclusions Physical, functional, and socioemotional effects need to be considered when measuring QoL in patients with HNL. This study describes initial development of the CALI‐HaN, an instrument that shows promise for clinical and research applications following future validation.