Development of a new health-related quality of life instrument for patients on home enteral nutrition according to caregivers' perceptions: The Home Enteral Nutrition Quality of Life (HENQoL) care instrument

BACKGROUND: Instruments for assessing the Health-Related Quality of Life (HRQoL) of patients receiving Home Enteral Nutrition (HEN) that can be complete by caregivers are scarce in the literature. OBJECTIVE: This study aimed to develop a specific instrument for assessing the HRQoL of HEN users, to be completed by caregivers. METHODS: This was a methodological study that utilized both qualitative and quantitative methods. Following the definition of the instrument, its content validity was assessed using the Delphi method, with a content validity index ≥ 0.78. Semantic analysis was conducted with a subsample of formal and informal caregivers. The study employed the item response theory and classical test theory. Item fit, differential item functioning (DIF), ordering of polytomous categories, and information power function associated with internal consistency reliability were calculated. RESULTS: For the pilot study, 66 interviews were conducted with formal and informal caregivers. Three items with zero variance and one item with DIF were excluded. Good overall internal consistency was achieved (Cronbach's alpha=0.84). Two items had an Outfit index >1.5. The information function of each item and the corrected item-total correlation ranged from 0.99-3.99 and -0.04-0.60, respectively, indicating low adequacy of some items. Despite this, these items did not affect the internal consistency, so they were retained. The final version consisted of 51 items across 10 domains. CONCLUSION: The development of the Home Enteral Nutrition Quality of Life (HENQoL) care instrument was completed, and its content was considered valid, reliable, and suitable for future validation studies.