RESUMEN
OBJECTIVE: To design and validate an age and condition-specific health status instrument to best reflect the parental experience caring for these children with complex needs and home Nasogastric Tube (NGT) placement. STUDY DESIGN: Combined Qualitative and Quantitative design, testing and implementation for item production and reduction, followed by formal validation by evaluating validity, reliability, and establishing a clinically meaningful change score. SETTINGS: Tertiary care, multi-disciplinary aerodigestive center. PARTICIPANTS: All caregivers whose infant met criteria for eligibility for discharge home from the NICU or Special Care Nursery (SCN) with NGT in place were offered inclusion in this group. Intervention/Exposure: Structured qualitative interviews of these caregivers to explore and define these concepts and domains, to item generate and then reduce, and then psychometric analyses. METHODS: Structured, moderated qualitative interviews with parents/caregivers of children who have undergone home NGT care of their children for item creation, design, and then reduction. Reliability was assessed by Cronbach alpha analysis. Construct validity and clinically meaningful change score was assessed using various query methods. MAIN OUTCOME MEASURES: Cronbach's alpha to assess reliability, a priori hypotheses validity analyses, and minimally important clinical difference calculation. RESULTS: Scaled scores of this condition specific instrument ranged from 14 to 74 where higher scores indicate better QOL related to managing the NGT. Cronbach's alpha with all 14 items was 0.93. Validity was assessed by a self-assessment question to discriminate between change (95% CI: 8.5-14.1; p < 0.0001) as well as by other comparators to identify the instrument's ability to discriminate among populations where parents felt a difference in experience. The minimally important difference was calculated at 18 points. CONCLUSION: This represents the initial validation of the first condition and age-specific health status instrument to assess parent experience of caring for infants requiring a home NGT for dysphagia.