Abstract
BackgroundThere are no clinical outcome assessment (COA) tools developed in accordance with Food and Drug Administration (FDA) guidance suitable for the evaluation of symptoms associated with respiratory syncytial virus (RSV) infection among infants. The Gilead RSV Caregiver Diary (GRCD) is being developed to fulfill this need; the present research evaluates the GRCD and documents its reliability, validity, and responsiveness among children < 24 months of age with acute RSV infection.MethodsA prospective, observational study was conducted in the United States during the 2014–2015 northern hemisphere winter season. Subjects were < 24-month, full-term, previously healthy infants with confirmed RSV infection and ≤5 days of symptoms. The GRCD was completed twice daily for 14 days by caregivers. Additional data were collected during the initial visit, subsequent visits, and end-of-study interview. Test-retest reliability (kappa and intraclass correlation coefficients [ICCs]), construct validity (correlations and factor analyses), discriminating ability (analyses of variance and chi-square), and responsiveness (effect sizes and standardized response means) were evaluated.ResultsA total of 103 subjects were enrolled (mean age 7.4 ± 5.3 months). GRCD items were grouped into different subscales according to question content, which, with the exception of the behavior impact domain (ICC = 0.43), demonstrated internal consistency (alphas = 0.78–0.94) and test-retest reliability (ICCs = 0.77–0.94). Hypothesized correlations with parent global ratings of RSV severity ranged from 0.45 to 0.70 and provided support for construct validity. Support for discriminating ability was limited. Effect sizes ranged from − 1.48 to − 4.40, indicating the GRCD was responsive to change.ConclusionsThese psychometric analyses support the validity, reliability, and responsiveness of the GRCD for assessing RSV symptoms in children < 24 months of age.
Highlights
There are no clinical outcome assessment (COA) tools developed in accordance with Food and Drug Administration (FDA) guidance suitable for the evaluation of symptoms associated with respiratory syncytial virus (RSV) infection among infants
While there are tools used to monitor symptoms in RSVinfected pediatric patients, none were developed in accordance with United States (US) Food and Drug Administration (FDA) guidance and are not acceptable for new product labeling
Principal components analysis and exploratory factor analysis (EFA) were conducted in an effort to understand the structure of the Gilead RSV Caregiver Diary (GRCD) and determine an optimal scoring algorithm
Summary
There are no clinical outcome assessment (COA) tools developed in accordance with Food and Drug Administration (FDA) guidance suitable for the evaluation of symptoms associated with respiratory syncytial virus (RSV) infection among infants. The Bronchiolitis Caregiver Diary (BCD) [4] and Canadian Acute Respiratory Illness and Flu Scale (CARIFS) [5] reported qualitative research during the instrument development phase, these two measures targeted populations other than infants and young children < 24 months of age with acute RSV disease. Content validity and psychometric evidence are not available for any of these measures for assessment of RSV symptom severity in children with acute RSV infection and are not considered appropriate for use in clinical trials with the goal of supporting labeling claims for a new therapeutic agent
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