AIMS: RSV-related lower respiratory tract infection is a major cause of hospital admissions and death in young children worldwide. To meet the need for a comprehensive assessment of respiratory and behavioral signs for infants or young children with RSV, two clinical outcome assessment measures, the PRESORS ObsRO and ClinRO, have been developed according to guidelines set forth by the Food and Drug Administration. The objective was to assess the psychometric properties of a classification system for symptom resolution (Resolved or Not Resolved scores) for the two PRESORS measures.
METHODS: The analyses were conducted on the Resolved/Not Resolved scores of each PRESORS measure for individual symptoms and summaries of Key RSV Symptoms, Respiratory Symptoms, General Illness Behaviors, and Overall RSV Symptoms, using baseline to Day 14 blinded data of 106 hospitalized children aged C 28 days to 36 months from a phase 2 clinical trial for rilematovir, an RSV fusion inhibitor. Descriptive statistics were examined for distribution abnormality. Test–retest reliability was analyzed in stable patients defined by several criteria. Correlations and cross-tabulation for construct validity and for the ability to detect change were computed with supporting measures (e.g., global ratings, supplemental oxygen/feeding/hydration, and discharge readiness).
RESULTS: Ceiling effects (best outcomes) were minimal at baseline for all PRESORS ObsRO and ClinRO summaries (B 12.3% resolved). Summaries generally demonstrated moderate to substantial test–retest reliability (79–95.2% absolute agreement; simple kappa, 0.38–0.68) in patients with no change in global RSV severity or health status. Expected frequency patterns and moderate to strong correlations (|r|= 0.39–1.00) were observed between all PRESORS summaries and the global ratings and discharge readiness at Day 5. A higher proportion of unresolved cases was observed among inpatients and particularly in patients with supplemental oxygen across time points, supporting discriminating ability. Compared with changes in global RSV severity or health status from baseline to Day 8/end of treatment, responsiveness correlations were mostly moderate to strong (|r|= 0.39–0.63) with anticipated change patterns for all PRESORS summaries.
CONCLUSION: The results support the PRESORS ObsRO and ClinRO as appropriate measures to monitor RSV signs/symptoms resolution for hospitalized pediatric patients in clinical research.
