Quality of life burden on United States infants and caregivers due to lower respiratory tract infection and adjusting for selective testing: Pilot prospective observational study.

Background and Aims: Policymakers need data about the burden of respiratory syncytial virus (RSV) lower respiratory tract infections (LRTI) among infants. This study estimates quality of life (QoL) for otherwise healthy term US infants with RSV‐LRTI and their caregivers, previously limited to premature and hospitalized infants, and corrects for selective testing. Methods: The study enrolled infants <1 year with a clinically diagnosed LRTI encounter between January and May 2021. Using an established 0–100 scale, the 36 infants' and caregivers' QoL at enrollment and quality‐adjusted life year losses per 1000 LRTI episodes (quality‐adjusted life years [QALYs]/1000) were validated and analyzed. Regression analyses examined predictors of RSV‐testing and RSV‐positivity, creating modeled positives. Results: Mean QoL at enrollment in outpatient (n = 11) LRTI‐tested infants (66.4) was lower than that in not‐tested LRTI infants (79.6, p = 0.096). For outpatient LRTI infants (n = 23), median QALYs/1000 losses were 9.8 and 0.25 for their caregivers. RSV‐positive outpatient LRTI infants (n = 6) had significantly milder QALYs/1000 losses (7.0) than other LRTI‐tested infants (n = 5)(21.8, p = 0.030). Visits earlier in the year were more likely to be RSV‐positive than later visits (p = 0.023). Modeled RSV‐positivity (51.9%) was lower than the observed rate (55.0%). Infants' and caregivers' QALYs/1000 loss were positively correlated (rho = 0.34, p = 0.046), indicating that infants perceived as sicker imposed greater burdens on caregivers. Conclusions: The overall median QALYs/1000 losses for LRTI (9.0) and RSV‐LRTI (5.6) in US infants are substantial, with additional losses for their caregivers (0.25 and 0.20, respectively). These losses extend equally to outpatient episodes. This study is the first reporting QALY losses for infants with LRTI born at term or presenting in nonhospitalized settings, and their caregivers. PLAIN ENGLISH SUMMARY: New approaches for preventing respiratory syncytial virus in young children are showing progress. To evaluate their value, policymakers need information about the loss of quality of life from this infection. Currently, the only data relate to cases in premature, hospitalized infants with laboratory‐confirmed infection, but they represent only a tiny minority of the cases. In 2021, during the COVID‐19 pandemic, we enrolled 36 infants treated for lower respiratory tract infection in the Duke University Health System (DUHS). We assessed their quality of life from before the onset of this illness until 2 weeks after enrollment. Some, but not all, were tested for the virus in the course of their care. We developed a statistical model of predicted likelihood of infection to address the variability in laboratory testing. We found that infants who were tested for the virus had lower quality of life compared to those not tested. This fact suggested that doctors prioritized the sicker infants for viral testing. We found that for every 1000 outpatient cases of the virus, infants lost 9.8 quality‐adjusted life years. Due to stress and other factors, their parents or caregivers lost an additional 0.25 such years. The burden of this virus in infants is substantial. To our knowledge, this study is the first to quantify the burden of this disease among infants not hospitalized. [ABSTRACT FROM AUTHOR]