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. 2023 Jun 16;6(6):e1338.
doi: 10.1002/hsr2.1338. eCollection 2023 Jun.

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

Dhwani Hariharan  1 , V S Senthil Kumar  1 , Elizabeth L Glaser  1 , William H Crown  1 , Zachary A Wolf  2 , Kimberley A Fisher  3 , Charles T Wood  3 , William F Malcolm  3 , Christopher B Nelson  4 , Donald S Shepard  1
Affiliations

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

Dhwani Hariharan et al. Health Sci Rep. .

Abstract

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.

Keywords: RSV; caregiver; lower respiratory tract infection; quality of life; quality‐adjusted life year (QALY); respiratory syncytial virus.

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Conflict of interest statement

Christopher B. Nelson is an employee of Sanofi and may hold shares and/or stock options in the company. All other authors received grant funding from Sanofi and AstraZeneca (through Sanofi). Kimberley A. Fisher, Charles T. Wood, William F. Malcolm received grant funding for this study from Sanofi and AstraZeneca through Clinetic. Donald S. Shepard has received financial support from Abbott, Inc, Takeda Vaccines, Inc. and Trustees of Columbia University, New York, in the past 36 months. Dhwani Hariharan, William H. Crown and V.S. Senthil Kumar have received financial support from Bill & Melinda Gates Foundation and The Global Fund to Fight AIDS, Tuberculosis and Malaria, in the past 36 months.

Figures

Figure 1
Figure 1
Observed interview timeline and quality of life questionnaire components. Note: QoL denotes quality of life; LRTI denotes lower respiratory tract infection; Q1 denotes first quartile (25th percentile); Q3 denotes third quartile (75th percentile); first visit denotes infant's earliest clinical encounter in the DUHS during the study period with LRTI diagnosis; T0 denotes enrollment interview following first visit; T7 denotes first post‐enrollment follow‐up interview; T14 denotes second postenrollment follow‐up interview.
Figure 2
Figure 2
All infants (N = 36): mean infant and caregiver QoL on a 0–100 scale by status of RSV testing (A, C) and observed RSV positivity (B, D) of infants treated in all settings. Note: (for Figures 2 and 3): QoL denotes quality of life; RSV denotes respiratory syncytial virus; scale: 0 = worst imaginable health, 100 = best imaginable health; error bars represent standard deviations. All panels refer to infants treated in all settings. (A) Presents mean infant QoL at 4 time points among infants tested for RSV versus infants not tested for RSV at enrollment. (B) Presents mean infant QoL at 4 points among tested infants comparing RSV‐negative and RSV‐positive infants. (C) Presents mean QoL among caregivers of enrolled infants at 4 time points comparing caregiver QoL of RSV‐tested vs RSV‐not tested infants. (D) Presents mean QoL among caregivers of infants tested for RSV comparing caregiver QoL of RSV‐negative and RSV‐positive infants. QoL, quality of life; RSV, respiratory syncytial virus.
Figure 3
Figure 3
Outpatient infants (N = 23): mean infant and caregiver QoL on a 0–100 scale by status of RSV testing (A, C) and observed RSV positivity (B, D) of infants treated only in the outpatient setting. Note: see Figure 2 notes. All panels refer to infants treated only in the outpatient setting. (A) presents mean infant QoL at 4 time points among infants tested for RSV versus infants not tested for RSV at enrollment. (B) presents mean infant QoL at 4 points among tested infants comparing RSV‐negative and RSV‐positive infants. (C) presents mean QoL among caregivers of enrolled infants at 4 time points comparing caregiver QoL of RSV‐tested versus RSV‐not tested infants. (D) presents mean QoL among caregivers of infants tested for RSV comparing caregiver QoL of RSV‐negative and RSV‐positive infants. QoL, quality of life; RSV, respiratory syncytial virus.
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