Abstract
Background Several immunisation candidates against RSV are in late-stage clinical trials. To evaluate the benefits of a potential vaccination programme, both economic and health benefits will be needed. Health benefits are usually measured in Health-related Quality of Life (HRQoL) loss using standardised questionnaires. However, there are no RSV-specific questionnaires validated for children under 2 years, in whom most RSV episodes occur. Therefore, HRQoL estimates are taken from literature or inadequate tools. We determined HRQoL loss and direct costs due to an RSV episode in children younger than 2 years and their caregivers during a month of follow up, using a new questionnaire administered online.Methods An observational prospective multicentre surveillance study was conducted in children aged younger than two years. Children were recruited from 8 primary care centres and 1 hospital in the Valencia region and Catalonia (Spain). RSV-positive cases were obtained by immunochromatographic test. HRQoL was assessed using a new ad-hoc 38 item-questionnaire developed. Parents of infected children completed 4 questionnaires at four timepoints (day 0, 7, 14 and 30) after diagnosis.Results 117 children were enrolled in the study and 86 (73.5%) were RSV + . Median (interquartile range; IQR) scores were 0.52 (0.42–0.68), 0.65 (0.49–0.79), 0.82 (0.68–0.97) and 0.94 (0.81–1), for days 0, 7, 14 and 30, respectively. Compared to total recovery (Q30), HRQoL loss was 37.5%, 31.5% and 8.9% on days 0, 7 and 14 since diagnosis of the disease. The total median cost per patient (including treatments) was €598.8 (IQR: 359.63–2425.85).Conclusions RSV had almost 40% impact on HRQoL during the first week since onset of symptoms and the median cost per episode and patient was about €600. These results represent a substantial input for health-economic evaluations of future RSV-related interventions such as vaccination.
Highlights
Several immunisation candidates against Respiratory syncytial virus (RSV) are in late-stage clinical trials
Demographic and clinical characteristics of the study population A total of 117 children were enrolled in the study, of those 38 required hospitalisation
The direct costs associated with RSV infection during one month of follow-up were estimated in the same cohort of participants
Summary
Several immunisation candidates against RSV are in late-stage clinical trials. There are no RSV-specific questionnaires validated for children under 2 years, in whom most RSV episodes occur. We determined HRQoL loss and direct costs due to an RSV episode in children younger than 2 years and their caregivers during a month of follow up, using a new questionnaire administered online. The RSV burden is huge, Díez‐Gandía et al BMC Infect Dis (2021) 21:924 accounting for about 33 million ALRI episodes, 3 million hospital admissions and 60,000 in-hospital deaths [1, 2]. No vaccine is available for RSV prevention. 6 monoclonal antibodies and more than 40 RSV vaccine candidates are under study, 18 of them in clinical trials [3]. A preventive intervention for RSV is on the horizon and could be available soon
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