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. 2021 Jul 26;21(1):705.
doi: 10.1186/s12879-021-06397-w.

Evaluation of a standardised protocol to measure the disease burden of respiratory syncytial virus infection in young children in primary care

J J G T van Summeren  1 , C Rizzo  2 , M Hooiveld  3 , J C Korevaar  3 , J M T Hendriksen  3 , M L A Dückers  3   4 , D Loconsole  5 , M Chironna  5 , M Bangert  6 , C Demont  6 , A Meijer  7 , S Caini  3 , E Pandolfi  2 , J Paget  3
Affiliations

Evaluation of a standardised protocol to measure the disease burden of respiratory syncytial virus infection in young children in primary care

J J G T van Summeren et al. BMC Infect Dis. .

Abstract

Background: A better understanding of the burden of respiratory syncytial virus (RSV) infections in primary care is needed for policymakers to make informed decisions regarding new preventive measures and treatments. The aim of this study was to develop and evaluate a protocol for the standardised measurement of the disease burden of RSV infection in primary care in children aged < 5 years.

Methods: The standardised protocol was evaluated in Italy and the Netherlands during the 2019/20 winter. Children aged < 5 years who consulted their primary care physician, met the WHO acute respiratory infections (ARI) case definition, and had a laboratory confirmed positive test for RSV (RT-PCR) were included. RSV symptoms were collected at the time of swabbing. Health care use, duration of symptoms and socio-economic impact was measured 14 days after swabbing. Health related Quality of life (HRQoL) was measured using the parent-proxy report of the PedsQL™4.0 generic core scales (2-4 years) and PedsQL™4.0 infant scales (0-2 years) 30 days after swabbing. The standardised protocol was evaluated in terms of the feasibility of patient recruitment, data collection procedures and whether parents understood the questions.

Results: Children were recruited via a network of paediatricians in Italy and a sentinel influenza surveillance network of general practitioners in the Netherlands. In Italy and the Netherlands, 293 and 152 children were swabbed respectively, 119 and 32 tested RSV positive; for 119 and 12 children the Day-14 questionnaire was completed and for 116 and 11 the Day-30 questionnaire. In Italy, 33% of the children had persistent symptoms after 14 days and in the Netherlands this figure was 67%. Parents had no problems completing questions concerning health care use, duration of symptoms and socio-economic impact, however, they had some difficulties scoring the HRQoL of their young children.

Conclusion: RSV symptoms are common after 14 days, and therefore, measuring disease burden outcomes like health care use, duration of symptoms, and socio-economic impact is also recommended at Day-30. The standardised protocol is suitable to measure the clinical and socio-economic disease burden of RSV in young children in primary care.

Keywords: Child preschool; General practice; Health care utilization; Infant; Paediatrician; Quality of life; Respiratory syncytial virus; Socio-economic impact.

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Conflict of interest statement

JvS, MH, JK, MD, DL, MC, JH, SC, EP, AM, declare to have no conflicts of interest.

JP declares that Nivel has received unrestricted research grants from WHO, Sanofi Pasteur and the Foundation for Influenza Epidemiology.

CR declares that Ospedale Pediatrico Bambino Gesù (OPBG) has received unrestricted research grants from WHO, ECDC, Seqirus, Sanofi Pasteur, Merck Sharp & Dohme, GlaxoSmithKline.

MB and CD are employees of Sanofi Pasteur and may hold shares and/or stock options in the company.

Figures

Fig. 1
Fig. 1
Flowchart of patient recruitment and data collection process. In Italy (dark blue boxes) patients were selected via a network of pediatricians involved in study, in the Netherlands (light blue boxes) patients were selected via the routine influenza surveillance system. In both countries, parents of RSV positive children were invited to complete the Day-14 and Day-30 questionnaires (grey boxes). In patients selected via the routine influenza surveillance (Netherlands), informed consent for swab collection was obtained via the routine surveillance procedures. In addition, parents of RSV positive children were asked for informed consent to participate in the study. aThe questions related to medical history were added to the Day-14 questionnaire in the Netherlands because it was not possible to complete the questions in the Day-1 questionnaire for practical reasons
Fig. 2
Fig. 2
Final protocol to measure the clinical and socio-economic disease burden in primary care in young children. Children can be selected via a network of pediatricians or GPs involved in study (dark blue boxes), or via a routine influenza surveillance network in primary care (light blue boxes). Parents of RSV positive children will complete the Day-14 and Day-30 questionnaires (grey boxes). In children selected via the routine influenza surveillance program informed consent for swab collection is obtained via the routine surveillance procedures. Parents of RSV positive children are asked for informed consent for this study and will be asked to complete the Day-14 and Day-30 questionnaires. a Questions related to medical history are added to the Day-14 questionnaire in countries where it is not possible to complete the questions in the Day-1 questionnaire for practical reasons. b Quality of life is measured with one question on the child’s health status of today and one question on the guardian’s health status of today measured on a Visual Analogue Scale. c Topics 1 (health care use) and 3 (socio-economic impact) in the Day-30 questionnaire are introduced with a general question to examine whether the more detailed questions are required
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