Burden of Respiratory Syncytial Virus (RSV) in Children in Sweden (BRICS): A Retrospective Study in Sweden

NCT05622331 | Completed

• 2 other identifiers: RSV00046U1111-1280-4878
• Study Type: observational
• Target: 1,100,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Primary Objective:

• Estimate the hospital-associated healthcare resource use (HCRU), and associated costs, of RSV infection in children in comparison to the non-RSV control cohort (general population) and patients with rhinovirus infection. Secondary Objectives:
• Describe demographic and clinical patient characteristics of RSV infected children.
• Estimate and compare the incidence of RSV infection and acute respiratory infections (ARIs) in children.
• Estimate the mortality associated with RSV infection in children.
• Estimate the social economic burden of RSV infection in children in relation to parents staying home from work to care for their sick child (VAB leave) in comparison to non-RSV control cohort (i.e. parents to children in the general population).
• Estimate the net days with VAB leave and the compensation disbursed (temporary parental benefit) associated with RSV infection in children.
• Estimate the indirect costs that can be attributed to VAB leave.
• Examine the medium- and long-term complications associated with an RSV diagnosis in children in comparison to the non-RSV control chart (general population) and patients with rhinovirus infection.
• Examine and describe risk factors associated with an RSV infection in children
• Estimate the healthcare resource use (HCRU), and associated costs, of RSV infection in children, for a subset of patients where primary care data is available, in comparison to the non-RSV control cohort (general population).

Conditions

Respiratory Syncytial Virus (RSV)

Outcome Measures

Primary Outcomes (18)

• Short-term healthcare: Number of specialist outpatient visits

  Number of RSV specialist outpatient hospital visits during follow-up

  Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date

• Short-term healthcare: Number of hospitalizations

  Number of hospitalizations/stays related to RSV during follow-up

  Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date

• Short-term healthcare: Length of hospitalizations

  The length of hospitalizations/stays related to RSV during follow-up

  Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date

• Short-term healthcare: Number of Intensive Care Unit (ICU) hospitalizations

  Number of ICU hospitalizations/stays related to RSV during follow-up

  Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date

• Short-term healthcare: Length of ICU hospitalizations

  The length of ICU hospitalizations/stays related to RSV during follow-up

  Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date

• Short-term healthcare: Number of RSV-related medical/surgical procedures

  Number of RSV-related medical/surgical procedures during follow-up

  Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date

• Short-term healthcare: Number of dispensed prescriptions of RSV-related medications

  Number of dispensed prescriptions of RSV-related medications during follow-up

  Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date

• Short-term healthcare: The costs of direct medical (in- and outpatient care)

  Direct medical (in- and outpatient care) costs related to RSV infection

  Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date

• Short-term healthcare: The costs of RSV-related medications

  The costs of dispensed prescriptions of RSV-related medications based on pharmacy retail price

  Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date

• Medium-term healthcare: Number of specialist outpatient visits

  Number of RSV specialist outpatient hospital visits during follow-up

  Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date

• Medium-term healthcare: Number of hospitalizations

  Number of hospitalizations/stays related to RSV during follow up

  Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date

• Medium-term healthcare: Length of hospitalizations

  The length of hospitalizations/stays related to RSV during follow up

  Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date

• Medium-term healthcare: Number of Intensive Care Unit (ICU) hospitalizations

  Number of ICU hospitalizations/stays related to RSV during follow-up

  Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date

• Medium-term healthcare: Length of ICU hospitalizations

  The length of ICU hospitalizations/stays related to RSV during follow-up

  Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date

• Medium-term healthcare: Number of RSV-related medical/surgical procedures

  Number of RSV-related medical/surgical procedures during follow-up

  Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date

• Medium-term healthcare: Number of dispensed prescriptions of RSV-related medications

  Number of dispensed prescriptions of RSV-related medications during follow-up

  Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date

• Medium-term healthcare: The costs of direct medical (in- and outpatient care)

  Direct medical (in- and outpatient care) costs related to RSV infection

  Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date

• Medium-term healthcare: The costs of RSV-related medications

  The costs of dispensed prescriptions of RSV-related medications based on pharmacy retail price

  Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date

Secondary Outcomes (24)

• Patient characteristics

  Analysis period: July 1st 2006 - June 30th 2021 Reporting period: at index date or during look-back period

• Incidence of RSV/ARIs

  Analysis period: July 1st 2006 - June 30th 2021 Reporting period: by respiratory years

• Number of laboratory-confirmed RSV cases with RSV diagnosis

  Analysis period: July 1st 2006 - June 30th 2021 Reporting period: at index date or during look-back period

• Number of laboratory-confirmed RSV cases with no RSV diagnosis

  Analysis period: July 1st 2006 - June 30th 2021Reporting period: at index date or during look-back period

• Number of diagnosed RSV cases with no RSV laboratory tests conducted

  Analysis period: July 1st 2006 - June 30th 2021 Reporting period: at index date or during look-back period

Study Arms (10)

RSV cohort

Children (\<5 years of age at diagnosis) with a diagnosis of RSV (ICD-10 code) in hospital care between July 1st 2006 and June 30th 2021

Regional primary care RSV cohort

Children (\<5 year of age) with a diagnosis of RSV (ICD-10 code) in primary care identified in regional databases (Region Skåne, Region Halland and VGR) between July 1st 2006 and June 30th 2021

Regional laboratory RSV cohort

Children (\<5 years of age) with a positive laboratory RSV test result (multiplex/rapid PCR, antigen, immunofluorescence or immunochromatography rapid test) in primary or hospital care, identified in regional laboratory databases (Region Skåne and Region Halland) between July 1st 2006 and June 30th 2021

Acute Respiratory Infections (ARI) cohort

Children (\<5 of age) with a diagnosis of ARI (ICD-10 code,) in hospital care between July 1st 2006 and June 30th 2021

Regional ARI cohort

Children (\<5 years of age) with a diagnosis of RSV (ICD-10 code, see Table 1) in primary care, identified in regional databases (Region Skåne, Region Halland and VGR)

Rhinovirus cohort

Children (\<5 of age) with a diagnosis of rhinovirus (ICD-10 code,) in hospital care between July 1st 2006 and June 30th 2021

Human Metapneumovirus (HMPV) cohort

Children (\<5 of age) with a diagnosis of HMPV (ICD-10 code,) in hospital care between July 1st 2006 and June 30th 2021

Parainfluenza cohort

Children (\<5 of age) with a diagnosis of parainfluenza (ICD-10 code,) in hospital care between July 1st 2006 and June 30th 2021

Parent cohort

Parents to all children will be linked to the study population, which is possible through linkage between children and parents by their personal identifiers

Non-RSV control cohort

A non-RSV control population consisting of children (\<5 years of age) will be extracted to estimate the burden compared to the general population

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The source population for this study will consist of all children (≤5 years of age) in Sweden with an RSV infection or any acute respiratory infection (ARI) between January 1rst 2001 and latest available date, identified from three sources: * Primary or secondary diagnosis in hospital care (National Patient Registry) * Primary or secondary diagnosis in primary care (regional databases) * Positive RSV laboratory test result (Regional laboratory data) The expected study sample is 38,000 unique pediatric patients with an RSV diagnosis, identified in the National Patient Register between 2001 and 2020. The expected RSV sample size, the non-RSV control population will consist of 80,000-160,000 individuals, matched 1:10. The expected number of ARI infections during the time period is estimated to around 1 million. This totals a study sample of between 1-1.1 million.

You may qualify if:

• Children (≤5 years of age) with an RSV infection or any acute respiratory infection (ARI) between July 1st 2001 and latest available date, identified in either hospital care, regional primary care or laboratory database.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead
• Quantify Research: collaborator

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 18, 2022
• Study Start: July 1, 2006
• Primary Completion: April 19, 2024
• Study Completion: April 19, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share