Burden of Respiratory Syncytial Virus (RSV) in Children in Sweden (BRICS): A Retrospective Study in Sweden
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,100,000
- 主要终点
- Short-term healthcare: Number of dispensed prescriptions of RSV-related medications
研究概览
简要总结
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:
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Describe demographic and clinical patient characteristics of RSV infected children.
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Estimate and compare the incidence of RSV infection and acute respiratory infections (ARIs) in children.
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Estimate the mortality associated with RSV infection in children.
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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).
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Estimate the net days with VAB leave and the compensation disbursed (temporary parental benefit) associated with RSV infection in children.
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Estimate the indirect costs that can be attributed to VAB leave.
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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.
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Examine and describe risk factors associated with an RSV infection in children
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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).
详细描述
The overall study period will be between July 1st 2001 and to latest available date (likely June 30th 2022).
Patients will be identified for inclusion in the study population between July 1st 2006 and June 30th 2021.
Patients will be followed from time of inclusion until end of the study period or until death.
All patients will have an index date corresponding to the date of diagnosis of incident infection in primary and/or hospital care during the identification period. An incident infection is defined as the occurrence of infections more than 30 (>30) days apart. This implies that a patient can have more than one index date during the study period. Patients that are included in both the RSV cohort and the regional primary care RSV cohort may have two different index dates for the same incident infection, depending on the objective. This is if a patient is first treated in primary care and then hospitalized. The index date is defined differently for the two cohorts, as the first diagnosis in hospital care for the RSV cohort and first diagnosis in primary care OR hospital care for the regional primary care cohort. The non-RSV controls will have the same index date as their matched RSV patient.
The look-back period will be used to inform baseline characteristics as well as patients' medical and diagnosis history. All patients will have possible look-back from birth for information on the patient's hospital care history and from 2005 for information on the patient's prescribed drugs history. The individual look-back and follow-up will depend on the time of inclusion in the study population as well as age at inclusion.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •There are no exclusion criteria for this study.
结局指标
主要结局
Short-term healthcare: Number of dispensed prescriptions of RSV-related medications
时间窗: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date
Number of dispensed prescriptions of RSV-related medications during follow-up
Short-term healthcare: The costs of RSV-related medications
时间窗: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date
The costs of dispensed prescriptions of RSV-related medications based on pharmacy retail price
Short-term healthcare: Number of specialist outpatient visits
时间窗: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date
Number of RSV specialist outpatient hospital visits during follow-up
Short-term healthcare: Number of hospitalizations
时间窗: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date
Number of hospitalizations/stays related to RSV during follow-up
Short-term healthcare: Number of Intensive Care Unit (ICU) hospitalizations
时间窗: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date
Number of ICU hospitalizations/stays related to RSV during follow-up
Medium-term healthcare: Number of Intensive Care Unit (ICU) hospitalizations
时间窗: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date
Number of ICU hospitalizations/stays related to RSV during follow-up
Medium-term healthcare: The costs of RSV-related medications
时间窗: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date
The costs of dispensed prescriptions of RSV-related medications based on pharmacy retail price
Short-term healthcare: Length of hospitalizations
时间窗: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date
The length of hospitalizations/stays related to RSV during follow-up
Short-term healthcare: Length of ICU hospitalizations
时间窗: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date
The length of ICU hospitalizations/stays related to RSV during follow-up
Short-term healthcare: Number of RSV-related medical/surgical procedures
时间窗: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date
Number of RSV-related medical/surgical procedures during follow-up
Medium-term healthcare: Number of specialist outpatient visits
时间窗: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date
Number of RSV specialist outpatient hospital visits during follow-up
Medium-term healthcare: Number of hospitalizations
时间窗: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date
Number of hospitalizations/stays related to RSV during follow up
Short-term healthcare: The costs of direct medical (in- and outpatient care)
时间窗: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date
Direct medical (in- and outpatient care) costs related to RSV infection
Medium-term healthcare: Length of hospitalizations
时间窗: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date
The length of hospitalizations/stays related to RSV during follow up
Medium-term healthcare: Number of RSV-related medical/surgical procedures
时间窗: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date
Number of RSV-related medical/surgical procedures during follow-up
Medium-term healthcare: Number of dispensed prescriptions of RSV-related medications
时间窗: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date
Number of dispensed prescriptions of RSV-related medications during follow-up
Medium-term healthcare: Length of ICU hospitalizations
时间窗: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date
The length of ICU hospitalizations/stays related to RSV during follow-up
Medium-term healthcare: The costs of direct medical (in- and outpatient care)
时间窗: Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date
Direct medical (in- and outpatient care) costs related to RSV infection
次要结局
- Incidence of RSV/ARIs(Analysis period: July 1st 2006 - June 30th 2021 Reporting period: by respiratory years)
- Patient characteristics(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)
- Socioeconomic burden: Net days of VAB leave(Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date)
- Proportion of patients that develop respiratory complications (ICD-10 codes)(Analysis period: July 1st 2006 - July 31st 2021 Reporting period: per year during 5 years from index date)
- Incidence of RSV per 1000 person-years(Analysis period: July 1st 2006 - July 31st 2021 Reporting period: per year during 5 years from index date)
- 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 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)
- Primary Care: Number of primary care contacts(Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date)
- Primary Care: Number of specialized outpatient care visits(Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date)
- Socioeconomic burden: Net VAB leave benefit(Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date)
- Socioeconomic burden: Indirect costs of VAB leave due to RSV(Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 12 months from (first) index date)
- Hazard ratios (HR)(Analysis period: July 1st 2006 - July 31st 2021 Reporting period: per year during 5 years from index date)
- Primary Care: Length of hospitalizations(Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date)
- Primary Care: Number of RSV-related medical/surgical procedures(Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date)
- Mortality(Analysis period: July 1st 2006 - July 31st 2021 Reporting period: 30 days from index date)
- Incidence rate ratios (IRR)(Analysis period: July 1st 2006 - July 31st 2021 Reporting period: per year during 5 years from index date)
- Estimation of hazard ratio of each risk factor on being diagnosed with RSV(Analysis period: July 1st 2006 - July 31st 2021Reporting period: look back period)
- Primary Care: Number of ICU hospitalizations(Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date)
- Primary Care: Length of ICU hospitalizations(Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date)
- Primary Care: Number of hospitalizations(Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date)
- Primary Care: Number of dispensed prescriptions of RSV-related medications(Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date)
- Primary Care: The costs of direct medical (in- and outpatient care)(Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date)
- Primary Care: The costs of RSV-related medications(Analysis period: Date of first available data - July 31st 2021 Reporting period: 30 days from index date)