Impact of Pneumococcal Conjugate Vaccines on Otitis Media and Acute Otitis Media in Swedish Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Assessment of the impact of PCVs by describing, separately for Skåne and VGR (Västra Götalandsregionen), trends over time in the incidence of OM and AOM among children during the pre-PCV, PCV7, and Synflorix®/PCV13-eras
研究概览
简要总结
The goal of this study is to look at the effect of pneumococcal conjugate vaccines (PCV) on physician-diagnosed otitis media (OM) and acute otitis media (AOM) incidence in Swedish children by collecting and analyzing patient level observational data already available in existing regional and national databases.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 是
入选标准
- •Data from all children ≤ 5 years old in VGR and Skåne in each year during the study period (2004 - 2013)
排除标准
- •Not Applicable
结局指标
主要结局
Assessment of the impact of PCVs by describing, separately for Skåne and VGR (Västra Götalandsregionen), trends over time in the incidence of OM and AOM among children during the pre-PCV, PCV7, and Synflorix®/PCV13-eras
时间窗: During 10 years: from January 1, 2004 to December 31, 2013
A step-wise approach will be applied: 1. Descriptive analyses to assess any trends in OM and AOM incidence, any seasonality (repeating pattern of incidence related to time such as seasons, quarters and months), the order of seasonality, extreme observations/outliers, whether incidence trends include abrupt changes. 2. If trends or seasonality are identified, a time series analysis will be conducted in 2 steps. a. Time series analysis of monthly incidence, using smoothing technique to estimate differences in pre-PCV, PCV7, and Synflorix®/PCV13 vaccination periods. b. Interrupted time-series analysis if the above steps show any differences in pre- and post- vaccination introduction periods. Diagnoses of AOM recorded under the ICD-10 code H66 (suppurative and unspecified OM) and ICD-10 H66.0 (acute suppurative OM); Chronic OM under ICD-10 code H66.3 (other chronic suppurative OM) and other OM underICD-10 code H66.9 (OM unspecified) and H65 (non-suppurative OM).
次要结局
- Assessment of possible individual-level predictors for the time to the first OM or AOM diagnosis(During 10 years: from January 1, 2004 to December 31, 2013)
- Assessment of the Costs for OM and AOM-related healthcare resource utilization(During 10 years: from January 1, 2004 to December 31, 2013)
- Assessment of the impact of PCVs by describing trends over time in the rate of antibiotics dispensed for OM and AOM diagnoses among children with OM or AOM(During 10 years: from January 1, 2004 to December 31, 2013)
- Assessment of the impact of PCVs by describing the trends over time in the incidence of severe AOM (Medical Products Agency 2010, Lieberthal 2013) among children(During 10 years: from January 1, 2004 to December 31, 2013)
- Assessment of the the impact of PCVs by describing trends over time in the rate of tympanostomy tube insertions among children with OM and AOM(During 10 years: from January 1, 2004 to December 31, 2013)