Tools to Reduce Infant RSV Morbidity and Asthma: Use, Adherence and Effectiveness

描述(由申请人提供)：婴儿呼吸道合胞病毒(RSV)感染是与显著的婴儿发病率和哮喘发展相关的一个普遍和可改变的环境因素。虽然大多数感染RSV的儿童症状轻微，但也有相当一部分儿童经历了更严重的疾病，通常需要住院治疗，有时还需要重症监护。我们和其他人已经证明，在RSV感染严重到需要医疗护理的儿童中，感染的严重程度与随后的哮喘发展和严重程度有很强的相关性。此外，我们还显示了呼吸道合胞病毒引起的婴儿疾病与儿童哮喘发病之间的因果关系。由于目前还没有RSV疫苗，RSV免疫预防是目前唯一可用的替代方法，获得许可用于预防高危婴儿群体中RSV引起的发病率。 对RSV发病率过高的儿童进行了RSV免疫预防评估。虽然已经有一些随机临床试验招募了有选择的人群，投入大量资源以确保依从性已经确立了“有效性”(它能奏效吗？)，但“有效性”(它能奏效吗？)数据是有限的，而且相互冲突。还没有调查评估美国医疗补助和参保“真实世界”人群的使用模式、依从性和有效性。也没有任何关于降低RSV婴儿发病率对哮喘等长期结果的影响的研究。这些都是在为儿科最昂贵的预防性治疗提供信息以及评估我们目前唯一可用的降低婴儿呼吸道合胞病毒发病率的“工具”的有效性时需要回答的至关重要的问题。最后，也没有关于降低呼吸道合胞病毒婴儿发病率对哮喘发展的更长期影响的调查，哮喘是一种已知在大多数被认为是呼吸道合胞病毒高风险儿童群体中更常见的终生慢性病。 我们将利用田纳西州医疗补助计划登记的两个基于分母的研究人群和六个Kaiser Permanente-Northern California综合医疗实践的三个特定目标，对1995至2008年间出生的婴儿进行纵向跟踪研究，以：(1)确定RSV免疫预防的利用模式和依从性；(2)确定RSV免疫预防对RSV住院和门诊就诊的有效性，以及与出生时机的比较有效性；以及(3)评估RSV免疫预防对哮喘发病的影响，估计效果大小，并比较RSV免疫预防对哮喘初始阶段的影响，以及我们已展示的出生时机对减少儿童哮喘的影响。

DESCRIPTION (PROVIDED BY APPLICANT): One ubiquitous and modifiable environmental factor associated with both significant infant morbidity, as well as asthma development, is infant respiratory syncytial virus (RSV) infection. While most children who experience RSV infection have mild symptoms, a significant minority experience more severe disease, often requiring hospitalization and sometimes intensive care. We, and others, have shown that, among children with RSV infection severe enough to require medical attention, the severity of the infection has a strong association with subsequent development and severity of asthma. In addition, we have shown a causal relationship between RSV-attributable infant illness and childhood asthma inception. Because an RSV vaccine is not currently available, RSV immunoprophylaxis is the only currently available alternative approach, licensed for use in preventing RSV-attributable morbidity in high-risk infant groups. RSV immunoprophylaxis been evaluated in children who experience excessive RSV morbidity. While there have been a number of randomized clinical trials that have enrolled selective populations investing significant resources to ensure adherence that have established "efficacy" (can it work?), the "effectiveness" (does it work?) data are limited and conflicting. No investigations have assessed patterns of use, adherence, and effectiveness in US Medicaid and insured "real world" populations. Neither are there any investigations of the impact of reducing RSV infant morbidity on long-term outcomes such as asthma. These are critically important questions to answer in informing policy for the most costly preventive therapy in pediatrics, and in assessing effectiveness of our only currently available "tool" for decreasing infant RSV morbidity. Lastly, neither are there investigations of the more long-term impact of reducing RSV infant morbidity on the development of asthma, a lifelong chronic disease known to be more common among most groups of children considered high-risk for RSV. In three specific aims utilizing two denominator-based study populations of children enrolled in Tennessee Medicaid and six Kaiser Permanente-Northern California integrated medical care practices, we will study infants born between 1995 and 2008 and followed longitudinally to: (1) Determine RSV immunoprophylaxis utilization patterns and adherence; (2) Determine the effectiveness of RSV immunoprophylaxis on RSV hospitalizations and outpatient visits as well as comparative effectiveness with birth timing; and (3) assess the impact of RSV immunoprophylaxis on asthma inception, estimate the effect size, and compare the impact of RSV immunoprophylaxis on asthma inception with the effect we have shown of timing of birth on reducing childhood asthma.