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

描述（由申请人提供）：一种普遍存在且可改变的环境因素与显著的婴儿发病率以及哮喘发展相关，即婴儿呼吸道合胞病毒（RSV）感染。虽然大多数经历RSV感染的儿童症状轻微，但有相当一部分人经历了更严重的疾病，通常需要住院治疗，有时需要重症监护。我们和其他人已经表明，在RSV感染严重到需要医疗照顾的儿童中，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，我们已经证明了RSV引起的婴儿疾病和儿童哮喘发病之间的因果关系。由于RSV疫苗目前不可用，RSV免疫预防是目前唯一可用的替代方法，被许可用于预防高危婴儿群体中RSV所致的发病。 在RSV发病率过高的儿童中评价了RSV免疫预防。虽然已经有一些随机临床试验招募了选择性人群，投入大量资源以确保已经建立“疗效”的依从性（它能起作用吗？），有效性（effectiveness）数据有限且相互矛盾。没有调查评估美国医疗补助和被保险的“真实的世界”人群的使用模式、依从性和有效性。也没有任何关于降低RSV婴儿发病率对长期结局（如哮喘）影响的研究。这些都是至关重要的问题，以回答在儿科最昂贵的预防性治疗的政策，并在评估我们目前唯一可用的“工具”，以减少婴儿RSV发病率的有效性。最后，也没有研究降低RSV婴儿发病率对哮喘发展的更长期影响，哮喘是一种终身慢性疾病，已知在大多数RSV高风险儿童群体中更常见。 在三个具体目标中，我们将利用两个参与田纳西州医疗补助计划和六个Kaiser Permanente-Northern加州综合医疗护理实践的儿童的基于免疫者的研究人群，研究1995年至2008年出生的婴儿，并进行纵向随访，以：（1）确定RSV免疫预防的使用模式和依从性;（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间的比较有效性;（3）评估RSV免疫预防对哮喘发病的影响，估计效应量，并将RSV免疫预防对哮喘发病的影响与我们已经证明的出生时间对减少儿童哮喘的影响进行比较。

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.