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存在且可改变的环境因素。虽然大多数感染呼吸道合胞病毒的儿童症状轻微，但有相当一部分儿童的病情更为严重，通常需要住院治疗，有时还需要重症监护。我们和其他人的研究表明，在严重到需要就医的呼吸道合胞病毒感染儿童中，感染的严重程度与随后的发展和哮喘的严重程度有很强的相关性。此外，我们已经表明rsv引起的婴儿疾病与儿童哮喘发病之间存在因果关系。由于目前没有RSV疫苗，RSV免疫预防是目前唯一可用的替代方法，获准用于预防高危婴儿群体中RSV引起的发病率。

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.