Comparative Safety and Effectiveness of Antipsychotics

描述（由申请人提供）：近年来，非典型抗精神病药物（AAPs）在整个年龄段的使用急剧增加和扩大，包括广泛用于非标签适应症。然而，有关这些药物的相对安全性和有效性的重要基本问题仍未得到解答，特别是在易感儿童和老年人中。我们将为医疗补助计划的参保者解决这些问题，医疗补助计划是为最严重的精神疾病患者提供的主要精神卫生保健支付者。我们将联合三个站点的专业知识和资源，为医疗补助和医疗保险受益人以及其他利益相关者解决这一关键的公共卫生挑战。项目联盟的组织是建立在CERTs网络中最强大的现有工作线和相关方法学专业知识的基础上，以及强大的现有合并数据集，这些数据集可以支持从拨款期开始的工作，以便将这些资源利用成一个更大、更强大的整体。个别研究将涉及以下目标：

DESCRIPTION (provided by applicant): Recent years have seen sharply increased and broadened use of atypical antipsychotic medications (AAPs) across the age spectrum including extensive use for non-labeled indications. Yet important basic questions remain unanswered concerning comparative safety and effectiveness of these medications, especially among vulnerable children and elderly. We will address these questions for enrollees in Medicaid, the primary mental health care payer for the most seriously mental ill. We will unite expertise and resources from three sites to address this critical public health challenge for Medicaid and Medicare beneficiaries and other stakeholders. The project consortium was organized to build on the strongest existing lines of work and relevant methodological expertise within the CERTs network, and on powerful existing merged datasets that could support the initiation of work from the start of the grant period, in order to leverage these resources into a larger and more powerful whole. Individual studies will address the following aims: 1. For elderly nursing home (NH) residents, utilize a unique linked dataset developed by the mental health CERT that merges medication/diagnostic information from claims with a prospective, structured clinical assessment of residents to evaluate comparative effectiveness and safety of individual antipsychotic drugs in large usual-care populations. Important clinical outcomes examined include mortality; cardiovascular, cerebrovascular, metabolic, infectious, and other medical outcomes; and functional and clinical outcomes including behavioral symptoms and cognitive function. 2. Assess clinical outcomes of antipsychotic therapy in large usual-care populations of children and adolescents. We will conduct a cohort study of important clinical outcomes and comparative safety of newly initiated AP therapy in youth (2-20 years of age) with diagnoses consistent with ADHD or behavioral or mood disorders, compared with a propensity-score-matched cohort of children with other treatment modalities. Analyses will be initially conducted in Tennessee Medicaid, with access to both electronic/paper medical records for validation of study variables/endpoints, and, using the validated definitions, extended to a national Medicaid population of youth to increase power to examine comparative safety. Among youth diagnosed with schizophrenia, we will also examine markers of effectiveness across individual drugs including drug discontinuation and psychiatric hospitalization. 3. For the broader population of all non-institutionalized AP users, utilize 50-state Medicaid data to determine if individual APs vary with regard to important AP risks, including prolactinomas (all ages), incident diabetes mellitus or hyperlipidemia (adults), and all-cause mortality (elderly). Using powerful existing merged datasets, we can initiate substantive analyses at the start of the project. Early in the project period, we will implement additional linkages and expand an existing 8-state dataset to national scope, providing enhanced power needed to assess comparative safety and effectiveness across drugs and important subpopulations. New linkages include validation of claims-based measures of adverse effects against medical charts, links between administrative and electronic medical record data, and expansion of a unique existing merged dataset on the nursing home population. The study will integrate analyses in the well established Tennessee Medicaid population with multistate Medicaid data that offer great power for comparative safety and effectiveness research. It will build on past CERTs investments, the expertise of preeminent methodological leaders, and important prior lines of research on antipsychotic use and outcomes at the three sites to implement a rigorous set of studies aimed at providing evidence that is critically needed to guide optimal clinical use of antipsychotic drugs for vulnerable populations.