Antidepressant Treatment and Suicidality: Biostatistical/Methodological Solutions

抗抑郁治疗和自杀：生物统计/方法学解决方案

基本信息

批准号：
8089395
负责人：
ROBERT D GIBBONS
金额：
$ 67.29万
依托单位：
UNIVERSITY OF CHICAGO
依托单位国家：
美国
项目类别：
财政年份：
2008
资助国家：
美国
起止时间：
2008-09-25 至 2014-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8089395
关键词：
Accounting Address Adolescent Adolescent Psychiatry Adult Adverse event Age Antidepressive Agents Area Autacoids Biological Biostatistical Methods Blood Circulation Boxing Cause of Death Centers for Disease Control and Prevention (U.S.)Cessation of life Child Child Psychiatry Clinical Code Collaborations Computerized Medical Record Country County Cross-Cultural Comparison Data Data Files Data Set Data Sources Databases Development Drug Prescriptions Electronics Epidemiology Etiology Europe European Event General Population Goals Grant Health Health Policy Health Services Health Status Human Hylobates Genus Individual Information Management Information Systems International Laboratories Lead Link Major Depressive Disorder Managed Care Maps Medical Medical Records Mental Depression Methodology Methods Modeling Molecular Mood Disorders Natural experiment Netherlands Outcome Patients Persons Pharmaceutical Preparations Pharmacoepidemiology Pharmacy facility Population Population Database Population Surveillance Positioning Attribute Prevention Research Property Psychiatrist Psychiatry Public Health Public Policy Race Recording of previous events Records Relative (related person)Reporting Research Research Personnel Research Project Grants Resources Risk Robin bird Role Safety Sampling Science Screening procedure Selective Serotonin Reuptake Inhibitor Series Solutions Statistical Methods Subgroup Suicide Suicide attempt Suicide prevention Surveillance Methods System Testing Time United States United States Department of Veterans Affairs United States National Center for Health Statistics Vertebral column Violence Vital Statistics Woman Work Youth accomplished suicide age group base cost design disorder prevention expectation experience health economics improved indexing male member multidisciplinary novel population based prevent psychologic sex social statistics suicidal behavior suicidal morbidity suicidal risk suicide mortality suicide rate suicide victim trend young adult

项目摘要

DESCRIPTION (provided by applicant): ABSTRACT The purpose of this proposal is to develop, test, and apply new statistical methodologies that can be used to identify low base rate drug adverse event (AE) interactions. These new methods will then be applied to a wide range of existing non- experimental datasets to examine the relationship between antidepressants and suicide attempts and completion. We have designed this research project as an integral collaboration between biostatisticians, research psychiatrists and clinicians, economists, and pharmacoepidemiologists, working with large ecological and medical records/claims electronic patient databases covering years where antidepressant use is varying dramatically. Three major specific aims are proposed: (a) the development of new statistical surveillance methods for detecting drug-AE interactions, (b) the development and application of analytic methods for ecological and population data, and (c) the development of and application of statistical methods for analysis of person-level data from large scale medical records/claims databases both in the U.S. and in Europe. The datasets that we have been granted access to include the FDA spontaneous reporting system (SRS/AERS/MedWatch), electronic medical record/claims databases in the U.S. (VA, and PHARMetrics), and similar data from the Netherlands (PHARMO). The work in this proposal will be carried out by a research consortium that will study national and international drug safety issues. The multidisciplinary group includes the areas of statistics (Drs. Gibbons, (PI), Brown (co-PI), Bhaumik, Hur, Marcus, and Rosenbaum), psychiatry from adult (Mann), and child (Brent) perspectives, health economics/econometrics (Heckman), and pharmacoepidemiology (Valuck). Collaboration with members of the VA (Cunningham), and PHARMO (Erkens, Herings) is an integral part of the proposal. PUBLIC HEALTH RELEVANCE: The enormous human cost of suicide makes research and prevention a national priority. Traditional approaches to drug safety have proved inadequate to address current public health issues. Providing statistical and methodological advances for the active surveillance of Drug-AE interactions, such as antidepressants and suicide, is a necessary first step in the establishment of a science-based health policy system, and is the primary goal of this proposal.

描述（由申请人提供）：摘要本提案的目的是开发，测试和应用可用于识别低基础速率药物不良事件（AE）相互作用的新统计方法。然后，这些新方法将应用于广泛的现有非实验数据集，以检查抗抑郁药与自杀尝试和完成之间的关系。我们将这项研究项目设计为生物统计学家，研究精神科医生，临床医生，经济学家和药物ePIDEPIDEMIologists之间的整体合作，与大型生态和医疗记录/索赔电子数据库合作，涵盖抗抑郁药的使用情况，抗抑郁药的使用情况很大。提出了三个主要的特定目的：（a）开发用于检测药物相互作用的新统计监视方法，（b）开发和应用生态和人口数据的分析方法，以及（c）开发和应用统计方法，用于分析来自美国和欧洲的大规模医疗记录/索赔数据库中人级数据的分析和应用。我们已获得访问的数据集包括美国自发报告系统（SRS/AERS/MEDWATCH），美国的电子病历/索赔数据库（VA和Pharmetrics）以及荷兰（Pharmo）的类似数据。该提案中的工作将由一个研究联盟进行，该联盟将研究国家和国际药物安全问题。多学科小组包括统计领域（Gibbons，（PI）博士，Brown（Co-Pi），Bhaumik，Hur，Marcus和Rosenbaum），成人（Mann）的精神病学和儿童（Brent）Perspectives，Health Economic/Econalics/Econalics/Conanicals（Heckman）（Heckman）和Pharmacoepidemiologicy（Valuck）。与VA（Cunningham）成员的合作，Pharmoo（Erkens，Herings）是该提案不可或缺的一部分。公共卫生相关性：自杀的巨大成本使研究和预防成为国家优先事项。传统的药物安全方法证明是不足以解决当前的公共卫生问题。为抗抑郁药和自杀等积极监视药物相互作用的积极监视是建立基于科学的健康政策系统的必要第一步，并且是该提案的主要目标。