Novel Longitudinal Methods for SMART Studies of Drug Abuse and HIV

药物滥用和艾滋病毒 SMART 研究的新纵向方法

• 批准号: 9322376
• 负责人: Daniel Almirall
• 金额: $ 49.25万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-01 至 2020-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9322376
• 关键词: AIDS prevention; Alcohol or Other Drugs use; Behavior Therapy; Behavioral Sciences; Clinical; Cocaine Dependence; Data; Data Analyses; Data Analytics; Decision Making; Drug abuse; Drug usage; Experimental Designs; Future; HIV; HIV risk; Hand; Individual; Intervention; Journals; Lead; Methodology; Methods; Modeling; Modernization; Opiate Addiction; Outcome; Outcome Measure; Outcome Study; Patients; Peer Review; Pregnant Women; Procedures; Property; Psychological reinforcement; Public Health; Publishing; Reporting; Research; Research Design; Research Personnel; Resources; Risk Behaviors; Sample Size; Science; Scientist; Testing; Time; Woman; Work; analytical method; base; cost; drug development; drug use screening; effective intervention; improved; innovation; longitudinal analysis; method development; multilevel analysis; novel; personalized decision; public health relevance; randomized trial; response; therapy design; treatment program; trial design; user friendly software; user-friendly

 DESCRIPTION (provided by applicant): The treatment of drug use and HIV often requires sequential, individualized decision-making concerning the type or delivery of treatment. An adaptive intervention is a treatment design that uses ongoing information from the patient to guide whether, and how to modify the treatment over time. By providing the appropriate treatment to those who need it, when they need it, adaptive interventions hold the promise of improving long-term outcomes for greater numbers of people, thereby increasing the reach and impact of drug use and HIV treatments in real-world settings. The sequential multiple assignment randomized trial (SMART), a major step forward in the science of adaptive interventions, is an experimental design explicitly for identifying and constructing efficacious adaptive interventions. However, in order to make the SMART maximally useful to drug use and HIV intervention scientists, methodological work is needed to expand the options for analyzing data that arise from a SMART, which are limited in important ways. In particular, modern longitudinal data analysis methods that are used by the great majority of studies in today's drug use and HIV research do not accommodate and cannot be used to take advantage of the unique features of a SMART, hence their application can lead to greatly reduced statistical power or even incorrect conclusions. This makes it impossible for investigators using SMARTs to scientifically benefit from the power, elegance, and nuance afforded by longitudinal data. Our objective is to bridge this critical gap by developing and evaluating new multilevel methods for analyzing longitudinal continuous, binary, and zero- inflated drug-use and HIV outcome measures arising from a SMART; developing new sample size calculators for planning SMART studies with longitudinal continuous, binary or zero- inflated outcome measures; applying and illustrating these methods using data from three SMART studies in drug abuse and HIV; and developing free, user-friendly resources to implement these methods. The methods developed in this project will improve clinical and public health outcomes by enabling drug use and HIV scientists to develop more potent adaptive interventions to guide the individualization of drug use and HIV treatments.

 描述（由申请人提供）：药物使用和艾滋病毒的治疗往往需要顺序，个性化的决策有关的类型或提供治疗。适应性干预是一种治疗设计，它使用来自患者的持续信息来指导是否以及如何随着时间的推移修改治疗。通过在需要时向需要者提供适当治疗，适应性干预措施有望改善更多人的长期结果，从而扩大吸毒和艾滋病毒治疗在现实世界中的覆盖面和影响。序贯多重分配随机试验（SMART）是适应性干预科学的重要一步，是一种明确用于识别和构建有效适应性干预的实验设计。然而，为了使SMART对药物使用和艾滋病毒干预科学家最大限度地有用，需要开展方法学工作，以扩大SMART产生的数据分析选择，这些数据在重要方面受到限制。特别是，在当今的药物使用和艾滋病毒研究中，绝大多数研究所使用的现代纵向数据分析方法不适应也不能用于利用SMART的独特功能，因此，它们的应用可能导致统计功效大大降低，甚至得出不正确的结论。这使得使用SMART的研究人员无法从纵向数据提供的力量，优雅和细微差别中科学地受益。我们的目标是通过开发和评估新的多层次方法来弥合这一关键差距，这些方法用于分析SMART产生的纵向连续、二元和零膨胀的药物使用和艾滋病毒结局指标;开发新的样本量计算器，用于规划具有纵向连续、二元或零膨胀结局指标的SMART研究;使用三项药物滥用和艾滋病毒SMART研究的数据应用和说明这些方法;开发免费的、用户友好的资源来实现这些方法。该项目开发的方法将使药物使用和艾滋病毒科学家能够开发更有效的适应性干预措施，以指导药物使用和艾滋病毒治疗的个性化，从而改善临床和公共卫生结果。