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Statistics, Epidemiology and Data Management

统计、流行病学和数据管理

基本信息

批准号：
8601225
负责人：
BRUCE LEVIN
金额：
$ 26.56万
依托单位：
NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-02-01 至 2018-01-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8601225
关键词：
AIDS prevention AIDS/HIV problem Address Adherence Adolescent Applications Grants Area Argentina Attention Award Behavioral Behavioral Research Biological Biological Assay Brazil Caring Characteristics Child Clinical Clinical Trials Data Monitoring Committees Clinical Trials Design Collection Communicable Diseases Communication Communities Complex Consultations Cost Effectiveness Analysis Country Data Detection Development Diagnosis Discipline Doctor of Philosophy Drug Formulations Effectiveness of Interventions Emerging Technologies Ensure Epidemic Epidemiology Equation Faculty Family Female Condoms Foundations Future Gender Geographic Information Systems Goals Guidelines HIV HIV Seropositivity HIV risk Health Services Health Services Research Human immunodeficiency virus test Incidence International Intervention Intervention Studies Intervention Trial Leadership Life Light Local Microbicides Marshal Mentally Ill Persons Methods Modality Modeling Monitor Multimedia New York New York City Observational Study Outcome Outcome Measure Performance Persons Phase Pilot Projects Policies Population Prevalence Prevention Prevention strategy Process Prophylactic treatment Recommendation Research Research Design Research Infrastructure Research Methodology Research Personnel Research Project Grants Research Subjects Research Technics Resolution Resources Respondent Risk Risk Behaviors Role Safety Sampling Science Secure Serologic tests Seroprevalences Simulate Social support South Africa Specificity Staging Statistical Models Subgroup System Techniques Technology Testing Thinking Treatment outcome United States National Institutes of Health Work Youth antiretroviral therapy arm cohort comparative effectiveness cost effectiveness data integrity data management design distributed data effectiveness research experience high risk high standard implementation research implementation science innovation instrumentation intervention effect mathematical model member men men who have sex with men microbicide multi-site trial policy implication programs quality assurance scale up skills social statistics tool transmission process treatment strategy treatment trial

项目摘要

The SED Core is a resource, on both classic and innovative research design and statistical analysis strategies. Methodological demands and design options for high-impact HIV social and behavioral research are becoming increasingly complex and diverse as the field evolves. Innovative approaches to design and statistical analysis are critical to address key research and implementation challenges of the HIV epidemic that as outlined in the US NHAS [1], apply to addressing disparities [2] and implementation gaps in resource-rich [3,4] and resource-limited settings [5-9]. Additionally, important new trials have demonstrated efficacy with the Test and Treat paradigm [10,11], pre-exposure prophylaxis (PrEP) [12], use of early antiretroviral therapy (ART) with infected people for prevention of further transmission [13], integration of TB and HIV treatment [14,15], and topical microbicides [16], In light of these recent developments as well as expected advances resulting from other major trials underway or planned, the need for rigorous studies of the real-world effectiveness of interventions as they are scaled-up (often in combination with other interventions) has never been greater. Likewise, well-considered application of comparative effectiveness research, cost-effectiveness analysis, and mathematical modeling inform policy formulation and potential for integration into practice. SED Core leadership and faculty are internationally recognized experts in the design and conduct of clinical [17-22] and behavioral [23,24] intervention trials - both in the US and in low- and mid-resource countries - and the sophisticated determinants studies that inform them. Examples of HIV Center projects developed with support from the Core include studies on the acceptability and use of new HIV prevention technologies, e.g., female condom, microbicides [23-27]; gender-specific prevention trials [23,24,28]; and determinants of risk, seroprevalence, and motivators for HIV testing among high risk men who have sex with men (MSM). The Core has supported the development and data management of innovative interventions for HIV prevention among severely mentally ill populations in Brazil and for adherence to ART in New York [29] and South Africa [30,31]. A range of studies on children, adolescents and families, including large longitudinal cohorts of perinatally infected children in New York City (NYC) [32,33] and interventions for high risk adolescents in NYC [34], New York State (NYS) [35], and South Africa [36], have relied on the analytical and data management foundations provided by the SED Core. SED Core faculty have themselves conducted studies on HIV incidence and prevalence estimations [37-40]; factors associated with HIV testing [40,41] and diagnosis [42]; linkage to [43-45] and retention in [46-48] HIV care following diagnosis; timely ART initiation [49,50]; and other HIV care and treatment outcomes [47,48,51-61]. They have been at the forefront of responding to the US NHAS and the implementation of effective HlV-prevention and treatment strategies, with studies on disparities among persons living with HIV [62], policy implications [63], mathematical modeling [41,64], comparative effectiveness design [17,18,20], and cost effectiveness modeling [65]. Thus, through the SED Core, HIV Center Investigators will have access to the expertise needed to further advance the field with cutting edge study design and statistical analysis, epidemiology, and data management techniques. Our established consultation and communication process (see Section 5) represents a successful integration of effort between Center investigators and SED Core members. Consultation sessions held by the Core in the previous cycle are provided in Appendix E.l. Problem resolution is a key indicator of SED Core performance. A few brief examples illustrate how the Core works in this capacity. ¿ The Core worked with both Claude Ann Mellins, Ph.D., on Adapting CHAMP-*- for South Africa: Supporting HIV Infected Youth and Families [36] and with Robert Remien, Ph.D., on A Multimedia Social Support Intervention: Adherence to HIV Care In South Africa [30], to carefully identify the general goals of these NIH-supported pilot intervention studies. Pilot studies must determine auxiliary parameters such as prevalences of binary outcome measures and standard deviations for key continuous outcomes so that a future large study can be properly and realistically planned. Effect size estimation, however, is not a proper goal for a pilot study. The SED Core provided effective support to Center investigators to clearly state these key points in the submitted proposals that resulted in awarded studies. The SED Core's approach and recommendations were affirmed by the revised guidelines for RS4 pilot grant applications. 466 statistics. Epidemiology, and Data Management Core Remien, Robert H. ¿ Dr. Alex Carballo-Dieguez's study. Predictors of HIV Risk Behavior Among Men in Argentina [66] revealed unusually high estimates of HIV incidence using Respondent Driven Sampling and Serological Testing Assays for the detection of Recent HIV Seroconversion (STAPHS) in a sample of 500 MSM. SED Core members developed adjustments for specificity of recency determinations that were much more realistic.

SED核心是一个资源，在经典和创新的研究设计和统计分析策略。随着该领域的发展，高影响力的艾滋病毒社会和行为研究的方法需求和设计选择正变得越来越复杂和多样化。设计和统计分析的创新方法对于解决美国NHAS [1]中概述的艾滋病毒流行病的关键研究和实施挑战至关重要，适用于解决资源丰富[3，4]和资源有限环境[5-9]中的差距[2]和实施差距。此外，重要的新试验已经证明了检测和治疗模式[10，11]、暴露前预防（PrEP）[12]、对感染者使用早期抗逆转录病毒治疗（ART）以预防进一步传播[13]、结核病和艾滋病毒治疗的整合[14，15]和局部杀微生物剂[16]的有效性。鉴于这些最新进展以及正在进行或计划进行的其他重大试验所带来的预期进展，对干预措施在扩大规模（通常与其他干预措施相结合）时的真实有效性进行严格研究的必要性从未如此之大。同样，经过深思熟虑的比较有效性研究、成本效益分析和数学建模的应用为政策制定和融入实践的潜力提供了信息。 SED核心领导和教师是国际公认的专家，在设计和进行临床[17-22]和行为[23，24]干预试验-无论是在美国和低-和中等资源国家-和复杂的决定因素研究，为他们提供信息。在核心支助下开发的艾滋病毒中心项目的例子包括关于新的艾滋病毒预防技术的可接受性和使用的研究，女用避孕套、杀微生物剂[23-27];针对不同性别的预防试验[23，24，28];以及高危男男性行为者（MSM）中的风险决定因素、血清阳性率和HIV检测动机。核心组织支持巴西制定和管理创新干预措施，以预防严重精神病患者感染艾滋病毒，并支持纽约[29]和南非[30，31]坚持抗逆转录病毒疗法。一系列关于儿童、青少年和家庭的研究，包括纽约市[32，33]围产期感染儿童的大型纵向队列研究，以及纽约市[34]、纽约州[35]和南非[36]高危青少年的干预措施，都依赖于SED核心提供的分析和数据管理基础。 SED核心教师自己进行了关于艾滋病毒发病率和流行率估计[37-40]的研究;与艾滋病毒检测[40，41]和诊断[42]相关的因素;诊断后与[43-45]和保留[46-48]艾滋病毒护理的联系;及时启动ART [49，50];以及其他艾滋病毒护理和治疗结果[47，48，51 -61]。他们一直处于响应美国NHAS和实施有效的HIV预防和治疗策略的最前沿，研究HIV感染者之间的差异[62]，政策影响[63]，数学建模[41，64]，比较有效性设计[17，18，20]和成本效益建模[65]。因此，通过SED核心，HIV中心研究人员将获得进一步推进该领域所需的专业知识，包括尖端的研究设计和统计分析、流行病学和数据管理技术。我们建立的咨询和沟通流程（见第5节）代表了中心研究人员和SED核心成员之间的成功整合。核心委员会在上一个周期举行的磋商会议见附录E.1。问题解决是SED核心性能的关键指标。几个简短的例子说明了核心如何在这方面发挥作用。核心与克劳德·安·梅林斯博士，关于为南非改编CHAMP-*：支持感染艾滋病毒的青年和家庭[36]，并与罗伯特·雷米恩博士，多媒体社会支持干预：坚持南非的艾滋病护理[30]，仔细确定这些NIH支持的试点干预研究的总体目标。试点研究必须确定辅助参数，如二元结局指标的患病率和关键连续结局的标准差，以便未来的大型研究可以正确和现实地计划。然而，效应量估计不是试点研究的适当目标。SED核心提供了为中心研究者提供有效支持，以在提交的提案中明确说明这些关键点，从而获得研究。经修订的RS 4试点赠款申请指南肯定了SED核心的方法和建议。 466统计。流行病学和数据管理核心Remien，Robert H。 Alex Carballo-Dieguez博士的研究阿根廷男性艾滋病毒危险行为的预测因素[66]显示，使用应答者驱动抽样和血清学检测试验检测500名MSM样本中的近期艾滋病毒血清转化（STAPHS），对艾滋病毒发病率的估计值异常高。SED核心成员为近因确定的具体性制定了更加现实的调整。