Statistics, Epidemiology and Data Management

统计、流行病学和数据管理

• 批准号: 8999008
• 负责人: BRUCE LEVIN
• 金额: $ 24.59万
• 依托单位: NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8999008
• 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 Treatment; Clinical Trials Data Monitoring Committees; Collection; Communicable Diseases; Communication; Communities; Complex; Consultations; Cost Effectiveness Analysis; Country; Data; Detection; Development; Diagnosis; Discipline; Doctor of Philosophy; Effectiveness of Interventions; Emerging Technologies; Ensure; Epidemic; Epidemiology; Equation; Faculty; Family; Female Condoms; Formulation; Foundations; Future; Gender; Geographic Information Systems; Goals; Guidelines; HIV; HIV Seropositivity; HIV prevention trial; HIV risk; HIV/TB; 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; Prevention trial; 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; Social support; South Africa; Specificity; Staging; Statistical Data Interpretation; Statistical Models; Subgroup; System; Techniques; Technology; Testing; Thinking; Treatment outcome; United States National Institutes of Health; Work; Youth; antiretroviral therapy; arm; behavioral outcome; behavioral study; cohort; comparative effectiveness; cost effectiveness; data integrity; data management; design; distributed data; effectiveness research; experience; high risk; high standard; high-risk adolescents; 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; trial design

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核心是经典和创新研究设计和统计的资源 分析策略。随着领域的发展，对高影响HIV的社会和行为研究的方法论需求和设计选择变得越来越复杂和潜水。设计和统计分析的创新方法对于应对美国NHAS [1]所述的HIV流行的关键研究和实施挑战至关重要，适用于解决分布[2]和资源丰富[3,4]和资源限制的设置[5-9]中的分布[2]和实施差距。另外，重要的新试验证明了测试和治疗范式[10,11]，暴露前预防（PREP）[12] [12]，早期抗逆转录病毒疗法（ART）与感染者预防进一步传播[13] [13]，TB和HIV治疗的整合[14,15]，以及最新的Microbicides [16]，以及这些最新的[16] [16]，这些[16]，这些[16]，这些[16]，这些[16]，这些[16] [16]。正在进行或计划中，需要对干预措施的现实世界有效性进行严格研究（通常与其他干预措施结合使用）从未有所更大。同样，对比较有效性研究，成本效益分析和数学建模的良好应用程序的应用，为策略制定和将整合到实践中的潜力提供了信息。 SED核心领导力和教职员工是国际公认的临床设计和行为[17-22]和行为[23,24]干预试验的专家，无论是在美国还是在低层和中期国家 - 以及详尽的确定的研究。在核心支持的支持下开发的HIV中心项目的例子包括有关新艾滋病毒预防技术的可接受性和使用的研究，例如女性避孕套，菌心[23-27]；性别特异性预防试验[23,24,28]；以及与男性发生性关系的高风险男性（MSM）中艾滋病毒测试的风险，塞拉力率和电动机的决定者。该核心支持巴西严重精神病患者的创新干预措施的创新干预措施的发展和数据管理，并遵守纽约艺术[29]和南非[30,31]。一系列有关儿童，青少年和家庭的研究，包括纽约市的围产期感染儿童（NYC）[32,33]的大量纵向同龄人和NYC [34]，纽约州（NYS）（NYS）[35] [35]和南非[36]的高风险青少年的干预措施依赖于该分析和数据管理的核心。 SED核心教师本身就艾滋病毒事件和患病率估计进行了研究[37-40]；与HIV检测[40,41]和诊断[42]相关的因素；诊断后[46-48]艾滋病毒护理中的[43-45]和保留率；及时的艺术启动[49,50]；以及其他艾滋病毒护理和治疗结果[47,48,51-61]。他们一直处于对美国NHA的反应以及实施有效的HLV预防和治疗策略的最前沿，并研究了患有艾滋病毒的人[62]，政策含义[63]，数学建模[41,64]的研究[17,18,20]，以及成本效益的模型[65]。通过SED核心，艾滋病毒中心研究人员将可以通过尖端研究设计和统计分析，流行病学和数据管理技术进一步推进该领域所需的专业知识。 我们既定的咨询和沟通过程（请参阅第5节）代表了中心调查员与SED核心成员之间的成功整合。核心在上一个周期举行的咨询会议在附录E.L.中提供。解决问题是SED核心性能的关键指标。一些简短的例子说明了核心如何以这种身份工作。 �核心与克劳德·安·梅林斯（Claude Ann Mellins）博士合作，以适应南非的冠军 - * - 支持艾滋病毒感染的青年和家庭[36]以及与罗伯特·雷米安（Robert Remien）博士的多媒体社会支持干预：遵守南非的艾滋病毒护理[30]，以仔细识别这些NIH支持的试点干预研究的一般目标。试点研究必须确定辅助参数，例如二进制结果指标的流行率和关键连续结果的标准出发，以便可以正确地和现实地计划未来的大型研究。 但是，效应尺寸估计并不是试点研究的正确目标。提供的SED核心 有效的支持中心调查人员在提交的提案中清楚地说明了这些要点，这些提案导致了颁发的研究。 SED核心的方法和建议受RS4试点赠款申请的修订指南的影响。 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风险行为的预测因素[66]表明，使用受访者驱动的采样和血清学测试测定法检测了500 MSM样本中最近的HIV血清转化（孔），很少使用受访者驱动的采样和血清学测试测定法。 SED核心成员对更现实的新近度确定的特异性进行了调整。