Evaluation and Administration Support for Pragmatic Trials

描述(由申请人提供)：资助者和政策制定者越来越意识到有必要支持反映真实世界、卫生干预措施的相对有效性的研究(CBO，2007)。致力于产生更多“基于实践的证据”(Green，2006)的研究人员可能会面临意想不到的困难挑战，因为他们与社区合作伙伴合作，寻求在临床实践环境中进行高影响力、以患者为中心的研究，并协商日益整合的卫生信息技术环境。然而，研究翻译的多重障碍可能在研究人员和程序开发人员的控制之下(Glasgow and Emmons，2007)。跟踪关键的试验指标和里程碑，并与调查人员密切合作以了解他们的进展，可以将注意力集中在与更有效和 有效的试验规划和实施。美国国立卫生研究院(NIH)计划支持12个不同的(跨六个NIH研究所)低成本、务实、以患者为中心的随机对照试验，这为我们提供了机会，在进行这些潜在的高影响试验时，提高我们目前对“什么是有效的”的认识，并系统地评估所需设计元素对试验效率、成本和影响等关键指标的影响。NIH正在寻求一个评估和行政协调中心，以评估有助于在UH2规划阶段(第1年)和UH3实施阶段(第2至第5年)取得成功的方法和过程。UH2规划阶段将侧重于每个受赠者实现启动和规划里程碑的效率，评估试验准备所需的时间，并评估与成功相关的战略。在UH3实施阶段，评估将考虑招募的及时性、患者留住、使用综合 电子资源，以及回答关键研究问题的能力。评估和行政协调中心将(1)对根据RFA-HL-14-019资助的试验的准备情况和成功情况进行以利用为重点的混合方法计划评估；以及(2)通过为RFA-HL-14-019资助的试验提供行政支持来支持NIH，包括协助受赠者记录里程碑、沟通任务和会议后勤。

DESCRIPTION (provided by applicant): Funders and olicymakers have become increasingly aware of the need to support studies that reflect the real world, comparative effectiveness of health interventions (CBO, 2007). Investigators striving to generate more "practice-based evidence" (Green, 2006) may be faced with unexpected and difficult challenges as they collaborate with community partners, seek to conduct high-impact, patient-centered research in clinical practice settings, and negotiate an increasingly integrated health information technology environment. However, the multiple barriers to research translation are potentially within the control of researchers and program developers (Glasgow and Emmons, 2007).Tracking critical trial metrics and milestones, and working closely with investigators to understand their progress, can direct attention to social, organizational, and ecological factors linked to more efficient and effective trial planning and implementation. The National Institutes of Health (NIH) initiative to support a group of 12 varied (across six NIH institutes) low-cost, pragmatic, patient-centered RCTs provides the opportunity to improve our current knowledge of "what works" when conducting these potentially high-impact trials and to systematically evaluate the impact of the required design elements on key metrics such as trial efficiency, cost, and impact. The NIH is seeking an evaluation and administration coordinating center to assess methods and processes that contribute to success during the UH2 planning phase (Year 1) and the UH3 implementation phase (Years 2 to 5). The UH2 planning phase will focus on how efficiently each grantee achieves start-up and planning milestones, assess time required for trial readiness, and evaluate strategies associated with success. During the UH3 implementation phase, the evaluation will consider the timeliness of recruitment, patient retention, success using integrated electronic sources, and the ability to answer key research questions. The evaluation and administrative coordinating center will (1) conduct a utilization-focused, mixed-methods program evaluation of the readiness and success of the trials funded under RFA-HL-14-019; and (2) support the NIH by providing administrative support for trials funded under RFA-HL-14-019, including assisting grantees with documentation of milestones, communication tasks, and meeting logistics.