Evaluation and Administration Support for Pragmatic Trials

描述（由申请人提供）：资助者和决策者越来越意识到有必要支持反映现实世界卫生干预措施相对有效性的研究（预算办公室，2007年）。努力产生更多“基于实践的证据”（Green, 2006）的调查人员可能会面临意想不到的困难挑战，因为他们与社区伙伴合作，寻求在临床实践环境中开展高影响力、以患者为中心的研究，并与日益一体化的卫生信息技术环境进行谈判。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范围内（Glasgow和Emmons， 2007）。跟踪关键的试验指标和里程碑，并与研究人员密切合作以了解其进展，可以将注意力转移到与更高效和更健康相关的社会、组织和生态因素上

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.