The Health ePeople Resource for Mobilized Research

 描述(由申请人提供)：我们寻求创建健康电子人资源，这是一个灵活、易于访问和可靠的基础设施，用于进行移动健康研究。这一努力将建立在目前的Health eHeart Study的基础上，这是一个基于互联网的临床研究平台，已从世界各地招募了20,000多名积极参与的参与者。虽然最初是为研究心血管疾病而开发的，但来自多个领域的研究人员正在使用Health eHeart，并帮助我们启动当前RFA中设定的许多目标。我们成功地实现了一个用户友好的界面，用于收集患者报告的结果、经过验证的调查数据以及与多个传感器、设备和应用程序的集成；我们拥有IRB批准的使用模块化电子同意的系统；我们有20,000多名有兴趣为移动健康研究做出贡献的深度参与者；我们开发了外部研究人员以可定制的方式利用和登记他们自己的参与者的方法；我们开发了研究管理门户网站(包括实时仪表板和基于参与者特征的过滤系统)和可供外部研究人员使用的灵活消息传递系统；我们建立了一个数据库和数据管理系统，旨在坚持隐私、安全和可靠性的最高标准；我们对该平台进行了迭代和调整，以利用新兴技术和尖端方法。在这些优势的基础上，我们准备充分利用该奖项提供的机会，将Health eHeart研究转化为通用的Health ePeople资源。Health ePeople的主要目标将是提供一种资源，使mHealth研究变得方便和高效。该资源将帮助研究人员通过与传感器、设备和应用程序的集成来收集mHealth数据，提供在线调查，与包括电子健康记录在内的外部数据源连接，并使用新方法来确定和判断临床结果事件。该资源将支持已在Health ePeople队列中登记的患者的使用，或外部招募的参与者的“共同登记”(和数据链接)。我们将利用我们的经验，吸引并同意20,000多名患者，以壮大和扩大世界各地有兴趣为移动健康研究做出贡献的参与者队列(Health EPeople Cohort)。该平台将支持应用程序的开发和验证，包括随机对照试验。这项工作将利用我们与基金会和患者倡导团体合作的经验，以及我们在PCORnet的地位，以及由此产生的与PCORI资助的多个大型临床数据研究网络的合作关系，这些网络可以提供对数亿患者及其电子健康记录的访问。我们将开发技术、程序和治理，以支持快速访问Health ePeople队列进行研究、数据共享、分析并与外部数据库集成。最后，我们将开发和测试各种模式，以提供获得Health ePeople资源和服务的机会，以确保在获奖期后的财务可持续性。

 DESCRIPTION (provided by applicant): We seek to create the Health ePeople Resource, a nimble, readily-accessible, and reliable infrastructure to conduct mHealth research. This effort will build on the current Health eHeart Study, an internet-based clinical research platform that has enrolled more than 20,000 engaged participants from around the world. Although initially developed to study cardiovascular disease, Health eHeart is in use by investigators from multiple fields, and helps us jumpstart many of the objectives set out in the current RFA. We have successfully implemented a user-friendly interface built to collect patient-reported outcomes, validated survey data, and integrations with multiple sensors, devices, and apps; we have an IRB approved system using modular electronic consenting; we have over 20,000 deeply involved participants interested in contributing to mHealth research; we have developed ways for external investigators to utilize and enroll their own participants in a customizable fashion; we have developed a study management portal (including a real-time dashboard and participant characteristic- based filtering system) and a flexible messaging system that can be utilized by external investigators; we have built a database and data management system constructed to adhere to the highest standards of privacy, security, and reliability; and we have iterated and adapted the platform to take advantage of emerging technology and cutting-edge methods. Building from these strengths, we are ready to fully leverage the opportunities afforded by this award, transforming the Health eHeart Study into a general Health ePeople Resource. The primary goal of Health ePeople will be to provide a resource that enables convenient and efficient mHealth research. The Resource will help investigators collect mHealth data via integration with sensors, devices, and apps, deliver online surveys, connect with external data sources including electronic health records, and use novel methods for ascertaining and adjudicating clinical outcome events. The Resource will support utilization of patients already enrolled in the Health ePeople Cohort or "co-enrollment" (and data linkage) of participants recruited externally. We will utilize our experience engaging and consenting more than 20,000 patients to grow and expand a world-wide cohort of participants (the Health ePeople Cohort) interested in contributing to mHealth research. The platform will support development and validation of apps, including randomized controlled trials. This effort will leverage our experience working with foundations and patient-advocacy groups as well as our position in PCORnet and the resultant collaborative relationships with multiple large PCORI-funded Clinical Data Research Networks that can provide access to hundreds of millions of patients and their electronic health records. We will develop the technology, procedures and governance to support rapid access to the Health ePeople cohort for research, data sharing, analyses and integration with external databases. Finally, we will develop and test various models for providing access to Health ePeople resources and services that will assure financial sustainability beyond the award period.