Empowering the Participant Voice: Collaborative Infrastructure and Validated Tools for Collecting Participant Feedback to Improve the Clinical Research Enterprise

赋予参与者声音：用于收集参与者反馈以改进临床研究企业的协作基础设施和经过验证的工具

• 批准号: 10612803
• 负责人: Rhonda G. Kost
• 金额: $ 64.31万
• 依托单位: ROCKEFELLER UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-05-18 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10612803
• 关键词: Acceleration; Accreditation; Address; Adoption; Benchmarking; Charge; Clinical Research; Collaborations; Collection; Communication; Communities; Consensus; Consent; Custom; Data; Data Aggregation; Data Collection; Dedications; Development; Device or Instrument Development; Enrollment; Evaluation; Feedback; Foundations; Funding Agency; Goals; Grant; Health; Human; Informed Consent; Infrastructure; Institution; Leadership; Learning; Libraries; Measures; Metadata; Methods; Mission; Modeling; Motivation; Operations Research; Outcome Measure; Participant; Patients; Perception; Population; Process; Publications; Recommendation; Research; Research Infrastructure; Research Personnel; Research Priority; Research Project Grants; Resources; Secure; Site; Specific qualifier value; Standardization; Surveys; Technology; Testing; Translational Research; Trust; Universities; Validation; Visualization; Visualization software; Voice; clinical translation; dashboard; data integration; data interoperability; design; electronic data; empowerment; evidence base; experience; implementation barriers; implementation evaluation; improved; innovation; instrument; mobile computing; novel; programs; recruit; research and development; research study; success; technological innovation; tool; volunteer; web app

Summary/Abstract Partnering with research participants in order to understand and improve their experiences in research participation is a high priority for research investigators, institutions and their federal sponsors. However, researchers often lack the tools, expertise, and technology to easily collect the participant feedback needed to tailor studies in participant-responsive ways. A short, high quality validated tool for collecting participant experience data is already available, and increasingly investigators want to use it. The Research Participant Perception Survey (RPPS) was developed with the input of many participants and other stakeholders. Tested in thousands of research participants, the RPPS contains a highly reliable set of actionable measures of the research experience, including communication, consent, trust, and others. The goal of this project is to create innovative collaborative infrastructure to make the survey easy for any investigator or institution to use. This innovative project will form a collaboration effort among six Clinical Translational Science Awardee (CTSA) institutions and other stakeholders, who will combine their strengths to develop new streamlined infrastructure to enable routine collection of research participants’ feedback about their research experiences. The collaborators and stakeholders will develop a framework including a common set of standards to make sure the result data are comparable across institutions, recommendations for use cases to illustrate how the data can be valuable, and for returning results to stakeholders, user guides, and the tools to visualize the results on a dashboard and to conduct key analyses. Each collaborating site will survey participants in one or more ways and share feedback to refine the infrastructure and to showcase their examples of how participant feedback can be used to evaluate and improve research practices. The new infrastructure will be shared widely with the CTSAs and other REDCap users through the REDCap Shared Library, where all the components can be downloaded without charge. The infrastructure and results of use cases will be disseminated through presentations and publications. The new infrastructure will be highly sustainable, as REDCap is used by all CTSAs and over 3500 institutions worldwide. The ability to share survey data confidentially will allow the creation of benchmarks for comparison of practices within and across institutions. A learning collaborative of users of the RPPS surveys, infrastructure, and benchmarks, will make it possible to leverage the power of data across networks to identify priorities for improving research and collaborate on testing innovations for impact. The ability to readily collect the data needed to tailor practices in participant- and community-responsive ways, has the potential to improve the research participant experience, improve the consent process, improve representative recruitment, and accelerate study completion, to advance discoveries in human health.

摘要/摘要 与研究参与者合作，以了解和改善他们的研究经验 参与是研究人员、机构及其联邦资助者的首要任务。 研究人员往往缺乏工具、专业知识和技术来轻松收集参与者的反馈 需要以参与者响应的方式定制研究，用于收集简短的、高质量的、经过验证的工具。 参与者的经验数据已经可用，并且越来越多的研究人员希望使用它。 研究参与者认知调查 (RPPS) 是根据许多参与者的意见而制定的 RPPS 经过数千名研究参与者的测试，包含高度可靠的信息。 研究经验的一套可行措施，包括沟通、同意、信任和 该项目的目标是创建创新的协作基础设施来进行调查。 任何研究者或机构都可以轻松使用这个创新项目将形成协作努力。 六家临床转化科学奖获得者 (CTSA) 机构和其他利益相关者将 结合他们的优势开发新的简化基础设施，以实现日常收集 研究参与者对其研究经历的反馈。 将开发一个包括一套通用标准的框架，以确保结果数据 跨机构进行比较，推荐使用案例来说明数据如何 有价值的，并将结果返回给利益相关者、用户指南和可视化结果的工具 每个合作站点将调查一个或多个参与者。 方式并分享反馈来完善基础设施并展示参与者如何 反馈可用于评估和改进研究实践。 通过 REDCap 共享库与 CTSA 和其他 REDCap 用户广泛交流，其中所有 组件可以免费下载。基础设施和用例的结果将是。 通过演示和出版物进行传播。 因为 REDCap 被全球所有 CTSA 和 3500 多个机构使用，能够共享调查数据。 保密将允许创建基准来比较内部和外部的实践 RPPS 调查、基础设施和基准的用户之间的学习合作将 使利用跨网络数据的力量来确定改进的优先事项成为可能 研究并协作测试创新的影响力 轻松收集所需数据的能力。 以参与者和社区响应的方式定制实践，有可能改善 研究经验，改进同意程序，改进代表招募，以及 加速研究完成，推进人类健康领域的发现。