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: 9976814
• 负责人: Rhonda G. Kost
• 金额: $ 74.48万
• 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 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9976814
• 关键词: Accreditation; Address; Adoption; Benchmarking; Charge; Clinical; Clinical Research; Collaborations; Collection; Communication; Communities; Consensus; Consent; Custom; Data; Data Aggregation; Data Collection; Development; Device or Instrument Development; Enrollment; Equilibrium; Evaluation; Feedback; Foundations; Funding Agency; Goals; Grant; Health; Human; Informed Consent; Infrastructure; Institution; Leadership; Learning; Libraries; Measures; Metadata; Methods; Mission; Modeling; Motivation; Online Systems; 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; Time; Translational Research; Trust; Universities; Validation; Visualization software; Voice; dashboard; data integration; data interoperability; design; electronic data; empowered; evidence base; experience; improved; innovation; instrument; mobile computing; novel; programs; recruit; research and development; research study; success; tool; volunteer

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.

总结/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、机构及其联邦赞助者的高度优先事项。然而，在这方面， 研究人员通常缺乏工具、专业知识和技术，无法方便地收集参与者的反馈 需要以参与者响应的方式定制研究。一个短，高质量的验证工具，用于收集 参与者的经验数据已经可用，越来越多的调查人员希望使用它。 研究参与者感知调查（RPPS）是在许多参与者的投入下开发的， 其他利益攸关方。经过数千名研究参与者的测试，RPPS包含高度可靠的 一套可行的研究经验措施，包括沟通，同意，信任， 他人该项目的目标是创建创新的协作基础设施， 方便任何研究人员或机构使用。这一创新项目将形成一个合作努力 在六个临床转化科学获奖者（CTSA）机构和其他利益相关者中，谁将 联合收割机开发新的简化基础设施， 研究参与者对他们的研究经验的反馈。合作者和利益攸关方 将制定一个框架，包括一套共同的标准，以确保结果数据 跨机构的可比性，使用案例的建议，以说明数据如何可以 有价值，并将结果返回给利益相关者，用户指南和工具，以可视化结果 仪表板并进行关键分析。每个合作站点将调查一个或多个 方法和分享反馈，以完善基础设施，并展示他们的例子， 反馈可用于评估和改进研究实践。新的基础设施将共享 通过REDCap共享库与CTSA和其他REDCap用户广泛交流， 组件可以免费下载。用例的基础架构和结果将 通过演讲和出版物传播。新的基础设施将是高度可持续的， 因为REDCap被全球所有CTSA和3500多家机构使用。共享调查数据的能力 将允许创建基准，用于内部和跨部门的实践比较 机构职能体系RPPS调查，基础设施和基准用户的学习协作将 使利用跨网络的数据的力量来确定改进的优先级成为可能 研究和合作测试创新的影响。随时收集所需数据的能力 以参与者和社区响应的方式调整做法，有可能改善 研究参与者的经验，改善同意过程，改善代表招募，以及 加速研究完成，推进人类健康的发现。