Video repositories for clinical research: Overcoming barriers and testing utility

用于临床研究的视频存储库：克服障碍和测试实用性

• 批准号: 10523823
• 负责人: Elizabeth Foglia
• 金额: $ 24.96万
• 依托单位: VIRGINIA COMMONWEALTH UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10523823
• 关键词: Address; Agreement; Apgar Score; Area; Biological Specimen Banks; Blood Tests; Caring; Catchment Area; Characteristics; Clinical; Clinical Assessment Tool; Clinical Data; Clinical Research; Clinical Trials; Data; Data Aggregation; Data Security; Deposition; Development; Discipline of obstetrics; Disease; Elements; Enrollment; Ensure; Fostering; Funding Mechanisms; Future; General Population; Genetic; Glasgow Coma Scale; Goals; Guidelines; Health system; Healthcare; Individual; Institutional Review Boards; Legal; Legal system; Manuals; Measurable; Measures; Medical; Methods; Modification; Newborn Infant; Outcome; Outcomes Research; Paper; Parents; Parkinson Disease; Patient observation; Patients; Pediatrics; Persons; Pilot Projects; Practice Guidelines; Privacy; Process; Provider; Rare Diseases; Registries; Regulation; Reproducibility; Research; Research Personnel; Resuscitation; Rheumatoid Arthritis; Risk; Sampling; Sampling Biases; Science; Security; Site; Software Tools; Source; Standardization; Subjects Selections; Surveys; System; Technology; Telemedicine; Testing; Training; Validation; Validity and Reliability; Variant; Video Recording; Work; base; behavior measurement; biobank; clinical data repository; clinical research site; data registry; design; improved; innovation; large datasets; neglect; neonatal resuscitation; prevent; prototype; repository; social determinants; study population; telehealth; tool

Project Summary Patient observation is a cornerstone of provider assessment. In addition, observations are often included in clinical scoring systems, such as the Glasgow Coma Scale and the Apgar Score, which are used to classify patients and in research as surrogate outcomes. Most observation data, however, is subject to significant problems with inter-rater reliability, which makes them less robust compared with objective measurable data such as blood test values. This unreliability is due in part to using limited, unrepresentative subject samples during their creation and validation. To overcome this problem, the recommended approach is to use large data sets from a variety of sources. This has led to the creation of data registries and biorepositories. To date, however, there are almost no examples of repositories which curate observations via video recording. While the overall framework for the design and management of other registries and repositories is well established, concerns regarding privacy/security and liability risk have prevented video repository formation. The primary objective of this study is to design solutions to these concerns and produce a guideline or manual for the creation of clinical video repositories. The project is innovative in that very few such repositories currently exist, despite their clear advantages for improving observational science. The first Aim is to create a roadmap for a clinical video repository, using two sites to increase the likelihood of identifying barriers. Groups of stakeholders will be established at each site, to include Institutional Review Board officials, health system legal/compliance officials, and video subjects (parents of newborns for this prototype). Existing best practices guidelines will be modified to address video related issues, and completely anonymized videos will be created using inexpensive technology. The stakeholders will be engaged in an iterative Delphi-like process to judge the acceptability of proposed repository regulations and the anonymized videos, finally creating a complete guidance document for video repositories. The second Aim will be to test the utility of a prototype clinical video repository by a) inviting other sites to participate, to ensure the generalizability of the agreement and b) establish a newborn resuscitation video repository and use the videos to identify and then test observations made during resuscitation for their ability to differentiate between normal and abnormal newborn transitions. These could would subsequently be used for clinical studies to establish newborn assessment measures that are applicable to the current state of newborn resuscitation. Having a well-accepted system to accrue and use videos for clinical research will improve observational assessment reproducibility and open new areas of research, such as in improving telehealth interactions.

项目概要 患者观察是提供者评估的基石。此外，观察结果通常包含在 临床评分系统，例如格拉斯哥昏迷量表和阿普加评分，用于分类 患者和研究中作为替代结果。然而，大多数观测数据都受到显着影响 评估者间的可靠性问题，这使得它们与客观可测量数据相比不太稳健 例如血液检查值。这种不可靠性部分是由于使用了有限的、不具有代表性的受试者样本 在其创建和验证过程中。为了解决这个问题，推荐的方法是使用大数据 来自各种来源的集合。这导致了数据登记和生物样本库的创建。然而，迄今为止， 几乎没有通过视频记录来管理观察结果的存储库的例子。虽然整体 其他登记处和存储库的设计和管理框架已经完善，关切 关于隐私/安全和责任风险阻止了视频存储库的形成。主要目标 本研究旨在针对这些问题设计解决方案，并为创建临床治疗制定指南或手册。 视频存储库。该项目的创新之处在于，目前这样的存储库很少存在，尽管它们明确 改进观测科学的优势。第一个目标是为临床视频创建路线图 存储库，使用两个站点来增加识别障碍的可能性。利益相关者群体将 在每个地点设立，包括机构审查委员会官员、卫生系统法律/合规官员、 和视频主题（此原型的新生儿父母）。现有最佳实践指南将被修改 为了解决视频相关问题，将使用廉价技术创建完全匿名的视频。 利益相关者将参与类似德尔菲法的迭代过程来判断提议的可接受性 存储库法规和匿名视频，最终创建完整的视频指导文档 存储库。第二个目标是通过 a) 邀请其他人来测试原型临床视频存储库的实用性 参与地点，以确保协议的普遍性和 b) 建立新生儿复苏 视频存储库，并使用视频来识别并测试复苏期间的观察结果 区分正常和异常新生儿转变的能力。这些随后可能会是 用于临床研究，建立适用于当前状况的新生儿评估措施 新生儿复苏。拥有一个广为接受的系统来积累和使用视频进行临床研究将会有所改善 观察评估的可重复性并开辟新的研究领域，例如改善远程医疗 互动。