Video repositories for clinical research: Overcoming barriers and testing utility

项目摘要 患者观察是提供者评估的基石。此外，观察结果往往包括在 临床评分系统，如格拉斯哥昏迷量表和阿普加评分，用于分类 患者和研究作为替代结果。然而，大多数观测数据都受到重大影响。 评分者间可靠性的问题，这使得它们与客观的可测量数据相比不那么稳健 例如血液测试值。这种不可靠性部分是由于使用有限的，不具代表性的主题样本 在其创建和验证过程中。为了克服这个问题，推荐的方法是使用大数据 来自各种来源的集合。这导致了数据登记册和生物储存库的建立。然而，迄今为止， 几乎没有通过视频记录来管理观测的资料库的例子。而整体 其他登记册和储存库的设计和管理框架已经建立， 关于隐私/安全性和责任风险的风险已经阻止了视频存储库的形成。的主要目的 本研究旨在为这些问题设计解决方案，并为创建临床 视频仓库该项目的创新之处在于，目前很少有这样的储存库存在，尽管它们有明确的 改善观测科学的优势。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。利益攸关方团体将 在每个研究中心建立，包括机构审查委员会官员、卫生系统法律的/合规官员， 和视频对象（对于这个原型来说是新生儿的父母）。将修改现有的最佳做法准则 为了解决视频相关问题，将使用廉价的技术制作完全匿名的视频。 利益相关者将参与一个迭代的类似德尔菲的过程，以判断建议的可接受性。 存储库规则和匿名视频，最后为视频创建一个完整的指导文档 储存库。第二个目标将是测试原型临床视频库的实用性，方法是：a）邀请其他 研究中心参与，以确保协议的普遍性和B）建立新生儿复苏 视频库，并使用视频来识别，然后测试在复苏过程中观察到的 区分正常和异常新生儿过渡的能力。这些可能随后将成为 用于临床研究，以建立适用于当前状态的新生儿评估措施， 新生儿复苏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改善 观察评估的可重复性和开放新的研究领域，如改善远程医疗 交互.

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.