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.

Project Narrative Proposal Title: Video repositories for clinical research: Overcoming barriers and testing utility. Research into patient observation (a fundamental part of healthcare provision) methods and results has been limited, usually to small single center studies. A central repository that collects videos from multiple sites and a wide variety of subjects would be a powerful tool to advance this neglected area of clinical research, but there a number of concerns that have created barriers to their creation. The objectives of this proposal are to formulate a detailed guide to the successful creation of a clinical video repository, and to test its usefulness by inviting other sites to deposit videos of newborn resuscitations for a pilot study.