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Validating a Scalable, Open Science Framework for Collecting Laboratory-Grade Data Remotely in Specialized Populations

验证可扩展的开放科学框架，用于在特殊人群中远程收集实验室级数据

基本信息

批准号：
10289016
负责人：
Bridgette Lynne Kelleher
金额：
$ 23.05万
依托单位：
PURDUE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-01 至 2023-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10289016
关键词：
Acute Address Assessment tool Attention Behavioral Biological Assay COVID-19 pandemic Calibration Caregivers Child Clinic Clinical Clinical Research Clinical Sciences Clinical Trials Cognitive Computer software Data Data Collection Development E-learning Ensure Equipment Failure Floor Fragile X Syndrome Funding Heart Rate Human Resources Individual Intellectual functioning disability Laboratories Measures Methods Modeling Monitor Multi-Institutional Clinical Trial Natural History Outcome Outcome Measure Output Parents Participant Patient Monitoring Patients Pharmaceutical Preparations Population Positioning Attribute Procedures Process Protocols documentation Psychophysiology Publishing Research Research Personnel Resources Science Signal Transduction Site Standardization Symptoms Techniques Testing Time Training Translating Travel United States National Institutes of Health base clinical outcome measures cohort cost cost effective data analysis pipeline data standards efficacy validation graphical user interface high risk population improved innovation network models open data patient response peer programs remote delivery self-directed learning skills sustained attention telehealth tool treatment trial user friendly software user-friendly virtual

项目摘要

PROJECT SUMMARY The limited repertoire of clinical outcome measures suitable for children with intellectual and developmental disabilities (IDD) is compromising the promise of clinical trials. Non-standardized laboratory techniques that capture “spectral” signals – such as psychophysiological assays – are increasingly recognized as promising methods for monitoring patient responses over time. However these tools require specialized equipment and personnel to administer and are not easily deployed via telehealth, biasing spectral studies toward patients who are able and willing to travel to clinics. Thus, there is a significant gap in available telehealth-based protocols for collecting laboratory-grade data remotely in IDD populations. The present study addresses this gap by developing a comprehensive training protocol for PANDABox (Parent Assisted Neurodevelopmental Assessment), an open-science, telehealth-based assessment protocol that PI Kelleher developed for remotely collecting high quality, integrated clinical, behavioral, and spectral assays from participants with IDD. Published findings indicate that PANDABox is highly feasible and acceptable to caregivers and generates high quality, integrated, “laboratory-grade” data at low cost. Already, PANDABox is being deployed in a variety of treatment and natural history studies across IDD populations and is being translated to Spanish to promote accessibility. The present study aims to enhance the scalability of PANDABox by accomplishing two specific aims. First, we will develop and validate an open-science training protocol and peer-to-peer reliability network to facilitate standardized, cross-laboratory implementation of the PANDABox protocol in IDD. This protocol will include both a virtual training hub for self-paced training, as well as a reliability network to facilitate cross-site calibration. Second, we will create user-friendly software program to support users to efficiently process the PANDABox attention assay, which has produced promising outcomes in clinical trials but requires computational expertise to analyze, limiting its scalability. Addressing these gaps would shift the status quo of clinical science in IDD by (1) providing a scalable, accessible protocol for collecting laboratory- grade data remotely in IDD populations and (2) producing standardized data outputs necessary for large scale, multi-site, collaborative science.

项目总结