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:
  • 金额:
    $ 23.05万
  • 依托单位:
  • 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

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 适用于智力和智力障碍儿童的有限的临床结果衡量标准 发育性残疾(IDD)正在损害临床试验的前景。非标准化 捕捉“光谱”信号的实验室技术--如心理生理学分析-- 越来越多地被认为是随着时间的推移监测患者反应的有前途的方法。 然而,这些工具需要专门的设备和人员来管理,而不是 通过远程医疗轻松部署,将光谱研究偏向有能力和意愿的患者 去诊所旅行。因此,现有的基于远程健康的协议在以下方面存在显著差距 在缺碘人群中远程收集实验室级别的数据。本研究旨在解决这一问题 通过为PANDABox(家长协助)制定全面的培训方案来实现GAP 神经发育评估),这是一种基于远程健康的开放科学评估方案, Pi Kelleher开发用于远程收集高质量、集成的临床、行为和 IDD参与者的光谱分析。公布的研究结果表明,PANDABox具有很高的 可行且可接受的照顾者,并产生高质量的、集成的“实验室级” 以低成本获得数据。PANDABox已经被部署在各种治疗和天然药物中 跨IDD人群的历史研究,正在被翻译成西班牙语以促进 可访问性。本研究的目的是通过实现PANDABox的可伸缩性 有两个明确的目标。首先,我们将制定和验证一项开放科学培训方案,并 点对点可靠性网络,以促进标准化、跨实验室实施 IDD中的PANDABox协议。该协议将包括用于自定进度的虚拟培训中心 培训,以及一个可靠性网络,以促进跨地点校准。第二,我们将创造 人性化的软件程序,支持用户高效处理PANDABox注意事项 化验,在临床试验中产生了有希望的结果,但需要计算 专业知识难以分析,限制了其可扩展性。解决这些差距将改变 IDD的临床科学通过(1)提供可扩展的、可访问的协议来收集实验室- 在缺碘人群中远程评分数据和(2)产生必要的标准化数据输出 适用于大规模、多站点、协作科学。

项目成果

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Bridgette Lynne Kelleher其他文献

Bridgette Lynne Kelleher的其他文献

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{{ truncateString('Bridgette Lynne Kelleher', 18)}}的其他基金

Optimizing a Personalized Health Approach for Virtually Treating High-Risk Caregivers During COVID-19 and Beyond
优化个性化健康方法,以虚拟方式治疗 COVID-19 期间及之后的高风险护理人员
  • 批准号:
    10363469
  • 财政年份:
    2022
  • 资助金额:
    $ 23.05万
  • 项目类别:
Optimizing a Personalized Health Approach for Virtually Treating High-Risk Caregivers During COVID-19 and Beyond
优化个性化健康方法,以虚拟方式治疗 COVID-19 期间及之后的高风险护理人员
  • 批准号:
    10709470
  • 财政年份:
    2022
  • 资助金额:
    $ 23.05万
  • 项目类别:
Telehealth Assessment of Syndromic Autism Risk in Infants
婴儿综合症自闭症风险的远程医疗评估
  • 批准号:
    10181077
  • 财政年份:
    2017
  • 资助金额:
    $ 23.05万
  • 项目类别:
Telehealth Assessment of Syndromic Autism Risk in Infants
婴儿综合症自闭症风险的远程医疗评估
  • 批准号:
    9386578
  • 财政年份:
    2017
  • 资助金额:
    $ 23.05万
  • 项目类别:
Predicting Autism through Behavioral and Biomarkers of Attention in Infants
通过婴儿注意力的行为和生物标志物预测自闭症
  • 批准号:
    8575340
  • 财政年份:
    2011
  • 资助金额:
    $ 23.05万
  • 项目类别:
Predicting Autism through Behavioral and Biomarkers of Attention in Infants
通过婴儿注意力的行为和生物标志物预测自闭症
  • 批准号:
    8254642
  • 财政年份:
    2011
  • 资助金额:
    $ 23.05万
  • 项目类别:
Predicting Autism through Behavioral and Biomarkers of Attention in Infants
通过婴儿注意力的行为和生物标志物预测自闭症
  • 批准号:
    8391338
  • 财政年份:
    2011
  • 资助金额:
    $ 23.05万
  • 项目类别:

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