High-Impact Trials Center: Techniques Development Component

项目摘要 最近的技术进步已经启动了生物传感器、可穿戴设备和生物传感器的蓬勃发展的新领域。 用于监测生理反应、运动模式、步数、卡路里消耗 饮食摄入卡路里计数和个人健康信息。这些工具的使用-在许多情况下是为了实现目标- 设置（例如，“每天10，000步”）--在所有年龄段的儿童和成人中迅速增长。在 与此同时，人们对将这些技术应用于生物医学研究的兴趣也越来越大。一 对于医学康复研究人员来说，特别有吸引力的研究应用是更多的潜在可能性。 严格的以家庭或社区为基础的干预性研究;能够收集生理或 其他有用的数据相对容易。这些技术将使研究人员能够进行T2-T3 研究，并为服务不足的残疾人或慢性病患者提供更多机会， 参与临床试验或其他基于家庭的干预研究。然而， 医疗康复领域缺乏对这些设备的有效性和可靠性测试。因此中央 P2C国家资源中心的技术开发组件（Tech-C）的目标， 影响医疗康复临床试验是填补该领域的一个重大空白，将催化更严格， 家庭医疗康复临床试验。我们将通过提供HITC验证来实现这一目标 实验室向全国医学康复界研究人员进行效度评价， 临床试验中用于远程数据收集的新型和现有工具和技术的可靠性。基础上 HITC验证实验室将提供资源和专业知识， 研究人员在他们的追求有用的，以家庭为基础的监测和干预技术。我们的中心目标 将通过以下具体目标实现：目标1。我们将在全国范围内进行需求评估， 与CCIT和Promo-C合作。目标2.通过调查全国医疗康复用户群， 研究人员（再次与CCIT和Promo-C合作），我们将与研究人员合作， 目前可用的，去识别的数据集进行分析，并帮助指导（通过咨询服务， 与Collab-C合作）开展短期、多地点试点研究， HITC验证实验室进行验证的数据集。目标3.与行业合作伙伴合作，其他 P2C资源中心和全国HITC用户群的调查人员，我们将进行内部调查。 对最常见的市售可穿戴设备和生物传感器设备进行验证研究。通过实现 为了实现这些目标，HITC验证实验室将满足对医疗保健的重要和不断增长的需求。 康复研究社区。

PROJECT SUMMARY Recent technological advances have initiated a booming new field of biosensors, wearable devices, and smartphone apps for monitoring physiological responses, movement patterns, step counts, caloric expenditure, dietary intake calorie counts, and personal health information. Usage of these tools – in many cases for goal- setting (e.g., “10,000 steps per day”) – is growing at a rapid pace among children and adults of all ages. In parallel, there is an ever-heightening interest in applying these technologies to biomedical research. A particularly attractive research application for medical rehabilitation researchers is the potential for more rigorous home-based or community-based interventional research; enabling the collection of physiological or other useful data with relative ease. Such technologies would empower researchers conducting T2-T3 research, and provide underserved persons with disabilities or chronic conditions more opportunities to participate in clinical trials or other home-based interventional studies. However, a major problem facing the medical rehabilitation field is a lack of validity and reliability testing of these devices. Therefore, the central goal of the Techniques Development Component (Tech-C) of the P2C National Resource Center for High- Impact Clinical Trials in Medical Rehabilitation is to fill a major gap in the field that will catalyze more rigorous, home-based medical rehabilitation clinical trials. We will achieve this goal by providing a HITC Validation Laboratory to the national community of medical rehabilitation researchers to evaluate the validity and reliability of novel and existing tools and technology used for remote data collection in clinical trials. Building on our own experiences, the HITC Validation Laboratory will provide the resources and expertise to assist researchers in their pursuit of useful, home-based monitoring and intervention technologies. Our central goal will be achieved via the following specific aims: Aim 1. We will conduct a nationwide needs assessment in collaboration with the CCIT and Promo-C. Aim 2. By surveying the national user base of medical rehabilitation researchers (again in collaboration with the CCIT and Promo-C), we will work with investigators to obtain currently available, de-identified datasets for analysis, and to help guide (via consultative services in collaboration with Collab-C) the development of short-term, multi-site pilot studies that would generate new datasets for validation by the HITC Validation Laboratory. Aim 3. In collaboration with industry partners, other P2C resource centers, and investigators across the national HITC user base, we will conduct in-house validation studies of the most common, commercially available wearable and biosensor devices. By achieving these aims, the HITC Validation Laboratory will meet a significant and growing need for the medical rehabilitation research community.