Secure web-based intake and tracking tools for CAM research and clinical practice

描述（由申请人提供）：本第一阶段小企业创新研究提案是对RFA-AT- 09-004临床研究CAM干预的转化工具的回应。提出的技术开发和测试项目将三个重要功能集成到一个动态数据收集和报告系统中。这个新系统的三个组成部分是：(1)ReliefInsite平台，这是一个复杂且用户友好的安全符合HIPAA的网络服务，基于开源技术，目前用于持续的患者评估和纵向报告，将为此开发新的应用程序；(2) TEAMSI，一个尖端的针灸图表记录工具，可以从患者那里收集额外的针灸特定临床信息，并轻松绘制针灸治疗图表；(3)结合来自NIH患者报告结果测量信息系统（PROMIS）和RTI国际CAM-PRO的患者-提供者互动测量的经过验证的患者报告结果测量，以及研究所需的人口统计数据和提供者信息。提出的系统将提供一个动态的数据收集工具，它将促进1)通过操作治疗方案的随机对照试验的疗效评估，以及2)通过捕获临床护理“真实世界”中正在发生的事情来研究结果研究的临床有效性。新系统的主要特点包括：在单一系统中合并患者和提供者文件；一种评估患者对治疗、药物和自我护理依从性的方法；评估干预措施的剂量反应和追踪不良事件的机会；提供标准化的治疗算法和必要的手动方法，以支持更严格的研究设计。该应用程序将整合各种条件和治疗方法的有用信息和措施，同时创建一个针对针灸的应用程序，以推进针灸研究，并作为未来CAM模式特定设计的原型。

DESCRIPTION (provided by applicant): This Phase I Small Business Innovation Research proposal is in response to RFA-AT- 09-004 Translational Tools for Clinical Studies of CAM Interventions. The proposed technology development and testing project integrates three important capabilities into one dynamic data collection and reporting system. The three components of this new system are (1) the ReliefInsite platform, a sophisticated and user-friendly secure HIPAA compliant web service, built on open-source technology, currently used for on-going patient assessment and longitudinal reporting for which new applications will be developed; (2) TEAMSI, a cutting edge documentation instrument for acupuncture charting to collect additional acupuncture-specific clinical information from patients and easily chart acupuncture treatments; and (3) incorporation of validated patient-reported outcome measures from the NIH Patient Reported Outcome Measurement Information System (PROMIS) and the RTI International CAM-PRO measures of patient-provider interaction, as well as demographics and provider information needed for research. The proposed system will provide a dynamic data collection tool that will facilitate both 1) the assessment of efficacy in randomized control trials of by operationalizing treatment protocols and 2) the study of clinical effectiveness in outcome studies by capturing what is going on in the "real world" of clinical care. Key features of the new system include: incorporation of both patient and provider documentation in a single system; a means to assess patient adherence to treatments, medications, and self-care; the opportunity to evaluate dose responses to the intervention and track adverse events; and a means to provide standardized treatment algorithms and manualization approaches necessary to support more rigorous study designs. The application will incorporate information and measures useful across conditions and treatment approaches, while creating an acupuncture-specific application to advance acupuncture research and serve as a prototype for future CAM modality-specific designs. PUBLIC HEALTH RELEVANCE: Given widespread use of complementary and alternative medicine (CAM) such as acupuncture, there is a need for translational research tools to support studies of safety, efficacy and clinical effectiveness of treatment for various conditions. The proposed project will develop a state of the art, user-friendly data collection system to seamlessly integrate data collected from patients and clinicians in clinical and research settings.