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

描述(由申请人提供)：本第一阶段小型企业创新研究提案是对RFA-AT-09-004《CAM干预临床研究翻译工具》的响应。拟议的技术开发和测试项目将三个重要能力整合到一个动态数据收集和报告系统中。这个新系统的三个组件是(1)ReliefInsite平台，这是一个复杂且用户友好的安全HIPAA兼容Web服务，它基于开源技术构建，目前用于持续的患者评估和纵向报告，并将为其开发新的应用程序；(2)TEAMSI，一个用于针灸图表的尖端文档工具，可以从患者那里收集更多特定针灸的临床信息，并轻松绘制针灸治疗图表；以及(3)纳入NIH患者报告结果衡量信息系统(PROIS)和RTI International CAM-PRO患者与提供者互动措施，以及研究所需的人口统计和提供者信息。拟议的系统将提供一种动态数据收集工具，这将有助于1)通过实施治疗方案来评估随机对照试验的疗效，以及2)通过捕捉临床护理的“真实世界”所发生的情况来研究结果研究中的临床有效性。新系统的主要特点包括：将患者和提供者的文件合并到一个系统中；评估患者对治疗、药物和自我护理的依从性的手段；评估对干预措施的剂量反应和跟踪不良事件的机会；以及提供支持更严格的研究设计所需的标准化治疗算法和手册方法的手段。该应用程序将整合跨条件和治疗方法的有用信息和措施，同时创建针灸专用应用程序，以推进针灸研究，并作为未来CAM特定模式设计的原型。 公共卫生相关性：鉴于补充和替代医学(CAM)的广泛使用，如针灸，需要翻译研究工具来支持对各种疾病治疗的安全性、有效性和临床有效性的研究。拟议的项目将开发一种最先进的、用户友好的数据收集系统，以无缝地整合从临床和研究环境中的患者和临床医生收集的数据。

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.