Research Platform Integrating Patient Reported and Clinical Outcomes Data Sources

整合患者报告和临床结果数据源的研究平台

• 批准号: 8394790
• 负责人: John Christopher Weiss
• 金额: $ 14.95万
• 依托单位: DYNAMIC CLINICAL SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-01 至 2013-08-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8394790
• 关键词: Address; Area; Blinded; Budgets; Clinical; Clinical Data; Clinical Research; Clinical Trials; Computerized Medical Record; Cost Control; Data; Data Collection; Data Sources; Databases; Face; FarGo; Frequencies; Genetic Transcription; Goals; Gold; Health; Individual; Information Technology; Link; Logic; Manuals; Online Systems; Outcome; Outcome Measure; Participant; Patient Outcomes Assessments; Patients; Phase; Phase IV Clinical Trials; Process; Prospective Studies; Reporting; Research; Research Contracts; Research Personnel; Resources; Sample Size; Secure; Site; Solutions; Specific qualifier value; System; Testing; Time; Translational Research; Trees; Update; base; comparative; cost; design; experience; innovation; large-scale database; prospective; prototype; repository; routine care; tool; usability; user-friendly

DESCRIPTION (provided by applicant): While large, prospective, blinded trials are the gold standard in clinical research, they require significant commitments of resources and time. Further, since these trials seek the answer to rather specific questions, the applicability and scalability of data obtained in these large trials is limited by the way in which it was collected. These trials will likely continue to be the final word in translational research, but in the face o contracting research budgets it is increasingly important to conduct only those studies that have a reasonable likelihood of answering the research hypotheses. Another reality of large, prospective clinical studies is that study designers must make a number of critical decisions (e.g., sample size) before the first data are collected. While statistical analyses exist to estimae sample size, they are often based on incomplete and sometimes insufficient preliminary information. Prior to embarking on an expensive prospective study, it would be particularly advantageous for investigators to have access to a large repository of high quality, codified, de- identified patient data. Given the recent ascension and recognized importance of patient reported outcomes (PRO) data in clinical trials, Dynamic Clinical Systems (DCS) is developing a research platform to open access to its large scale database of clinical PRO data. DCS will provide a unique and innovative solution that enables sustainable data collection and secure data access by opening its Web-based PRO system to researchers. This will provide researchers with access to de-identified PRO data broadly collected during routine care and in clinical studies. Further, DCS will boost the breadth and depth of its PRO data by integrating with complementary data sources and linking longitudinal patient-centric data. The result will be a continuously populating, secure PRO database available to researchers through a user-friendly interface. In Phase I we will 1) integrate our PRO database with a partner database to demonstrate feasibility and 2) create a prototype interface for research access. Feasibility will be established if the integration prototype seamlessly transfers data and passes tree test scenarios. We will test usability by querying clinical researchers as they use the interface prototype. PUBLIC HEALTH RELEVANCE: Patient-reported outcomes (PRO) measured with sophisticated, yet easy-to-use assessments are a key way in which patients and study participants can communicate with their clinician or study coordinator, respectively. Dynamic Clinical Systems is developing an information technology solution that automates this process so that clinical trials are less expensive, require fewer numbers of participants, are less burdensome, and collect information about the patient's experience from the patient's perspective.

描述（由申请人提供）：虽然大型、前瞻性、盲法试验是临床研究的金标准，但它们需要大量的资源和时间。此外，由于这些试验寻求相当具体的问题的答案，在这些大型试验中获得的数据的适用性和可扩展性受到其收集方式的限制。 这些试验可能仍然是转化研究的最终决定因素，但面对不断收缩的研究预算，只进行那些有合理可能回答研究假设的研究变得越来越重要。大型前瞻性临床研究的另一个现实是，研究设计者必须做出许多关键决策（例如，在收集第一批数据之前，虽然存在统计分析来估计样本量，但它们通常基于不完整的，有时是不充分的初步信息。在开始一项昂贵的前瞻性研究之前，研究者能够访问一个大型的高质量、编码化、去识别化的患者数据库将是特别有利的。鉴于近期临床试验中患者报告结局（PRO）数据的Ascension和公认的重要性，Dynamic Clinical Systems（DCS）正在开发一个研究平台，以开放对其大规模临床PRO数据数据库的访问。DCS将提供一个独特的创新解决方案，通过向研究人员开放其基于Web的PRO系统，实现可持续的数据收集和安全的数据访问。这将使研究人员能够访问在常规护理和临床研究中广泛收集的去识别PRO数据。此外，DCS将通过与互补数据源集成并链接以患者为中心的纵向数据来提高其PRO数据的广度和深度。其结果将是一个不断填充的，安全的PRO数据库，通过用户友好的界面提供给研究人员。在第一阶段，我们将1）整合我们的PRO数据库与合作伙伴数据库，以证明可行性和2）创建一个原型接口的研究访问。如果集成原型无缝地传输数据并通过树测试场景，则将建立可行性。我们将通过询问临床研究人员来测试可用性，因为他们使用界面原型。 公共卫生关系：通过复杂但易于使用的评估测量的患者报告结局（PRO）是患者和研究参与者分别与其临床医生或研究协调员沟通的关键方式。Dynamic Clinical Systems正在开发一种信息技术解决方案，该解决方案可以自动化这一过程，从而使临床试验成本更低，需要的参与者数量更少，负担更轻，并从患者的角度收集有关患者体验的信息。