Defining Interoperability Standards for PRO Assessments

定义 PRO 评估的互操作性标准

• 批准号: 7940970
• 负责人: DerShung Yang
• 金额: $ 49.99万
• 依托单位: BRIGHTOUTCOME INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7940970
• 关键词: Address; Adopted; Adoption; Area; Clinical Data; Clinical Research; Clinical Trials; Communication; Communities; Computerized Medical Record; Data; Development; Electronics; Funding; Goals; Government; Hand; Health Care Reform; Hospitalization; Individual; Industry; Investments; Management Information Systems; Measurement; Medical; Outcome Assessment; Outcomes Research; Patient Care; Patient Outcomes Assessments; Patients; Process; Provider; Public Health; Questionnaires; Reporting; Research; Research Activity; Research Personnel; Risk; Solutions; Standardization; System; Technology; Testing; United States National Institutes of Health; Vendor; Well in self; base; clinical practice; computerized; data exchange; health care delivery; health information technology; improved; instrument; interest; interoperability; medical information system; prevent; response; systems research; theories; tool

DESCRIPTION (provided by applicant): This application addresses broad Challenge Area (06): Enabling Technologies and specific Challenge Topic: 06-CA-101: Enhancing Electronic Patient-Reported Outcomes Assessment in Clinical Research or Healthcare Delivery. There is a growing recognition of the importance of subjective patient-reported outcomes (PRO) in patient care. Several recent studies have observed positive impacts of routine use of PRO assessments in clinical practice, reporting improved physical, functional and emotional well-being, reduced hospitalization, better detections of less observable and subjective PRO concerns, and better patient-provider communication. Recognizing the value and potential of PRO assessments, the NIH is completing a 5-year $25MM Roadmap Initiative, called the Patient-Reported Outcomes Management Information System (PROMIS), and in the process of funding the second round of PROMIS research activities. The goal of the PROMIS Initiative is to develop and validate a new set of standardized PRO instruments based on modern computerized adaptive testing (CAT) and item response theory (IRT). A primary benefit, amongst many others, of CAT/IRT-based instruments is that they are dynamically administered, tailored to each individual's past responses, and hence much shorter (i.e., fewer items) but without sacrificing measurement precision. Parallel to the PROMIS endeavor, enormous interests exist within both the government and the private industry in developing interoperability standards to facilitate data exchange between heterogeneous healthcare information systems; in particular the government's Health Information Technology (HIT) Initiative that heavily leverages existing industry standards. Standardization efforts for the clinical research community are also in progress; most notably by the Clinical Data Interchange Standards Consortium (CDISC). The promotion of electronic medical records (EMR) system by the Administration as part of the healthcare reform effort furthers the cause of data standardization. Ideally, the vast investment on EMR and data standardization and on PRO-related research such as the PROMIS project should bring the goal of wide adoption of PRO in clinical research and practice closer to fruition. Unfortunately a major gap still exists to prevent this goal from being achieved, namely the lack of data standardization for PRO instruments and assessment results. There has been no concerted effort to bring the PRO community into any data standardization endeavors. This project thus intends to bridge this gap between the PROMIS Initiative and various standardization initiatives so that the benefits of the PROMIS project and the field of outcomes research in general can be fully realized. Specifically, this project seeks to a) establish interoperability data standards for patient-reported outcomes (PRO) instruments and assessment results, including both the conventional static PRO questionnaires and the new adaptive item banks from the NIH PROMIS project; and b) develop interoperability reference implementations of these standards demonstrating integration scenarios with open-sourced electronic medical record (EMR) and clinical trial management (CTM) systems. The impact of this project is highly significant. Data standards are a necessary condition for PRO to be truly adopted and integrated in clinical research and practice. The PROMIS Initiative has already addressed many other barriers inhibiting the adoption of PRO. However, without the data standards, the status quo will still likely persist for years because of the lack of support from EMR/CTM vendors. With the standards, PRO data can become an integral part of clinical data in every EMR/CTM solution and we will then have a real chance to see these great PRO tools in the hands of clinicians and researchers. This project can result in high public health impact with relatively low technical risks. The impact will come from the proposed patient-reported outcomes (PRO)-specific interoperability standards that could help electronic medical record or clinical trial management solution vendors adopt PRO assessments, in particular those adaptive PRO item banks developed by the NIH PROMIS project, into their offerings, finally making PRO available in the hands of clinicians and researchers. Significant efforts have been spent in defining other types of medical data by various standards organizations, providing many technical precedents that can guide our standards development efforts and mitigate technical risks.

描述（由申请人提供）：本申请涉及广泛的挑战领域（06）：使能技术和具体挑战主题：06- ca -101：在临床研究或医疗保健服务中加强电子患者报告结果评估。越来越多的人认识到主观患者报告结果（PRO）在患者护理中的重要性。最近的几项研究已经观察到在临床实践中常规使用PRO评估的积极影响，报告改善了身体、功能和情绪健康，减少了住院时间，更好地发现了不易观察到的和主观的PRO问题，以及更好的医患沟通。认识到PRO评估的价值和潜力，NIH正在完成一项5年2500万美元的路线图倡议，称为患者报告的结果管理信息系统（PROMIS），并正在资助第二轮PROMIS研究活动。PROMIS计划的目标是基于现代计算机自适应测试（CAT）和项目反应理论（IRT）开发和验证一套新的标准化PRO仪器。基于CAT/ irt的仪器的一个主要优点是，它们是动态管理的，根据每个人过去的反应量身定制，因此更短（即更少的项目），但不牺牲测量精度。与PROMIS努力并行的是，政府和私营行业在开发互操作性标准以促进异构医疗信息系统之间的数据交换方面存在巨大利益；特别是政府的卫生信息技术（HIT）计划，该计划大量利用了现有的行业标准。临床研究界的标准化工作也在进行中；最著名的是临床数据交换标准联盟（CDISC）。作为医疗改革工作的一部分，政府推动电子病历系统，进一步推动了数据标准化的事业。理想情况下，对电子病历和数据标准化以及PRO相关研究（如PROMIS项目）的大量投资应该会使PRO在临床研究和实践中广泛采用的目标更接近实现。不幸的是，仍然存在一个重大差距来阻止这一目标的实现，即缺乏PRO仪器和评估结果的数据标准化。目前还没有协调一致的努力将PRO社区带入任何数据标准化工作中。因此，本项目旨在弥合PROMIS倡议与各种标准化倡议之间的差距，以便充分实现PROMIS项目和一般成果研究领域的好处。具体而言，该项目旨在a)建立患者报告结果（PRO）工具和评估结果的互操作性数据标准，包括传统的静态PRO问卷和来自NIH PROMIS项目的新适应性项目库；b)开发这些标准的互操作性参考实现，展示与开源电子病历（EMR）和临床试验管理（CTM）系统的集成场景。这个项目的影响是非常重大的。数据标准是PRO在临床研究和实践中真正被采用和整合的必要条件。PROMIS倡议已经解决了许多其他阻碍PRO采用的障碍。然而，如果没有数据标准，由于缺乏EMR/CTM供应商的支持，现状仍可能持续数年。有了这些标准，PRO数据可以成为每个EMR/CTM解决方案中临床数据的组成部分，然后我们将有真正的机会看到临床医生和研究人员手中这些伟大的PRO工具。该项目可产生较大的公共卫生影响，但技术风险相对较低。影响将来自拟议的患者报告结果（PRO）特定互操作性标准，该标准可以帮助电子病历或临床试验管理解决方案供应商采用PRO评估，特别是由NIH PROMIS项目开发的自适应PRO项目库，最终使临床医生和研究人员可以使用PRO。各种标准组织在定义其他类型的医疗数据方面已经付出了巨大的努力，提供了许多技术先例，可以指导我们的标准开发工作并减轻技术风险。