Defining Interoperability Standards for PRO Assessments

定义 PRO 评估的互操作性标准

• 批准号: 7832165
• 负责人: DerShung Yang
• 金额: $ 49.95万
• 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 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7832165
• 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）：此申请应解决广泛的挑战领域（06）：启用技术和特定挑战主题：06-CA-101：增强电子患者报告的临床研究或医疗保健服务中的评估评估。人们对主观患者报告结果（PRO）在患者护理中的重要性越来越认识到。最近的一些研究观察到在临床实践中常规使用PRO评估的积极影响，报告了改善的身体，功能和情感健康，住院减少，更好地发现较不可观察和主观的PRO关注以及更好的患者提供沟通。 NIH认识到Pro评估的价值和潜力，正在完成一项为期5年的25mm路线图计划，称为患者报告的结果管理信息系统（Promis），并在为第二轮Promis研究活动提供资金的过程中。 Promis倡议的目标是基于现代计算机化自适应测试（CAT）和项目响应理论（IRT）开发和验证一组新的标准化专业工具。基于CAT/IRT的工具中的主要好处是，它们是动态管理的，是针对每个人的过去响应量身定制的，因此较短（即较少的项目），但没有牺牲测量精度。与Promis努力平行，政府和私营企业中都存在着巨大的利益，以开发互操作性标准，以促进异质医疗保健信息系统之间的数据交换；特别是政府的健康信息技术（HIT）倡议，该计划严重利用了现有的行业标准。临床研究界的标准化工作也正在进行中；最值得注意的是，临床数据互换标准财团（CDISC）。作为医疗改革努力的一部分，政府促进电子病历（EMR）系统的促进进一步促进了数据标准化的原因。理想情况下，对EMR和数据标准化以及与Promis项目等相关研究的巨额投资应将广泛采用PRO在临床研究和实践中的目标更接近实现。不幸的是，仍然存在一个主要的差距，以防止实现这一目标，即缺乏专业工具和评估结果的数据标准化。没有一致努力将专业社区带入任何数据标准化努力。因此，该项目打算在Promis倡议和各种标准化计划之间弥合这一差距，以便可以充分实现Promis项目的好处和结果研究领域。具体而言，该项目旨在a）为患者报告的结果（PRO）工具和评估结果建立互操作性数据标准，包括传统的静态Pro问卷和NIH Promis项目的新自适应项目库； b）开发这些标准的互操作性参考实现，这些标准证明了与开源电子病历（EMR）和临床试验管理（CTM）系统的集成方案。该项目的影响非常重要。数据标准是PRO真正采用和整合到临床研究和实践中的必要条件。 Promis倡议已经解决了许多其他障碍，这些障碍抑制了Pro的采用。但是，没有数据标准，由于EMR/CTM供应商缺乏支持，因此现状仍可能会持续多年。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不可或缺的一部分，然后我们将有机会在临床医生和研究人员手中看到这些出色的Pro工具。该项目可能会导致高公共健康影响，而技术风险相对较低。影响将来自拟议的患者报告的结果（PRO）特定的互操作性标准，这些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，特别是那些由NIH Promis项目开发的自适应Pro项目，最终将其提供给他们的产品，最终在临床医生和研究者的手中提供专业服务。通过各种标准组织定义其他类型的医疗数据，已经花费了重大努力，提供了许多技术先例，这些先例可以指导我们的标准开发工作并减轻技术风险。