Using Ethics and User-Centered Design to Create Templates for EHR-Mediated Return of Genetic Test Results

项目总结/摘要 患者参与对于实施精准医疗的基因组组件至关重要-谨慎 包括患者的观点和需求。然而，许多患者可能会遇到严重的障碍， 了解遗传信息和/或使用电子患者门户网站，许多卫生系统 用于满足与实验室和测试结果返回相关的有意义使用条款。虽然 遗传结果的返回和患者门户网站的使用都受到了相当大的关注， 关于通过患者门户网站返回基因检测结果的研究-即使有更多的检测结果 患者可以通过电子方式。精准医疗的成功不仅依赖于背后的算法 临床决策支持和“大数据”分析，但也对激活的病人： 健康相关的信息，并有动力和支持采取行动。 伦理问题将有助于确保在开发技术时考虑患者的观点 已准备好用于临床部署。该项目的目标是确定患者和关键利益相关者的需求， 包括来自代表性不足人群的患者，关于接受 通过患者门户网站以电子方式获得基因检测结果。这项研究将在华盛顿大学进行 医学（华盛顿大学医学）系统，为华盛顿西部的多样化患者群体提供护理 国家通过其网络的医院和社区为基础的诊所，并使用史诗软件的电子 健康记录患者门户模块。具体而言，拟议的研究将：（1）探索以下患者： 已收到基因测试结果和非基因测试结果电子他们的经验，收到这些 结果及其对电子申报表的看法，以及遗传结果申报表与 非遗传结果;（2）通过探索患者门户网站，扩大对返回结果阈值的理解 已收到基因测试结果的用户电子报税表如何影响报税门槛及细微差别 和挑战，提出信息的积极和消极的结果;和（3）遵循以用户为中心 设计原则，对门户用户和非用户进行关于可接受性的认知访谈， 使用（1）和（2）中的数据和模板选项创建的结果原型的电子返回的易用性 支持在UW Medicine系统内外使用。拟议的R21探索性研究将 提供不同人群对患者门户网站使用的患者观点的初步数据， 以电子方式返回遗传结果，包括围绕确定结果的阈值进行重要工作， 适用于电子交付和开发内容易于理解的报告模板 并支持患者赋权并增强他们对自身健康的参与。

PROJECT SUMMARY/ABSTRACT Patient engagement is critical for implementation of the genomic component of precision medicine—with care taken to include the perspectives and needs of patients. Yet many patients may experience significant barriers to understanding genetic information and/or using the electronic patient portals that many health systems are using to meet the terms of meaningful use related to the return of laboratory and test results. Although the return of genetic results and patient portal use have each received considerable attention, there have been few studies concerning the return of genetic test results via patient portals—even as more test results are made available to patients electronically. The success of precision medicine relies not only on algorithms behind clinical decision support and “Big Data” analytics but also on the activated patient: the patient who receives health-related information and is motivated and supported to act upon it. Prospective attention to practical and ethical concerns will help to ensure that patient perspectives are taken into account as developing technology is prepared for clinical deployment. The goal of the project is to define patient and key stakeholder needs, including those of patients from underrepresented populations, concerning the acceptability of receiving genetic test results electronically via a patient portal. The study will take place in the University of Washington Medicine (UW Medicine) system, which provides care for a diverse patient population in western Washington State through its network of hospital- and neighborhood-based clinics and uses Epic software's Electronic Health Record patient portal module. Specifically, the proposed investigation will: (1) explore with patients who have received genetic test results and non-genetic test results electronically their experience receiving those results and their views on their electronic return and how genetic results return differs, or does not differ, from non-genetic results; (2) expand the understanding of return of results thresholds by exploring with patient portal users who have received genetic test results how electronic return affects return thresholds and the nuances and challenges of presenting information for positive and negative results; and (3) following User-Centered Design principles, conduct cognitive interviews with portal users and non-users about the acceptability and ease of use of electronic return of results prototypes created using data from (1) and (2) with template options supporting use within and without the UW Medicine system. The proposed R21 exploratory research will provide preliminary data on patient perspectives across diverse populations on the use of patient portals to return genetic results electronically, including important work around thresholds for determining results that are appropriate for electronic delivery and developing report templates whose content is readily comprehensible and supports patient empowerment and enhances their engagement in their own health.