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

项目摘要/摘要 患者的参与对精确医学基因组部分的实施至关重要--小心 考虑到患者的观点和需求。然而，许多患者可能会经历重大的障碍 了解遗传信息和/或使用许多医疗系统所具有的电子患者门户 用于满足有意义的使用条款，涉及实验室和检测结果的返回。尽管 遗传结果的返回和患者门户的使用都受到了相当大的关注，但很少有 关于通过患者门户返回基因测试结果的研究-即使做出了更多的测试结果 以电子方式提供给患者。精准医学的成功不仅仅依赖于背后的算法 临床决策支持和大数据分析，以及对激活的患者的支持：接受 与健康有关的信息，并被激励和支持采取行动。前瞻性地关注实用性和 伦理关注将有助于确保在开发技术时考虑患者的观点 已经为临床部署做好了准备。该项目的目标是定义患者和关键利益相关者的需求， 包括来自代表人数不足的人群的患者，关于接受 通过患者门户网站以电子方式进行基因测试结果。这项研究将在华盛顿大学进行 医学(UW Medicine)系统，该系统为华盛顿西部的不同患者群体提供护理 通过其医院和社区诊所网络，并使用Epic软件的电子 健康记录患者门户模块。具体地说，拟议的调查将：(1)与以下患者探讨 以电子方式收到基因检测结果和非基因检测结果 结果及其对电子返回的看法以及遗传结果返回如何与不同 非遗传结果；(2)通过探索患者门户，扩展对结果返回阈值的理解 已收到基因测试结果的用户电子退货如何影响退货门槛和细微差别 以及为正面和负面结果呈现信息的挑战；以及(3)遵循以用户为中心 设计原则，对门户用户和非用户进行认知访谈，了解可接受性和 使用带有模板选项的(1)和(2)中的数据创建的电子结果返回原型易于使用 支持在UW医疗系统内部和外部使用。拟议的R21探索性研究将 提供有关不同人群中使用患者门户的患者观点的初步数据 以电子方式返回遗传结果，包括围绕阈值确定符合以下条件的结果的重要工作 适用于电子交付和开发内容易于理解的报告模板 并支持患者赋权并提高他们对自身健康的参与度。

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.