Clinical Decision Support for Unsolicited Genomic Results

项目摘要 随着健康个体越来越多地接受基因组检测结果， 结果（例如疾病或药物不良反应），医疗保健提供者将需要确保结果 通过处理结果的接收、工作流程的挑战和责任问题，谨慎处理。 考虑到临床基因组测试可以在临床环境之外启动（例如，在一项研究中， 从临床医生的角度来看，它们可以被表征为未经请求的基因组结果（UGR）。临床决策 支持（CDS）通过向临床医生提供建议，有很大的潜力来简化UGR的采用 以及在特定时间呈现的患者相关信息以增强临床护理。为UGR部署CDS 然而，在医疗保健环境中，以可扩展方式，将取决于我们利用当地机构的能力， 政策和监督结构，以批准CDS对UGR的指导和战略。的具体目标 本研究计画旨在发展与评估循证决策支援系统 随时间推移（EDIT）模型，用于对UGR的已部署CDS进行优先级排序和修订。EDIT模型将使 地方监督委员会，如药房和治疗委员会，在CDS审查中发挥作用 在现有的社会制度体系中，利用公认的组织 流程.这项工作的直接好处将是一个可供监督使用的EDIT仪表板 委员会优先考虑新的和修订部署的CDS，和基础设施，以关闭学习的循环 通过将监督委员会成员批准的CDS修订版转移到部署的CDS中， UGR。EDIT模型的实施将通过混合方法研究策略来告知：策略1，我们将 与监督委员会成员进行重点小组讨论，以了解当前的作用、任务和目标 以及收集关于最佳流程的意见，以优先考虑、审查和批准 作为委员会会议活动的一部分，为UGR制定新的和经修订的CDS。研究策略二，我们会进行一项 对患者进行的调查研究，以评估使用CDS返回UGR的偏好，以及使用 监督委员会成员收集关于EDIT仪表板设计的反馈。战略三，我们将进行 在部署EDIT模型之前和之后，对当地监督委员会会议进行时间运动观察， 为了计划未来的多机构时间运动研究，使用统计功效检测 使用EDIT仪表板和不使用EDIT仪表板的监督委员会。假设是， 通过使用EDIT仪表板，新的和修订的CDS的优先级将更短。总的来说，EDIT模型 建立流程，降低实施强大的基因组医学计划的障碍， 然后是其他人。基因组创新奖将使我能够研究，在团队科学项目中， EDIT模式可以加快UGR CDS的机构审批流程。更广泛的影响 这项工作的重点是能够研究医疗保健提供者对UGR部署CDS的采用率。

Project Summary As healthy individuals increasingly can receive genomic testing results that indicate their risk for poor outcomes (e.g. diseases or adverse drug reactions), healthcare providers will need to ensure that the results are handled prudently, by addressing the receipt of the results, the workflow challenges, and liability issues. Given that clinical genomic tests can be initiated outside of the clinical setting (e.g., in a research study), from the clinician’s perspective, they can be characterized as unsolicited genomic results (UGR). Clinical decision support (CDS) has great potential to ease the adoption of UGR by providing clinicians with recommendations and patient-related information presented at particular times to enhance clinical care. Deploying CDS for UGR in a healthcare setting in a scalable way, however, will depend on our capacity to leverage local institutional policy and oversight structures to approve of CDS guidance and strategies for UGR. The specific objective of this research program is to develop and evaluate the Evidence-based Decision support Implementation over Time (EDIT) model for prioritizing and revising deployed CDS for UGR. The EDIT model will empower local oversight committees such as Pharmacy & Therapeutics committees to have a role in the CDS review and deployment processes within existing institutional social systems using accepted organizational processes. The direct benefits of this work will be an EDIT dashboard that can be used by oversight committees to prioritize new and to revise deployed CDS, and infrastructure to close the loop of the learning health system by transferring CDS revisions approved by oversight committee members into deployed CDS for UGR. EDIT model implementation will be informed by mixed methods research strategies: Strategy 1, we will conduct focus groups with oversight committee members in order to understand current roles, tasks and goals of the committee, as well as to capture opinions about the best processes to prioritize, review and approve of new and revised CDS for UGR as part of committee meeting activities. Research Strategy 2, we will conduct a survey study with patients to assess preferences for the return of UGR with CDS and usability studies with oversight committee members to gather feedback on the EDIT dashboard design. Strategy 3, we will conduct time-motion observations of local oversight committee meetings prior to and after deploying the EDIT model in order to plan a future, multi-institution, time-motion study with statistical power to detect differences between oversight committees that use the EDIT dashboard and those that do not. The hypothesis is that time spent prioritizing new and revised CDS will be shorter with use of the EDIT dashboard. Overall, the EDIT model establishes processes that lower barriers to implementing robust genomic medicine programs that can be followed by others. The Genomic Innovator Award will enable me to study, in team-science projects, how the EDIT model can accelerate the institutional review and approval process of CDS for UGR. The broader impact of this work is being able to study rate of UGR adoption by healthcare providers for deployed CDS for UGR.