Development of a Patient-Facing Portal for the Receipt, Interpretation and Tracking Utility of Pharmacogenetic (PGx) Data

摘要 精神疾病的药物选择一般是通过试错法，不良反应发生率很高 和次优功效。因此，药物遗传学（PGx）数据特别有益于促进安全的药物选择。 并且是成本有效的，降低了资源利用率，并且改善了患者的 参与，有可能克服药物不依从性。然而在精神病学领域 患者对PGx的熟悉程度仍然较低，表明需要改进面向患者的PGx材料。 该项目的目标是通过以下方式增强患者对其基因组信息的持续参与：a） 通过开发以消费者为中心的患者报告，增加患者对PGx结果的理解;以及B） 使用PGx指导的药物选择促进患者-提供者的沟通和共同决策 在持续的基础上，通过增加患者自我报告的精神症状， 以真实的时间传达给健康护理提供者的心理测量量表。这种持续的自我报告将 作为讨论药物方案变更的切入点，将向 使用以消费者为中心的PGx报告的患者。持续和一致的患者-提供者沟通是 已知的是加强患者参与，进一步鼓励患者使用跟踪系统。供应商使用将 通过可用于远程患者监控的计费代码来鼓励。该项目有三个具体 目标。目标1是开发一个更容易被没有生物医学背景的人访问的PGx报告。 专业PGx检测报告将采用AHRQ健康素养通用注意事项进行调整 工具包，之后将进行用户理解研究，以评估对报告的理解， 外行人目标2是在患者门户网站中整合结局跟踪量表，以支持自愿跟踪 患者结果的纵向和持续的共享决策与医疗保健提供者。为此， 诊断特异性心理测量量表将与患者平台一起集成 提醒系统，将每2周向患者发送文本/电子邮件提醒，并链接到心理测量 量表，以及指定社区成员的提醒系统，以进一步鼓励患者 订婚还将开发一个警报系统，以通知患者和指定的社区成员， 评估之间的分数变化>30%，促使患者与他们的医疗保健提供者交谈。用户 将进行验收测试（UAT），以验证系统是否按预期运行。目标3：发展 应用程序编程接口（API），用于将患者的纵向心理测量评分直接报告给 医疗保健提供者门户，以促进患者与提供者之间的沟通和持续的PGx指导用药 选择基于患者自我报告结果的提供者警报系统，包括自杀倾向的迹象， 也将被开发，随后是UAT。项目的成功完成将首次将联合收割机纵向 在心理健康领域，为患者和提供者提供患者结局跟踪和PGx指导。

ABSTRACT Selection of medication for mental illness is generally through trial-and-error, with high rates of adverse reactions and sub-optimal efficacy. Pharmacogenetic (PGx) data is thus of particular benefit to facilitate selection of safe and effective medications and is cost effective, decreases resource utilization, and improves patient engagement, with the potential to overcome medication non-adherence. Nevertheless, in the field of psychiatry, patients' familiarity with PGx remains low, demonstrating the need for improved patient-facing PGx materials. The objective of this project is to enhance sustained patient engagement with their genomic information by: a) increasing patient understanding of PGx results by developing a consumer-focused patient report; and b) facilitating patient-provider communication and shared decision making using PGx-guided medication selection on an ongoing basis by increasing patient self-reporting of psychiatric symptoms using regularly administered psychometric scales that are communicated to healthcare providers in real time. This ongoing self-reporting will serve as the entry point to discussions regarding changes to medication regimens, which will be explained to patients using the consumer-focused PGx report. Ongoing and consistent patient-provider communication is known to reinforce patient engagement, further encouraging patient use of the tracking system. Provider use will be encouraged through the billing codes available for remote patient monitoring. This project has three Specific Aims. Aim 1 is to develop a PGx report that is more accessible to individuals without a biomedical background. The Professional PGx assay report will be adapted using the AHRQ Health Literacy Universal Precautions Toolkit, following which a user comprehension study will be conducted to assess understanding of the report by lay individuals. Aim 2 is to integrate outcome tracking scales within the patient portal to support voluntary tracking of patient outcomes longitudinally and ongoing shared decision making with healthcare providers. For this aim, diagnosis-specific psychometric scales will be integrated into the patient platform, together with a patient reminder system that will send text/email reminders to patients every 2 weeks with a link to the psychometric scales, as well as a reminder system for a designated community member to further encourage patient engagement. An alert system will also be developed to notify patients and designated community members if scores change by >30% between evaluations, prompting the patient to speak to their healthcare provider. User acceptance testing (UAT) will be performed to verify that the systems operate as intended. Aim 3 is to develop an application programming interface (API) to report patients’ longitudinal psychometric scoring directly to the healthcare provider portal to facilitate patient-provider communication and ongoing PGx-guided medication choice. A provider alert system based on patients’ self-reported outcomes, including indications of suicidality, will also be developed, followed by UAT. Successful project completion will, for the first time, combine longitudinal patient outcome tracking and PGx guidance, for both patients and providers, in the mental health field.