Implementing genomic medicine through pragmatic trials in diverse and underserved populations across Indiana.

只有在患者知情的情况下，药物基因组学才能有效地和符合伦理地实施到常规护理中 关于他们的药物基因组测试的结果，这样他们就可以了解他们的 并将相关发现通知未来的提供者。教育面临着巨大的挑战 这一地区的病人。详细的解释可能会令人困惑，并导致危险的错误，例如 在没有询问医疗保健提供者的情况下错误地停止用药。已经被用来解释 药物基因组学结果还没有在不同的患者群体和现实生活中的临床情况下进行测试。 采用PGx试验(药物遗传学中的抑郁症和阿片类药物实用试验)，由 在实践中实施基因组学(IGNITE)NHGRI网络，提供了一个极好的学习机会 更多关于如何充分告知患者他们的药物基因组结果。这次试行将招收4500人 有抑郁、慢性疼痛或预期术后疼痛的患者。一半的人将随机接受 两个基因的药物基因组测试，CYP2C19和CYP2D6，结果将输入电子 病历指导抗抑郁药和止痛药的处方。在完成参与后，所有 患者将收到一封信，告知他们的药物基因组测试结果。对于建议的 补充，我们将对来自所有网站的150名参与者进行电话采访，他们收到 他们的药物基因组测试结果(120个具有可操作结果，30个具有不可操作结果)。我们的长- 学期目标是支持药物基因组学在临床医学中合乎道德和有效的使用。主 该项目的目标是利用一项大型研究来(A)探索患者对他们如何学习的观点 他们的药物基因组学结果，(B)决定披露这些结果的信件的可用性和可接受性 结果，以及(C)确定患者对这些结果的客观理解。之前的研究已经测量到 患者的主观理解(他们对自己的知识水平的感觉)，而不是客观的衡量 理解(他们在知识测试中的表现)。我们的目标是：1：评估患者如何学习 关于他们的药物基因组测试结果，并确定书面材料的可接受性和可用性 公布那些检测结果。2：确定患者对药物基因组学检测结果的理解 以及对未来医疗保健的影响，包括他们与未来提供者讨论结果的意图。我们的 该项目是创新的，因为我们将确定患者对药物基因组学的观点和理解 在一系列现实生活中的临床环境中接受测试的不同人群的测试结果。该项目将 通过提供关于返回的药物基因组结果的证据来产生显著的进步 制定实践指南，并将为未来的生物伦理学研究创造资源。实现我们的目标 将进一步推动NHGRI在一个特别重要的领域将基因组学整合到医疗保健中的使命，因为 药物基因组学很可能是第一批广泛应用于一般实践的基因技术之一。

Pharmacogenomics can only be effectively and ethically implemented into routine care if patients are informed about the results of their pharmacogenomic testing, so they can understand changes made to their medications and inform future providers about relevant findings. There are significant challenges to educating patients in this area. Detailed explanations may be confusing and lead to dangerous mistakes, such as stopping a medicine incorrectly without asking a healthcare provider. Materials that have been used to explain pharmacogenomic results have not been tested in diverse groups of patients and in real-life clinical situations. The ADOPT PGx trial (A Depression and Opioid Pragmatic Trial in Pharmacogenetics), funded by the Implementing Genomics in Practice (IGNITE) network of NHGRI, provides an excellent opportunity to learn more about how to adequately inform patients about their pharmacogenomic results. The trial will enroll 4500 patients with depression, chronic pain, or expected post-operative pain. Half will be randomized to undergo pharmacogenomic testing for two genes, CYP2C19 and CYP2D6, and results will be entered in the electronic medical record to guide prescription of anti-depressants and pain medicines. After completing participation, all patients will be sent a letter informing them of their pharmacogenomic test results. For the proposed supplement, we will conduct telephone interviews with 150 participants total from all sites after they receive their pharmacogenomic test results (120 with actionable results and 30 with non-actionable results). Our long- term goal is to support the ethical and effective use of pharmacogenomics in clinical medicine. The main objectives of the project are to leverage a large study to (a) explore patients’ perspectives on how they learned their pharmacogenomics results, (b) determine the usability and acceptability of a letter disclosing those results, and (c) determine patients’ objective understanding of those results. Previous studies have measured patients’ subjective understanding (how they feel about their level of knowledge) without measuring objective understanding (how they perform on a knowledge test). Our Aims are to: 1: Assess how patients learned about their pharmacogenomic test results and determine the acceptability and usability of written materials disclosing those test results. 2: Determine patients’ understanding of their results of pharmacogenomics testing and implications for future healthcare, including their intentions to discuss results with future providers. Our project is innovative because we will identify patients’ perspectives and understanding of pharmacogenomic test results in a diverse population who underwent testing in a range of real-life clinical settings. The project will produce a significant advance by providing evidence about return pharmacogenomic results that will inform development of practice guidelines and will create resources for future bioethics research. Achieving our aims will further NHGRI’s mission of integrating genomics into medical care in a particularly important area, since pharmacogenomics will likely be one of the first genetic technologies to be used widely in general practice.