Patients' Views About the Disclosure of Collateral Findings in Pragmatic Clinical Trials: a Focus Group Study
Patients' Views About the Disclosure of Collateral Findings in Pragmatic Clinical Trials: a Focus Group Study
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DOI：
10.1007/s11606-020-06113-5
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发表时间：
2020-08-19
影响因子：
5.7
通讯作者：
Sugarman, Jeremy
中科院分区：
文献类型：
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作者：
Bollinger, Juli M.;Geller, Gail;Sugarman, Jeremy
越来越多的临床试验（PCT）被用于有效地生成证据，为医疗保健决策提供信息。尽管他们越来越多的接受，PCTs可能涉及各种伦理问题，包括实用的临床试验附带结果（PCT-CF）的管理，即出现在PCTs中的信息，与主要研究问题无关，但可能对患者，临床医生和卫生系统产生影响。目的了解患者对PCT-CF披露的看法，包括如何披露、由谁披露、信息的性质和程度。设计前瞻性、定性的焦点组研究。参与者焦点小组于2019年7月和8月在马里兰州的巴尔的摩、德克萨斯州的休斯顿和华盛顿州的西雅图（总体N = 66）进行。方法所有组都讨论了一个假设的场景，涉及检测禁忌药物的PCT-CF。与会者被问及他们对PCT-CF的反应以及与其披露有关的问题。对了解PCT-CF的反应是混合的，从担心重大的健康问题，对禁忌药物未被注意和/或未经其许可被纳入研究的愤怒，到对信息的感激。对如何披露这些信息的偏好各不相同，但受到几个一致愿望的驱动，即最大限度地减少患者的伤害和焦虑，并表现出信任和尊重。许多人希望他们的治疗临床医生被告知PCT-CF，以便他们准备回答患者的问题并讨论治疗方案。结论PCT-CFs的检出率可能随着PCTs的进一步扩大而增加。因此，临床医生无疑将参与PCT-CF的管理。我们的数据说明了临床医生在告知患者PCT-CF时可能面临的一些挑战，以及需要制定以符合患者偏好和价值观的方式披露PCT-CF的指南。
Background Pragmatic clinical trials (PCTs) are increasingly being conducted to efficiently generate evidence to inform healthcare decision-making. Despite their growing acceptance, PCTs may involve a variety of ethical issues, including the management of pragmatic clinical trial-collateral findings (PCT-CFs), that is, information that emerges in PCTs that is unrelated to the primary research questions but may have implications for patients, clinicians, and health systems. Objective We sought to understand patients' views about PCT-CF disclosure, including how, by whom, and the nature and extent of information provided. Design Prospective, qualitative focus group study. Participants Focus groups were conducted in Baltimore, MD; Houston, TX; and Seattle, WA (overallN= 66), during July and August 2019. Approach All groups discussed a hypothetical scenario involving the detection of a PCT-CF of contraindicated medications. Participants were asked about their reactions to the PCT-CF and issues related to its disclosure. Key Results Reactions to learning about the PCT-CF were mixed, ranging from fear of a significant health problem, anger that the contraindicated medications had gone unnoticed and/or for being included in research without their permission, to gratitude for the information. Preferences for how such disclosures are made varied but were driven by several consistent desires, namely minimizing patient harm and anxiety and demonstrating trust and respect. Many wanted their treating clinician to be informed of the PCT-CF so that they would be prepared to answer patients' questions and to discuss treatment options. Conclusions The detection of PCT-CFs is likely to increase with further expansion of PCTs. As such, clinicians will undoubtedly become involved in the management of PCT-CFs. Our data illustrate some of the challenges clinicians may face when their patients are informed of a PCT-CF and the need to develop guidance for disclosing PCT-CFs in ways that align with patients' preferences and values.