Incidental Finding Preferences in Whole Genome Sequencing: A Randomized Trial

描述（由申请人提供）：即将将全基因组测序（WGS）纳入临床护理，这突出表明在如何向患者传达结果方面缺乏共识。特别是，WGS将产生大量关于疾病易感性的信息，这些信息已被证明是有效的，但缺乏改变预防或治疗临床建议的能力。披露这些信息的最大担忧之一是，它可能促使患者要求不必要的后续服务，并导致过度使用有限的医疗资源。然而，这些信息可能对患者有重要的个人意义，患者可能会觉得有权获得这些信息，如果被拒绝，他们可能会感到不满。拟议的研究旨在提高我们的理解不同的策略，披露WGS风险信息对患者的满意度和后续信息寻求的影响，特别是临床服务，通过呈现不同的假设WGS结果的合作伙伴医疗保健系统的患者。将250名受试者随机分配至三个假设披露组之一：（1）“无披露”组，其中参与者将仅被告知测序未识别出需要立即临床反应的信息，（2）“完全披露”组，其中参与者将接收大量临床效用有限的风险信息，或（3）“患者偏好”臂，其中参与者将指示他们想要接收什么样的风险信息，并且相应地呈现信息。然后，他们将被询问他们寻求后续临床服务的可能性，并跟踪在线信息寻求行为。此外，满意度 在告知参与者其他披露方法后，将对披露的过程和内容提出质疑。这项研究的结果将提供关于WGS信息如何以最大限度地提高满意度的方式向患者披露的关键见解，同时最大限度地减少对医疗保健的不必要需求。

DESCRIPTION (provided by applicant): The impending incorporation of whole genome sequencing (WGS) into clinical care highlights the lack of consensus about how to communicate results to patients. In particular, WGS will generate incredible amounts of information about susceptibility to disease that has proven validity, but lacking the power to change clinical recommendations for prevention or treatment. Among the greatest concerns about disclosing this information is its potential to motivate patients to request unnecessary follow-up services and lead to overuse of limited healthcare resources. Yet, the information may have important personal meaning to patients, and patients may feel entitled to it and dissatisfied if it is withhed. The proposed research aims to improve our understanding about the impact of different strategies for disclosing WGS risk information on patient satisfaction and follow-up information seeking, particularly for clinical services, by presenting patients of the Partners HealthCare System different hypothetical WGS results. 250 participants will be randomized into one of three hypothetical disclosures arms: (1) a 'No Disclosure' arm where participants will be informed merely that sequencing identified no information that necessitated an immediate clinical response, (2) a 'Full Disclosure' arm where participants will receive a large array of risk information with limited clinical utility, or (3) a 'Patient Preferences' arm where participants wil indicate what kind of risk information they would want to receive and information is presented accordingly. They will then be queried about their likelihood of seeking follow-up clinical services, and online information seeking behaviors will be tracked. In addition, satisfaction about the process and content of disclosure will be queried after participants are informed about alternative disclosure approaches. Findings from this research will provide critical insight about how WGS information can be disclosed to patients in ways that maximize satisfaction while minimizing unnecessary demands for healthcare.