Adequate selection of patients for thyroid biopsy: evaluation of a shared decision making conversation aid

摘要 这项由国家癌症研究所颁发的导师临床科学家研究职业发展奖(K08)是 旨在为首席研究员内基·辛格·奥斯皮纳博士提供支持，使其成为 以患者为中心的甲状腺癌护理领域的独立调查者。有一种流行的甲状腺疾病 直接伤害患者并使医疗系统不堪重负的癌症诊断。不加区别的活组织检查 没有患者参与决策过程的甲状腺结节会导致过度诊断 在美国每年被诊断为甲状腺癌的5万名患者中，有超过50%的人患有甲状腺癌。 对话辅助工具可以支持临床实践中的共享决策，并允许患者和临床医生 协作并找到适合个别患者需求的医疗决策。因此，一种对话辅助工具 支持关于是否需要甲状腺活检和甲状腺癌诊断的决策，是一种新的 这项提案可以导致对甲状腺癌诊断采取更谨慎的方法。这项拟议的研究旨在 致：AIM1。更新为支持中的共享决策而开发的对话帮助原型 甲状腺癌与AIM2的诊断进行一项试点临床试验，以评估进行 评估这种对话在支持共享决策方面的有效性的更大研究，减少了 不必要的甲状腺活检的数量和导致以患者为中心的甲状腺癌诊断的改善。 为了达到AIM1，我们将对使用过AIM1的患者和临床医生进行半结构化访谈 对话在决策过程中的帮助和评估这些临床访问的记录，以获得 通过质的研究方法，深入了解他们使用对话辅助工具的经验 以及更新对话辅助原型的反馈。在AIM2中，此更新的对话帮助将用于 试点随机试验，其中提出评估甲状腺结节的患者将被随机接受 关于甲状腺活检和甲状腺癌诊断的咨询，使用对话辅助接受护理 (干预组)或不使用会话辅助工具(对照组)。这项研究的结果将告知 一项更大规模的研究的可行性和设计，以评估支持共享决策的有效性 不必要的甲状腺活检和甲状腺癌的诊断率。这项研究的长期目标是 支持共享决策和以患者为中心的甲状腺癌诊断。辛格·奥斯皮纳博士将接受 在定性研究、传播与实施科学和临床试验方面的正规课程工作 设计。此外，她拥有一支杰出的、尽职尽责的多学科指导团队，包括 感兴趣领域的国际公认的专家。这个团队将支持她的职业发展和 有指导的研究经验。长期目标是让辛格·奥斯皮纳博士成为一名独立的 以患者为中心的甲状腺癌护理领域的研究人员，并评估一种可以帮助 减少对甲状腺癌的过度诊断，及其危害。

Summary This Mentored Clinical Scientist Research Career Development Award (K08) by the National Cancer Institute is designed to provide the principal investigator Dr. Naykky Singh Ospina with the support to become an independent investigator in the field of patient centered thyroid cancer care. There is an epidemic of thyroid cancer diagnosis that directly harms patients and overwhelms the medical system. Indiscriminate biopsy of thyroid nodules without engagement of patients in the decision making process leads to over diagnosis of more than 50% of the 50,000 patients that are diagnosed with thyroid cancer annually in the United States. Conversation aids can support shared decision making in clinical practice and allow patients and clinicians to collaborate and find the medical decision that fits the needs of individual patients. As such, a conversation aid to support the decision making regarding the need for thyroid biopsy and thyroid cancer diagnosis, is a novel proposal that can lead to a more careful approach to thyroid cancer diagnosis. The proposed research seeks to: AIM1. Update a conversation aid prototype that was developed to support shared decision making in the diagnosis of thyroid cancer and AIM2. Conduct a pilot clinical trial to evaluate the feasibility of conducting a larger study evaluating the efficacy of this conversation aid in supporting shared decision making, decreasing the number of unnecessary thyroid biopsies and leading to improved patient centered thyroid cancer diagnosis. To achieve AIM1, we will conduct semi-structured interviews of patients and clinicians who have used the conversation aid in the decision-making process and evaluate recordings of these clinical visits, to obtain through qualitative research methods an in-depth understanding of their experience using the conversation aid and feedback to update the conversation aid prototype. In AIM2, this updated conversation aid will be used in a pilot randomized trial, where patients presenting for evaluation of thyroid nodules will be randomized to receive counseling about thyroid biopsy and thyroid cancer diagnosis, to receive care using conversation aid (intervention group) or not using the conversation aid (control group). The results of this study will inform the feasibility and design of a larger study, to evaluate the efficacy of supporting shared decision making on the rate of unnecessary thyroid biopsies and thyroid cancer diagnosis. The long-term goal of this research is to support shared decision-making and patient centered thyroid cancer diagnosis. Dr. Singh Ospina, will receive formal course work in qualitative research, communication and implementation science, and clinical trials design. In addition, she has an exceptional and committed multidisciplinary mentoring team that includes internationally recognized experts in the fields of interest. This team will support her career development and mentored research experience. The long term goals are for Dr. Singh Ospina to become an independent investigator in the field of patient centered thyroid cancer care and evaluating a conversation aid that can help decrease the over diagnosis of thyroid cancer, and it’s harms.