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

总结 这个指导临床科学家研究职业发展奖（K08）由国家癌症研究所是 旨在为首席研究员Naykky Singh Ospina博士提供支持， 在以患者为中心的甲状腺癌护理领域的独立研究者。有一种流行病甲状腺 癌症诊断直接伤害患者并扰乱医疗系统。不分青红皂白的活检 甲状腺结节在没有患者参与决策过程的情况下，会导致更多的过度诊断。 在美国，每年被诊断患有甲状腺癌的50，000名患者中有超过50%。 会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 协作并找到适合个体患者需求的医疗决策。因此，一种谈话辅助设备， 支持有关甲状腺活检和甲状腺癌诊断需要的决策，是一种新颖的方法 这一建议可以导致更仔细的甲状腺癌诊断方法。拟议的研究旨在 目标：AIM1。更新一个对话辅助原型，该原型是为支持 甲状腺癌和AIM的诊断2.开展试点临床试验，以评估开展 一项更大规模的研究评估了这种对话辅助工具在支持共同决策方面的功效， 不必要的甲状腺活检的数量，并导致改善以患者为中心的甲状腺癌诊断。 为了实现AIM 1，我们将对使用过 在决策过程中的谈话援助，并评估这些临床访问的记录，以获得 通过定性研究方法深入了解他们使用会话辅助工具的经历 和反馈来更新会话辅助原型。在AIM 2中，此更新的会话辅助将用于 初步随机试验，其中接受甲状腺结节评价的患者将随机接受 关于甲状腺活组织检查和甲状腺癌诊断的咨询，使用谈话辅助工具接受护理 （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 一项更大规模研究的可行性和设计，以评估支持共同决策对 不必要的甲状腺活检和甲状腺癌诊断率。这项研究的长期目标是 支持共同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，沟通和实施科学，和临床试验的正式课程工作 设计此外，她还拥有一支出色而敬业的多学科指导团队，其中包括 国际公认的专家在感兴趣的领域。该团队将支持她的职业发展， 指导研究经验。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调查员，并评估可以帮助 减少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.