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

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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.