Clinical Utility of Preoperative Thyroid GuidePx® Testing

Thyroid GuidePx® Tested Cohort

Decision impact

Decision impact is defined as any change in treatment decision based on the Thyroid GuidePx® test results, including changes in surgical approach, reduction of unnecessary treatments, and addition of recommended treatments. Decision impact is measured using study-specific clinician and patient questionnaires administered before and after test results are available. Clinician decision impact is assessed by comparing treatments considered prior to testing with treatments recommended after review of test results, as well as clinician agreement with the statement "The test helped to make a treatment decision" rated on a 5-point Likert scale. Patient decision impact is assessed by patient report of whether the test helped them make a treatment-related decision (Yes/No) and the degree to which the test contributed to their care.

A copy of the questionnaires can be uploaded as required (study document upload is currently disabled).

Incidence of total thyroidectomies

Incidence of total thyroidectomy of the tested cohort will be compared to historical controls.

Incidence of completion thyroidectomies

Incidence of completion thyroidectomy of the tested cohort will be compared to historical controls.

Recurrence outcomes

Recurrence outcomes, including biochemical recurrence (i.e., thyroglobulin ≥ 1 ng/mL) and/or tumor recurrence confirmed by imaging (i.e., CT, Ultrasound, etc.) of the tested cohort will be compared to historical controls. In the tested cohort, recurrence outcomes will be compared in Type 3 PTC (high risk) to Type 1 and 2 PTC (low risk).

Costs

Costs related to treatment and follow-up will be compared in the tested cohort will be compared to historical controls For the cost analysis, costs related to clinician visits, treatments and complications will be compared in the study cohort and historical controls.