Decision Aid for Thyroid Nodules

Overseen by Lukasz Czerwonka, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Stony Brook University

Disqualifiers: Thyroid surgery, Thyroid cancer

No Placebo Group

Trial Summary

What is the purpose of this trial?

Patients with small favorable malignant or indeterminate thyroid nodules will receive information about management of thyroid nodules. Participants will be asked to complete brief surveys at the time of enrollment, shortly after the consultation appointment with the surgeon, and a few months after either the consultation or the surgery, to assess their satisfaction with their decision and decision making process. All participants will receive routine care and counseling by their endocrinologist and surgeon.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your usual medications, as the trial involves routine care and counseling.

What data supports the effectiveness of the treatment Thyroid Nodule Management Education, Decision Aid for Thyroid Nodules Management?

The integration of artificial intelligence decision aids in thyroid nodule management has been shown to reduce workload and enhance efficiency, suggesting that decision aids can improve the management process. Additionally, patient-centered decision making is recognized as beneficial in managing thyroid nodules, indicating that educational and decision support tools may help patients make informed choices. ^{1 2 3 4 5}

How does the Decision Aid for Thyroid Nodules treatment differ from other treatments for thyroid nodules?

The Decision Aid for Thyroid Nodules treatment is unique because it integrates artificial intelligence (AI) to assist radiologists in making personalized decisions, potentially reducing their workload and enhancing efficiency. This approach differs from traditional treatments by focusing on decision support rather than direct medical intervention. ^{2 6 7 8 9}

Research Team

Lukasz Czerwonka, MD

Principal Investigator

[e-mail]

Eligibility Criteria

This trial is for individuals with small thyroid nodules (2cm or smaller) that are possibly malignant or of uncertain nature, without a history of thyroid surgery or cancer. Participants will receive education on managing thyroid nodules and complete surveys to evaluate their satisfaction with the decision-making process.

Inclusion Criteria

My thyroid biopsy shows uncertain or cancerous results.

My thyroid nodule is 2cm or smaller.

Exclusion Criteria

I have had thyroid cancer in the past.

I have had surgery on my thyroid.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Consultation and Information

Participants receive information about management of thyroid nodules and complete brief surveys at the time of enrollment and shortly after the consultation appointment with the surgeon

1-2 weeks

2 visits (in-person)

Follow-up

Participants complete surveys a few months after the consultation or surgery to assess satisfaction with their decision and decision-making process

6 months

1 visit (virtual)

Treatment Details

Interventions

• Thyroid Nodule Management Education (Behavioral Intervention)

Trial Overview The study focuses on providing patients with information about managing small potentially malignant or indeterminate thyroid nodules. It aims to see if this education affects patient satisfaction regarding treatment decisions after consulting with surgeons.

Participant Groups

Group I: Thyroid nodule information Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Stony Brook University

Lead Sponsor

Trials

225

Recruited

41,700+

Dr. James A. Hayward

Stony Brook University

Chief Executive Officer since 1990

PhD in Molecular Biology from the State University of New York at Stony Brook

Dr. Louis A. Peña

Stony Brook University

Chief Medical Officer since 2023

MD from Harvard Medical School

Findings from Research

In a study of 956 patients with indeterminate thyroid nodules, 56% opted for surgery, while 43% chose surveillance, highlighting a significant preference for surgical intervention among patients.

Factors influencing the decision for surgery included larger nodule size, younger age, and higher Bethesda classification, but also varied significantly based on the attending surgeon and the payment model, suggesting a need for standardized management discussions to enhance patient-centered decision making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment Choices in Managing Bethesda III and IV Thyroid Nodules: A Canadian Multi-institutional Study. Kuta, V., Forner, D., Azzi, J., et al.[2022]

An optimized integration of AI decision aids in thyroid nodule management can reduce diagnostic time for senior radiologists without compromising accuracy, while junior radiologists may benefit more from a traditional all-AI strategy.

The study analyzed 1754 ultrasonographic images from 1048 patients to develop the optimized strategy and then tested it on 300 images from 268 patients, finding no significant differences in diagnostic sensitivity or specificity between the two approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integration of Artificial Intelligence Decision Aids to Reduce Workload and Enhance Efficiency in Thyroid Nodule Management. Tong, WJ., Wu, SH., Cheng, MQ., et al.[2023]

There is a general consensus among major thyroid nodule guidelines from various organizations, but some disagreements exist, particularly regarding the use of scintigraphy and calcitonin screening, which may stem from differences in disease prevalence across countries.

Significant gaps in evidence highlight the need for further research, especially in defining ultrasound malignancy criteria and evaluating new diagnostic techniques, which currently require clinicians to rely on their judgment and patient preferences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thyroid nodule guidelines: agreement, disagreement and need for future research. Paschke, R., Hegedüs, L., Alexander, E., et al.[2022]

The 2009 American Thyroid Association guidelines offer important recommendations for managing thyroid nodules and differentiated thyroid cancer based on the best available evidence.

Clinicians and patients should be cautious when applying these guidelines, as ongoing controversies and varying healthcare practices may influence the interpretation and implementation of the recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

2009 American Thyroid Association guidelines on thyroid nodules. Perros, P.[2019]

The revised American Thyroid Association guidelines provide updated recommendations for managing thyroid nodules and differentiated thyroid cancer, reflecting the latest research and therapeutic options.

These guidelines aim to enhance clinical strategies for optimal patient care, ensuring that healthcare providers have access to the most current data for effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thyroid gland: Revised guidelines for the management of thyroid cancer. Boelaert, K.[2022]

Thyroid nodules are more common in older adults, but while they generally have a lower risk of being cancerous, any cancers that are found tend to be of a higher-risk type.

There is a lack of specific evidence for evaluating and managing thyroid nodules in older adults, making it crucial to consider individual patient circumstances and the potential risks and benefits of treatment, especially given their higher likelihood of serious health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thyroid Nodule Evaluation and Management in Older Adults: A Review of Practical Considerations for Clinical Endocrinologists. Ospina, NS., Papaleontiou, M.[2023]

The increase in thyroid nodules detection is primarily due to more frequent use of diagnostic sonography, with most nodules being benign and rarely malignant.

Fine-needle aspiration cytology (FNAc) is crucial for determining whether a thyroid nodule is malignant, and management options for benign nodules include monitoring, iodine supplementation, hormone therapy, and newer techniques like laser photocoagulation, all requiring careful consideration of benefits and risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Benign thyroid nodules: diagnostic and therapeutic approach]. Durante, C., Cava, F., Paciaroni, A., et al.[2022]

A statistical prediction model developed from a study of 261 thyroid nodules (204 benign and 57 malignant) identified key features like irregular shape and microcalcifications that are associated with cancer risk.

The model demonstrated high accuracy (92.5%) in predicting malignancy, suggesting it could serve as an effective decision support tool for managing thyroid nodules, particularly in distinguishing benign from malignant cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A predictive model to distinguish malignant and benign thyroid nodules based on age, gender and ultrasonographic features. Girardi, FM., Silva, LMD., Flores, CD.[2022]

The paper reviews existing resources for managing thyroid nodules, highlighting the strengths and weaknesses of narrative clinical guidelines and clinical risk calculators.

It introduces the Thyroid Nodule Management App (TNAPP), a web-based tool that transforms traditional guidelines into a computer-interpretable format, offering personalized recommendations for clinicians at the point of care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-interpretable guidelines: electronic tools to enhance the utility of thyroid nodule clinical practice guidelines and risk stratification tools. Garber, JR., Patkar, V.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Treatment Choices in Managing Bethesda III and IV Thyroid Nodules: A Canadian Multi-institutional Study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Integration of Artificial Intelligence Decision Aids to Reduce Workload and Enhance Efficiency in Thyroid Nodule Management. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Thyroid nodule guidelines: agreement, disagreement and need for future research. [2022]

4. England pubmed.ncbi.nlm.nih.gov

2009 American Thyroid Association guidelines on thyroid nodules. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Thyroid gland: Revised guidelines for the management of thyroid cancer. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Thyroid Nodule Evaluation and Management in Older Adults: A Review of Practical Considerations for Clinical Endocrinologists. [2023]

7. Italy pubmed.ncbi.nlm.nih.gov

[Benign thyroid nodules: diagnostic and therapeutic approach]. [2022]

8. Brazil pubmed.ncbi.nlm.nih.gov

A predictive model to distinguish malignant and benign thyroid nodules based on age, gender and ultrasonographic features. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Computer-interpretable guidelines: electronic tools to enhance the utility of thyroid nodule clinical practice guidelines and risk stratification tools. [2023]