Study on HRQOL and Cost-effectiveness Analysis in Management of Patients With <2cm Thyroid Nodules

The University of Hong Kong (HKU)

Status: Completed

Conditions: Thyroid Nodules

Treatments: Other: Fine Needle Aspiration Cytology

Study type: Interventional

Funder types: Other

Identifiers

NCT02398721

UW 14-500

Details and patient eligibility

About

Ideally randomized controlled trials should be carried out to compare the cost-effectiveness between FNAC and watchful waiting but such studies are very difficult to conduct in practice because they require following up very large number of subjects for a long period of time.

The aims are to determine the health-related quality of life (HRQOL) and HRQOL preference (utility) of patients undergoing watchful observation (no FNAC) and routine FNAC, and to determine the cost-effectiveness of two strategies in managing small incidental thyroid nodules for the Chinese population in Hong Kong.

Enrollment: 314 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18 or above
• Have life expectancy of at least 6 months
• Have an incidental nodule which measures between 1.0 to 2.0cm in the largest dimension on ultrasound guidance (USG) and has benign ultrasonographic features such as spongiform or honeycomb appearance, purely-cystic, egg shell type calcification, iso-echoic or hyper-echoic in relation to the rest of the thyroid tissue and peripheral vascularity on Doppler USG. For subjects with more than one nodule on USG, provided that the other nodules are not >2.0cm or have suspicious features (see below), they will still be eligible.
• Normal thyroid function (both serum thyroid-stimulating hormone (TSH) and free T4 levels within normal range)
• Given consent to take part in the study

Exclusion criteria

• Have suspicious ultrasonographic features such as microcalcifications, marked hypoechogenicity, irregular margins and / or taller than wide and intranodular vascularity on transverse view on Doppler USG that warrant a FNAC
• Nodule size > 2.0cm
• Insisting or refusing FNAC or surgical intervention despite medical reassurance
• Inability to understand or communicate in Cantonese or Chinese
• Significant cognitive impairment judged by the doctor to be unable to answer the questionnaire
• Too ill to carry out interview
• Refusal to give consent

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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314 participants in 2 patient groups

FNAC

Other group

Description:

patients will then be randomized routine FNAC strategy

Treatment:

Other: Fine Needle Aspiration Cytology

No FNAC

No Intervention group

Description:

patients will be randomized to watchful observation strategy (no FNAC)