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

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Randomized Study on Health-related Quality of Life of Patients With Incidental Small (<2cm) Asymptomatic Thyroid Nodules and Cost-effectiveness Analysis in Managing Small Incidental Thyroid Nodules

Conditions
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Thyroid Nodules

Intervention / Treatment
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* Other: Fine Needle Aspiration Cytology


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: FNAC<br>patients will then be randomized routine FNAC strategy | Other: Fine Needle Aspiration Cytology<br> <br> * Other names: FNAC;|
| No Intervention: No FNAC<br>patients will be randomized to watchful observation strategy (no FNAC) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The measurement of HRQoL by SF-6D Health Survey | Health-related Quality of Life (HRQoL) preference value measured by The Chinese (HK) SF-6D Health Survey will be calculated by the Hong Kong population specific algorithm. It ranges from 0 (dead) to 1 (perfect health) | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effectiveness of managing small incidental thyroid nodules and treatment effect on the HRQOL of patients with thyroid carcinoma | The effectiveness of managing small incidental thyroid nodules is quantified by quality-adjusted life years (QALYs), which will be calculated as the product of average duration of each stage (including no illness) and the SF-6D preference value for that particular health state. The direct health care costs of different strategies in managing small incidental thyroid nodules will be estimated using the costs published by the Government Gazette and previous literatures. HRQOL measured by the Chinese (Hong Kong) Short Form-12 (SF-12) Health Survey version 2 and FACT-G will be evaluated to identify these major problem of life. Health service utilizations of patients with thyroid neoplasm will be surveyed. Treatment effect on the HRQOL of patients with thyroid carcinoma will be explored. | Two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FNAC, Small Incidental Thyroid Nodules