A randomized trial comparing health-related quality-of-life and utility measures between routine fine-needle aspiration cytology (FNAC) and surveillance alone in patients with thyroid incidentaloma measuring 1–2\u2009cm

Abstract

Purpose To present the impact of treatment on health-related quality-of-life (HRQOL) and health utility measures from the randomized controlled trial (ClinicalTrials.gov Identifier: NCT02398721) that investigated the FNAC versus watchful surveillance in patients with incidental benign thyroid nodules. Methods Health utility and HRQOL were evaluated using the EQ-5D 5-level (EQ-5D-5L), 6-item Short-Form Health Survey (SF-6D), and generic 12-item Short-Form Health Survey (SF-12v2) at baseline, 3-month, 6-month, and 12-month assessments. A repeated measure analysis of variance evaluated differences in HRQOL scores between treatment groups over time. Multiple imputations were used to impute missing data at each time point. Results HRQOL data completion rates were 99.7% at baseline, 92.7% at 3-month, 93.9% at 6-month, 92.7% at 12-month, and 88.6% at 18-month follow-up after baseline. There were significant mean differences in SF-6D, EQ-5D-5L, and SF-12v2 over time except the domain of vitality and mental health of SF-12v2. Mean change of SF-12v2 scores and utility scores from baseline between groups did not exceed minimal important difference. No significant treatment group by time interactions were found in all HRQOL and utility scores except in the vitality domain and PCS of SF-12v2 ( p value\u2009=\u20090.033; 0.024). Conclusions When compared with watchful surveillance, FNAC intervention was associated with better vitality and physical-related HRQOL scores but did not provide better preservation of utility score improvement over the 18-month period. These findings support the routine FNAC approach for nodules that have a low-suspicion sonographic pattern and measure between 1.0 and 2.0\u2009cm.