Health-Related Quality-Of-Life And Utility Measures Impact In A Randomized Controlled Study Of Fine Needle Aspiration Cytology (FNAC) Versus Watchful Observation In Patients With Incidental Symptomatic Thyroid Nodules

OBJECTIVES: 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 observation in patients with symptomatic benign thyroid nodules. METHODS: Health utility and HRQOL were evaluated using the EuroQoL 5-dimension 5-level (EQ-5D-5L), 6-item Short Form Health Survey (SF-6D), cancer-specific Functional Assessment of Cancer Therapy-general (FACT-G) 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 (ANOVA) evaluated differences in HRQOL scores between treatment groups over time. Multiple imputation was 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 and 92.7% at 12-month after baseline. There were significant mean differences in SF-6D, EQ-5D-5L, FACT-G and SF-12v2 over time except PWB, EWB of FACT-G and mental health of SF-12v2. Mean change of 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 = 0.033; 0.024). CONCLUSIONS: When compared to watchful observation, FNAC intervention was associated with better vitality and physical-related HRQOL scores but did not provide better preservation of utility score improvement over the 12-month period.