| Autor: |
Roy, Kelly, Robinson, James K. |
| Předmět: |
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| Zdroj: |
Journal of Gynecologic Surgery; Apr2022, Vol. 38 Issue 2, p143-147, 5p |
| Abstrakt: |
Objective: To determine quality-adjusted life years (QALYs) over 3 years after transcervical fibroid ablation (TFA) with the Sonata System. Methods: The SONATA trial was a prospective multicenter interventional trial that assessed the safety and efficacy of TFA for treatment of women with symptomatic uterine fibroids. Change in generic health status was assessed with the EuroQol 5-Dimension questionnaire (0–1 scale). Fibroid-specific quality of life (QOL) was measured on a 0 to 100 scale with the health-related quality of life subscale of the Uterine Fibroid Symptom and Quality-of-Life (UFS-QOL). The number of QALYs gained relative to baseline and cumulative QALYs were calculated using the area under the curve at each follow-up visit over 3 years. Results: Among 147 women receiving TFA, fibroid-specific QOL increased from 40 ± 21 at baseline to 84 ± 19 at 1 year and 83 ± 23 at 3 years (p < 0.001). Generic QOL increased from 0.72 ± 0.21 at baseline to 0.89 ± 0.12 at 1 year and 0.88 ± 0.16 at 3 years (p < 0.001). Over 3 years, TFA resulted in 1.24 ± 0.64 QALYs gained when using fibroid-specific health utility scores and 0.49 ± 0.61 QALYs gained when using generic health utility scores. Cumulative QALYs experienced at 3 years as a percentage of perfect health were 82% with fibroid-specific scores and 88% with generic health scores. Conclusions: Women treated by TFA with the Sonata System for symptomatic uterine fibroids reported durable improvements in generic and fibroid-specific QOL, as well as clinically meaningful increases in QALYs over 3 years. Clinical Trials.gov ID: NCT02228174. (J GYNECOL SURG 38:143) [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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