J Chen1, Y Li2, Z Wang1, P McCulloch3, L Hu1, W Chen4, G Liu2, J Li2, J Lang5. 1. College of Biomedical Engineering, Chongqing Medical University, Chongqing, China. 2. The Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, China. 3. Nuffield Department of Surgical Science, Oxford University, Oxford, UK. 4. Clinical Center for Tumor Therapy, 2nd Affiliated Hospital of Chongqing Medical University, Chongqing, China. 5. Department of Obstetrics and Gynaecology, Peking Union Medical College, Beijing, China.
Abstract
OBJECTIVE: To evaluate the clinical outcomes of high-intensity focused ultrasound (HIFU) and surgery in treating uterine fibroids, and prepare for a definitive randomised trial. DESIGN: Prospective multicentre patient choice cohort study (IDEAL Exploratory study) of HIFU, myomectomy or hysterectomy for treating symptomatic uterine fibroids. SETTING: 20 Chinese hospitals. POPULATION OR SAMPLE: 2411 Chinese women with symptomatic fibroids. METHODS: Prospective non-randomised cohort study with learning curve analysis (IDEAL Stage 2b Prospective Exploration Study). MAIN OUTCOME MEASURES: Complications, hospital stay, return to normal activities, and quality of life (measured with UFS-Qol and SF-36 at baseline, 6 and 12 months), and need for further treatment. Quality-of-life outcomes were adjusted using regression modelling. HIFU treatment quality was evaluated using LC-CUSUM to identify operator learning curves. A health economic analysis of costs was performed. RESULTS: 1353 women received HIFU, 472 hysterectomy and 586 myomectomy. HIFU patients were significantly younger (P < 0.001), slimmer (P < 0.001), better educated (P < 0.001), and wealthier (P = 0.002) than surgery patients. Both UFS and QoL improved more rapidly after HIFU than after surgery (P = 0.002 and P = 0.001, respectively at 6 months), but absolute differences were small. Major adverse events occurred in 3 (0.2%) of HIFU and in 133 (12.6%) of surgical cases (P < 0.001). Median time for hospital stay was 4 days (interquartile range, 0-5 days), 10 days (interquartile range, 8-12.5 days) and 8 days (interquartile range, 7-10 days). CONCLUSIONS: HIFU caused substantially less morbidity than surgery, with similar longer-term QoL. Despite group baseline differences and lack of blinding, these findings support the need for a randomised controlled trial (RCT) of HIFU treatment for fibroids. The IDEAL Exploratory design facilitated RCT protocol development. TWEETABLE ABSTRACT: HIFU had much better short-term outcomes than surgery for fibroids in 2411-patient Chinese IDEAL format study.
OBJECTIVE: To evaluate the clinical outcomes of high-intensity focused ultrasound (HIFU) and surgery in treating uterine fibroids, and prepare for a definitive randomised trial. DESIGN: Prospective multicentre patient choice cohort study (IDEAL Exploratory study) of HIFU, myomectomy or hysterectomy for treating symptomatic uterine fibroids. SETTING: 20 Chinese hospitals. POPULATION OR SAMPLE: 2411 Chinese women with symptomatic fibroids. METHODS: Prospective non-randomised cohort study with learning curve analysis (IDEAL Stage 2b Prospective Exploration Study). MAIN OUTCOME MEASURES: Complications, hospital stay, return to normal activities, and quality of life (measured with UFS-Qol and SF-36 at baseline, 6 and 12 months), and need for further treatment. Quality-of-life outcomes were adjusted using regression modelling. HIFU treatment quality was evaluated using LC-CUSUM to identify operator learning curves. A health economic analysis of costs was performed. RESULTS: 1353 women received HIFU, 472 hysterectomy and 586 myomectomy. HIFUpatients were significantly younger (P < 0.001), slimmer (P < 0.001), better educated (P < 0.001), and wealthier (P = 0.002) than surgery patients. Both UFS and QoL improved more rapidly after HIFU than after surgery (P = 0.002 and P = 0.001, respectively at 6 months), but absolute differences were small. Major adverse events occurred in 3 (0.2%) of HIFU and in 133 (12.6%) of surgical cases (P < 0.001). Median time for hospital stay was 4 days (interquartile range, 0-5 days), 10 days (interquartile range, 8-12.5 days) and 8 days (interquartile range, 7-10 days). CONCLUSIONS:HIFU caused substantially less morbidity than surgery, with similar longer-term QoL. Despite group baseline differences and lack of blinding, these findings support the need for a randomised controlled trial (RCT) of HIFU treatment for fibroids. The IDEAL Exploratory design facilitated RCT protocol development. TWEETABLE ABSTRACT: HIFU had much better short-term outcomes than surgery for fibroids in 2411-patient Chinese IDEAL format study.