{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T18:47:03Z","timestamp":1790880423259,"version":"4.1.0"},"reference-count":24,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2017,6,5]],"date-time":"2017-06-05T00:00:00Z","timestamp":1496620800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"National Key Technology R&D Program","award":["2011BAI14B01"],"award-info":[{"award-number":["2011BAI14B01"]}]}],"content-domain":{"domain":["obgyn.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJOG"],"published-print":{"date-parts":[[2018,2]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>To evaluate the clinical outcomes of high\u2010intensity focused ultrasound (<jats:styled-content style=\"fixed-case\">HIFU<\/jats:styled-content>) and surgery in treating uterine fibroids, and prepare for a definitive randomised trial.<\/jats:p><\/jats:sec><jats:sec><jats:title>Design<\/jats:title><jats:p>Prospective multicentre patient choice cohort study (<jats:styled-content style=\"fixed-case\">IDEAL<\/jats:styled-content> Exploratory study) of <jats:styled-content style=\"fixed-case\">HIFU<\/jats:styled-content>, myomectomy or hysterectomy for treating symptomatic uterine fibroids.<\/jats:p><\/jats:sec><jats:sec><jats:title>Setting<\/jats:title><jats:p>20 Chinese hospitals.<\/jats:p><\/jats:sec><jats:sec><jats:title>Population or sample<\/jats:title><jats:p>2411 Chinese women with symptomatic fibroids.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Prospective non\u2010randomised cohort study with learning curve analysis (<jats:styled-content style=\"fixed-case\">IDEAL<\/jats:styled-content> Stage 2b Prospective Exploration Study).<\/jats:p><\/jats:sec><jats:sec><jats:title>Main outcome measures<\/jats:title><jats:p>Complications, hospital stay, return to normal activities, and quality of life (measured with <jats:styled-content style=\"fixed-case\">UFS<\/jats:styled-content>\u2010Qol and <jats:styled-content style=\"fixed-case\">SF<\/jats:styled-content>\u201036 at baseline, 6 and 12 months), and need for further treatment. Quality\u2010of\u2010life outcomes were adjusted using regression modelling. <jats:styled-content style=\"fixed-case\">HIFU<\/jats:styled-content> treatment quality was evaluated using <jats:styled-content style=\"fixed-case\">LC<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">CUSUM<\/jats:styled-content> to identify operator learning curves. A health economic analysis of costs was performed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>1353 women received <jats:styled-content style=\"fixed-case\">HIFU<\/jats:styled-content>, 472 hysterectomy and 586 myomectomy. <jats:styled-content style=\"fixed-case\">HIFU<\/jats:styled-content> patients were significantly younger (<jats:italic>P<\/jats:italic> &lt; 0.001), slimmer (<jats:italic>P<\/jats:italic> &lt; 0.001), better educated (<jats:italic>P<\/jats:italic> &lt; 0.001), and wealthier (<jats:italic>P<\/jats:italic> = 0.002) than surgery patients. Both <jats:styled-content style=\"fixed-case\">UFS<\/jats:styled-content> and QoL improved more rapidly after <jats:styled-content style=\"fixed-case\">HIFU<\/jats:styled-content> than after surgery (<jats:italic>P<\/jats:italic> = 0.002 and <jats:italic>P<\/jats:italic> = 0.001, respectively at 6 months), but absolute differences were small. Major adverse events occurred in 3 (0.2%) of <jats:styled-content style=\"fixed-case\">HIFU<\/jats:styled-content> and in 133 (12.6%) of surgical cases (<jats:italic>P<\/jats:italic> &lt; 0.001). Median time for hospital stay was 4 days (interquartile range, 0\u20135 days), 10 days (interquartile range, 8\u201312.5 days) and 8 days (interquartile range, 7\u201310 days).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p><jats:styled-content style=\"fixed-case\">HIFU<\/jats:styled-content> caused substantially less morbidity than surgery, with similar longer\u2010term QoL. Despite group baseline differences and lack of blinding, these findings support the need for a randomised controlled trial (<jats:styled-content style=\"fixed-case\">RCT<\/jats:styled-content>) of <jats:styled-content style=\"fixed-case\">HIFU<\/jats:styled-content> treatment for fibroids. The <jats:styled-content style=\"fixed-case\">IDEAL<\/jats:styled-content> Exploratory design facilitated <jats:styled-content style=\"fixed-case\">RCT<\/jats:styled-content> protocol development.<\/jats:p><\/jats:sec><jats:sec><jats:title>Tweetable abstract<\/jats:title><jats:p><jats:styled-content style=\"fixed-case\">HIFU<\/jats:styled-content> had much better short\u2010term outcomes than surgery for fibroids in 2411\u2010patient Chinese <jats:styled-content style=\"fixed-case\">IDEAL<\/jats:styled-content> format study.<\/jats:p><\/jats:sec>","DOI":"10.1111\/1471-0528.14689","type":"journal-article","created":{"date-parts":[[2017,4,19]],"date-time":"2017-04-19T07:53:40Z","timestamp":1492588420000},"page":"354-364","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":143,"title":["Evaluation of high\u2010intensity focused ultrasound ablation for uterine fibroids: an <scp>IDEAL<\/scp> prospective exploration 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