Brooks Elizabeth A, Singer Allison M, Delvadia Dipak R, Forstein David, Beaudoin Teresa J, Bauserman Robert L, Yuen Matt W, Little Carter A, Zambelli-Weiner April
TTi Health Research & Economics, Westminster, MD, USA.
Benaroya Research Institute at Virginia Mason Medical Center, Seattle, WA, USA.
Clinicoecon Outcomes Res. 2020 Jun 12;12:299-306. doi: 10.2147/CEOR.S253891. eCollection 2020.
The CHOICES study compared short-term resource utilization, facility costs, and perioperative patient outcomes between transcervical fibroid ablation (TFA) with the Sonata® system and myomectomy through a case-matched comparative trial design. This is the first facility-level comparative study conducted for TFA.
The study enrolled 88 patients from 4 centers equally divided among the two cohorts. The TFA arm consisted of 44 women who had enrolled in the SONATA Pivotal IDE trial, whereas the myomectomy arm included 44 patients who were identified through retrospective case-matching to the enrolled SONATA patients at the same 4 centers.
TFA had a significantly lower mean operating room duration (90 minutes) and length of stay (5.2 hours) than myomectomy (143 minutes and 45.8 hours, respectively). The average total mean facility costs for TFA procedure ($7,563) were significantly lower than those associated with myomectomy ($11,425; p=0.002). TFA mean facility costs were also compared with other stratifications of myomectomy (inpatient or outpatient and surgical route). TFA facility costs were significantly lower than that associated with inpatient, abdominal, or laparoscopic myomectomy (all p<0.001).
TFA using the Sonata system has a significantly shorter operating room time and length of stay than myomectomy for the treatment of symptomatic uterine fibroids. All procedure, anesthesia, laboratory, pathology, and pharmacy costs were significantly higher for myomectomy as compared to TFA. TFA was also associated with significantly lower facility procedure-related costs compared to myomectomy, including inpatient, abdominal, or laparoscopic myomectomy.
CHOICES研究通过病例匹配比较试验设计,比较了使用Sonata®系统进行经宫颈肌瘤消融术(TFA)和子宫肌瘤切除术的短期资源利用、机构成本及围手术期患者结局。这是首次针对TFA开展的机构层面的比较研究。
该研究从4个中心招募了88例患者,平均分为两个队列。TFA组由44名参加SONATA关键器械临床试验豁免研究的女性组成,而子宫肌瘤切除组包括44例通过回顾性病例匹配确定的患者,这些患者来自与参加SONATA研究的患者相同的4个中心。
与子宫肌瘤切除术相比,TFA的平均手术室时长(90分钟)和住院时长(5.2小时)显著更短(分别为143分钟和45.8小时)。TFA手术的平均机构总成本(7563美元)显著低于子宫肌瘤切除术的成本(11425美元;p = 0.002)。TFA的平均机构成本还与子宫肌瘤切除术的其他分层情况(住院或门诊以及手术途径)进行了比较。TFA的机构成本显著低于住院、开腹或腹腔镜子宫肌瘤切除术的成本(所有p<0.001)。
对于有症状的子宫肌瘤治疗,使用Sonata系统的TFA与子宫肌瘤切除术相比,手术室时间和住院时长显著更短。与TFA相比,子宫肌瘤切除术的所有手术、麻醉、实验室、病理和药房成本均显著更高。与子宫肌瘤切除术相比,TFA的机构手术相关成本也显著更低,包括住院、开腹或腹腔镜子宫肌瘤切除术。