Evidence Table - Group Health Cooperative

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Clinical Area: MR-guided focused ultrasound surgery with ExAblate system for treatment of uterine fibroids. Reference: Stewart EA et al. Clinical outcomes of ...
Evidence Table Clinical Area: Reference:

MR-guided focused ultrasound surgery with ExAblate system for treatment of uterine fibroids Stewart EA et al. Clinical outcomes of focused ultrasound surgery for treatment of uterine fibroids. Fertil and Steril 2006; 85: 22-29. (Additional information: Hindley et al. AJR 2004; 183: 1713-1719).

Study Type: Case Series Study Aim: To report on outcomes after MR-guided focused ultrasound surgery (MRgFUS) with ExAblate system for treatment of uterine fibroids Outcomes • Primary: 10-point improvement in the symptom severity scale (SSS) of the Uterine Fibroid Symptoms Quality-of-Life questionnaire (UFS-QOL) at six months after treatment. • Secondary: Health-related quality of life scale in UFS-QOL; SF-36. Design • Number of subjects: n=109 treated. • Description of study population: Mean age=44.8 ± 4.9 years; 81% white; 94% premenopausal. • Inclusion criteria: At least 18 years old; did not desire future pregnancies; clinically significant uterine fibroids. • Exclusion criteria: Excluded women with MR evidence of adenomyosis alone, myomas where focused ultrasound energy could traverse bowel or bladder, degenerating and necrotic myomas, fibroids >10 cm in diameter and uteri >24 week pregnancy equivalent. • Consecutive patients? Not discussed. • Intervention: Treatment with the ExAblate 2000 system (Insightec, Israel) which integrates a 1.5 Tesla MRI system with a focused ultrasound tranducer. A test sonication at low energy was done before therapeutic treatment to confirm targeting accuracy. Therapeutic sonication was then used to ablate the targeted tissue, heating tissue to 65-85o, resulting in coagulative necrosis. Each sonication took approximately 20 seconds, with a cooldown period of 90 seconds before the next sonication. Total treatment time was no more than 3 hours. Treatment of multiple myomas was allowed, but most patients had a single myoma. • Source of outcome data: Self-report measures. • Length of follow-up: 12 months, primary outcome assessed at 6 months. P

P

Validity • Was population homogenous? Reasonably homogenous. • Potential selection biases: No specific biases identified. • Were intervention/ care/follow-up similar in each group? Yes. • Did an objective observer assess outcomes? NA, self-report. • Completeness of follow-up: 100% at 6 months; 82/108 (75%) at 12 months. • Industry funding? Yes, funded by Insightec, manufacturer of ExAblate system.

2 • Conclusions regarding validity of methods: The major limitations are that there was no control or comparison group and no blinding. These can introduce bias, especially when the primary outcomes are patient-reported and subjective. Advantages include clear eligibility criteria, a validated symptom rating tool and a well-defined primary outcome measure.. Results Note: Maximum Symptom Severity Score (SSS)= 100 U

U

Mean baseline SSS Mean 6-month SSS

61.7 ± 15.2 37.3 ± 21.0

Mean decrease in score baseline to 6 months=23.8 points. P-value