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Topic Suggestion Description

Date submitted: June 03, 2014

Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.
Description of a question or questions about a health care test or treatment:
o In women with leiomyomas who are candidates for surgery, does the use of adjunctive medical treatment result in better outcomes? (Preoperative adjuvants & intraoperative adjuvants)
o What are the risks and benefits to expectant management of asymptomatic leiomyomas (Note: specifically trying to differentiate benign from leiomyosarcoma type fibroids.)
o In women with leiomyomas who desire to become pregnant, does surgical removal of leiomyomas increase the pregnancy rate, and does the pregnancy rate vary by leiomyoma subtype?
o In women with leiomyomas, what is safety and efficacy of treatment with uterine artery embolization compared with abdominal hysterectomy?
o In women with leiomyomas, what is the safety and efficacy of treatment with magnetic resonance imaging-guided focused ultrasonography compared with abdominal hysterectomy?
o In menopausal women with leiomyomas, what is the effect of hormone therapy on leiomyoma growth, bleeding, and pain, compared with no hormone treatment?
o In asymptomatic women with leiomyomas, does expectant management produce a better outcome than surgical treatment in relation to long-term morbidity?
o What are the risks and benefits of morcellation used as part of laparoscopic myomectomy or hysterectomy for leiomyomas?
o In women with fibroids, what is the safety and efficacy of laparoscopic myomectomy compared with abdominal hysterectomy for treatment of fibroids?
o In women with fibroids, what is the safety and efficacy of laparoscopic myomectomy compared with vaginal hysterectomy for treatment of fibroids?
o In women with leiomyomas, what is the safety and efficacy of vaginal hysterectomy compared with abdominal hysterectomy for treatment of leiomyomas?

Treatments for comparison:
o Different routes of myomectomy and hysterectomy
o Efficacy and safety of uterine artery embolization versus total abdominal hysterectomy and MRI-guided focused ultrasound surgery
o Safety and efficacy of minimally invasive surgery for hysterectomy versus total abdominal hysterectomy
o Medications such as contraceptive steroids, NSAIDs, GnRH agonists, aromatase inhibitors, and progesterone modulators

Relevant patients, group(s) or subgroups of people (this may include details such as age range, gender, coexisting diagnoses, and reasons for therapy.)
o Relevant patients: Women with a diagnosis of leiomyomas.
o Subgroups: Leiomyomas are not unique to any particular population, but do have a higher incidence among black women. In addition, the resources available for treatment vary widely. Identifying the most effective and least resource intensive management approaches would be particularly helpful in low-resource settings.

The important health-related benefits and harms you are interested in. For example, improvements in symptoms or problems with diagnosis.
o Benefits: As alternatives to hysterectomy become increasingly available, the efficacies and risks of these treatments are important to delineate. We are interested medical and surgical treatment alternatives to hysterectomy for leiomyomas.
o Harms: Treatment and management strategies are aimed at abnormal uterine bleeding, pelvic pressure, preserving future fertility, and retaining uteri. Sequelae include reoccurrence, menorrhagia, occult malignancy, and severe abdominal pain.

Importance

Describe why this topic is important.
Leiomyomas are the most common pelvic tumors in women and associated with significant morbidity and economic burden. Based on the 2007 US Census Bureau, there were more than 355,000 leiomyoma-related admissions per year. Fibroids are the most common indication for hysterectomies, accounting for an estimated 40% of hysterectomies, with approximately 600,000 hysterectomies performed in the U.S. each year. Among women younger than 40 years, approximately 30% of hysterectomies are performed laparoscopically through minimally invasive surgery, almost 44% of hysterectomies in women aged 40 to 49 years are performed laparoscopically, and roughly 16% of hysterectomies in women aged 50 to 59 years are performed laparoscopically.

Obstetricians and gynecologists continually focus on providing the best medical care at the lowest risk. When indicated, minimally invasive gynecologic surgical procedures, such as vaginal or laparoscopic hysterectomy, are preferred because they reduce a patient's overall operative risk.

Potential Impact

How will an answer to your research question be used or help inform decisions for you or your group?
Treatment of leiomyomas varies widely among practitioners, and among medical specialties. A uniform approach supported by evidence will help to improve care for women by moving practitioners to follow similar well-supported protocols. In addition, clinicians will be more equipped to make appropriate management decisions for leiomyomas based on the needs of the individual patient, resources, and limitations unique to the institution or type of practice.

Nominator Information

Other Information About You: (optional)
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Professional Society
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American College of Obstetricians and Gynecologists
Please tell us how you heard about the Effective Health Care Program
Stephanie Chang, MD MPH (Agency for Healthcare Research and Quality)