Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.

What are the comparative treatments including pharmacology, minimally invasive procedures and surgical treatments for women with uterine fibroids? What are the comparative benefits and harms for the various possible treatments? What evidence exists to support the various options for women with fibroids and where are the evidence gaps?

Does your question include a comparison of different health care approaches? (If no, your topic will still be considered.)

yes

If yes, explain the specific technologies, devices, drugs, or interventions you would like to see compared:

Pharmacological options (including gonadotropin antagonists, non-steroidal anti-inflammatory drugs, hormone treatment) vs. surgical vs. minimally invasive surgical options (uterine artery embolization, MRI guided focused ultrasound, cryoablation

What patients or group(s) of patients does your question apply to? (Please include specific details such as age range, gender, coexisting diagnoses, and indications for therapy.)

Pre and post menopausal women.

Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.)

Difference in ethnic populations

Regional variation in available treatment options

Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.)

With evidence-based options on non-surgical and minimally surgical options, women may choose different alternatives to reduce the side effects of the fibroids and avoid morbidities associated with hysterectomy. Additional evidence on treatmetns that might allow some women to extend child bearing choices/timelines rather than losing that option.

• Prolonging option for child bearing
• Improve patient symptoms (such as bleeding, pain, etc)
• Decreasing time lost from work due to symptoms
• Decreasing time lost from work due to prolonged recovery from hysterectomy
• Improved quality of life

Describe any health-related risks, side effects, or harms that you are concerned about.

For women who forego hysterectomy in favor of other treatments, what are the risks, side effects and harms of the non surgical and minimally invasive procedures over time, e.g., recurrence of symptomatic fibroids, infection, bleeding, catastrophic complications requiring emergency hysterectomy?

Appropriateness for EHC Program

Does your question include a health care drug, intervention, device, or technology available (or likely to be available) in the U.S.?

yes

Which priority area(s) and population(s) does this topic apply to? (check all that apply)

EHC Priority Conditions (updated in 2008)

• Functional limitations and disability

AHRQ Priority Populations

• Low income groups
• Minority groups
• Women

Federal Health Care Program

• Medicaid
• Medicare

Importance

Describe why this topic is important.

Uterine Fibroids are common as non-malignant tumors in both pre- and post-menopausal women. They can be painful and disabling, can affect activities of daily living, and/or cause missed family/work time. There are a range of treatments including hysterectomy, but the effectiveness of the alternatives are not clear. Yet the alternatives may provide women preferable choice over a full hysterectomy, allowing a woman to factor in other consideration into a treatment decision.

What specifically motivated you to ask this question? (For example, you are developing a clinical guideline, working with a policy with large uncertainty about the appropriate approach, costly intervention, new research you have read, items in the media you may have seen, a clinical practice dilemma you know of, etc.)

Interest in giving patients range of evidenced-based options so they can consider alternatives a hysterectomy. Women need evidenced-based alternatives to hysterectomy in order to consider various benefits and harms of the range of treatments based on their values and priorities. UnitedHealthcare has a Womens’ Health Initiative. Better guidance for management of this common issue in womens’ health would be a valued addition to this program.

Does your question represent uncertainty for clinicians and/or policy-makers? (For example, variations in clinical care, controversy in what constitutes appropriate clinical care, or a policy decision.)

yes

If yes, please explain:

The non-hysterectomy options might be less morbid than hysterectomy, but their effectiveness over the long term is uncertain. Women who choose a less invasive option may have recurrence of symptoms and may eventually require a hysterectomy in any event.

Potential Impact

How will an answer to your research question be used or help inform decisions for you or your group?

• Provide guidance to patients
• Determine which minimally invasive treatments to cover
• Educate physicians

Describe the timeframe in which an answer to your question is needed.

Within the next 12 months, if possible.

Describe any health disparities, inequities, or impact on vulnerable populations your question applies to.

Regional variation based upon availability of various options

Variation based on income or ethnicity

Variation based upon available subspecialist, e.g. gynecologist vs. interventional radiologist

Nominator Information

Other Information About You: (optional)

Please choose a description that best describes your role or perspective: (you may select more than one category if appropriate)

• Provide guidance to patients
• Determine which minimally invasive treatments to cover
• Educate physicians

Are you making a suggestion as an individual or on behalf of an organization?

Organization

Please tell us how you heard about the Effective Health Care Program