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

For women with dysfunctional uterine bleeding not due to fibroids, what are the comparative benefits and harms of hormonal treatments (including L-IUS intrauterine hormonal treatment), ablative approaches, and hysterectomy, considering the various types of hysterectomy approaches with their differences in recovery time, operative complications, and other issues including cost.

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

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

Oral contraceptives, injectible and oral progestin therapies, L-IUS, first-generation ablative techniques, second-generation ablative techniques, vaginal total hysterectomy, laparoscopic (total and supra-cervical) hysterectomy, abdominal hysterectomy (total and supracervical), laparascopic-assisted vaginal hysterectomy (total)

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.)

Premenopausal women, generally aged 28 to 54 years without structural abnormalities (e.g., uterine fibroids) and with symptomatic uterine bleeding requesting therapy.

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

Obese women may have different treatment choices or options. Women who have completed their childbearing may be considered differently. Women closer to menopause may be considered differently. Women's whose surgical risks are elevated. Overall, women may vary individually in terms of their preferences for certainty of treament effect vs. potential risks. It would be of interest to understand if there are any predictable factors around which this variation could be considered.

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

Symptom improvement, increased function (including decrease in days lost from work), quality of life, satisfaction with outcome, match at the individual level between treatment outcome and desired state of individual prior to treatment (for example, never want to bleed again no matter what or anything that will allow me to not have unexpected heavy bleeding).

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

Hormonal treatments can cause thromboembolic complications and some women experience unwanted side effects, including emotional side-effects and weight gain. L-IUS can cause risk of uterine perforation, can be displaced and need retrieval and side-effects such as cramping. Ablative techniques have associated anethestic risks, uterine perforation risks, may mask future malignancy and have a certain failure rate due to incomplete procedures. Hysterectomy-associated risks include anesthetic risks, operative risks--including bowel perforation and infection, persistent bleeding with supracervical techniques. Post-operatively different approaches have different recovery times and associated risks, including long-term development of adhesions which can affect future success with colonoscopy.

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
• Pregnancy, including preterm birth

AHRQ Priority Populations

• Women

Federal Health Care Program

• Medicaid

Importance

Describe why this topic is important.

Overall, the estimate is that around 10% of women are affected by medical conditions related to DUB such as anemia--with a higher proportion (30-50%)reporting symptoms consistent with DUB (i.e. heavy bleeding) sometime in their lifetime. Treatment choices in the absence of a structural cause for bleeding problems are confusing and not well delineated in terms of how to choose the appropriate treatment for women or for their clinicians.

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.)

This topic was motivated from personal clinical practice dilemmas and the interest in clinical practice tools that could help women make these decisions. Also, the right outcome that people may choose (reducing hysterectomies) may not be the outcome women would always choose. Trying to make treatment options and outcomes more patient-centered and clearer, with a clearer articulation of evidence supporting relative risks and benefits for different treatment choices, would be a great service.

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:

Many treatments, few evidence-based guidelines for non-structurally caused DUB.

Potential Impact

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

I will work to disseminate this within my local and national OB-GYN network and to encourage my professional society (ACOG) to write evidence-based guidelines.

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

Anytime would be better than never.

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

Access to different treatments certainly varies by socioeconomic status. Access could be made more egalitarian if we were clear what treatments provide equivalent benefits with relatively similar harms across this spectrum of approaches.

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)

I will work to disseminate this within my local and national OB-GYN network and to encourage my professional society (ACOG) to write evidence-based guidelines.

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

Individual

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

My professional workplace