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

Identification of Comparative Effectiveness Research Review Topics For Common Gynecological Conditions.

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

no

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

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.)

women of all races and particular attention to subpopulations as relevant (medicaid, low socieconomic status, pre-existing disabilities, obesity, adolescents and teens, elderly) in the US population, across the lifespan with high-burden gyn conditions clearly defined by established incidence and prevalence, burden of disease (may include but not limited to economic, social, health, medical, healthcare system considerations).

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

All races and ethnicities of women are affected by gynecological conditions. A systematic review which analyzes the current evidence base to identify gynecological topics with particular focus on those conditions with a high burden and prevalence in subpopulations would be helpful to ascertain which conditions have evidence gaps or controversies in treatments, interventions, care coordination and access. Furthermore, a process which then engages both technical experts and stakeholders to determine criteria (ie timeliness of review, importance of controversy or dilemma, impact) for prioritization of these topics for comparative effectiveness reviews would provide a streamlined method or approach for conducting a 'series' and branches of effective health care program evidence reviews,technical briefs and comparative effectiveness reviews oriented towards gynecological conditions, interventions and treatments.

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

patient centered outcomes including child-bearing, fertility/conception, pregnancy, maternal, fetal, newborn and child health outcomes and co-morbidities, quality of life, menstrual patterns, costs

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

harms or benefits of controversial interventions, new technologies and treatments related to gynecological conditions.

patient centered outcomes related to gynecological conditions : infertility, medical and mental health complications during pregnancy, medical, surgical and interventional management and impact on future mode of delivery, fetal and newborn outcomes,

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)

• Developmental delays, attention-deficit hyperactivity disorder, and autism
• Functional limitations and disability
• Obesity
• Pregnancy, including preterm birth

AHRQ Priority Populations

• Low income groups
• Minority groups
• Women

Federal Health Care Program

None

Importance

Describe why this topic is important.

The 2008 AHRQ National Health Disparities and Quality Reports highlights the US statistical trends observed since 2004 in women’s health disparities. An identified need of particular importance in women includes prevention and access within the scope of reproductive gynecologic health. The scope of current literature addressing diseases affecting women’s health often does not permit definitive conclusions about benefit, harm, or relative costs to clearly guide women’s choices which are often uniquely different than those for men. Significant research gaps cited in prior AHRQ systematic evidence reviews exploring women’s gynecologic health issues include well-conducted trials in U.S. populations that directly compare interventions on short- and, especially, long-term outcomes, studies on therapeutics for medical management, and information on treatment decisions for women who eventually desire the ability to conceive and sustain a full term pregnancy. Analysis of comparative effectiveness of gynecological management is complicated by at least four phenomena. First, the ‘burden’ of disease, etiology and natural history of gynecological disorders is unclear among different populations and worldwide, including the development of disease and require detailed long-term prospective study examining patterns of growth and multiple factors. Second, the choice of initial therapy and timing of therapy may be influenced by patient characteristics, including co-morbidities and race that also affect the risk of certain clinical end points and provider choice and facility resources and demographics. Third, many patients do not achieve satisfactory outcomes with primary treatment interventions and require an additional procedure or intervention for management, leaving questions about physiological, genetic and/or environmental reasons for development of disease and symptom control, complications post treatment or procedure and characterizing what patient factors in turn are best su

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.)

Patients dealing with gynecological conditions and their clinicians are often faced with the confusion and uncertainties related to the short and long-term outcomes of interventions to treat mostly symptoms related to their gynecological conditions (ie antiinflammatories, pain medications, psychotropics and surgery) and not the etiology often with no explicit evidence supporting indication for these treatments or interventions and are often given with trial and error, subjecting women to recurrent procedures, interventions, multiple therapies and limited understanding of long-term consequences on a woman's health and function. A systematic review which explores the breadth of gynecological conditions and which concurrently helps identify what are the current clinical dilemmas or controversies for stakeholders including patients, consumers, clinicians, policy-makers, funding agencies, investigators and guideline developers excluding recent or current gyn reviews in progress can help guide the prioritization of gynecological conditions into evidence synthesis, generation and translation activities in this area to help meet needs of these stakeholders.

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:

yes variations in clinical care, impact of access and health systems coordination of services and delivery of routine, preventive gynecological health care in geographic settings and understanding disparities in subpopulations (ie medicaid populations vs. private insurance), (access to subspecialty services, vs. community clinics)

Potential Impact

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

Prioritization of comparative effectiveness research topics and categorization of topics by needs for evidence synthesis, evidence generation, evidence translation and dissemination.

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

Either a generalist systematic review or ARRA topic horizon scanning topic is suggested for this activity within a 10-12 month time frame.

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

minority health, geriatric elderly women, adolescents, teens, pediatric health. This nomination is proposing comprehensive examination and map of common gynecological conditions within the US across the lifespan of women from the pediatric years through older aged women to better understand what systematic reviews and comparative effectiveness research can have the most value and impact.

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)

Prioritization of comparative effectiveness research topics and categorization of topics by needs for evidence synthesis, evidence generation, evidence translation and dissemination.

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

medical officer