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

For couples trying to get pregnant, how effective are cervical caps? Are they effective compared with intrauterine insemination? How do they compare to in vitro fertilization? Do they work better for any particular age or type of patient?

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:

It would be good to have a chart of comparative effectiveness by age of mother and likely outcomes in number of children each produces and at what gestation. This chart could compare the most common devices and techniques including: intrauterine insemination, and in vitro fertilization.

When used alone, are the outcomes comparable to natural conception? In other words, do they tend to deliver full-term singletons?

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.)

Several types of couples maybe helped by cervical caps: couples who have tried natural conception for >5 months, unsuccessfully; those where the man has had a reverse vasectomy; those where the woman may have been diagnosed with a tilted uterus or hostile vaginal environment; and couples who cannot afford other infertility interventions; couples that have limited time together like military

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

Not that I know of.

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

The health benefits of a cervical cap or relative to the health risk of other forms of conception and assisted reproductive technologies. Cervical caps are very well tolerated and present no systemic adverse effects.

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

Pregnancy is the only health risks to using a cervical cap. Pregnancy carries risks for both the mother and the fetus.

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)

• Pregnancy, including preterm birth

AHRQ Priority Populations

• Low income groups
• Women

Federal Health Care Program

None

Importance

Describe why this topic is important.

Becoming pregnant is important to most couples. These success or failure of having children has an impact on relationships and marriages in the US. Understanding the available options and their potential outcomes would be helpful to insurers and couples alike. Today, providers have no incentive to produce this sort of comparison. The published literature has overwhelmingly treated high tech expensive solutions since 1985 to the exclusion of other options. The increased use of IVF has led to a large increase in preterm multiple births and the related costs and health effects.

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.)

Speaking with many insurers, this question is common when discussing assistant reproductively technologies. It would help insurers develop clinical guidelines.

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:

Mandates to cover in fertility in numerous states raise the question what sort of assisted reproductive technology should be covered? Are there less expensive options that should be used before 12 months had passed with unsuccessful conception? How can payers compare various procedures and technologies for conception?

Potential Impact

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

It will help manufacturers address opportunities by creating products that work and provide benefit at a reasonable cost. It will provide a wonderful resource of unbiased opinion, which will be a welcome reference in a field with relatively little comparative data. Many patients are being encouraged to use IVF to the exclusion of other ART.

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

A response within 9 months would be pleasant.

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

Medicaid does not cover ART. While conception caps aid conception, they are inexpensive compared to other technologies and procedures. They may offer poorer patients opportunities to create families.

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)

It will help manufacturers address opportunities by creating products that work and provide benefit at a reasonable cost. It will provide a wonderful resource of unbiased opinion, which will be a welcome reference in a field with relatively little comparative data. Many patients are being encouraged to use IVF to the exclusion of other ART.

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

Attended a GA Bio meeting discussing CER, where I met Scott Smith, PhD.