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

For asthmatic and asthma-prone children, what is the comparative effectiveness of treating with allergen-specific immunotherapy plus standard vs. standard alone?

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:

Allergen immunotherapy has been long used in this country. In pracice, multiple allergens are often used. There has not been a comprehensive study comparing the use of this treatment in the way it is ordinarily employed vs. similar care without immunotherapy. Small studies with single allergens have looked very promising,but comparing the effectiveness of 2 modes of treatment the way they are really employed has not been studied in this population, one that likely stands to derive the most benefit.

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.)

Would suggest ages 2-12 with asthma or positive asthma predictive index (family history of asthma, eczema, allergic rhinits, eosinophilia, etc.) Indications for therapy to prevent development of asthma, induce remission, or lessen severity.

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

Asthmatic children and asthma susceptible children are 2 subgroups. Could also stratify by environmental factor, socioeconomic status, ethnicity.

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

Want to understand the potential for the administration of allergen immunotherapy via our current state-of-the-art protocols to prevent the development of or lessen the burden of asthma.

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

Would like to determine the relative safety of immunotherapy in this population.

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)

• Pulmonary disease/asthma

AHRQ Priority Populations

• Low income groups
• Minority groups
• Children
• Individuals with special health care needs, including individuals with disabilities or who need chronic care or end-of-life health care

Federal Health Care Program

• Medicaid
• State Children's Health Insurance Program (SCHIP)

Importance

Describe why this topic is important.

Asthma is a huge burden fot the patients who have it as well as for our healthcare system. There are many studies suggesting immunotherapy may have very significant disease-reduction potential but there has never been a large-scale study comparing its effect the way it is ordinarily used today vs.same therapy/therapy goals without immunotherapy.

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.)

The practice of allergy immunotherapy is very poorly standardized accross the country. Studies in the literature have looked at smaller subgroups of patients, often with one or few components of immunotherapy, but have not adequately looked at the effectiveness of immunotherapy the way it is actually practiced, with multiple allergens. We need to establish the baseline effectiveness of current state-of-the-art so we can understand if it is a valuable addition to therapy and so that we can then study variations to hopefully improve effectiveness.

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:

It might be that consideration of early implementation of immunotherapy in asthma-susceptible children becomes a quality measure, thus important for consideration by clinicians and policy-makers.

Potential Impact

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

It will help clinicians decide if and when to implement allergen immunotherapy in ashtmatic or asthma-prone children and how to determine appropriate constitution of that immunotherapy if it is indicated.

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

The sooner the better. Asthma is a huge burden from a disease and cost standpoint. Immunotherapy is currently used, but with varying indications and constitution. It may represent and extremely cost-effective approach, but this needs to be demonstrated.

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

Asthma has had a disproportionate impact on inner-city and lower socioeconomic status children.

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 clinicians decide if and when to implement allergen immunotherapy in ashtmatic or asthma-prone children and how to determine appropriate constitution of that immunotherapy if it is indicated.

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

Organization

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