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

Why are there no discussion on comparing the effectiveness of medical foods to phamaceuticals in the treatment of diseases in children? For example the effectiveness of the Ketogenic diet in children with epilepsy compared to pharmaceuticals.

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:

The use of Ketocal ketogenic formula to pharmaceutical drugs in the treatment of epilepsy.

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.)

Children over age 1 with intractable epilepsy.

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

Children with special healthcare needs.

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

Improvement in patient symptoms (seizures), patient mental acuity, patients activity levels using the Ketogenic diet compared to using pharmaceuticals.

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

None

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

• 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.

Medical foods have long been recognized as a viable treatment means and are often more economical. But because our society has been so indoctrinated to using a "pill" for every condition. Medical foods are never even given a seat at the table when dicussions of health dollars occur.

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 movie "First Do No Harm" that chronicled a family's journey and struggle for their epileptic son. Charlie Abramson.

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:

While the evidence clearly indicates diet is more effective than drugs in many instances. The Medical community is not aware of use of the diet or thinks that it is too hard in general.

Potential Impact

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

Children with epilepsy placed on the diet will have a better access to the Ketogenic diet.

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

Within the next 18 months.

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

Currently the Ketogenic diet is administered through Ketogenic centers across the country. For indigent families it would require them to travel to one of the centers, and lodge there for the treatment period. The cost of travel and lodging is an impediment to access to this vital treatment.

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)

Children with epilepsy placed on the diet will have a better access to the Ketogenic diet.

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