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

For children with newly diagnosed epilepsy, ketogenic diet treatment should be evaluated against traditional anti-seizure medication.

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:

Ketogenic diet versus traditional anti-seizure drug therapy for newly diagnosed epilepsy in infants and children.

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.)

Infants and children through age 18 years.

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

Certain epilepsy syndromes have been identified as being responsove to ketogenic diet treatment already and this subgroup of patients could be targeted.

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

1. Improvements in seizure-control and the possiblity of complete seizure-freedom, 3) Improvements in cognition due to improved seizure control 4) Improvements in physical health due to improvements in seizure control 5) Fewer adverse effects than drug therapy.

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

Ketogenic diet therapy is a medical diet which requires the medical management by a physician, dietitian and nurse. The diet is contraindicated if there is a metabolic defect in fatty acid metabolism. These defects however are very rare.

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

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.

Ketogenic diet therapy has been in use since the 1920s but it's use has been limited by the fact that there is limited training to health care personnel and a lack of reimbursement for prescribing this therapy (even though it is much cheaper than seizure medications).

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.)

We are a non-profit organization that has provided funding for basic science research, we have an Scientific Advisory Board of Physicians and Dietitians, and have supported training to health care professionals on ketogenic diet therapy. We facilitated the group of authors for "Optimal clinical management of children receiving theketogenic diet: Recommendations of the International Ketogenic Diet Study Group". This was published in the Epilepsia journal in 2008.

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:

The only groups that may be against this therapy are the pharmacuetical industries that manufacture anti-epileptic drugs.

Potential Impact

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

The answer to the research question will improve the medical care of children diagnosed with epilepsy.

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

Our foundation has been in existence for 15 years. We would like to find an answer in the next 5 years.

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

Ketogenic diet therapy is contraindicated in individuals that have a defect in fatty acid metabolism which is a very rare metabolic defect that can be tested for.

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)

The answer to the research question will improve the medical care of children diagnosed with epilepsy.

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