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

To test whether CKD patients who are referred to renal nutritionists and receive counseling on how to change their diet to conform to their kidney condition are less likely to require dialysis and/or a kidney transplant. Can they improve their GFR by changing their diet?

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:

The intervention or non-intervention of counseling by a renal nutritionist for chronic kidney disease patients to educate them on the changes in diet they need to make to improve their GFR and/or keep it from going lower.

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.)

All CKD patients, especially those who are also diabetic and are in stage 3 or 4 of kidney disease. Patients who need to lower their serum phosphorous and or serum potassium levels.

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

A possible subgroup could be patients who have been medicated for CKD but have not been instructed about the need to change their diet to avoid further deterioration of their kidney function and ensuing serious side effects. I am a CKD patient - neither my family doctor nor my nephrologist told me I needed to change my diet. I received info from HHS which indicated I was in third stage of CKD with a GFR of 37. I called the Natl. Kidney Found. and was told how I needed to change my diet and was sent voluminous materials to educate me on what foods to avoid and why and what foods and how much I could consume. Upon my insistence I was referred to a dietitian for further counseling - within six months simply by changing my diet my GFR rose to 51. I believe a great deal of money could be saved and needless suffering avoided if CKD patients received such counseling.

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

So many CKD patients end up by needing dialysis and eventually a kidney transplant. In addition many become anemic, have frequent fracture due to calcium leaking from their bones as a result of the inability of their kidneys to eliminate certain waste if they are consuming too much protein, foods high in potassium and phosphorous. I would hope that by changing their diet they could avoid further loss of kidney function and the need for dialysis and or a kidney transplant.

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

I am not aware of any health-related risks in changing their diets as a way of practicing prevention of further deterioration of their kidney function. I would hope that part of this study would include the need to educate patients and doctors on the urgency of taking this preventive measure.

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.?

unsure

Which priority area(s) and population(s) does this topic apply to? (check all that apply)

EHC Priority Conditions (updated in 2008)

• Cardiovascular disease, including stroke and hypertension
• Depression and other mental health disorders
• Diabetes mellitus
• Functional limitations and disability
• Infectious diseases, including HIV/AIDS

AHRQ Priority Populations

• Low income groups
• Minority groups
• Women
• Elderly
• 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
• Medicare

Importance

Describe why this topic is important.

Diabetes has grown to epidemic proportions in our nation. Frequently diabetic patients, the elderly, etc. also suffer kidney impairment - weakened kidneys can affect many other organs of the body, cause severe anemic and other serious side effects. Prevention of reaching higher stages of kidney disease can keep patients from needing to go on dialysis and from suffering other serious side effects. Dialysis and kidney transplants cost the federal government billions annually. Instead these funds could be used for needed research, etc. and CKD patients could live longer and healthier.

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.)

Based on my own experience, I have been trying to get HHS to investigate whether my experience is unusual or whether it could be replicated. Here in Florida dialysis has become a lucrative industry - often the facility is run by the specialists who are treating CKD patients. I was appalled that neither of my doctors told me my GFR was dangerously low - I was under the care of my family doctor for more than ten years; after being told by a lab technician that my BUN was too high for them to inject dye as part of a contrast x-ray exam, I insisted on being referred to a nephrologist - I was under his care for more than a year; each time I asked him if I needed to change my diet he would say, no you won't have a problem for a long time. This was cold comfort for me and I decided to do research on my own. Sadly, mine is not an isolated case - two of my friends both of whom are on insulin and under the care of endocrinologists have no awareness of the need to know their GFR - one friend had a GFR of 36. I impressed upon her the urgency of changing her diet - upon her insistence she was referred to a nephrologist and again upon her insistence was finally sent to a renal dietitian. I believe it is essential for patients to educated on the importance of their lab tests and what their results indicate so they can be their own best health care advocates.

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:

I believe my question represents uncertainty for clinicians on what constitutes adequate preventive care for CKD patients. It seems doctors as well as specialists either are reluctant or need to be educated on the importance of exercising preventive health care by referring CKD patients to trained renal nutritionists so their patients can receive counseling on how they must change their diet to avoid a worsening of their chronic kidney disease.

Potential Impact

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

The supporting research should result in implementation of recommended preventive measures to ensure CKD patients will not suffer further deterioration of their kidney function; instead by changing their diet they will see steady improvement of their GFR, avoiding the need for dialysis, etc.

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

I believe the sooner an answer is forthcoming the greater will be the opportunity to save CKD patients needless suffering and save Medicare and Medicaid many billions of dollars.

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

The least educated CKD patients are most vulnerable to lack of adequate preventive care. Sadly many patients lack the information to enable them to ask questions of their practitioners and suffer needless complications and further deterioration of their chronic kidney disease.

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 supporting research should result in implementation of recommended preventive measures to ensure CKD patients will not suffer further deterioration of their kidney function; instead by changing their diet they will see steady improvement of their GFR, avoiding the need for dialysis, etc.

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

I am on your website