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

For the estimated 70 million Americans with hypertension and the tens of millions more at risk, how would government regulations lowering sodium content in restaurant and processed foods compare to usual treatment (relying on the health care delivery system to diagnose and treat) to reduce hypertension and the resulting cardiovascular disease in the overall population.

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 is well-established that high sodium consumption increases hypertension and cardiovascular disease. Regulatory approaches have been proposed to lower overall population sodium consumption, and the United Kingdom has made lowering salt in processed and restaurant foods one of its top public health priorities. There are studies comparing the hypertension and cardiovascular disease consequences of low-sodium and high-sodium diets. This data and the cost of regulatory implementation could be used to generate a scientific analysis of the overall costs and benefits (cost of regulation minus reduction of health care costs associated with reduced hypertension and cardiovascular disease) of various regulatory measures.

This could be compared to the increase in costs using usual care for hypertension and cardiovascular disease (intensified diagnosis and treatment) to achieve similar reductions in hypertension and cardiovascular disease in the overall population.

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.)

An estimated 70 million Americans suffer from hypertension, with only two-thirds being treated for the condition and only half of those being treated achieving control through medical means. Tens of millions of Americans are at risk of developing hypertension within their lifetimes due to dietary exposure to high levels of sodium.

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

While the entire adult population would benefit (long-term hypertension leads to chronic disease, therefore early interventions like reductions in dietary sodium could be especially beneficial), people over 50, African-Americans, and low-income populations who are more likely to be exposed to high-sodium diets are especially at risk.

According to new data from the Centers for Disease Control and Prevention, almost 70 percent of American adults should consume no more than 1,500 milligrams of sodium per day. The average sodium intake is now 3,436 mg/day.

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

Preventing disease is a superior approach to improving overall population health and individual well-being than treating disease in individuals after it has appeared.

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)

• Cardiovascular disease, including stroke and hypertension

AHRQ Priority Populations

• Low income groups
• Minority groups
• Elderly

Federal Health Care Program

• Medicaid
• Medicare

Importance

Describe why this topic is important.

Cardiovascular disease remains the nation’s number-one cause of early mortality, and unsuccessfully treated and untreated hypertension is a major cause of cardiovascular disease. According to a RAND Corp. study, reducing average sodium intake by 1,100 mg per day would save more than $18 billion annually in direct medical costs, with roughly half of those costs borne by government (largely Medicare and Medicaid).

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 Center for Science in the Public Interest has worked for several decades without success to convince the Food and Drug Administration to remove sodium’s designation as Generally Recognized as Safe and take other actions to reduce sodium levels in the food supply (three-fourths of all sodium comes from packaged and restaurant foods). A scientific study objectively evaluating the benefits, risks and costs of regulatory action might encourage regulatory agencies to act.

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:

Some researchers have cast doubt on the ability of regulatory action to reduce sodium consumption to reduce blood pressure and cardiovascular disease on a population-wide basis. Special interests groups have opposed these measures fearing it will impact their sales and profits. Their unscientific assertions have paralyzed regulatory authorities

Potential Impact

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

(See answer to question 9.)

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

The sooner the better.

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

As mentioned above, low-income people, African-Americans, and the elderly are disproportionately affected by untreated hypertension, and would benefit more than the general population from regulatory approaches to curbing sodium content in restaurant and processed foods.

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)

(See answer to question 9.)

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