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

The Obesity Action Coalition is interested in an investigation of the comparative effectiveness of treatments for obesity including:

1. What is the comparative effectiveness of bariatric surgery (gastric bypass, lap band, lap sleeve) versus standard medical treatment (including commercial weight loss plans, medical nutrition therapy (dietary counseling) and healthcare professional supervised diet and behavior modification with and without pharmacotherapy) for people with BMI 40 or above?
2. What is the comparative effectiveness of bariatric surgery (gastric bypass, lap band, lap sleeve) versus standard medical treatment (including commercial weight loss plans, medical nutrition therapy (dietary counseling) and healthcare professional supervised diet and behavior modification with and without pharmacotherapy) for people with BMI 35 or above?
3. Is there a difference in patient outcomes for surgery versus medical management for people with BMI 40 or above who have other co-morbidities (type 2 Diabetes, hypertension, and cardio-vascular disease)?
4. Is there a difference in patient outcomes due to relative degrees of obesity (e.g. BMI strata)?
5. Is there a difference in patient outcomes due to differences in age, gender, socioeconomic status or race/ethnicity?

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:

Bariatric surgery (gastric bypass, lap band, lap sleeve)

versus standard medical therapy (including commercial weight loss plans, medical nutrition therapy (dietary counseling) and healthcare professional supervised diet and behavior modification with and without pharmacotherapy).

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.)

Adults undergoing treatment for severe obesity (BMI greater than or equal to 35 with obesity related co-morbidity or BMI greater than or equal to 40.)

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

• For people with BMI 35-40 versus 40+?
• Do women have different outcomes than men?
• Do people of differing race/ethnicity have different outcomes?
• Does socioeconomic status affect outcomes?
• Does age affect outcomes?

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

The benefits of determining which treatments for obesity are most effective for which patients include:

• Decreased morbidity and mortality
• Minimizing side/effects or harms from ineffective treatments
• Reduced complications from co-morbid conditions (e.g. GERD, type 2 diabetes, CVD, etc.)
• Improvement in quality of life

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

The potential harms for obesity treatments include:

• Increased morbidity and mortality
• Increased complications from co-morbid conditions (e.g. GERD, type 2 diabetes, CVD, etc.)
• Long-term side effects

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)

• Arthritis and nontraumatic joint disorders
• Cancer
• Cardiovascular disease, including stroke and hypertension
• Depression and other mental health disorders
• Diabetes mellitus
• Functional limitations and disability
• Obesity
• Pregnancy, including preterm birth
• Pulmonary disease/asthma

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.

Data suggests that more than one-third of American adults are obese (defined as a BMI of 30 or more). Obesity is a major contributor to premature death. Being obese raises an individual’s risk for type 2 diabetes and cardiovascular disease as well as many other health conditions such as osteoarthritis, sleep apnea, hypertension and some kinds of cancer. In addition, being obese negatively impacts the quality of life for these individuals through discrimination, social isolation and psychosocial impacts such as reduced self-esteem and depression.

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 treatment of obesity is a multi-billion dollar industry. Yet very little evidence exists for the safety and comparative effectiveness of many of these treatments. Obese patients are vulnerable to promises of quick fixes and instant cures. The OAC is interested in knowing which treatments work best for which patients and when, with the fewest side effects or harms associated with these treatments.

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:

Numerous clinician surveys have shown a lack of knowledge of the treatments of obesity. This lack of knowledge presents a barrier to helping those patients who struggle with obesity. A clearer understanding of the effectiveness of obesity treatments in comparison to one another will serve as a guide to the public, clinicians and policymakers in making better treatment choices.

Such materials will also benefit policymakers in their efforts to combat obesity as a societal epidemic by helping them to better understand how to effectively address obesity in those who already struggle with their weight.

Potential Impact

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

Answers will be used to inform consumer and clinician members of our organization and the general public to assist in decisionmaking at the point of care. In addition, answers can be used to assist in our efforts to inform decisions by payers and other policymakers.

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

As soon as possible.

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

Although obesity prevention is a high profile issue, obesity intervention and treatment does not garner similar attention. More than one-third of Americans are already obese with nearly two-thirds of us overweight or obese. Despite these staggering numbers and the tremendous health costs and consequences that they lead to, most Americans lack the ability and coverage to have a conversation with their doctor about their weight. Such visits are almost always denied by insurers, employers and government health programs

who nearly universally exclude any medical intervention dealing with weight issues.

Added to the complexity is the fact that obesity does not impact all Americans equally. People of non-white racial/ethnic background suffer disproportionately from obesity. Blacks, Hispanics and American Indians have much higher risk of being obese than do whites. In addition, geographic differences exist in the rate of obesity in the US. The South, the Midwest and tribal lands in the West have some of the highest rates of obesity and diabetes.

Retrieved from: http://www.cdc.gov/obesity/data/trends.html#Race

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)

Answers will be used to inform consumer and clinician members of our organization and the general public to assist in decisionmaking at the point of care. In addition, answers can be used to assist in our efforts to inform decisions by payers and other policymakers.

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

Scientific Resource Center- Stakeholder Engagement Team--liaison, Cathy Gordon, MPH