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

In a landmark decision in December 2012, The American Psychiatric Association recognized binge eating disorder (BED) as a distinct eating disorder in the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). The information obtained from following set of related questions will serve to update our current understanding of effective treatments and outcomes of BED.

• What is the evidence for the efficacy of treatments or combination of treatments for BED?
• What is the evidence of harms associated with the treatment or combination of treatments for BED?
• What factors are associated with the efficacy of treatment among patients with BED?
• Does the efficacy of treatment for BED differ by sex, gender, age, race, ethnicity, or cultural group?
• What are the outcomes of BED?
• Do outcomes differ by sex, gender, age, race, ethnicity, or cultural group?

In 2006, AHRQ published the results of a systematic review on Management of Eating Disorders. That review included 25 BED treatment studies and 3 studies on BED outcomes. Treatment and outcomes research has dramatically increased since the last review and because of the increased focus on the BED at this time we feel that it is crucial that patients, practitioners, and researchers have access to an up-to-date synthesis of the evidence.

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:

Our questions compare the efficacy of various psychological treatments alone, various pharmacological treatments alone, and their combination in an effort to reduce BED symptoms and improve associated outcomes (e.g., Type 2 diabetes, obesity, depression).

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.)

Our questions apply to both male and female adolescents (13-17) and adults (18+) who meet either DSM-IV or DSM-5-equivalent criteria for BED.

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

We are particularly interested in investigating the treatment and outcomes of BED in ethnic minorities. BED is more prevalent in Hispanic and African American populations, yet little is known about treatment outcomes in these groups.

We are also invested in gaining a greater understanding of effective treatment options and outcomes in men, given that the prevalence of the disorder is roughly equal in men and women – a finding that is unique to BED as an eating disorder.

An additional subgroup of interest is individuals with BED who have undergone gastric-bypass surgery.

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

We are interested in the primary health outcomes of BED (e.g., cessation/reduction in binge eating behavior).

We are also interested in intermediate outcomes including weight, Type 2 diabetes, psychiatric symptoms, gastrointestinal symptoms, and quality of life.

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

In the psychological trials potential harms include: worsening of BED (and/or associated symptoms) with premature dropout.

In the pharmacological trials potential harms include: sedation, dry mouth, headache, nausea, insomnia, diarrhea, fatigue, increased urinary frequency, sexual dysfunction, abnormal dreams, sweating, palpitations, arrhythmia, and cramping/diffuse pain, and weight gain.

Potential harms in the combination trials could include harms from both the psychological and pharmacological trials.

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
• Dementia, including Alzheimer's disease
• Depression and other mental health disorders
• Developmental delays, attention-deficit hyperactivity disorder, and autism
• Diabetes mellitus
• Obesity
• Pregnancy, including preterm birth

AHRQ Priority Populations

• Low income groups
• Minority groups
• Women
• Children

Federal Health Care Program

• Medicaid
• Medicare

Importance

Describe why this topic is important.

The recent decision of the American Psychiatric Association to recognize BED as a distinct eating disorder in the newly released DSM-5 highlights the importance of determining the efficacy of various treatment options and differential efficacy according to patient characteristics such as sex, race and ethnicity, age, and post-surgical status (i.e., bariatric surgery). It is estimated that approximately 3.5 percent of American women and 2 percent of American men suffer from BED and the disorder is associated with important medical and psychiatric morbidities including: obesity, Type 2 diabetes, hypertension, major depression, and anxiety disorders. Despite the prevalence and symptom burden associated with BED, knowledge of the most efficacious treatment options is limited. Given the recognition of BED, this review is timely and highly relevant to informing individuals with BED, clinical practice, to planning of clinical services, and to third party payer decisions regarding coverage for this disorder.

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 Binge Eating Disorder Association (BEDA) has a longstanding history of advocacy efforts to both recognize BED as an official eating disorder and to provide patients with the most up-to-date information regarding treatment options and support networks. The questions addressed in this proposal support BEDA's mission and serve to disseminate empirically-based treatment information to the public. In addition to furthering the important mission of BEDA, the questions in this proposal highlight the significant uncertainty about the most efficacious treatment approach for those with BED. If selected, this topic would help to provide definitive answers for patients, providers, and scientists who are devoted to the accurate identification and management of BED. We are particularly motivated to identify appropriate treatment options given the increasing awareness and recognition of BED with its recent inclusion in the DSM-5

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 current treatment options for BED are varied. Pharmacological agents range from second generation antidepressants, to appetite suppressants, and anticonvulsants. Psychological interventions include cognitive-behavioral approaches, lifestyle changes, and interpersonal psychotherapy. Even within individual approaches little is known regarding optimal dosage, duration, and format of intervention (e.g., frequency of sessions, individual or group format, therapist-led or self-help format.) The questions addressed in the current topic proposal would reduce uncertainty for clinicians and policy-makers and provide the information needed for developing more definitive evidence-based guidelines for clinical care.

Potential Impact

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

The knowledge obtained from the proposed questions would be used to provide information about front line BED treatments to patients, clinicians, service planners, researchers, and the broader community. Such information would inform the optimal management of BED and its associated conditions including obesity, Type 2 diabetes, hypertension, and psychiatric illness. The efficient management of BED and its associated conditions has the potential to reduce the burden on third party payers and to allow for a smoother integration of BED treatments in a managed care system.

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

Given the recent DSM revisions, we believe that answers to our questions are needed as soon as possible. However, we recognize that time will be needed to identify and summarize the evidence. It would be helpful to many in the field to know that a project is underway and when it could be expected to be completed.

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

The questions proposed will allow us to better understand the extent to which ethnic/racial minorities and cultural group might differentially benefit from BED treatment. The questions will also allow us to investigate how age and/or sex might impact the overall effect of 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)

The knowledge obtained from the proposed questions would be used to provide information about front line BED treatments to patients, clinicians, service planners, researchers, and the broader community. Such information would inform the optimal management of BED and its associated conditions including obesity, Type 2 diabetes, hypertension, and psychiatric illness. The efficient management of BED and its associated conditions has the potential to reduce the burden on third party payers and to allow for a smoother integration of BED treatments in a managed care system.

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

From individuals at UNC Chapel Hill