[Federal Register Volume 79, Number 200 (Thursday, October 16, 2014)]
[Notices]
[Pages 62156-62158]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-24507]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Scientific Information Request on Management and Outcomes of 
Binge Eating Disorder (BED)

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Request for scientific information submissions.

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SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is 
seeking scientific information submissions from the public. Scientific 
information is being solicited to inform our review of Management and 
Outcomes of Binge Eating Disorder, which is currently being conducted 
by AHRQ's Evidence-based Practice Center (EPC) Program. Access to 
published and unpublished pertinent scientific information will improve 
the quality of this review. AHRQ is conducting this systematic review 
pursuant to Section 902(a) of the Public Health Service Act, 42 U.S.C. 
299a(a).

DATES: Submission deadline on or before November 17, 2014.

ADDRESSES:
    Online submissions: http://effectivehealthcare.AHRQ.gov/index.cfm/submit-scientific-information-packets/. Please select the study for 
which you are submitting information from the list to upload your 
documents.
    Email submissions: <a href="/cdn-cgi/l/email-protection#7e2d372e2d3e1b0e1d53421f5e160c1b1843" http: src.org">src.org</a>">SIPS@epc-src.org</a>.
    Print submissions:
    Mailing Address: Portland VA Research Foundation, Scientific 
Resource Center, ATTN: Scientific Information Packet Coordinator P.O. 
Box 69539, Portland, OR 97239.
    Shipping Address (FedEx, UPS, etc.): Portland VA Research 
Foundation, Scientific Resource Center, ATTN: Scientific Information 
Packet Coordinator, 37105W U.S. Veterans Hospital Road, Mail Code: R&D 
71, Portland, OR 97239.

FOR FURTHER INFORMATION CONTACT: Ryan McKenna, Telephone: 503-220-8262 
ext. 58653 or Email: <a href="/cdn-cgi/l/email-protection#6e3d273e3d2e0b1e0d43520f4e061c0b0853" http: src.org">src.org</a>">SIPS@epc-src.org</a>.

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality has commissioned the Evidence-based Practice Center (EPC) 
Program to complete a review of the evidence for Management and 
Outcomes of Binge Eating Disorder.
    The EPC Program is dedicated to identifying as many studies as 
possible that are relevant to the questions for each of its reviews. In 
order to do so, we are supplementing the usual manual and electronic 
database searches of the literature by requesting information from the 
public (e.g., details of studies conducted). We are looking for studies 
that report on Management and

[[Page 62157]]

Outcomes of Binge Eating Disorder, including those that describe 
adverse events. The entire research protocol, including the key 
questions is also available online at: http://effectivehealthcare.ahrq.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=1942.
    This notice is to notify the public that the EPC Program would find 
the following information on Management and Outcome of Binge Eating 
Disorder helpful:
    <bullet> A list of completed studies that your organization has 
sponsored for this indication. In the list, please indicate whether 
results are available on ClinicalTrials.gov along with the 
ClinicalTrials.gov trial number.
    <bullet> For completed studies that do not have results on 
ClinicalTrials.gov, please provide a summary, including the following 
elements: Study number, study period, design, methodology, indication 
and diagnosis, proper use instructions, inclusion and exclusion 
criteria, primary and secondary outcomes, baseline characteristics, 
number of patients screened/eligible/enrolled/lost to follow-up/
withdrawn/analyzed, effectiveness/efficacy, and safety results.
    <bullet> A list of ongoing studies that your organization has 
sponsored for this indication. In the list, please provide the 
ClinicalTrials.gov trial number or, if the trial is not registered, the 
protocol for the study including a study number, the study period, 
design, methodology, indication and diagnosis, proper use instructions, 
inclusion and exclusion criteria, and primary and secondary outcomes.
    <bullet> Description of whether the above studies constitute ALL 
Phase II and above clinical trials sponsored by your organization for 
this indication and an index outlining the relevant information in each 
submitted file.
    Your contribution will be very beneficial to the EPC Program. The 
contents of all submissions will be made available to the public upon 
request. Materials submitted must be publicly available or can be made 
public. Materials that are considered confidential; marketing 
materials; study types not included in the review; or information on 
indications not included in the review cannot be used by the EPC 
Program. This is a voluntary request for information, and all costs for 
complying with this request must be borne by the submitter.
    The draft of this review will be posted on AHRQ's EPC Program Web 
site and available for public comment for a period of 4 weeks. If you 
would like to be notified when the draft is posted, please sign up for 
the email list at: http://effectivehealthcare.AHRQ.gov/index.cfm/join-the-email-list1/.
    The systematic review will answer the following questions. This 
information is provided as background. AHRQ is not requesting that the 
public provide answers to these questions. The entire research protocol 
is available online at: http://effectivehealthcare.ahrq.govisearch-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=1942.

The Key Questions

    KQ 1: What is the evidence for the effectiveness of treatments or 
combinations of treatments for binge eating disorder?
    KQ 2: What is the evidence for harms associated with treatments for 
binge eating disorder?
    KQ 3: Does the effectiveness of treatments for binge eating 
disorder differ by age, sex, race, ethnicity, initial body mass index, 
duration of illness, or coexisting conditions?
    KQ 4: What is the course of illness of binge eating disorder?
    KQ 5: Does the course of illness of binge eating disorder differ by 
age, sex, race, ethnicity, sexual orientation, body mass index, 
duration of illness, or coexisting conditions?
    KQ 6: What is the evidence for the effectiveness of treatments or 
combinations of treatments for loss-of-control eating among bariatric 
surgery patients?
    KQ 7: What is the evidence for harms associated with treatments for 
loss-of-control eating among bariatric surgery patients?
    KQ 8: Does the effectiveness of treatments for loss-of-control 
eating among bariatric surgery patients differ by age, sex, race, 
ethnicity, initial body mass index, duration of illness, or coexisting 
conditions?
    KQ 9: What is the course of illness of loss-of-control eating among 
bariatric surgery patients?
    KQ 10: Does the course of illness of loss-of-control eating among 
bariatric surgery patients differ by age, sex, race, ethnicity, sexual 
orientation, initial body mass index, duration of illness, or 
coexisting conditions?
    KQ 11: What is the evidence for the effectiveness of treatments or 
combinations of treatments for loss-of-control eating among children?
    KQ 12: What is the evidence for harms associated with treatments 
for loss-of-control eating among children?
    KQ 13: Does the effectiveness of treatments for loss-of-control 
eating among children differ by age, sex, race, ethnicity, initial body 
mass index, duration of illness, or coexisting conditions?
    KQ 14: What is the course of illness of loss-of-control eating 
among children?
    KQ 15: Does the course of illness of loss-of-control eating among 
children differ by age, sex, race, ethnicity, initial body mass index, 
duration of illness, or coexisting conditions?

PICOTS (Population(s), Intervention(s), Comparator(s), Outcome(s), 
Timing, Setting)

Population(s)

<bullet> Individuals meeting either DSM-IV or DSM-5 criteria for binge 
eating disorder (BED)
<bullet> Post-bariatric surgery patients meeting criteria for loss-of-
control (LOC) eating after surgery \l\
<bullet> Children (6 years of age and older) meeting criteria for LOC 
eating \2\
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    \1\ Bariatric surgery patients may have had either BED or LOC 
eating diagnoses before surgery, but after surgery they are 
typically diagnosed only with LOC eating (i.e., loss-of-control 
eating behaviors without having consumed an unusually large amount 
of food).
    \2\ Children, especially those who are preadolescent, tend to be 
diagnosed only with LOC eating, not BED, in part because parents or 
others may limit the quantity of food they are permitted to consume.
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Interventions

    Applies only to KQs on effectiveness and harms of BED treatment in 
adults (KQs 1, 2, and 3), LOG treatment in bariatric patients (KQs 6, 
7, and 8), and LOG treatment in children (KQs 11, 12, and 13).

<bullet> Pharmacological interventions
[cir] Antidepressants, including: (1) Selective serotonin reuptake 
inhibitors (SSRIs); (2) serotonin-norepinephrine reuptake inhibitors 
(SNRIs, excluding Sibutramine because it is unavailable in the United 
States); (3) norepinephrine reuptake inhibitors (NRIs); and (4) 
tricyclic antidepressants
[cir] Anticonvulsants (antiepileptics)
[cir] Weight loss drugs (orlistat)
[cir] Appetite suppressants (excluding rimonabant because it is 
unavailable in the United States)
[cir] Gamma-aminobutyric acid agonists
[cir] Mixed gamma-aminobutyric acid agonist/glutamate antagonists
[cir] Central nervous system stimulants
<bullet> Psychological or behavioral interventions
[cir] Cognitive behavioral therapy (CBT)
[cir] Interpersonal psychotherapy (IPT)
[cir] Dialectical behavior therapy (DBT)
[cir] Family-based therapy (for LOC eating in children and adolescents)

[[Page 62158]]

[cir] Parent training (for LOC eating in children and adolescents)
[cir] Behavioral weight loss interventions
[cir] Virtual reality therapy
[cir] Nutritional counseling or low-calorie diet (or both)
[cir] Exercise
[cir] Health education
<bullet> Complementary and alternative medicine (CAM) interventions
[cir] Nutraceuticals and dietary supplements
[cir] Acupuncture
<bullet> Combinations of pharmacotherapies; combinations of 
psychological interventions; combinations of CAM interventions; 
combinations of pharmacotherapy, psychological, behavioral, and/or CAM 
interventions
<bullet> Characteristics of interventions
[cir] Pharmacotherapy and CAM: Dosages, duration of treatment
[cir] Psychological or behavioral: Format (e.g., individual or group, 
therapist-led or self-help), frequency, duration of treatment

Comparators

    Applies only to KQs on effectiveness and harms of BED treatment in 
adults (KQs 1, 2, and 3), LOC treatment in bariatric patients (KQs 6, 
7, and 8), and LOC treatment in children (KQs 11, 12, and 13).

<bullet> Placebo or usual care
<bullet> Any active intervention or combination of active interventions 
from among those listed above

Outcomes

<bullet> Intermediate outcomes
[cir] Change in weight or body mass index (BMI) (or both)
[cir] Appetite-regulating peptide hormones
[cir] Blood lipids (cholesterol, triglycerides)
[cir] Blood glucose, hemoglobin Alc
[cir] Blood pressure
<bullet> Final health outcomes
[cir] Behavioral
<bullet> Binge eating: Frequency of binge episodes, frequency of binge 
days, binge abstinence
<bullet> LOC eating: Frequency of LOC eating episodes, LOC eating 
abstinence
[cir] Psychological
<bullet> Shape and weight concerns, restraint, hunger, disinhibition
<bullet> Depressive disorders and symptoms
<bullet> Anxiety
<bullet> Substance abuse
[cir] Physical health and functioning
<bullet> BMI, weight status or stabilization
<bullet> Hypertension
<bullet> Type 2 diabetes, impaired glucose tolerance, insulin 
resistance
<bullet> Dyslipidemia
<bullet> Heart disease
<bullet> Gastric reflux (gastroesophageal reflux disorder), 
gastroparesis, other gastrointestinal diagnoses or problems
<bullet> Irritable bowel syndrome
<bullet> Menstrual problems (female), hormonal problems (male or 
female)
<bullet> Reproductive function
[cir] Social and occupational functioning
<bullet> Work or school days lost
<bullet> Marital or partner status
<bullet> Quality of life: Health-related quality of life or patient-
reported outcomes not otherwise listed above
<bullet> Harms: Applies only to harms of treatment (KQs 2, 7, and 12)
[cir] Pharmacotherapy and CAM: Sedation, dry mouth, headache, nausea, 
insomnia, diarrhea, fatigue, increased urinary frequency, sexual 
dysfunction, abnormal dreams, sweating, palpitations, arrhythmia, 
cramping, diffuse pain, weight gain
[cir] Psychological or behavioral therapy: Negative effects of 
disclosing symptoms during initial evaluation or therapy
[cir] Worsening of BED or LOC eating (or associated symptoms)
<bullet> Health care use and costs
[cir] Use of health care services: Emergency room visits, 
hospitalizations (psychiatric hospitals, residential institutions, 
general hospitals), ambulatory physician visits (medical care, 
psychiatric care), ambulatory visits to other health care professionals 
(e.g., clinical psychologists), nutritional counseling
[cir] Costs of services: Emergency room visits, hospitalizations 
(psychiatric hospitals, residential institutions, general hospitals), 
ambulatory physician visits (medical care, psychiatric care), 
ambulatory visits to other health care professionals, 
pharmacotherapies, and treatment costs for any harms

Timing

<bullet> Treatment studies: No minimum duration
<bullet> Course of illness studies: 1-year minimum followup

Settings

<bullet> Inpatient, including hospitals and residential treatment 
centers
<bullet> Outpatient, including schools and homes

    The relationship between the patient population, interventions, 
comparators, outcomes and timing of outcomes assessment (PICOTs) is 
depicted for each of the treatment KQs (Figure 1 in http://effectivehealthcare.ahrq.gov/search-for-guides-reviews-and-reqorts/?pageaction=displayproduct&productID=1942#9028) and each of the course 
of illness KQs (Figure 2 in http://effectivehealthcare.ahrq.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=1942#9028).

    Dated: October 6, 2014.
Richard Kronick,
AHRQ Director.
[FR Doc. 2014-24507 Filed 10-15-14; 8:45 am]
BILLING CODE 4160-90-M


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