[Federal Register Volume 81, Number 236 (Thursday, December 8, 2016)]
[Notices]
[Pages 88682-88684]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29408]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Scientific Information Request on Short and Long Term Outcomes 
After Bariatric Therapies in the Medicare Population

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 to inform our review of 
Short and Long Term Outcomes after Bariatric Therapies in the Medicare 
Population, which is currently being conducted by the AHRQ's Evidence-
based Practice Centers (EPC) Programs. 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unpublished pertinent scientific information will improve the quality 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 January 9, 2017.

ADDRESSES:
    Email submissions: src.org">SEADS@epc-src.org.
    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, 3710 SW., U.S. Veterans Hospital Road, Mail Code: R&D 71, 
Portland, OR 97239

FOR FURTHER INFORMATION CONTACT: Ryan McKenna, Telephone: 503-220-8262 
ext. 51723 or Email: src.org">SIPS@epc-src.org.

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality has commissioned the Evidence-based Practice Centers (EPC) 
Programs to complete a review of the evidence for Short and Long Term 
Outcomes after Bariatric Therapies in the Medicare Population.
    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 Short and Long Term Outcomes after Bariatric Therapies 
in the Medicare Population, including those that describe adverse 
events. The entire research protocol, including the key questions, is 
also available online at: http://www.ahrq.gov/sites/default/files/wysiwyg/research/findings/ta/topicrefinement/bariatric-surgery-protocol.pdf.
    This notice is to notify the public that the EPC Program would find 
the following information on Short and Long Term Outcomes after 
Bariatric Therapies in the Medicare Population helpful:
    [ssquf] 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.
    [ssquf] 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.
    [ssquf] 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.
    [ssquf] 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: https://subscriptions.ahrq.gov/accounts/USAHRQ/subscriber/new?topic_id=USAHRQ_18.
    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:

[[Page 88683]]

http://www.ahrq.gov/sites/default/files/wysiwyg/research/findings/ta/topicrefinement/bariatric-surgery-protocol.pdf.
    KQ 1: What are the theorized mechanisms of action of bariatric 
procedures on weight loss and on type 2 diabetes in the Medicare 
population?
    KQ 2: In studies that are applicable to the Medicare population and 
enroll patients who have undergone bariatric therapy, what are
    I. the characteristics and indications of the patients including 
descriptives of age, BMI, and comorbid conditions
    II. the characteristics of the interventions, including the 
bariatric procedures themselves as well as pre- and/or post-surgical 
surgical work-ups (e.g., psychiatric evaluations, behavioral and 
nutritional counseling)
    III. the outcomes that have been measured, including peri-operative 
(i.e., 90 days or less after bariatric surgery), short-term (2 years or 
less from surgery), mid-term (more than 2 but 5 or less years), and 
long-term (more than 5 years after surgery) outcomes?
    KQ 3:
    I. In Medicare-eligible patients, what is the effect of different 
bariatric therapies (contrasted between them or vs. non-bariatric 
therapies) on weight outcomes (including failure to achieve at least 
minimal weight loss)?
    II. What patient--(KQ2 I) and intervention-level characteristics 
(KQ2 II) modify the effect of bariatric therapies on weight outcomes 
(including failure to achieve at least minimal weight loss)?
    III. In Medicare-eligible patients who have undergone bariatric 
therapy, what is the frequency and the predictors of failing to achieve 
at least minimal weight loss?
    KQ 4:
    I. In Medicare-eligible patients, what is the comparative 
effectiveness and safety of different bariatric interventions 
(contrasted between them or vs. non-bariatric interventions) with 
respect to the outcomes in KQ2 III?
    II. What patient--(KQ2 I) and intervention-level (KQ2 II) 
characteristics modify the effect of the bariatric therapies on the 
outcomes in KQ2 III?
    KQ 5:
    I. In Medicare-eligible patients who have undergone bariatric 
therapy, what is the association between weight outcomes and eligible 
short- and long-term outcomes (other than weight outcomes)?
    II. In Medicare-eligible patients, what proportion of the bariatric 
intervention effect on eligible short- and long-term outcomes (other 
than weight outcomes) is accounted for by changes in weight outcomes?
    PICOTS (Population, Intervention, Comparator, Outcome, Timing, 
Setting)
    Population: Medicare-eligible population to include those age 65 
and older and the disabled.
    Interventions: Bariatric treatments including anatomic alteration, 
FDA-approved device placements, open surgical procedures, as well as 
laparoscopic and endoscopic procedures

I. Surgical bariatric therapies
    A. Adjustable gastric banding (AGB)
    1. LAP-band, pars flaccida technique
    2. LAP-band, perigastric technique
    3. Swedish-band (also known as REALIZE-band), pars flaccida 
technique
    4. Swedish-band (also known as REALIZE-band), pars flaccida 
technique, single bolus filling
    5. Gastroplasties
    B. Horizontal banded gastroplasty
    C. Vertical banded gastroplasty
    D. Endoluminal vertical gastroplasty
    1. Sleeve gastrectomy
    2. Gastric plication (also referred to as gastric greater curvature 
plication or gastric imbrication)
    3. Jejunoileal bypass
    4. Biliopancreatic diversion (BPD)
    E. Biliopancreatic diversion (BPD) with RYGB (BPD-RYGB)
    F. BPD with duodenal switch (BPD-DS)
    1. Roux-en-Y Gastric Bypass (RYGB)
    2. Mini-gastric bypass
    3. Single Anastomosis Duodeno-Ileostomy (SADI)
    4. Vagal blockade
    5. Omentum removal (omentectomy)
    6. Gastric stimulation (also referred to as gastric pacing)
    7. Mucosal ablation
II. Endoscopic bariatric therapies
    A. Space-occupying endoscopic bariatric therapies
    1. Intragastric balloons
    B. Nonballoon devices
    1. Aspiration therapy
    2. Endoscopic sleeve gastroplasty
    3. Endoscopic gastrointestinal bypass devices
    C. Duodenojejunal bypass sleeve
    D. Gastroduodenojejunal bypass sleeve
    1. Duodenal mucosal resurfacing
    2. Self-assembling magnets for endoscopy

    Comparisons: Comparisons of interest include comparisons between 
different surgical interventions, or between surgical and non-surgical 
interventions
    Outcomes: Outcomes will be classified as peri-operative (i.e., 90 
days or less after bariatric surgery), short-term (2 years or less from 
surgery), mid-term (more than 2 but 5 or less years), and long-term 
(more than 5 years after surgery). The following outcome categories are 
of interest:

I. Mortality
II. Weight loss
III. Reoperations/need for revisional bariatric surgery
IV. Postoperative complications including mortality
V. Metabolic/diabetes-related outcomes
    A. Correction of glucose tolerance, including elimination of all 
medications with Hemoglobin A1c (HbA1c) <6
    B. Diabetes: New onset diabetes; treatment of diabetes; diabetic 
complications (microvascular disease, kidney disease, retinopathy)
    C. Hypoglycemic-like syndromes such as nesidioblastosis, post-
gastric surgery hypoglycemia, and dumping syndrome
    D. Non-alcoholic steatohepatitis (NASH) and/or non-alcoholic fatty 
liver disease (NAFLD)
VI. Reflux
VII. Cardiovascular outcomes
    A. Myocardial infarction
    B. Stroke
    C. Hypertension
VIII. Respiratory disease
    A. Asthma
    B. COPD
IX. Orthopedic outcomes
    A. Fractures
    B. Falls
    C. Osteoporosis/bone-mineral density (DEXA, DEEG)
X. Sleep apnea including the discontinuation of CPAP or BiPAP
XI. Incidence of specific cancers (breast, colorectal cancer, 
endometrial cancer, esophageal adenocarcinoma, gall bladder cancer, and 
renal cell cancer)
XII. Nutritional deficiencies including zinc, iron, thiamine, and 
vitamin D, and associated disorders such as neuropathy and bone disease
XIII. Renal function as measured by creatinine clearance or urinary 
albumin excretion
XIV. Compliance to follow-up
XV. Mental health outcomes. Incidence of suicide and suicide attempts
    A. Incidence of depression
    B. Alcohol addiction after surgery/Substance abuse
    C. Psychiatric hospitalizations
    D. Anxiety
    E. Panic disorder
    F. Borderline personality disorder
    G. PTSD
    H. Bipolar disorder
XVI. Function and quality of life (validated measurements only), e.g., 
i. Cognitive functioning

[[Page 88684]]

    A. Sexual functioning
    B. Ability to participate in an exercise program
    C. Ability to return to work
    D. Physical performance test pain (joint pain, joint aches)
    E. Regular daily activities
    F. Polypharmacy
    G. Admission to a skilled-nurse facility
XVII. Access to plastic surgery
XVIII. Readmissions/rehospitalizations

Timing:
No time limit
Setting:
Any

Sharon B. Arnold,
AHRQ Deputy.
[FR Doc. 2016-29408 Filed 12-7-16; 8:45 am]
 BILLING CODE 4160-90-P