81 FR 88682 - Scientific Information Request on Short and Long Term Outcomes After Bariatric Therapies in the Medicare Population
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality Federal Register Volume 81, Issue 236 (December 8, 2016)
Agency for Healthcare Research and Quality
Federal Register Volume 81, Issue 236 (December 8, 2016)
| Page Range | 88682-88684 | |
| FR Document | 2016-29408 |
[Federal Register Volume 81, Number 236 (Thursday, December 8, 2016)] [Notices] [Pages 88682-88684] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-29408] ======================================================================= ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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 Access to published and unpublished pertinent scientific information will improve the quality of this review.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">[email protected]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">[email protected]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
![88682 Federal Register / Vol. 81, No. 236 / Thursday, December 8, 2016 / Notices
SUMMARY: Notice is hereby given of the SUMMARY: The Agency for Healthcare Long Term Outcomes after Bariatric
names of the members of the Research and Quality (AHRQ) is seeking Therapies in the Medicare Population
Performance Review Board. scientific information submissions to helpful:
FOR FURTHER INFORMATION CONTACT: inform our review of Short and Long D A list of completed studies that
William ‘‘Todd’’ Cole, Director Office of Term Outcomes after Bariatric your organization has sponsored for this
Human Resources, Federal Maritime Therapies in the Medicare Population, indication. In the list, please indicate
Commission, 800 North Capitol Street which is currently being conducted by whether results are available on
NW., Washington, DC 20573. the AHRQ’s Evidence-based Practice ClinicalTrials.gov along with the
Centers (EPC) Programs. Access to ClinicalTrials.gov trial number.
SUPPLEMENTARY INFORMATION: Sec. D For completed studies that do not
4314(c) (1) through (5) of title 5, U.S.C., published and unpublished pertinent
scientific information will improve the have results on ClinicalTrials.gov,
requires each agency to establish, in please provide a summary, including
accordance with regulations prescribed quality of this review. AHRQ is
conducting this systematic review the following elements: Study number,
by the Office of Personnel Management, study period, design, methodology,
one or more performance review boards. pursuant to Section 902(a) of the Public
Health Service Act, 42 U.S.C. 299a(a). indication and diagnosis, proper use
The board shall review and evaluate the instructions, inclusion and exclusion
initial appraisal of a senior executive’s DATES: Submission Deadline on or
criteria, primary and secondary
performance by the supervisor, along before January 9, 2017.
outcomes, baseline characteristics,
with any recommendations to the ADDRESSES: number of patients screened/eligible/
appointing authority relative to the Email submissions: SEADS@epc- enrolled/lost to follow-up/withdrawn/
performance of the senior executive. src.org. analyzed, effectiveness/efficacy, and
Print submissions: safety results.
THE MEMBERS OF THE
PERFORMANCE REVIEW BOARD Mailing Address: Portland VA Research D A list of ongoing studies that your
ARE: Foundation, Scientific Resource organization has sponsored for this
Center, ATTN: Scientific Information indication. In the list, please provide the
1. Rebecca F. Dye, Commissioner Packet Coordinator, P.O. Box 69539, ClinicalTrials.gov trial number or, if the
2. Richard A. Lidinsky, Jr., Portland, OR 97239 trial is not registered, the protocol for
Commissioner Shipping Address (FedEx, UPS, etc.): the study including a study number, the
3. Michael A. Khouri, Commissioner Portland VA Research Foundation, study period, design, methodology,
4. William P. Doyle, Commissioner Scientific Resource Center, ATTN: indication and diagnosis, proper use
5. Clay G. Guthridge, Chief Scientific Information Packet instructions, inclusion and exclusion
Administrative Law Judge Coordinator, 3710 SW., U.S. Veterans criteria, and primary and secondary
6. Erin M. Wirth, Administrative Law Hospital Road, Mail Code: R&D 71, outcomes.
Judge Portland, OR 97239 D Description of whether the above
7. Florence A. Carr, Director, Bureau of studies constitute all Phase II and above
FOR FURTHER INFORMATION CONTACT:
Trade Analysis clinical trials sponsored by your
Ryan McKenna, Telephone: 503–220–
8. Rebecca A. Fenneman, Director, organization for this indication and an
8262 ext. 51723 or Email: SIPS@epc-
Office of Consumer Affairs & index outlining the relevant information
src.org.
Dispute Resolution Services in each submitted file.
9. Karen V. Gregory, Managing Director SUPPLEMENTARY INFORMATION: The Your contribution will be very
10. Peter J. King, Director, Assistant Agency for Healthcare Research and beneficial to the EPC Program. The
Managing Director Quality has commissioned the contents of all submissions will be made
11. Sandra L. Kusumoto, Director, Evidence-based Practice Centers (EPC) available to the public upon request.
Bureau of Certification and Programs to complete a review of the Materials submitted must be publicly
Licensing evidence for Short and Long Term available or can be made public.
12. Mary T. Hoang, Chief of Staff Outcomes after Bariatric Therapies in Materials that are considered
13. Tyler J. Wood, General Counsel the Medicare Population. confidential; marketing materials; study
The EPC Program is dedicated to types not included in the review; or
Rachel E. Dickon, identifying as many studies as possible information on indications not included
Assistant Secretary. that are relevant to the questions for in the review cannot be used by the EPC
[FR Doc. 2016–29383 Filed 12–7–16; 8:45 am] each of its reviews. In order to do so, we Program. This is a voluntary request for
BILLING CODE 6731–AA–P are supplementing the usual manual information, and all costs for complying
and electronic database searches of the with this request must be borne by the
literature by requesting information submitter.
DEPARTMENT OF HEALTH AND from the public (e.g., details of studies The draft of this review will be posted
HUMAN SERVICES conducted). We are looking for studies on AHRQ’s EPC Program Web site and
that report on Short and Long Term available for public comment for a
Agency for Healthcare Research and Outcomes after Bariatric Therapies in period of 4 weeks. If you would like to
Quality the Medicare Population, including be notified when the draft is posted,
those that describe adverse events. The please sign up for the email list at:
Scientific Information Request on entire research protocol, including the https://subscriptions.ahrq.gov/accounts/
Short and Long Term Outcomes After key questions, is also available online
sradovich on DSK3GMQ082PROD with NOTICES
USAHRQ/subscriber/new?topic_
Bariatric Therapies in the Medicare at: http://www.ahrq.gov/sites/default/ id=USAHRQ_18.
Population files/wysiwyg/research/findings/ta/ The systematic review will answer the
AGENCY: Agency for Healthcare Research topicrefinement/bariatric-surgery- following questions. This information is
and Quality (AHRQ), HHS. protocol.pdf. provided as background. AHRQ is not
This notice is to notify the public that requesting that the public provide
ACTION: Request for Scientific
the EPC Program would find the answers to these questions. The entire
Information Submissions.
following information on Short and research protocol, is available online at:
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![88684 Federal Register / Vol. 81, No. 236 / Thursday, December 8, 2016 / Notices
A. Sexual functioning To request additional information on pre-test counseling session are offered to
B. Ability to participate in an exercise the proposed project or to obtain a copy all persons who participate in an NHBS
program of the information collection plan and interview.
C. Ability to return to work instruments, call (404) 639–7570 or The surveillance system is focused on
D. Physical performance test pain send an email to omb@cdc.gov. Written behaviors directly related to HIV
(joint pain, joint aches) comments and/or suggestions regarding transmission and those that are
E. Regular daily activities the items contained in this notice amenable to intervention through
F. Polypharmacy should be directed to the Attention: prevention programs. Information
G. Admission to a skilled-nurse CDC Desk Officer, Office of Management collected through the NHBS System
facility and Budget, Washington, DC 20503 or allows CDC to: (a) Describe the
XVII. Access to plastic surgery prevalence of and trends in risk
XVIII. Readmissions/rehospitalizations by fax to (202) 395–5806. Written
comments should be received within 30 behaviors; (b) describe the prevalence of
Timing: days of this notice. and trends in HIV testing and HIV
No time limit infection; (c) describe the prevalence of
Setting: Proposed Project
Any and trends in use of HIV prevention
National HIV Behavioral Surveillance services; and (d) identify met and unmet
Sharon B. Arnold, System ((NHBS), OMB Control No. needs for HIV prevention services in
AHRQ Deputy. 0920–0770, exp. 03/31/2017)— order to inform health departments,
[FR Doc. 2016–29408 Filed 12–7–16; 8:45 am] Revision—National Center for HIV, community-based organizations,
BILLING CODE 4160–90–P
Hepatitis, STD, and TB Prevention community planning groups and other
(NCHHSTP), Centers for Disease Control stakeholders. No other federal agency
and Prevention (CDC). systematically collects this type of
DEPARTMENT OF HEALTH AND Background and Brief Description information from persons at risk for HIV
HUMAN SERVICES infection.
The CDC currently sponsors the Venue-based sampling methods are
Centers for Disease Control and National HIV Behavioral Surveillance used to identify respondents for the
Prevention (NHBS) System. The system is designed MSM information collection cycle and
to describe and monitor the HIV risk respondent-driven sampling methods
[30Day–17–0770] behaviors, HIV seroprevalence and are used to identify respondents for the
Agency Forms Undergoing Paperwork incidence, and HIV prevention IDU cycle and the HET cycle. Consistent
Reduction Act Review experiences of persons at highest risk with these methods, persons who
for HIV infection in the United States. participate in the IDU and HET
The Centers for Disease Control and NHBS awardees are state and local interviews may be trained to recruit
Prevention (CDC) has submitted the health departments that provide HIV- additional respondents. Each person
following information collection request related services, conduct NHBS who serves as a peer recruiter will be
to the Office of Management and Budget interviews, and submit non-identifiable asked to participate in a short debriefing
(OMB) for review and approval in information to CDC. To be eligible for interview.
accordance with the Paperwork NHBS funding, a health department CDC requests OMB approval to
Reduction Act of 1995. The notice for must serve one of the 30 Metropolitan continue information collection for
the proposed information collection is Statistical Areas (MSA) in the U.S. with three years, with revisions. Selected
published to obtain comments from the high HIV prevalence. Twenty-two (22) questions in the eligibility screener and
public and affected agencies. programs receive NHBS funding and the behavioral assessment interview
Written comments and suggestions technical assistance from CDC at this instruments will be updated to improve
from the public and affected agencies time. Burden estimates are based on usability and data quality, and new
concerning the proposed collection of current availability of funds and questions will be added to provide
information are encouraged. Your recruitment targets for 22 CDC-funded measures of high priority emerging
comments should address any of the NHBS awardees. If additional funding is issues including pre-exposure
following: (a) Evaluate whether the received to support the participation of prophylaxis, treatment as prevention,
proposed collection of information is additional sites, CDC will submit a and opioid use and abuse. Lower
necessary for the proper performance of Change Request to make the appropriate priority questions and repetitive content
the functions of the agency, including adjustments to the total estimated will be deleted in order to manage
whether the information will have annualized burden. project cost and respondent burden.
practical utility; (b) Evaluate the Information collection is based on There are no changes to the estimated
accuracy of the agencies estimate of the rotating annual ‘‘cycles’’ of surveillance burden per response for any information
burden of the proposed collection of with three populations: Men who have collection instrument. However, total
information, including the validity of sex with men (MSM), injecting drug burden will decrease due to a reduction
the methodology and assumptions used; users (IDUs), and heterosexuals at in the number of health departments
(c) Enhance the quality, utility, and increased risk of HIV (HET). Screening funded to participate in the NHBS
clarity of the information to be interviews and specialized behavioral System (from 25 to 22). Compared to the
collected; (d) Minimize the burden of assessment interviews are conducted previous period of OMB approval, this
the collection of information on those once every three years with each will reduce the total estimated number
who are to respond, including through population: MSM in year 1, IDU in year
sradovich on DSK3GMQ082PROD with NOTICES
of interviews for each cycle from 12,500
the use of appropriate automated, 2, and HET in year 3. The target number (4,167 annualized) to 11,000 (3,667
electronic, mechanical, or other of annual interviews for each NHBS- annualized).
technological collection techniques or funded awardee is 500. Due to Information collected through the
other forms of information technology, differences in the risk characteristics of NHBS has a substantial impact on the
e.g., permitting electronic submission of the MSM, IDU and HET groups, the design and delivery of targeted
responses; and (e) Assess information behavioral assessment is customized for prevention programs aimed at reducing
collection costs. each group. In addition, an HIV test and new HIV infections and evaluating
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Document Created: 2016-12-08 00:27:05
Document Modified: 2016-12-08 00:27:05
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Request for Scientific Information Submissions. | |
| Dates | Submission Deadline on or before January 9, 2017. | |
| Contact | Ryan McKenna, Telephone: 503-220-8262 ext. 51723 or Email: [email protected] | |
| FR Citation | 81 FR 88682 |
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