Notice2022-10614
Supplemental Evidence and Data Request on Pharmacotherapy for Adults With Alcohol-Use Disorders in Outpatient Settings: Systematic Review Update
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 18, 2022
Issuing agencies
Health and Human Services DepartmentAgency for Healthcare Research and Quality
Abstract
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 on Pharmacotherapy for Adults with Alcohol-Use Disorders in Outpatient Settings: Systematic Review Update, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 96 (Wednesday, May 18, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 96 (Wednesday, May 18, 2022)]
[Notices]
[Pages 30224-30225]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-10614]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Pharmacotherapy for
Adults With Alcohol-Use Disorders in Outpatient Settings: Systematic
Review Update
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for supplemental evidence and data submissions.
-----------------------------------------------------------------------
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 on Pharmacotherapy
for Adults with Alcohol-Use Disorders in Outpatient Settings:
Systematic Review Update, which is currently being conducted by the
AHRQ's Evidence-based Practice Centers (EPC) Program. Access to
published and unpublished pertinent scientific information will improve
the quality of this review.
DATES: Submission Deadline on or before June 17, 2022.
ADDRESSES:
Email submissions: <a href="/cdn-cgi/l/email-protection#3a5f4a597a5b52484b14525249145d554c"><span class="__cf_email__" data-cfemail="cca9bcaf8cada4bebde2a4a4bfe2aba3ba">[email protected]</span></a>.
Print submissions:
Mailing Address: Center for Evidence and Practice Improvement, Agency
for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600
Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857
Shipping Address (FedEx, UPS, etc.): Center for Evidence and Practice
Improvement, Agency for Healthcare Research and Quality, ATTN: EPC
SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, MD
20857
FOR FURTHER INFORMATION CONTACT: Jenae Benns, Telephone: 301-427-1496
or Email: <a href="/cdn-cgi/l/email-protection#1c796c7f5c7d746e6d3274746f327b736a"><span class="__cf_email__" data-cfemail="5336233013323b21227d3b3b207d343c25">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and
Quality has commissioned the Evidence-based Practice Centers (EPC)
Program to complete a review of the evidence for Pharmacotherapy for
Adults with Alcohol-Use Disorders in Outpatient Settings: Systematic
Review Update. AHRQ is conducting this systematic review pursuant to
Section 902 of the Public Health Service Act, 42 U.S.C. 299a.
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 Pharmacotherapy for Adults with Alcohol-Use Disorders in
Outpatient Settings: Systematic Review Update, including those that
describe adverse events. The entire research protocol is available
online at: <a href="https://effectivehealthcare.ahrq.gov/products/alcohol-misuse-drug-therapy/protocol">https://effectivehealthcare.ahrq.gov/products/alcohol-misuse-drug-therapy/protocol</a>.
This is to notify the public that the EPC Program would find the
following information on Pharmacotherapy for Adults with Alcohol-Use
Disorders in Outpatient Settings: Systematic Review Update 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 <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> along with the
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> trial number.
[ssquf] For completed studies that do not have results on
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>, 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
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> 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 is very beneficial to the Program. Materials
submitted must be publicly available or able to 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
website and
[[Page 30225]]
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: <a href="https://www.effectivehealthcare.ahrq.gov/email-updates">https://www.effectivehealthcare.ahrq.gov/email-updates</a>.
The systematic review will answer the questions below. This
information is provided as background and AHRQ is not requesting that
the public provide answers to these questions.
Key Questions (KQ)
KQ 1a: Which medications are efficacious for improving consumption
outcomes for adults with alcohol-use disorders in outpatient settings?
KQ 1b: How do medications for adults with alcohol-use disorders
compare for improving consumption outcomes in outpatient settings?
KQ 2a: Which medications are efficacious for improving health
outcomes (including functioning and quality-of-life outcomes) for
adults with alcohol-use disorders in outpatient settings?
KQ 2b: How do medications for adults with alcohol-use disorders
compare for improving health outcomes (including functioning and
quality-of-life outcomes) in outpatient settings?
KQ 3a: What adverse effects are associated with medications for
adults with alcohol-use disorders in outpatient settings?
KQ 3b: How do medications for adults with alcohol-use disorders
compare for adverse effects in outpatient settings?
KQ 4: Are medications for treating adults with alcohol-use
disorders effective in primary care settings?
KQ 5: Are any of the medications more or less effective than other
medications for older adults, younger adults, smokers, or those with
co-occurring disorders?
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and
Setting)
<bullet> Population(s)
[cir] Adults (age 18 years or older) with alcohol-use disorders.
<bullet> Interventions
[cir] Pharmacotherapy for relapse prevention. This includes:
[ssquf] Medications approved by FDA for treating alcohol
dependence:
<bullet> Acamprosate
<bullet> disulfiram
<bullet> naltrexone (oral or injectable)
[ssquf] Certain medications in use off label that are available in
the United States:
<bullet> Baclofen
<bullet> gabapentin
<bullet> ondansetron
<bullet> topiramate
<bullet> prazosin
<bullet> varenicline
[cir] Studies evaluating pharmacotherapy that used co-interventions
with other treatments for AUDs (e.g., behavioral counseling, cognitive
behavioral therapy, motivational enhancement therapy, psychosocial
treatments, or self-help such as 12-step programs [e.g., Alcoholics
Anonymous]) will be eligible for inclusion, as long as they meet other
inclusion/exclusion criteria.
[cir] This review will not include pharmacotherapy for alcohol
withdrawal.
<bullet> Comparators
[cir] Studies must compare one of the medications listed above with
placebo or another eligible medication.
<bullet> Outcomes
[cir] Consumption outcomes:
[ssquf] Abstinence/any drinking
--rates of continuous abstinence
--percentage of days abstinent
--time to first drink/lapse
--time to heavy drinking/relapse
[ssquf] reduction in alcohol consumption
--number of heavy drinking days
--percentage of subjects with no heavy drinking days
--number of drinking days
--drinks per drinking day
--drinks per week
[cir] Health outcomes:
[ssquf] Accidents
[ssquf] injuries
[ssquf] quality of life
[ssquf] function
[ssquf] mortality
[cir] Adverse effects of intervention(s):
[ssquf] Withdrawals due to adverse events
[ssquf] nausea/vomiting
[ssquf] diarrhea
[ssquf] anorexia
[ssquf] alpitations
[ssquf] headache
[ssquf] dizziness
[ssquf] cognitive dysfunction
[ssquf] taste abnormalities
[ssquf] paresthesias (numbness, tingling)
[ssquf] metabolic acidosis
[ssquf] glaucoma
[ssquf] vision changes
[ssquf] suicidal ideation
[ssquf] insomnia
[ssquf] anxiety
[ssquf] rash
[ssquf] tiredness
[ssquf] weakness
[ssquf] constipation
<bullet> Timing
[cir] Studies with at least 12 weeks of planned pharmacologic
treatment and followup from the time of medication initiation.
<bullet> Setting
[cir] Outpatient healthcare settings; KQ 4 applies to primary care
settings only (i.e., internal medicine, family medicine, obstetrics/
gynecology, or college and university health clinics).
Dated: May 12, 2022.
Marquita Cullom,
Associate Director.
[FR Doc. 2022-10614 Filed 5-17-22; 8:45 am]
BILLING CODE 4160-90-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on May 18, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.