Notice2024-00505
Supplemental Evidence and Data Request on The Effect of Dietary Digestible Carbohydrate Intake on Risk of Cardiovascular Disease
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
January 12, 2024
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 The Effect of Dietary Digestible Carbohydrate Intake on Risk of Cardiovascular Disease, 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 Access to published and unpublished pertinent scientific information will improve the quality of this review.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
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<title>Federal Register, Volume 89 Issue 9 (Friday, January 12, 2024)</title>
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[Federal Register Volume 89, Number 9 (Friday, January 12, 2024)]
[Notices]
[Pages 2226-2228]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-00505]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on The Effect of Dietary
Digestible Carbohydrate Intake on Risk of Cardiovascular Disease
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for supplemental evidence and data submission.
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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 on The Effect of
Dietary Digestible Carbohydrate Intake on Risk of Cardiovascular
Disease, 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unpublished pertinent scientific information will improve the quality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 February 12, 2024.
ADDRESSES:
Email submissions: <a href="/cdn-cgi/l/email-protection#6005100320010812114e0808134e070f16"><span class="__cf_email__" data-cfemail="1570657655747d67643b7d7d663b727a63">[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: Kelly Carper, Telephone: 301-427-1656
or Email: <a href="/cdn-cgi/l/email-protection#d8bda8bb98b9b0aaa9f6b0b0abf6bfb7ae"><span class="__cf_email__" data-cfemail="d2b7a2b192b3baa0a3fcbabaa1fcb5bda4">[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 The Effect of Dietary
Digestible Carbohydrate Intake on Risk of Cardiovascular Disease. AHRQ
is conducting this 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 The Effect of Dietary Digestible Carbohydrate Intake on
Risk of Cardiovascular Disease.
The entire research protocol is available online at: <a href="https://effectivehealthcare.ahrq.gov/products/risk-cardiovascular-disease">https://effectivehealthcare.ahrq.gov/products/risk-cardiovascular-disease</a>.
This is to notify the public that the EPC Program would find the
following information on The Effect of Dietary Digestible Carbohydrate
Intake on Risk of Cardiovascular Disease helpful:
[ssquf] A list of completed studies that your organization has
sponsored for this topic. 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, if
relevant: 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 topic. 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, if relevant, 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 topic and an index outlining the relevant information in each
submitted file.
[[Page 2227]]
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 topics 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 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 review will answer the following questions. This information is
provided as background. AHRQ is not requesting that the public provide
answers to these questions.
Key Questions (KQ)
KQ 1: What is the association between dietary digestible
carbohydrate intake and the incidence of cardiovascular disease?
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and
Setting)
Inclusion and Exclusion Criteria by Population, Intervention,
Comparator, Outcome, Timing, Setting/Study Design (PICOTS)
------------------------------------------------------------------------
PICOTS elements Inclusion criteria Exclusion criteria
------------------------------------------------------------------------
Population.................. <bullet> <bullet>
Participants who Participants with
are generally diseases/health-
healthy, including related conditions
participants who that impact
are determined to carbohydrate
be overweight/ absorption or
obese, women who metabolism, cancer,
are pregnant or and malabsorption
lactating. syndromes.
<bullet> Age of <bullet>
participants:. Participants
[cir] Between 2 hospitalized with
years and 9 years an illness or
(before puberty).. injury.
[cir] Between 9 and <bullet>
17 years.. Participants with
[cir] 18 years and the endpoint
older.. outcomes of CVD
(i.e., studies that
aim to treat
participants
already been
diagnosed with the
endpoint outcomes
of interest).
<bullet>
Participants who
intend to reduce
weight or receive
treatments for
being overweight
and having obesity
through energy
restriction or
hypocaloric diets
for the purposes of
treating additional
or other medical
conditions.
<bullet>
Participants who
are determined to
be undernourished,
underweight,
stunted, or wasted.
<bullet>
Participants who
are pre-bariatric
or post-bariatric
surgery.
<bullet> People
younger than 2
years old.
Interventions............... <bullet> Total <bullet> Studies
dietary digestible that do not specify
carbohydrate intake the amount of total
from foods, digestible
beverages, and carbohydrate intake
dietary supplements. (e.g., studies that
[cir] Total dietary only report type or
digestible source of
carbohydrate intake digestible
defined as carbohydrate).
collective starch <bullet> Studies
and sugar intake; that do not
carbohydrate intake describe the entire
not including macronutrient
dietary fiber.. distribution of the
<bullet> A dietary diet (i.e., studies
pattern that that do not report
quantifies the total digestible
intake of total carbohydrate, total
dietary digestible fat, and total
carbohydrates and protein contents of
allows the experimental or
isolation of the baseline diets).
effect of <bullet> Studies
carbohydrate intake that only assess
from the effect of digestible
the intake of other carbohydrate intake
macronutrients.. via infusions
(rather than the GI
tract).
<bullet> Studies
that primarily
measure
postprandial
responses, as
opposed to longer
term studies.
<bullet> Studies
that examine food
products or dietary
supplements not
widely available to
U.S. consumers.
<bullet> Multi-
component
interventions that
do not isolate the
effect or
association of
digestible
carbohydrate.
Comparators................. <bullet> Different <bullet> Comparison
total dietary of different
digestible sources of
carbohydrate intake carbohydrate
level(s). without specifying
amount of
carbohydrate
intake.
<bullet> Studies
that do not attempt
to control for
energy intake of
participants such
that comparisons
are made on an
isocaloric basis.
<bullet> Comparisons
of available
carbohydrate
exposure should not
be confounded by
differences in
participants'
energy intake.
Outcomes.................... <bullet> <bullet>
Intermediate Hypertensive
outcomes: disorders during
[cir] LDL pregnancy and/or
cholesterol (LDL).. lactation (e.g.,
[cir] Total chronic
cholesterol (TC).. hypertension,
[cir] HDL gestational
cholesterol (HDL).. hypertension,
[cir] Non-HDL preeclampsia-
cholesterol.. eclampsia, chronic
[cir] TC:HDL ratio.. hypertension with
[cir] LDL:HDL ratio. superimposed
[cir] Triglycerides. preeclampsia).
[cir] Blood pressure
(systolic and/or
diastolic) and
hypertension..
<bullet> Final
outcomes:
[cir] Cardiovascular
disease (e.g.,
myocardial
infarction,
coronary heart
disease, congestive
heart failure,
peripheral artery
disease)..
[cir] Stroke........
[cir] Cardiovascular
disease-related
mortality..
[[Page 2228]]
Timing...................... <bullet> At least 4 <bullet> Less than 4
weeks. weeks.
Settings.................... <bullet> All except <bullet> Hospital
hospital and acute and acute care.
care.
Study design................ <bullet> Randomized <bullet> In vitro
controlled trials. studies,
<bullet> nonoriginal data
Nonrandomized (e.g., narrative
controlled trials, reviews, scoping
including quasi- reviews,
experimental and editorials,
controlled before- letters, or
and-after studies.. erratum),
<bullet> Prospective retrospective
cohort studies.. cohort studies,
<bullet> Nested case- case series,
control studies.. qualitative
<bullet> Relevant studies, cost-
systematic reviews, benefit analysis,
or meta-analyses cross-sectional
(used for (i.e.,
identifying nonlongitudinal)
additional studies, survey.
studies)..
Publications................ <bullet> Studies <bullet> Non-English
published in language studies.
English only.
<bullet> Studies
published in peer-
reviewed journals..
<bullet> Studies
published at and
after the year
2000..
------------------------------------------------------------------------
Abbreviations: CVD = cardiovascular disease; GI = gastrointestinal; HDL
= high-density lipoprotein; KQ = Key Question; LDL = low-density
lipoprotein PICOTS = populations, interventions, comparators,
outcomes, timing, and settings; RCT = randomized controlled trial; TC
= total cholesterol; U.S. = United States.
Dated: January 8, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024-00505 Filed 1-11-24; 8:45 am]
BILLING CODE 4160-90-P
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