Notice2024-27488
Supplemental Evidence and Data Request on Dietary Saturated Fat Replacement and Plasma Lipid and Cardiovascular Events
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
November 25, 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 Dietary Saturated Fat Replacement and Plasma Lipid and Cardiovascular Events, 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 Access to published and unpublished pertinent scientific information will improve the quality of this review.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 227 (Monday, November 25, 2024)</title>
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[Federal Register Volume 89, Number 227 (Monday, November 25, 2024)]
[Notices]
[Pages 92932-92935]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-27488]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Dietary Saturated Fat
Replacement and Plasma Lipid and Cardiovascular Events
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 Dietary
Saturated Fat Replacement and Plasma Lipid and Cardiovascular Events,
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 Access to published and unpublished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 December 26, 2024.
ADDRESSES:
Email submissions: <a href="/cdn-cgi/l/email-protection#9bfeebf8dbfaf3e9eab5f3f3e8b5fcf4ed"><span class="__cf_email__" data-cfemail="3653465576575e4447185e5e4518515940">[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#3356435073525b41421d5b5b401d545c45"><span class="__cf_email__" data-cfemail="3e5b4e5d7e5f564c4f1056564d10595148">[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 Dietary Saturated Fat
Replacement and Plasma Lipid and Cardiovascular Events. 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 Dietary Saturated Fat Replacement and Plasma Lipid and
Cardiovascular Events. The entire research protocol is available online
at: <a href="https://effectivehealthcare.ahrq.gov/products/saturated-fat-replacement/protocol">https://effectivehealthcare.ahrq.gov/products/saturated-fat-replacement/protocol</a>.
This is to notify the public that the EPC Program would find the
following information on Dietary Saturated Fat Replacement and Plasma
Lipid and Cardiovascular Events 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.
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://effectivehealthcare.ahrq.gov/email-updates">https://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 are the effects of replacing dietary intake of total or
individual saturated fatty acids with unsaturated, mono-unsaturated or
polyunsaturated fatty acids, carbohydrates, or protein on plasma lipid
concentrations in the general population?
KQ 2: What are the effects of replacing dietary intake of total or
individual saturated fatty acids with unsaturated, mono-unsaturated or
polyunsaturated fatty acids, carbohydrates, or protein on
cardiovascular events in the general population?
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and
Setting)
[Study eligibility criteria based on Population, Intervention,
Comparator, Outcome (PICO), and other elements]
------------------------------------------------------------------------
Element Inclusion criteria Exclusion criteria
------------------------------------------------------------------------
Population...................... Both Key Questions Both Key Questions
[[Page 92933]]
General <bullet>
population, Participants with
without CVD, with a health-related
or without condition or
modifiable CV taking
risk factors, medications that
including. impact fat
[cir] Dyslipidemia absorption, fat
(including if metabolism.
taking lipid <bullet>
lowering Participants
medications). taking weight
[cir] Overweight/ loss medications,
obese. including
[cir] glucagon-like
Hyperglycemia and peptide-1
related agonists.
conditions, <bullet>
including type 2 Undernourished,
diabetes. underweight,
[cir] Hypertension/ stunted, or
high blood wasted
pressure. participants.
Key Question 1.... <bullet>
Children and Participants who
adults. are pre- or post-
Key Question 2.... bariatric
Adults (>=18 years surgery.
old). <bullet>
Participants with
other chronic
diseases (e.g.,
cancer,
gastrointestinal
disease,
rheumatic
disease, chronic
kidney disease,
neurologic
diseases),
including type 1
diabetes.
<bullet>
Participants with
clinical CVD
(e.g., history of
myocardial
infarction,
angina, stroke,
arrhythmia),
including
congenital heart
diseases, or
familial
hypercholesterole
mia.
------------------------------------------------------------------------
Interventions................... Both Key Questions Both Key Questions
<bullet> Diets <bullet> Studies
with a lower that do not
intake of total quantify fatty
saturated fatty acid intake as
acids. either g/day or %
<bullet> Diets of total energy
with a lower intake from
intake of saturated fat.
individual <bullet> Analyses
saturated fatty with fat intake
acids. as a continuous
<bullet> Diets variable.
with a lower <bullet> Fatty
intake of a acid intake
combination of during a single
saturated fatty meal or eating
acids other than occasion.
stearic acid <bullet> Fatty
(ranging from C8 acid intake via
to C16; i.e., infusion (not
caprylic, orally).
caproic, lauric, <bullet> Food
myristic, products or
palmitic). dietary
<bullet> Saturated supplements not
fatty acid intake widely available
is exchanged for:. to U.S.
[cir] consumers.
Carbohydrates, <bullet> Multi-
including component
different types interventions
(complex (e.g., diet +
including fiber, exercise vs.
refined, sugars). exercise or plant
[cir] Protein..... sterols + diet
[cir] Unsaturated vs. plant
fatty acids, any. sterols) (adult
[cir] Mono- studies).
unsaturated fatty <bullet> Multi-
acids (MUFA). component
[cir] interventions of
Polyunsaturated statins + diet
fatty acids where statins are
(PUFA). being initiated.
[cir] Combination Dietary
of the above. interventions
<bullet> Dietary among existing
intake must be statin users will
defined or be included.
described <bullet>
prospectively (in Interventions
real time). designed to
<bullet> Must induce weight
specify daily loss or treat
quantity of overweight and
dietary saturated obesity through
fat intake. energy
restriction or
hypocaloric
diets.
<bullet>
Interventions
designed for the
purposes of
treating medical
conditions other
than modifiable
CV risk factors.
<bullet> Enteral
feeding.
Key Question 1....
For studies in
children,.
[cir] Include
multicomponent
interventions
(e.g., diet +
exercise vs.
exercise).
[cir] Infant
formula.
------------------------------------------------------------------------
Comparators..................... Both Key Questions Both Key Questions
<bullet> Diets Diets with a
with no exchange caloric intake
and, thus, a that are
higher intake of significantly
total saturated higher or lower
fatty acids, than the
individual intervention/
saturated fatty exposure diet.
acids, or Diets or
combination of interventions
saturated fatty that vary
acids. substantially in
<bullet> Well intake of
defined macronutrients
conventional or (or other
usual diet. factors) other
<bullet> Diets than the
with same intervention and
reduction in comparator of
saturated fat interest.
intake but Different dietary
different fat exposure
replacement (e.g., comparison
(e.g., 6% of undefined
saturated fatty quantiles).
acids in all
arms, replaced
with protein vs.
replaced with
carbohydrates).
------------------------------------------------------------------------
Outcomes........................ Key Question 1.... Key Question 1
[[Page 92934]]
<bullet> Plasma <bullet> Total
lipoprotein cholesterol (TC).
concentrations. <bullet> TC:HDL
[cir] LDL ratio.
cholesterol (LDL- <bullet> LDL:HDL
c). ratio.
[cir] HDL <bullet>
cholesterol (HDL- Chylomicrons.
c). <bullet> VLDL-c.
[cir] Non-HDL- <bullet> IDL-c.
cholesterol. <bullet> Other
[cir] apolipoproteins.
Triglycerides <bullet>
(triacylglycerol) Lipoprotein
(Tg). profiles.
[cir] <bullet>
Lipoprotein(a). Evaluations of
[cir] fatty acid
Apolipoprotein B biomarker levels.
(ApoB).
Key Question 2.... Key Question 2
<bullet> <bullet> Other
Cardiovascular cardiac or
events. vascular related
[cir] outcomes.
Atherosclerotic <bullet>
cardiovascular Participant
disease (total). reported events.
[cir] Major
adverse cardiac
(or cerebral)
events (MAC[C]E).
[cir] Specific
cardiovascular
events.
[ssquf] Myocardial
infarction.
[ssquf] Coronary
heart/artery
disease.
[ssquf] Peripheral
vascular/artery
disease.
[cir]
Revascularization
(for studies
published after
1995).
[cir]
Cardiovascular
disease-related
mortality.
[cir] Stroke......
[cir] Incident
atrial
fibrillation.
------------------------------------------------------------------------
Subgroups/effect modifiers of Both Key Questions None.
interest.
[cir] Specific
life stages
[cir] Infants (for
Key Question 1
only).
[cir] Children and
adolescents (for
Key Question 1
only).
[cir] Adults (19-
64).
[cir] Older adults
(>=65).
[cir] Pregnant or
postpartum.
[cir] Menopausal
status.
------------------------------------------------------------------------
<bullet> Other
characteristics
[cir] Sex (male,
female).
[cir]
Socioeconomic
status.
[cir] Social
determinants of
health.
[cir] Race/
ethnicity.
[cir] Physical
activity level.
[cir]
Anthropometry.
[cir] Health
status, including
type 2 diabetes.
[cir] Percent of
total energy
intake replaced.
[cir] Dietary
trans fatty acid
intake.
[cir] Baseline
lipid
concentrations.
[cir] Dietary
cholesterol
intake.
------------------------------------------------------------------------
Design.......................... Key Question 1.... Both Key Questions
<bullet> Studies <bullet>
of adults. Observational
[cir] Parallel or studies that do
cross-over not account for
randomized confounders.
controlled trials <bullet> Analyses
(RCTs). of dietary fat as
[ssquf] n >=25/ a continuous
group *. variable (e.g.,
<bullet> Studies RR per g/day
of children. intake) without
[cir] Parallel or an analysis at a
cross-over RCTs. threshold (e.g.,
[ssquf] n >=25/ RR for > vs <
group *. threshold).
[cir] <bullet> All other
Nonrandomized study designs.
comparative
studies.
[ssquf] Must
account for
potential
confounders.
[ssquf] Dietary
intake must be
defined or
described
prospectively.
[ssquf] n >=50/
group *.
[[Page 92935]]
Key Question 2....
<bullet> Studies
of adults.
[cir] Parallel or
cross-over RCTs.
[ssquf] n >=25/
group *.
[cir]
Nonrandomized
comparative
studies.
[ssquf] Must
account for
potential
confounders.
[ssquf] Dietary
intake must be
defined or
described
prospectively.
[ssquf] We will
aim for a minimum
of about 10
observational
studies for each
specific
intervention--CV
event pair (e.g.,
reduced saturated
fat and stroke).
We will thus
select the
largest
observational
studies within
each
category.[dagger].
[ssquf] n >=100/
group.
------------------------------------------------------------------------
Timing.......................... Key Question 1.... None.
<bullet> Minimum
intervention
length: 4 weeks.
<bullet> In cross-
over studies, any
change in outcome
measure must
exclude data from
the first week
after end of any
prior treatments.
Key Question 2....
<bullet> Minimum
follow-up.
[cir] If
population has no
CV risk factors:
10 years.
[cir] If
population has
one or more CV
risk factors (or
unselected
general
population): 5
years.
------------------------------------------------------------------------
Setting......................... <bullet> General <bullet> Hospital
community or other acute
settings, care settings.
including nursing <bullet>
homes, assisted Institutionalized
living , confined
facilities, etc. settings (e.g.,
prisons)
------------------------------------------------------------------------
Publication..................... <bullet> English
language
<bullet> Published
in peer-reviewed
journals.
------------------------------------------------------------------------
* Minimum sample size may be altered depending on the number of eligible
studies found.
[dagger] Applying this approach for the 2016 AHRQ report n-3 fatty acids
and cardiovascular disease (<a href="https://doi.org/10.23970/AHRQEPCERTA223">https://doi.org/10.23970/AHRQEPCERTA223</a>),
we included: for cardiac event outcomes, observational studies with at
least 10,000 participants; for stroke outcomes, at least 3000
participants; for arrhythmia outcomes, at least 2000 participants;
congestive heart failure outcomes, at least 700 participants; and for
peripheral vascular disease events and MACE outcomes, at least 500
participants. In all instances, if a study meets eligibility criteria
for any outcome, we will extract all outcomes of interest from that
study; therefore, there will be multiple instances of studies being
included for an outcome even though the study might not have met study
size criteria for that specific outcome.
CV = cardiovascular; CVD = cardiovascular disease; MUFA = mono-
unsaturated fatty acids; PUFA = polyunsaturated fatty acids; c =
cholesterol; LDL = low-density lipoprotein; IDL = intermediate-density
lipoprotein; HDL high-density lipoprotein; TC--total cholesterol; Tg =
Triglycerides/Triacylglycerols; apoA = apolipoprotein; MAC[C]E = Major
adverse cardiac (or cerebro) events; BMI = body mass index; KQ = key
question; N = number of participants.
Dated: November 19, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024-27488 Filed 11-22-24; 8:45 am]
BILLING CODE 4160-90-P
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