Notice2024-27798
Supplemental Evidence and Data Request on Dietary Intake of Polyunsaturated Fatty Acids and Plasma Lipid and Cardiovascular Events
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Published
November 27, 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 Intake of Polyunsaturated Fatty Acids 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 Access to published and unpublished pertinent scientific information will improve the quality of this review.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 229 (Wednesday, November 27, 2024)</title>
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[Federal Register Volume 89, Number 229 (Wednesday, November 27, 2024)]
[Notices]
[Pages 93603-93606]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-27798]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Dietary Intake of
Polyunsaturated Fatty Acids 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 Intake
of Polyunsaturated Fatty Acids 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 Access to published and unpublished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 27, 2024.
ADDRESSES:
Email submissions: <a href="/cdn-cgi/l/email-protection#95f0e5f6d5f4fde7e4bbfdfde6bbf2fae3"><span class="__cf_email__" data-cfemail="e0859083a081889291ce888893ce878f96">[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#86e3f6e5c6e7eef4f7a8eeeef5a8e1e9f0"><span class="__cf_email__" data-cfemail="1075607350717862613e7878633e777f66">[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 Intake of
Polyunsaturated Fatty Acids 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 Intake of Polyunsaturated Fatty Acids and Plasma
Lipid and Cardiovascular Events. The entire research protocol is
available online at: <a href="https://effectivehealthcare.ahrq.gov/products/polyunsaturated-fatty/protocol">https://effectivehealthcare.ahrq.gov/products/polyunsaturated-fatty/protocol</a>.
This is to notify the public that the EPC Program would find the
following information on Dietary Intake of Polyunsaturated Fatty Acids
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 different dietary polyunsaturated
fatty acid intake on plasma lipid concentrations in the general
population?
KQ 2: What are the effects of different dietary polyunsaturated
fatty acid intake 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]
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Element Inclusion criteria Exclusion criteria
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Population........................... Both Key Questions: Both Key Questions:
[[Page 93604]]
General population, without CVD, with or <bullet> Participants with a
without modifiable CV risk factors, health-related condition or
including taking medications that
[cir] Dyslipidemia (including if taking impact fat absorption, fat
lipid-lowering medications) metabolism.
[cir] Overweight/obese <bullet> Participants taking
[cir] Hyperglycemia and related weight loss medications,
conditions, including type 2 diabetes including glucagon-like
[cir] Hypertension/high blood pressure peptide-1 agonists.
Key Question 1: <bullet> Undernourished,
Children and adults underweight, stunted, or
Key Question 2: wasted participants.
Adults (>=18 years old) <bullet> Participants who are
pre- or post-bariatric
surgery.
<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
hypercholesterolemia.
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Interventions........................ Both Key Questions: Both Key Questions:
Dietary intake of <bullet> Studies that do not
Total n-3 or total n-6 PUFA quantify PUFA intake as
Individual PUFA (e.g., linoleic, ALA, EPA, either g/day or % of total
DHA) energy intake from PUFA.
Combination of long-chain PUFA (e.g., <bullet> Analyses with PUFA
EPA+DHA+DPA; DHA+ALA) intake as a continuous
PUFA intake must be defined or described variable.
prospectively <bullet> Fatty acid intake
Studies must specify daily quantity of via infusion (not orally).
PUFA intake <bullet> Food products or
Key Question 1: dietary supplements not
For studies in children, widely available to U.S.
[cir] Include multicomponent interventions consumers.
(e.g., diet + exercise vs. exercise) <bullet> Multi-component
[cir] Infant formula interventions (e.g.,
exercise + diet vs. exercise
or plant sterols + diet vs.
plant sterols) that do not
isolate the effect or
association of PUFA.
<bullet> Multi-component
interventions of statins +
diet where statins are being
initiated. Dietary
interventions among existing
statin users will be
included.
<bullet> Interventions
designed to induce weight
loss or treat overweight and
obesity through energy
restriction or hypocaloric
diets.
<bullet> Interventions
designed for the purposes of
treating medical conditions
other than modifiable CV
risk factors.
<bullet> DHA and/or EPA n-3
FA dose >4 g/d.
<bullet> Enteral feeding.
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Comparators.......................... Both Key Questions: Both Key Questions:
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Dietary intake of a different level of Diets with a caloric intake
fatty acids relevant to the exposure that are significantly
No added/supplement PUFA higher or lower than the
Placebo supplements intervention/exposure diet.
Diets or interventions that
vary substantially in intake
of macronutrients (or other
factors) other than the
intervention and comparator
of interest.
Different PUFA dietary
exposure (e.g., comparison
of undefined quantiles).
Outcomes............................. Key Question 1: Key Question 1:
<bullet> Plasma lipoprotein concentrations <bullet> Total cholesterol
[cir] LDL cholesterol (LDL-c) (TC).
[cir] HDL cholesterol (HDL-c) <bullet> TC:HDL ratio.
[cir] Non-HDL-cholesterol <bullet> LDL:HDL ratio.
[cir] Triglycerides (triacylglycerol) (Tg) <bullet> Chylomicrons.
[cir] Lipoprotein(a) <bullet> VLDL-c.
[cir] Apolipoprotein B (ApoB) <bullet> IDL-c.
<bullet> Other
apolipoproteins.
<bullet> Lipoprotein
profiles.
<bullet> Evaluations of fatty
acid biomarker levels.
[[Page 93605]]
Key Question 2: Key Question 2:
<bullet> Cardiovascular events <bullet> Other cardiac or
[cir] Atherosclerotic cardiovascular vascular related outcomes.
disease (total) <bullet> Participant reported
[cir] Major adverse cardiac (or cerebral) events.
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
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Subgroups/effect modifiers of Both Key Questions: None.
interest.
<bullet> 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
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Design............................... Key Question 1: Both Key Questions:
<bullet> Studies of adults <bullet> Observational
[cir] Parallel or cross-over randomized studies that do not account
controlled trials (RCTs) for confounders.
[ssquf] n >=25/group * <bullet> Analyses of dietary
<bullet> Studies of children fat as a continuous variable
[cir] Parallel or cross-over RCTs (e.g., RR per g/day intake)
[ssquf] n >=25/group * without an analysis at a
[cir] Nonrandomized comparative studies threshold (e.g., RR for > vs
[ssquf] Must account for potential < threshold).
confounders <bullet> All other study
[ssquf] n >=50/group * designs.
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 PUFA--CV event pair (e.g., EPA
and stroke). We will thus select the
largest observational studies within each
category.[dagger]
[ssquf] n >=100/group
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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
[[Page 93606]]
Key Question 2:
<bullet> Minimum follow-up
[cir] If population has no CV risk factors
(or unselected general population): 10
years
[cir] If population has one or more CV
risk factors: 5 years
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Setting.............................. <bullet> General community settings, <bullet> Hospital or other
including nursing homes, assisted living acute care settings.
facilities, etc. <bullet> Institutionalized,
confined settings (e.g.,
prisons).
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Publication.......................... <bullet> English language
<bullet> Published in peer-reviewed
journals
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* 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; PUFA = polyunsaturated fatty acids; ALA = alpha-linolenic
acid; EPA = eicosapentaenoic aci; DHA= docosahexaenoic acid; DPA = docosapentaenoic acid; n-3 = Omega 3; n-6 =
Omega 6; FA = fatty acid; 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 21, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024-27798 Filed 11-26-24; 8:45 am]
BILLING CODE 4160-90-P
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