Notice2024-26783
Supplemental Evidence and Data Request on Dietary Total Fat Intake and Dietary Polyunsaturated Fatty Acid Intake and Child Growth and Development Outcomes: A Systematic Review
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Published
November 18, 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 Total Fat Intake and Dietary Polyunsaturated Fatty Acid Intake and Child Growth and Development Outcomes: A Systematic Review, 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 Access to published and unpublished pertinent scientific information will improve the quality of this review.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 222 (Monday, November 18, 2024)</title>
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[Federal Register Volume 89, Number 222 (Monday, November 18, 2024)]
[Notices]
[Pages 90695-90698]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-26783]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Dietary Total Fat
Intake and Dietary Polyunsaturated Fatty Acid Intake and Child Growth
and Development Outcomes: A Systematic Review
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 Total
Fat Intake and Dietary Polyunsaturated Fatty Acid Intake and Child
Growth and Development Outcomes: A Systematic Review, 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 Access to published and unpublished pertinent scientific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 18, 2024.
ADDRESSES:
Email submissions: <a href="/cdn-cgi/l/email-protection#c1a4b1a281a0a9b3b0efa9a9b2efa6aeb7"><span class="__cf_email__" data-cfemail="7613061536171e0407581e1e0558111900">[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#9efbeefddefff6ecefb0f6f6edb0f9f1e8"><span class="__cf_email__" data-cfemail="91f4e1f2d1f0f9e3e0bff9f9e2bff6fee7">[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 Total Fat
Intake and Dietary Polyunsaturated Fatty Acid Intake and Child Growth
and Development Outcomes: A Systematic Review. 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 Total Fat Intake and Dietary Polyunsaturated
Fatty Acid Intake and Child Growth and Development Outcomes: A
Systematic Review. The entire research protocol is available online at:
<a href="https://effectivehealthcare.ahrq.gov/products/child-growth-development-outcomes/protocol">https://effectivehealthcare.ahrq.gov/products/child-growth-development-outcomes/protocol</a>.
This is to notify the public that the EPC Program would find the
following information on Dietary Total Fat Intake and Dietary
Polyunsaturated Fatty Acid Intake and Child Growth and Development
Outcomes: A Systematic Review 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 is the association between dietary intake of omega-6
and/or omega-3 polyunsaturated fatty acids during pregnancy and risk of
preterm birth?
KQ 1a: How are these associations affected by intervention/exposure
characteristics (for example, the ratio of different fatty acids)?
KQ 2: What is the association between dietary intake of omega-6
and/or omega-3 polyunsaturated fatty acids during pregnancy and/or
lactation and infant/child growth and developmental outcomes?
KQ 2a: How are these associations affected by intervention/exposure
characteristics (for example, the ratio of different fatty acids)?
[[Page 90696]]
KQ 3: What is the association between dietary intake of total fat
in individuals birth through 18 years of age and measures of growth and
development?
KQ4: What is the association between dietary intake of omega-6 and/
or omega-3 polyunsaturated fatty acids in individuals birth through 18
years of age and measures of growth and development?
PICOTS (Population, Intervention, Comparator, Outcome, Timing, Setting/Study Design)
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Element Inclusion criteria Exclusion criteria
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Population........................... Exposure population: <bullet> Non-human
<bullet> Individuals who are pregnant participants (e.g., animal
(KQ1) and/or lactating (KQ2) of any age studies, in-vitro models).
or individuals from birth through 18 <bullet> Studies that enroll
years of age (KQ3 and 4) from the general participants taking
population (including those with medications or with diseases/
overweight/obesity) not affected by a health-related conditions
disease or health-related condition that that impact fatty acid
impacts fat absorption and/or metabolism; absorption or metabolism
or taking medications that alter the (e.g., Crohn's disease,
absorption or metabolism of dietary fatty ulcerative colitis, short-
acid gut syndrome, cystic
Outcome population: fibrosis, celiac). This
<bullet> Offspring of the pregnant includes cancer and
individual (birth through 18 years) not malabsorption syndromes.
taking medications or affected by a <bullet> Studies that
disease or health-related condition that exclusively enroll
impacts fat absorption and/or metabolism participants hospitalized
Note: given the distinction between with an illness or injury.
chronological age versus pubertal stage, <bullet> Studies designed to
as well as heterogeneity in enrollment induce weight loss or treat
across age ranges, for studies meeting overweight and obesity
all other eligibility criteria, we will through energy restriction
consider exceptions to the age or hypocaloric diets for the
criterion.\a\ purposes of treating
additional or other medical
conditions.
<bullet> Studies that
exclusively enroll
participants with severe
undernourishment,
underweight, stunting, or
wasting.
<bullet> Studies that enroll
participants who are pre- or
post-bariatric surgery.
<bullet> Studies with
enrollment exclusively of:
pre-term babies (gestational
age <37 weeks), babies
admitted to the NICU, babies
that have low birth weight
(<2,500g) and/or babies that
are small for gestational
age (for assessment of
infant and child growth
parameters and developmental
outcomes).
<bullet> Studies that enroll
infants with conditions
treated/prevent by dietary
supplementation (e.g., G- or
GJ-tubes, fatty acid
oxidation disorders,
necrotizing enterocolitis,
attention deficit (and/or
hyperactivity) disorder,
ADHD, autism, etc.).
Intervention (Exposure).............. KQ1, 2, and 4: KQ1, 2, and 4:
<bullet> Dietary intake of total omega-3 <bullet> Studies that do not
PUFA, total omega-6 PUFA, or total PUFA quantify PUFA intake as
(omega-3 and omega-6) either grams/day or % of
<bullet> Dietary intake of individual PUFA total energy intake from
(examples: linoleic, alpha-linolenic, PUFA (e.g., studies where
EPA, DHA) exposure is number of fish
<bullet> Dietary intake of a combination servings per week).
of long-chain PUFA (example: EPA+DHA+DPA; <bullet> Studies that do not
DHA+ARA) provide absolute intake of
<bullet> Dietary intake of polyunsaturated fatty acids included in
fatty acids in terms of a ratio (example, ratios.
n-6:n-3 PUFA, DHA:ARA) <bullet> Studies that only
KQ3: assess fatty acid biomarker
<bullet> Total dietary fat intake (as wt% of total or
either grams/day or % of total energy concentrations.
intake from fat) <bullet> Studies that only
<bullet> A dietary pattern that describes assess fatty acid intake via
and quantifies intake of total dietary infusions (parenteral
carbohydrate, total fat, and total [intralipid] or stable
protein content (examples: low/high-fat isotope).
diet; low/high-carbohydrate diet; high- <bullet> Studies that only
protein; ketogenic diet) assess exposure to fatty
Note: Dietary intake can be from foods, acids from a single meal, or
supplements, and/or supplemented eating occasion such that
foods.\b\ usual intake cannot be
inferred.
<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 the PUFA
exposure.
<bullet> Observational
studies that do not account
for any confounders.
<bullet> Studies designed to
induce weight loss or treat
participants who are
determined to be overweight
and obese through energy
restriction or hypocaloric
diets for the purposes of
treating additional or other
medical conditions.
KQ3:
<bullet> Studies that do not
describe the energy and
entire macronutrient
distribution of the diet
(i.e., studies that do not
report total carbohydrate,
total fat, and total protein
contents of experimental or
baseline diets).
[[Page 90697]]
Comparator........................... KQ1, 2, and 4: <bullet> Diet(s) with an
<bullet> Placebo energy intake that is
<bullet> Dietary intake of a different statistically significantly
amount of fatty acids relevant to the higher or lower than the
exposure: intervention/exposure diet
[cir] Total omega-3 (e.g., not isocaloric
[cir] Total omega-6 comparison).
[cir] Individual PUFA <bullet> Studies that do not
[cir] Combination of long-chain PUFA have a statistically
[cir] Intake of PUFA in terms of a ratio significant difference
KQ3: between groups in PUFA or
<bullet> Dietary intake of a different total fat intake.
amount of total fat <bullet> Studies comparing
undefined exposures (e.g.,
comparisons of undefined
quartiles).
Outcome.............................. KQ2, 3, and 4: <bullet> BMI, BMI z-score.
Infant and child (birth through 18 years) <bullet> Body composition and
growth parameters distribution (e.g., % fat
<bullet> Birth weight mass, fat-free mass, skin
<bullet> Weight and Weight-for-age fold thicknesses).
percentile or Z-score adjusted for <bullet> Incidence and
gestational age prevalence of overweight,
<bullet> Length or Height and Length-for- obesity.
age or Height-for-age percentile and Z-
score adjusted for gestational age
<bullet> Head circumference and Head
circumference percentile and Z-score
adjusted for gestational age
Infant and child (birth through 18 years)
developmental outcomes \c\
<bullet> Cognitive/neurological
<bullet> Language/communication
<bullet> Movement/physical
<bullet> Visual function/acuity
<bullet> Social/emotional learning
KQ1:
<bullet> Risk of preterm birth
Timing............................... <bullet> All exposure or intervention
durations will be included
Setting.............................. <bullet> Outpatient; all settings except <bullet> Inpatient; hospital
hospital and acute care will be included and acute care.
Study Design......................... <bullet> Randomized controlled trials <bullet> Narrative reviews.
<bullet> Prospective cohort studies <bullet> Systematic reviews.
<bullet> Nested case-control studies <bullet> Meta-analyses.
<bullet> Scoping reviews.
<bullet> Umbrella reviews.
<bullet> Retrospective cohort
studies.
<bullet> Non-randomized
controlled trials, including
quasi-experimental and
controlled before-and-after
studies.
<bullet> Cross-sectional
studies.
<bullet> Case-control
studies.
<bullet> All other study
designs.
Geographic Location.................. <bullet> Locations with food products or <bullet> Locations not rated
dietary supplements widely available to very high on the HDI.
U.S. and/or Canadian consumers
<bullet> Countries rated very high on the
Human Development Index (HDI) \d\ at the
time of data collection
Study Size........................... <bullet> Studies including power <bullet> Studies with N <30
calculations or effect sizes participants (for RCTs: <10
<bullet> Studies with N >=30 participants participants analyzed per
(for randomized clinical trials [RCTs]): study arm), without power
>=10 participants analyzed per study arm) calculations or effect
sizes.
<bullet> Case studies and n =
1 samples.
<bullet> Non-randomized
studies that do not account
for any potential
confounders.
Language............................. <bullet> Articles published in English <bullet> Articles published
in languages other than
English.
Publication Dates.................... <bullet> Articles published during or <bullet> Articles published
after 2000 prior to 2000.
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\a\ For studies meeting all other eligibility criteria, studies enrolling populations aged 0 to older than 19
years will be included if: (a) results are stratified by age group, allowing extraction of data for
participants aged through 18 years; or (b) 85% of the population is aged through 18 years, if results are not
stratified by age group. The one exception is studies of adolescents; for those meeting all other eligibility
criteria, studies enrolling adolescents through age 26, regardless of result stratification or percentage of
population aged through 18 years, will be included. See the Study Selection section.
\b\ Dietary supplement is defined as a product intended to supplement the diet that contains one or more dietary
ingredients (including vitamins, minerals, herbs or other botanicals, amino acids, and other substances)
intended to be taken by mouth as a pill, capsule, table, or liquid, and that is labeled on the front panel as
being a dietary supplement.
\c\ See Section IV for an example table of measures with periodicity.
\d\ United Nations Development Programme Human Development Reports, <a href="https://hdr.undp.org/data-center/human-development-index#/indicies/HDI">https://hdr.undp.org/data-center/human-development-index#/indicies/HDI</a>.
[[Page 90698]]
Dated: November 8, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024-26783 Filed 11-15-24; 8:45 am]
BILLING CODE 4160-90-P
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