`[Federal Register Volume 89, Number 222 (Monday, November 18, 2024)]
[Notices]
[Pages 90695-90698]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 Access to published and unpublished pertinent scientific 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: [email protected].
    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: [email protected].

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: 
https://effectivehealthcare.ahrq.gov/products/child-growth-development-outcomes/protocol.
    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 ClinicalTrials.gov along with the ClinicalTrials.gov 
trial number.
    [ssquf] For completed studies that do not have results on 
ClinicalTrials.gov, 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 
ClinicalTrials.gov 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: https://effectivehealthcare.ahrq.gov/email-updates.
    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)
----------------------------------------------------------------------------------------------------------------
               Element                             Inclusion criteria                    Exclusion criteria
----------------------------------------------------------------------------------------------------------------
Population...........................  Exposure population:                         Non-human
                                        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        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
                                        Offspring of the pregnant           includes cancer and
                                        individual (birth through 18 years) not     malabsorption syndromes.
                                        taking medications or affected by a         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,    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.
                                                                                    Studies that
                                                                                    exclusively enroll
                                                                                    participants with severe
                                                                                    undernourishment,
                                                                                    underweight, stunting, or
                                                                                    wasting.
                                                                                    Studies that enroll
                                                                                    participants who are pre- or
                                                                                    post-bariatric surgery.
                                                                                    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).
                                                                                    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:
                                        Dietary intake of total omega-3     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
                                        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
                                        Dietary intake of a combination     servings per week).
                                        of long-chain PUFA (example: EPA+DHA+DPA;   Studies that do not
                                        DHA+ARA)                                    provide absolute intake of
                                        Dietary intake of polyunsaturated   fatty acids included in
                                        fatty acids in terms of a ratio (example,   ratios.
                                        n-6:n-3 PUFA, DHA:ARA)                      Studies that only
                                       KQ3:                                         assess fatty acid biomarker
                                        Total dietary fat intake (as        wt% of total or
                                        either grams/day or % of total energy       concentrations.
                                        intake from fat)                            Studies that only
                                        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-     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.
                                                                                    Studies that examine
                                                                                    food products or dietary
                                                                                    supplements not widely
                                                                                    available to U.S. consumers.
                                                                                    Multi-component
                                                                                    interventions that do not
                                                                                    isolate the effect or
                                                                                    association of the PUFA
                                                                                    exposure.
                                                                                    Observational
                                                                                    studies that do not account
                                                                                    for any confounders.
                                                                                    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:
                                                                                    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:                               Diet(s) with an
                                        Placebo                             energy intake that is
                                        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                        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
                                        Dietary intake of a different       total fat intake.
                                        amount of total fat                         Studies comparing
                                                                                    undefined exposures (e.g.,
                                                                                    comparisons of undefined
                                                                                    quartiles).
Outcome..............................  KQ2, 3, and 4:                               BMI, BMI z-score.
                                       Infant and child (birth through 18 years)    Body composition and
                                        growth parameters                           distribution (e.g., % fat
                                        Birth weight                        mass, fat-free mass, skin
                                        Weight and Weight-for-age           fold thicknesses).
                                        percentile or Z-score adjusted for          Incidence and
                                        gestational age                             prevalence of overweight,
                                        Length or Height and Length-for-    obesity.
                                        age or Height-for-age percentile and Z-
                                        score adjusted for gestational age
                                        Head circumference and Head
                                        circumference percentile and Z-score
                                        adjusted for gestational age
                                       Infant and child (birth through 18 years)
                                        developmental outcomes \c\
                                        Cognitive/neurological
                                        Language/communication
                                        Movement/physical
                                        Visual function/acuity
                                        Social/emotional learning
                                       KQ1:
                                        Risk of preterm birth
Timing...............................   All exposure or intervention
                                        durations will be included
Setting..............................   Outpatient; all settings except     Inpatient; hospital
                                        hospital and acute care will be included    and acute care.
Study Design.........................   Randomized controlled trials        Narrative reviews.
                                        Prospective cohort studies          Systematic reviews.
                                        Nested case-control studies         Meta-analyses.
                                                                                    Scoping reviews.
                                                                                    Umbrella reviews.
                                                                                    Retrospective cohort
                                                                                    studies.
                                                                                    Non-randomized
                                                                                    controlled trials, including
                                                                                    quasi-experimental and
                                                                                    controlled before-and-after
                                                                                    studies.
                                                                                    Cross-sectional
                                                                                    studies.
                                                                                    Case-control
                                                                                    studies.
                                                                                    All other study
                                                                                    designs.
Geographic Location..................   Locations with food products or     Locations not rated
                                        dietary supplements widely available to     very high on the HDI.
                                        U.S. and/or Canadian consumers
                                        Countries rated very high on the
                                        Human Development Index (HDI) \d\ at the
                                        time of data collection
Study Size...........................   Studies including power             Studies with N <30
                                        calculations or effect sizes                participants (for RCTs: <10
                                        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.
                                                                                    Case studies and n =
                                                                                    1 samples.
                                                                                    Non-randomized
                                                                                    studies that do not account
                                                                                    for any potential
                                                                                    confounders.
Language.............................   Articles published in English       Articles published
                                                                                    in languages other than
                                                                                    English.
Publication Dates....................   Articles published during or        Articles published
                                        after 2000                                  prior to 2000.
----------------------------------------------------------------------------------------------------------------
\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, https://hdr.undp.org/data-center/human-development-index#/indicies/HDI.



[[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`