Notice2024-11198
Supplemental Evidence and Data Request on Digestible Carbohydrate Intake and Maternal-Infant Outcomes: A Systematic Review
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Published
May 22, 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 Digestible Carbohydrate Intake and Maternal-Infant 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 Access to published and unpublished pertinent scientific information will improve the quality of this review.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 100 (Wednesday, May 22, 2024)</title>
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[Federal Register Volume 89, Number 100 (Wednesday, May 22, 2024)]
[Notices]
[Pages 44988-44990]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-11198]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Digestible Carbohydrate
Intake and Maternal-Infant 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 Digestible
Carbohydrate Intake and Maternal-Infant 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 Access to published and unpublished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 June 21, 2024.
ADDRESSES:
Email submissions: <a href="/cdn-cgi/l/email-protection#a5c0d5c6e5c4cdd7d48bcdcdd68bc2cad3"><span class="__cf_email__" data-cfemail="5f3a2f3c1f3e372d2e7137372c71383029">[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#6d081d0e2d0c051f1c4305051e430a021b"><span class="__cf_email__" data-cfemail="b7d2c7d4f7d6dfc5c699dfdfc499d0d8c1">[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 Digestible
Carbohydrate Intake and Maternal-Infant 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 Digestible Carbohydrate Intake and Maternal-Infant
Outcomes: A Systematic Review. The entire research protocol is
available online at: <a href="https://effectivehealthcare.ahrq.gov/products/carbohydrate-intake/protocol">https://effectivehealthcare.ahrq.gov/products/carbohydrate-intake/protocol</a>. This is to notify the public that the EPC
Program would find the following information on Digestible Carbohydrate
Intake and Maternal-Infant 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
[[Page 44989]]
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)
1. What is the association between dietary digestible carbohydrate
intake by a person during pregnancy and the weight, length, head
circumference, and other measures of size and body composition of the
infant obtained at birth? How are these associations affected by
characteristics of the pregnant person?
2. What is the association between dietary digestible carbohydrate
intake during pregnancy and gestational weight gain? How are these
associations affected by characteristics of the pregnant person?
3. What is the association between infant dietary digestible
carbohydrate intake, including digestible carbohydrate intake from
human milk, and measures of growth, size, and body composition in
individuals from birth to 24 months of age?
Inclusion and Exclusion Criteria by Population, Intervention,
Comparator, Outcome, Timing, Setting/Study Design (PICOTS)
------------------------------------------------------------------------
Element Inclusion criteria Exclusion criteria
------------------------------------------------------------------------
Population.................. KQ1 and KQ2:........ All KQs:
<bullet> Pregnant <bullet> Non-human
individuals and participants (e.g.,
newborns not animal studies, in-
affected by a vitro models).
disease or health- <bullet> Studies
related condition that enroll
that impacts participants with
carbohydrate diseases/health-
absorption and/or related conditions
metabolism that impact
KQ3:................ carbohydrate
<bullet> Infants absorption or
from birth to 24 metabolism (e.g.,
months of age not cancer,
affected by a malabsorption
disease or health- syndromes,
related condition diabetes).
that impacts <bullet> Studies
carbohydrate that exclusively
absorption and/or enroll participants
metabolism. hospitalized with
(1) an illness or
injury; or (2)
undernourished,
underweight,
stunted, or wasted
participants.
<bullet> Studies
designed to induce
weight loss or
treat overweight
and obesity through
energy restriction
or hypocaloric
diets for the
purposes of
treating additional
or other medical
conditions.
KQ1 and KQ2:
<bullet> Individuals
who are not
pregnant.
<bullet> Studies
that enroll
participants that
are pre- or post-
bariatric surgery.
KQ3
<bullet> Children
older than 24
months of age.
<bullet> Studies of
exclusively pre-
term babies
(gestational age
<37 weeks),
exclusively babies
that have low birth
weight (<2500g) and/
or exclusively
babies that are
small for
gestational age.
Intervention (Exposure)..... <bullet> Studies <bullet> Studies
that report total that do not specify
dietary digestible the amount of total
carbohydrate digestible
intake\a\ from carbohydrate intake
foods, beverages, (e.g., studies that
and dietary only report type or
supplements\b\ or source of digestible
report values that carbohydrate or
allow total report only total
digestible carbohydrate, but
carbohydrate intake not digestible
to be calculated, carbohydrate).
and percentage of <bullet> Studies
dietary intake that do not provide
consisting of total percentage of
dietary carbohydrate dietary intake from
with or without the total digestible
% from other carbohydrates or
macronutrients enough data to
(protein and fat) allow this to be
<bullet> A dietary calculated.
pattern that <bullet> Studies
describes and that only assess
quantifies intake digestible
of total dietary carbohydrate intake
digestible via infusions.
carbohydrate and <bullet> Studies
total energy that only assess
intake, with or exposure to
without total fat, digestible
and total dietary carbohydrate from a
protein content single meal or
(e.g., low/high-fat eating occasion
diet; low/high- such that usual
carbohydrate diet; intake cannot be
high-protein; inferred.
ketogenic diet; <bullet> Studies
Atkins diet; Zone that examine food
diet; Pritikin products or dietary
diet; Ornish diet). supplements not
widely available to
U.S. and/or
Canadian consumers.
<bullet> Multi-
component
interventions that
do not isolate the
effect of, or
association with,
digestible
carbohydrate.
Comparator.................. <bullet> <bullet> Studies
Consumption of that do not attempt
different levels of to control for
total dietary energy intake of
digestible participants such
carbohydrate intake that comparisons are
not made on an
isocaloric basis.
Comparisons of
digestible
carbohydrate
exposure should not
be confounded by
differences in
participants' energy
intake.
[[Page 44990]]
Outcome..................... KQ1:
Newborn size and
body composition..
<bullet> Birth
weight, weight-for-
age and percentile
or Z-score adjusted
for gestational age.
<bullet> Low birth
weight..
<bullet> Small-for-
gestational age..
<bullet> Large-for-
gestational age;
fetal macrosomia..
<bullet> Birth
length, length-for-
age and percentile
and Z-score
adjusted for
gestational age.
<bullet> Head
circumference and
percentile and Z-
score adjusted for
gestational age.
<bullet> BMI, BMI z-
score, weight-for-
length percentile,
and Z-score.
<bullet> Ponderal
index or other
composite measures..
<bullet> Body
composition and
distribution (e.g.,
% fat mass, fat-
free mass, skin
fold thicknesses,
circumferences).
KQ2:................
Gestational weight
gain..
<bullet> Change in
pregnant
individual's body
weight from
baseline (before or
during 1st
trimester of
pregnancy) to a
later time point
during pregnancy
and/or right before
delivery.
<bullet> Weight gain
in relationship to
weight gain
recommendations,
based on pre-
pregnancy BMI.
KQ3:................
Infant (up to 24
months of age)
growth, size, and
body composition.
<bullet> Weight-for-
age and percentile
or Z-score adjusted
for gestational age.
<bullet> Length-for-
age and percentile
and Z-score
adjusted for
gestational age.
<bullet> Head
circumference and
percentile and Z-
score adjusted for
gestational age.
<bullet> BMI, BMI z-
score, weight-for-
length percentile,
and Z-score.
<bullet> Body
composition and
distribution (e.g.,
% fat mass, fat-
free mass, skin
fold thicknesses,
circumferences).
<bullet> Incidence
and prevalence of
underweight,
failure to thrive,
stunting, wasting,
healthy weight,
overweight, obesity.
Timing...................... <bullet> All
exposure or
intervention
durations will be
included.
<bullet> KQ1 and
KQ2: exposure
during pregnancy..
<bullet> KQ3:
exposure from birth
to 24 months of
age..
Setting..................... <bullet> <bullet> Hospital
Outpatient; all and acute care.
settings except
hospital and acute
care will be
included
Study Design................ <bullet> Randomized <bullet> Narrative
controlled trials. reviews.
<bullet> Non- <bullet> Systematic
randomized reviews.
controlled trials, <bullet> Meta-
including quasi- analyses.
experimental and <bullet> Scoping
controlled before- reviews.
and-after studies. <bullet> Umbrella
<bullet> reviews.
Prospective cohort <bullet>
studies.. Retrospective
<bullet> Nested cohort studies.
case-control <bullet> Cross-
studies.. sectional studies.
<bullet> Case-
control studies.
<bullet> All other
study designs.
Geographic Location......... <bullet> Locations <bullet> Locations
with food products not rated high or
or dietary very high on the
supplements widely HDI.
available to U.S.
and/or Canadian
consumers, including
those rated high and
very high on the
Human Development
Index (HDI)\c\
Study Size.................. <bullet> Studies <bullet> Studies
with N >=30 with N <30
participants (for participants (for
randomized clinical RCTs: <10
trials [RCTs]): >=10 participants
participants analyzed per study
analyzed per study arm), and without
arm) power calculation.
Language.................... <bullet> Articles <bullet> Articles
published in English published in
languages other than
English.
Publication Dates........... <bullet> Articles <bullet> Articles
published during or published prior to
after 2000 2000.
------------------------------------------------------------------------
\a\ Total dietary digestible carbohydrate intake defined as collective
starch and sugar intake; carbohydrate intake not including dietary
fiber.
\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\ 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> HDI.
Dated: May 16, 2024.
Mamatha Pancholi,
Deputy Director.
[FR Doc. 2024-11198 Filed 5-21-24; 8:45 am]
BILLING CODE 4160-90-P
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