[Federal Register Volume 89, Number 100 (Wednesday, May 22, 2024)]
[Notices]
[Pages 44988-44990]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 Access to published and unpublished 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: [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 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: https://effectivehealthcare.ahrq.gov/products/carbohydrate-intake/protocol. 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 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

[[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: 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)

    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:
                                 Pregnant      Non-human
                              individuals and       participants (e.g.,
                              newborns not          animal studies, in-
                              affected by a         vitro models).
                              disease or health-     Studies
                              related condition      that enroll
                              that impacts           participants with
                              carbohydrate           diseases/health-
                              absorption and/or      related conditions
                              metabolism             that impact
                              KQ3:................   carbohydrate
                               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          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.
                                                     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:
                                                     Individuals
                                                     who are not
                                                     pregnant.
                                                     Studies
                                                     that enroll
                                                     participants that
                                                     are pre- or post-
                                                     bariatric surgery.
                                                    KQ3
                                                     Children
                                                     older than 24
                                                     months of age.
                                                     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).....     Studies       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      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
                               A dietary     calculated.
                               pattern that          Studies
                               describes and         that only assess
                               quantifies intake     digestible
                               of total dietary      carbohydrate intake
                               digestible            via infusions.
                               carbohydrate and      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;       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.
                                                     Multi-
                                                     component
                                                     interventions that
                                                     do not isolate the
                                                     effect of, or
                                                     association with,
                                                     digestible
                                                     carbohydrate.
Comparator..................                   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..
                               Birth
                               weight, weight-for-
                               age and percentile
                               or Z-score adjusted
                               for gestational age.
                                Low birth
                               weight..
                                Small-for-
                               gestational age..
                                Large-for-
                               gestational age;
                               fetal macrosomia..
                               Birth
                               length, length-for-
                               age and percentile
                               and Z-score
                               adjusted for
                               gestational age.
                               Head
                               circumference and
                               percentile and Z-
                               score adjusted for
                               gestational age.
                               BMI, BMI z-
                               score, weight-for-
                               length percentile,
                               and Z-score.
                                Ponderal
                               index or other
                               composite measures..
                               Body
                               composition and
                               distribution (e.g.,
                               % fat mass, fat-
                               free mass, skin
                               fold thicknesses,
                               circumferences).
                              KQ2:................
                              Gestational weight
                               gain..
                               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.
                               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.
                               Weight-for-
                               age and percentile
                               or Z-score adjusted
                               for gestational age.
                               Length-for-
                               age and percentile
                               and Z-score
                               adjusted for
                               gestational age.
                               Head
                               circumference and
                               percentile and Z-
                               score adjusted for
                               gestational age.
                               BMI, BMI z-
                               score, weight-for-
                               length percentile,
                               and Z-score.
                               Body
                               composition and
                               distribution (e.g.,
                               % fat mass, fat-
                               free mass, skin
                               fold thicknesses,
                               circumferences).
                               Incidence
                               and prevalence of
                               underweight,
                               failure to thrive,
                               stunting, wasting,
                               healthy weight,
                               overweight, obesity.
Timing......................    All
                               exposure or
                               intervention
                               durations will be
                               included.
                                KQ1 and
                               KQ2: exposure
                               during pregnancy..
                                KQ3:
                               exposure from birth
                               to 24 months of
                               age..
Setting.....................                   Hospital
                              Outpatient; all       and acute care.
                              settings except
                              hospital and acute
                              care will be
                              included
Study Design................    Randomized     Narrative
                               controlled trials.   reviews.
                               Non-          Systematic
                               randomized            reviews.
                               controlled trials,    Meta-
                               including quasi-      analyses.
                               experimental and      Scoping
                               controlled before-    reviews.
                               and-after studies.    Umbrella
                                             reviews.
                               Prospective cohort   
                               studies..             Retrospective
                                Nested       cohort studies.
                               case-control          Cross-
                               studies..             sectional studies.
                                                     Case-
                                                     control studies.
                                                     All other
                                                     study designs.
Geographic Location.........     Locations     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..................     Studies       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....................     Articles      Articles
                              published in English  published in
                                                    languages other than
                                                    English.
Publication Dates...........     Articles      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,
  https://hdr.undp.org/data-center/human-development-index#/indicies/HDI 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