[Federal Register Volume 89, Number 9 (Friday, January 12, 2024)]
[Notices]
[Pages 2226-2228]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-00505]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on The Effect of Dietary 
Digestible Carbohydrate Intake on Risk of Cardiovascular Disease

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 The Effect of 
Dietary Digestible Carbohydrate Intake on Risk of Cardiovascular 
Disease, 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unpublished pertinent scientific information will improve the quality 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 February 12, 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 The Effect of Dietary 
Digestible Carbohydrate Intake on Risk of Cardiovascular Disease. 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 The Effect of Dietary Digestible Carbohydrate Intake on 
Risk of Cardiovascular Disease.
    The entire research protocol is available online at: https://effectivehealthcare.ahrq.gov/products/risk-cardiovascular-disease.
    This is to notify the public that the EPC Program would find the 
following information on The Effect of Dietary Digestible Carbohydrate 
Intake on Risk of Cardiovascular Disease 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.

[[Page 2227]]

    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://www.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 digestible 
carbohydrate intake and the incidence of cardiovascular disease?

PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and 
Setting)

      Inclusion and Exclusion Criteria by Population, Intervention,
       Comparator, Outcome, Timing, Setting/Study Design (PICOTS)
------------------------------------------------------------------------
       PICOTS elements         Inclusion criteria    Exclusion criteria
------------------------------------------------------------------------
Population..................                
                               Participants who      Participants with
                               are generally         diseases/health-
                               healthy, including    related conditions
                               participants who      that impact
                               are determined to     carbohydrate
                               be overweight/        absorption or
                               obese, women who      metabolism, cancer,
                               are pregnant or       and malabsorption
                               lactating.            syndromes.
                               Age of       
                               participants:.        Participants
                              [cir] Between 2        hospitalized with
                               years and 9 years     an illness or
                               (before puberty)..    injury.
                              [cir] Between 9 and   
                               17 years..            Participants with
                              [cir] 18 years and     the endpoint
                               older..               outcomes of CVD
                                                     (i.e., studies that
                                                     aim to treat
                                                     participants
                                                     already been
                                                     diagnosed with the
                                                     endpoint outcomes
                                                     of interest).
                                                    
                                                     Participants who
                                                     intend to reduce
                                                     weight or receive
                                                     treatments for
                                                     being overweight
                                                     and having obesity
                                                     through energy
                                                     restriction or
                                                     hypocaloric diets
                                                     for the purposes of
                                                     treating additional
                                                     or other medical
                                                     conditions.
                                                    
                                                     Participants who
                                                     are determined to
                                                     be undernourished,
                                                     underweight,
                                                     stunted, or wasted.
                                                    
                                                     Participants who
                                                     are pre-bariatric
                                                     or post-bariatric
                                                     surgery.
                                                     People
                                                     younger than 2
                                                     years old.
Interventions...............   Total         Studies
                               dietary digestible    that do not specify
                               carbohydrate intake   the amount of total
                               from foods,           digestible
                               beverages, and        carbohydrate intake
                               dietary supplements.  (e.g., studies that
                              [cir] Total dietary    only report type or
                               digestible            source of
                               carbohydrate intake   digestible
                               defined as            carbohydrate).
                               collective starch     Studies
                               and sugar intake;     that do not
                               carbohydrate intake   describe the entire
                               not including         macronutrient
                               dietary fiber..       distribution of the
                               A dietary     diet (i.e., studies
                               pattern that          that do not report
                               quantifies the        total digestible
                               intake of total       carbohydrate, total
                               dietary digestible    fat, and total
                               carbohydrates and     protein contents of
                               allows the            experimental or
                               isolation of the      baseline diets).
                               effect of             Studies
                               carbohydrate intake   that only assess
                               from the effect of    digestible
                               the intake of other   carbohydrate intake
                               macronutrients..      via infusions
                                                     (rather than the GI
                                                     tract).
                                                     Studies
                                                     that primarily
                                                     measure
                                                     postprandial
                                                     responses, as
                                                     opposed to longer
                                                     term studies.
                                                     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
                                                     digestible
                                                     carbohydrate.
Comparators.................   Different     Comparison
                               total dietary         of different
                               digestible            sources of
                               carbohydrate intake   carbohydrate
                               level(s).             without specifying
                                                     amount of
                                                     carbohydrate
                                                     intake.
                                                     Studies
                                                     that do not attempt
                                                     to control for
                                                     energy intake of
                                                     participants such
                                                     that comparisons
                                                     are made on an
                                                     isocaloric basis.
                                                     Comparisons
                                                     of available
                                                     carbohydrate
                                                     exposure should not
                                                     be confounded by
                                                     differences in
                                                     participants'
                                                     energy intake.
Outcomes....................                
                               Intermediate          Hypertensive
                               outcomes:             disorders during
                              [cir] LDL              pregnancy and/or
                               cholesterol (LDL)..   lactation (e.g.,
                              [cir] Total            chronic
                               cholesterol (TC)..    hypertension,
                              [cir] HDL              gestational
                               cholesterol (HDL)..   hypertension,
                              [cir] Non-HDL          preeclampsia-
                               cholesterol..         eclampsia, chronic
                              [cir] TC:HDL ratio..   hypertension with
                              [cir] LDL:HDL ratio.   superimposed
                              [cir] Triglycerides.   preeclampsia).
                              [cir] Blood pressure
                               (systolic and/or
                               diastolic) and
                               hypertension..
                               Final
                               outcomes:
                              [cir] Cardiovascular
                               disease (e.g.,
                               myocardial
                               infarction,
                               coronary heart
                               disease, congestive
                               heart failure,
                               peripheral artery
                               disease)..
                              [cir] Stroke........
                              [cir] Cardiovascular
                               disease-related
                               mortality..

[[Page 2228]]

 
Timing......................   At least 4    Less than 4
                               weeks.                weeks.
Settings....................   All except    Hospital
                               hospital and acute    and acute care.
                               care.
Study design................   Randomized    In vitro
                               controlled trials.    studies,
                                             nonoriginal data
                               Nonrandomized         (e.g., narrative
                               controlled trials,    reviews, scoping
                               including quasi-      reviews,
                               experimental and      editorials,
                               controlled before-    letters, or
                               and-after studies..   erratum),
                               Prospective   retrospective
                               cohort studies..      cohort studies,
                               Nested case-  case series,
                               control studies..     qualitative
                               Relevant      studies, cost-
                               systematic reviews,   benefit analysis,
                               or meta-analyses      cross-sectional
                               (used for             (i.e.,
                               identifying           nonlongitudinal)
                               additional            studies, survey.
                               studies)..
Publications................   Studies       Non-English
                               published in          language studies.
                               English only.
                               Studies
                               published in peer-
                               reviewed journals..
                               Studies
                               published at and
                               after the year
                               2000..
------------------------------------------------------------------------
Abbreviations: CVD = cardiovascular disease; GI = gastrointestinal; HDL
  = high-density lipoprotein; KQ = Key Question; LDL = low-density
  lipoprotein PICOTS = populations, interventions, comparators,
  outcomes, timing, and settings; RCT = randomized controlled trial; TC
  = total cholesterol; U.S. = United States.


    Dated: January 8, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024-00505 Filed 1-11-24; 8:45 am]
BILLING CODE 4160-90-P