`[Federal Register Volume 89, Number 227 (Monday, November 25, 2024)]
[Notices]
[Pages 92932-92935]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-27488]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Dietary Saturated Fat 
Replacement and Plasma Lipid and Cardiovascular Events

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 
Saturated Fat Replacement and Plasma Lipid and Cardiovascular Events, 
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 Access to published and unpublished 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 26, 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 Saturated Fat 
Replacement and Plasma Lipid and Cardiovascular Events. 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 Saturated Fat Replacement and Plasma Lipid and 
Cardiovascular Events. The entire research protocol is available online 
at: https://effectivehealthcare.ahrq.gov/products/saturated-fat-replacement/protocol.
    This is to notify the public that the EPC Program would find the 
following information on Dietary Saturated Fat Replacement and Plasma 
Lipid and Cardiovascular Events 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 are the effects of replacing dietary intake of total or 
individual saturated fatty acids with unsaturated, mono-unsaturated or 
polyunsaturated fatty acids, carbohydrates, or protein on plasma lipid 
concentrations in the general population?
    KQ 2: What are the effects of replacing dietary intake of total or 
individual saturated fatty acids with unsaturated, mono-unsaturated or 
polyunsaturated fatty acids, carbohydrates, or protein on 
cardiovascular events in the general population?

 PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and
                                Setting)
     [Study eligibility criteria based on Population, Intervention,
             Comparator, Outcome (PICO), and other elements]
------------------------------------------------------------------------
             Element              Inclusion criteria  Exclusion criteria
------------------------------------------------------------------------
Population......................  Both Key Questions  Both Key Questions

[[Page 92933]]

 
                                  General             
                                   population,         Participants with
                                   without CVD, with   a health-related
                                   or without          condition or
                                   modifiable CV       taking
                                   risk factors,       medications that
                                   including.          impact fat
                                  [cir] Dyslipidemia   absorption, fat
                                   (including if       metabolism.
                                   taking lipid       
                                   lowering            Participants
                                   medications).       taking weight
                                  [cir] Overweight/    loss medications,
                                   obese.              including
                                  [cir]                glucagon-like
                                   Hyperglycemia and   peptide-1
                                   related             agonists.
                                   conditions,        
                                   including type 2    Undernourished,
                                   diabetes.           underweight,
                                  [cir] Hypertension/  stunted, or
                                   high blood          wasted
                                   pressure.           participants.
                                  Key Question 1....  
                                  Children and         Participants who
                                   adults.             are pre- or post-
                                  Key Question 2....   bariatric
                                  Adults (>=18 years   surgery.
                                   old).              
                                                       Participants with
                                                       other chronic
                                                       diseases (e.g.,
                                                       cancer,
                                                       gastrointestinal
                                                       disease,
                                                       rheumatic
                                                       disease, chronic
                                                       kidney disease,
                                                       neurologic
                                                       diseases),
                                                       including type 1
                                                       diabetes.
                                                      
                                                       Participants with
                                                       clinical CVD
                                                       (e.g., history of
                                                       myocardial
                                                       infarction,
                                                       angina, stroke,
                                                       arrhythmia),
                                                       including
                                                       congenital heart
                                                       diseases, or
                                                       familial
                                                       hypercholesterole
                                                       mia.
------------------------------------------------------------------------
Interventions...................  Both Key Questions  Both Key Questions
                                   Diets       Studies
                                   with a lower        that do not
                                   intake of total     quantify fatty
                                   saturated fatty     acid intake as
                                   acids.              either g/day or %
                                   Diets       of total energy
                                   with a lower        intake from
                                   intake of           saturated fat.
                                   individual          Analyses
                                   saturated fatty     with fat intake
                                   acids.              as a continuous
                                   Diets       variable.
                                   with a lower        Fatty
                                   intake of a         acid intake
                                   combination of      during a single
                                   saturated fatty     meal or eating
                                   acids other than    occasion.
                                   stearic acid        Fatty
                                   (ranging from C8    acid intake via
                                   to C16; i.e.,       infusion (not
                                   caprylic,           orally).
                                   caproic, lauric,    Food
                                   myristic,           products or
                                   palmitic).          dietary
                                   Saturated   supplements not
                                   fatty acid intake   widely available
                                   is exchanged for:.  to U.S.
                                  [cir]                consumers.
                                   Carbohydrates,      Multi-
                                   including           component
                                   different types     interventions
                                   (complex            (e.g., diet +
                                   including fiber,    exercise vs.
                                   refined, sugars).   exercise or plant
                                  [cir] Protein.....   sterols + diet
                                  [cir] Unsaturated    vs. plant
                                   fatty acids, any.   sterols) (adult
                                  [cir] Mono-          studies).
                                   unsaturated fatty   Multi-
                                   acids (MUFA).       component
                                  [cir]                interventions of
                                   Polyunsaturated     statins + diet
                                   fatty acids         where statins are
                                   (PUFA).             being initiated.
                                  [cir] Combination    Dietary
                                   of the above.       interventions
                                   Dietary     among existing
                                   intake must be      statin users will
                                   defined or          be included.
                                   described          
                                   prospectively (in   Interventions
                                   real time).         designed to
                                   Must        induce weight
                                   specify daily       loss or treat
                                   quantity of         overweight and
                                   dietary saturated   obesity through
                                   fat intake.         energy
                                                       restriction or
                                                       hypocaloric
                                                       diets.
                                                      
                                                       Interventions
                                                       designed for the
                                                       purposes of
                                                       treating medical
                                                       conditions other
                                                       than modifiable
                                                       CV risk factors.
                                                       Enteral
                                                       feeding.
                                  Key Question 1....
                                  For studies in
                                   children,.
                                  [cir] Include
                                   multicomponent
                                   interventions
                                   (e.g., diet +
                                   exercise vs.
                                   exercise).
                                  [cir] Infant
                                   formula.
------------------------------------------------------------------------
Comparators.....................  Both Key Questions  Both Key Questions
                                   Diets      Diets with a
                                   with no exchange    caloric intake
                                   and, thus, a        that are
                                   higher intake of    significantly
                                   total saturated     higher or lower
                                   fatty acids,        than the
                                   individual          intervention/
                                   saturated fatty     exposure diet.
                                   acids, or          Diets or
                                   combination of      interventions
                                   saturated fatty     that vary
                                   acids.              substantially in
                                   Well        intake of
                                   defined             macronutrients
                                   conventional or     (or other
                                   usual diet.         factors) other
                                   Diets       than the
                                   with same           intervention and
                                   reduction in        comparator of
                                   saturated fat       interest.
                                   intake but         Different dietary
                                   different           fat exposure
                                   replacement         (e.g., comparison
                                   (e.g., 6%           of undefined
                                   saturated fatty     quantiles).
                                   acids in all
                                   arms, replaced
                                   with protein vs.
                                   replaced with
                                   carbohydrates).
------------------------------------------------------------------------
Outcomes........................  Key Question 1....  Key Question 1

[[Page 92934]]

 
                                   Plasma      Total
                                   lipoprotein         cholesterol (TC).
                                   concentrations.     TC:HDL
                                  [cir] LDL            ratio.
                                   cholesterol (LDL-   LDL:HDL
                                   c).                 ratio.
                                  [cir] HDL           
                                   cholesterol (HDL-   Chylomicrons.
                                   c).                 VLDL-c.
                                  [cir] Non-HDL-       IDL-c.
                                   cholesterol.        Other
                                  [cir]                apolipoproteins.
                                   Triglycerides      
                                   (triacylglycerol)   Lipoprotein
                                   (Tg).               profiles.
                                  [cir]               
                                   Lipoprotein(a).     Evaluations of
                                  [cir]                fatty acid
                                   Apolipoprotein B    biomarker levels.
                                   (ApoB).
                                  Key Question 2....  Key Question 2
                                   Other
                                   Cardiovascular      cardiac or
                                   events.             vascular related
                                  [cir]                outcomes.
                                   Atherosclerotic    
                                   cardiovascular      Participant
                                   disease (total).    reported events.
                                  [cir] Major
                                   adverse cardiac
                                   (or cerebral)
                                   events (MAC[C]E).
                                  [cir] Specific
                                   cardiovascular
                                   events.
                                  [ssquf] Myocardial
                                   infarction.
                                  [ssquf] Coronary
                                   heart/artery
                                   disease.
                                  [ssquf] Peripheral
                                   vascular/artery
                                   disease.
                                  [cir]
                                   Revascularization
                                   (for studies
                                   published after
                                   1995).
                                  [cir]
                                   Cardiovascular
                                   disease-related
                                   mortality.
                                  [cir] Stroke......
                                  [cir] Incident
                                   atrial
                                   fibrillation.
------------------------------------------------------------------------
Subgroups/effect modifiers of     Both Key Questions  None.
 interest.
                                  [cir] Specific
                                   life stages
                                  [cir] Infants (for
                                   Key Question 1
                                   only).
                                  [cir] Children and
                                   adolescents (for
                                   Key Question 1
                                   only).
                                  [cir] Adults (19-
                                   64).
                                  [cir] Older adults
                                   (>=65).
                                  [cir] Pregnant or
                                   postpartum.
                                  [cir] Menopausal
                                   status.
------------------------------------------------------------------------
                                   Other
                                   characteristics
                                  [cir] Sex (male,
                                   female).
                                  [cir]
                                   Socioeconomic
                                   status.
                                  [cir] Social
                                   determinants of
                                   health.
                                  [cir] Race/
                                   ethnicity.
                                  [cir] Physical
                                   activity level.
                                  [cir]
                                   Anthropometry.
                                  [cir] Health
                                   status, including
                                   type 2 diabetes.
                                  [cir] Percent of
                                   total energy
                                   intake replaced.
                                  [cir] Dietary
                                   trans fatty acid
                                   intake.
                                  [cir] Baseline
                                   lipid
                                   concentrations.
                                  [cir] Dietary
                                   cholesterol
                                   intake.
------------------------------------------------------------------------
Design..........................  Key Question 1....  Both Key Questions
                                   Studies    
                                   of adults.          Observational
                                  [cir] Parallel or    studies that do
                                   cross-over          not account for
                                   randomized          confounders.
                                   controlled trials   Analyses
                                   (RCTs).             of dietary fat as
                                  [ssquf] n >=25/      a continuous
                                   group *.            variable (e.g.,
                                   Studies     RR per g/day
                                   of children.        intake) without
                                  [cir] Parallel or    an analysis at a
                                   cross-over RCTs.    threshold (e.g.,
                                  [ssquf] n >=25/      RR for > vs <
                                   group *.            threshold).
                                  [cir]                All other
                                   Nonrandomized       study designs.
                                   comparative
                                   studies.
                                  [ssquf] Must
                                   account for
                                   potential
                                   confounders.
                                  [ssquf] Dietary
                                   intake must be
                                   defined or
                                   described
                                   prospectively.
                                  [ssquf] n >=50/
                                   group *.

[[Page 92935]]

 
                                  Key Question 2....
                                   Studies
                                   of adults.
                                  [cir] Parallel or
                                   cross-over RCTs.
                                  [ssquf] n >=25/
                                   group *.
                                  [cir]
                                   Nonrandomized
                                   comparative
                                   studies.
                                  [ssquf] Must
                                   account for
                                   potential
                                   confounders.
                                  [ssquf] Dietary
                                   intake must be
                                   defined or
                                   described
                                   prospectively.
                                  [ssquf] We will
                                   aim for a minimum
                                   of about 10
                                   observational
                                   studies for each
                                   specific
                                   intervention--CV
                                   event pair (e.g.,
                                   reduced saturated
                                   fat and stroke).
                                   We will thus
                                   select the
                                   largest
                                   observational
                                   studies within
                                   each
                                   category.[dagger].
                                  [ssquf] n >=100/
                                   group.
------------------------------------------------------------------------
Timing..........................  Key Question 1....  None.
                                   Minimum
                                   intervention
                                   length: 4 weeks.
                                   In cross-
                                   over studies, any
                                   change in outcome
                                   measure must
                                   exclude data from
                                   the first week
                                   after end of any
                                   prior treatments.
                                  Key Question 2....
                                   Minimum
                                   follow-up.
                                  [cir] If
                                   population has no
                                   CV risk factors:
                                   10 years.
                                  [cir] If
                                   population has
                                   one or more CV
                                   risk factors (or
                                   unselected
                                   general
                                   population): 5
                                   years.
------------------------------------------------------------------------
Setting.........................   General     Hospital
                                   community           or other acute
                                   settings,           care settings.
                                   including nursing  
                                   homes, assisted     Institutionalized
                                   living              , confined
                                   facilities, etc.    settings (e.g.,
                                                       prisons)
------------------------------------------------------------------------
Publication.....................   English
                                   language
                                   Published
                                   in peer-reviewed
                                   journals.
------------------------------------------------------------------------
* Minimum sample size may be altered depending on the number of eligible
  studies found.
[dagger] Applying this approach for the 2016 AHRQ report n-3 fatty acids
  and cardiovascular disease (https://doi.org/10.23970/AHRQEPCERTA223),
  we included: for cardiac event outcomes, observational studies with at
  least 10,000 participants; for stroke outcomes, at least 3000
  participants; for arrhythmia outcomes, at least 2000 participants;
  congestive heart failure outcomes, at least 700 participants; and for
  peripheral vascular disease events and MACE outcomes, at least 500
  participants. In all instances, if a study meets eligibility criteria
  for any outcome, we will extract all outcomes of interest from that
  study; therefore, there will be multiple instances of studies being
  included for an outcome even though the study might not have met study
  size criteria for that specific outcome.
CV = cardiovascular; CVD = cardiovascular disease; MUFA = mono-
  unsaturated fatty acids; PUFA = polyunsaturated fatty acids; c =
  cholesterol; LDL = low-density lipoprotein; IDL = intermediate-density
  lipoprotein; HDL high-density lipoprotein; TC--total cholesterol; Tg =
  Triglycerides/Triacylglycerols; apoA = apolipoprotein; MAC[C]E = Major
  adverse cardiac (or cerebro) events; BMI = body mass index; KQ = key
  question; N = number of participants.


    Dated: November 19, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024-27488 Filed 11-22-24; 8:45 am]
BILLING CODE 4160-90-P`