[Federal Register Volume 89, Number 61 (Thursday, March 28, 2024)]
[Notices]
[Pages 21521-21523]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06595]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Fiber Intake and 
Laxation Outcomes

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 Fiber Intake and 
Laxation Outcomes, 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unpublished pertinent scientific information will improve the quality 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 April 29, 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 Fiber Intake and 
Laxation Outcomes. 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 Fiber Intake and Laxation Outcomes. The entire research 
protocol is available online at: https://effectivehealthcare.ahrq.gov/products/fiber-intake/protocol.
    This is to notify the public that the EPC Program would find the 
following information on Fiber Intake and Laxation Outcomes 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,

[[Page 21522]]

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 Question (KQ)

    KQ 1: What is the association between fiber intake and laxation/gut 
motility in apparently healthy individuals?
    KQ 1a: How does the association vary among people in different life 
stages?

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

  Study Eligibility Criteria Based on Population, Intervention, Comparator, Outcome (PICO), and Other Elements
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                 Element                              Inclusion criteria                  Exclusion criteria
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Population...............................   Individuals of any age,           Those with
                                            including pregnant or lactating women.    diseases/health-related
                                            General population, including     conditions or taking
                                            individuals with overweight/obese and     medications that could
                                            those at elevated cardiometabolic         impact gut motility/
                                            disease risk.                             laxation (e.g., irritable
                                            [cir] Overweight/obese.                   bowel syndrome; chronic
                                            [cir] Hyperglycemia and related           constipation; lactose
                                            conditions, including type 2 diabetes.    intolerance; use of
                                            [cir] Dyslipidemia.                       medications that stimulate
                                            [cir] Hypertension/high blood pressure.   laxation or cause
                                                                                      constipation).
                                                                                      Those with chronic
                                                                                      constipation (100% of
                                                                                      study population),
                                                                                      including functional
                                                                                      constipation.
                                                                                      Study eligibility
                                                                                      criteria includes
                                                                                      ``abnormal laxation'' as
                                                                                      defined by either a
                                                                                      minimum or maximum number
                                                                                      of defecations per week
                                                                                      (or equivalent).
                                                                                      Those with other
                                                                                      gastrointestinal-related
                                                                                      conditions, symptoms,
                                                                                      diagnoses;
                                                                                      [cir] Including
                                                                                      diverticulosis.
                                                                                      Those with
                                                                                      diseases/health-related
                                                                                      conditions or taking
                                                                                      medications that could
                                                                                      alter the gut microbiota
                                                                                      composition/diversity
                                                                                      (e.g., antibiotics).
                                                                                      Those with cancer,
                                                                                      gastrointestinal disease,
                                                                                      undernutrition, or who
                                                                                      have had gut resection or
                                                                                      bariatric surgery.
                                                                                      Those with acute
                                                                                      illness or injury.
                                                                                      Pre-term babies
                                                                                      (gestational age <37
                                                                                      weeks), babies with low
                                                                                      birth weight (<2,500 g) or
                                                                                      small for gestational age
                                                                                      (per study criteria).
                                                                                      Enteral/tube fed.
                                                                                      Animal, in vitro,
                                                                                      or other non-human
                                                                                      studies.
Interventions............................   Fiber intake, including           Diets (or other
                                            different types and sources of fiber.     interventions or
                                            Fiber naturally occurring in      exposures) where the fiber
                                            food, enriched in food, dietary           intake has not been
                                            supplements, and diets that can be        quantified or explicitly
                                            defined on the basis of fiber content.    specified.
                                            [cir] Must specify quantity of fiber      Combinations of
                                            intake.                                   fiber (from food or
                                                                                      dietary supplements) and
                                                                                      other entities with a
                                                                                      purported effect on
                                                                                      motility, digestion, or
                                                                                      microbiota (e.g., psyllium
                                                                                      + probiotic).
                                                                                      Combinations of
                                                                                      fiber supplements and
                                                                                      other entities (e.g.,
                                                                                      minerals, vitamins).
Comparators..............................   Different levels (dosages) of     Other entities
                                            fiber.                                    with a purported effect on
                                            No added fiber or placebo.        motility, digestion, or
                                            Different types or sources of     microbiota (e.g.,
                                            fiber.                                    probiotic).
                                            Different formulations of         Alternative food
                                            fiber.                                    group diets (e.g., red
                                                                                      meat, fish, high protein).
Interventions vs. Comparators............   Fiber (supplement) vs. no fiber   Fiber + probiotic
                                            (supplement).                             (etc.) vs. no intervention
                                            Higher fiber (diet) vs. lower     or placebo.
                                            fiber (diet).                             Fiber + probiotic
                                            Fiber vs. alternative fiber.      (etc.) vs. same probiotic
                                            Fiber vs. alternative fiber       (etc.).
                                            dose.                                     Fiber vs.
                                            Fiber vs. alternative fiber       probiotic (etc.).
                                            formulation.                              High-fiber diet
                                                                                      vs. red meat diet (etc.).
Outcomes.................................   Laxation (i.e., gut motility).    Other disease or
                                            [cir] Fecal frequency (e.g., number of    health outcomes.
                                            defecations per week).                    Flatulence,
                                            [cir] Gastrointestinal transit time.      eructation, bloating, etc.
                                            [ssquf] Bristol stool scale (stool
                                            consistency).
                                            [ssquf] Dye, marker studies.
                                            [cir] Fecal output, weight/bulk (g/
                                            day).
                                            [cir] Ease of defecation (e.g.,
                                            constipation).
Subgroups of interest....................   Specific life stages:            None.
                                            [cir] Infants.
                                            [cir] Children and adolescents.
                                            [cir] Adults (19-64).
                                            [cir] Older adults (>=65).
                                            [cir] Pregnant or postpartum.
                                            [cir] Sex (male, female).
Design...................................   Randomized controlled trials.     Observational
                                            [cir] Parallel or cross-over.             studies.
                                            N >=10/group.                     All other study
                                                                                      designs.

[[Page 21523]]

 
Timing...................................   Minimum duration of              None.
                                            intervention: 2 weeks.
                                            In cross-over studies, any
                                            change in outcome measure must exclude
                                            data from the first week after end of
                                            any prior treatments. This may be
                                            accomplished by a washout period of at
                                            least 1 week.
Setting..................................   General population.               Hospital or other
                                                                                      acute care settings.
Publication..............................   English language.                 Non-English
                                            Published in peer-reviewed        language text.
                                            journals.                                 Conference
                                                                                      abstracts and other non-
                                                                                      peer-reviewed data.
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    Dated: March 18, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024-06595 Filed 3-27-24; 8:45 am]
BILLING CODE 4160-90-P