Notice2024-06595
Supplemental Evidence and Data Request on Fiber Intake and Laxation Outcomes
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 28, 2024
Issuing agencies
Health and Human Services DepartmentAgency for Healthcare Research and Quality
Abstract
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on 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 Access to published and unpublished pertinent scientific information will improve the quality of this review.
Full Text
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<title>Federal Register, Volume 89 Issue 61 (Thursday, March 28, 2024)</title>
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[Federal Register Volume 89, Number 61 (Thursday, March 28, 2024)]
[Notices]
[Pages 21521-21523]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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unpublished pertinent scientific information will improve the quality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: <a href="/cdn-cgi/l/email-protection#6d081d0e2d0c051f1c4305051e430a021b"><span class="__cf_email__" data-cfemail="bbdecbd8fbdad3c9ca95d3d3c895dcd4cd">[email protected]</span></a>.
Print submissions:
Mailing Address: Center for Evidence and Practice Improvement, Agency
for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600
Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857
Shipping Address (FedEx, UPS, etc.): Center for Evidence and Practice
Improvement, Agency for Healthcare Research and Quality, ATTN: EPC
SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, MD
20857
FOR FURTHER INFORMATION CONTACT: Kelly Carper, Telephone: 301-427-1656
or Email: <a href="/cdn-cgi/l/email-protection#85e0f5e6c5e4edf7f4abededf6abe2eaf3"><span class="__cf_email__" data-cfemail="6207120122030a10134c0a0a114c050d14">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and
Quality has commissioned the Evidence-based Practice Centers (EPC)
Program to complete a review of the evidence for 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: <a href="https://effectivehealthcare.ahrq.gov/products/fiber-intake/protocol">https://effectivehealthcare.ahrq.gov/products/fiber-intake/protocol</a>.
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 <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> along with the <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>
trial number.
[ssquf] For completed studies that do not have results on
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>, a summary, including the following elements, if
relevant: study number, study period, design, methodology, indication
and diagnosis, proper use instructions, inclusion and exclusion
criteria, primary and secondary outcomes, baseline characteristics,
number of patients screened/eligible/enrolled/lost to follow-up/
withdrawn/analyzed, effectiveness/efficacy, and safety results.
[ssquf] A list of ongoing studies that your organization has
sponsored for this topic. In the list, please provide the
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> trial number or, if the trial is not registered, the
protocol for the study including, if relevant, a study number, the
study period, design, methodology, indication and diagnosis, proper use
instructions, inclusion and exclusion criteria, and primary and
secondary outcomes.
[ssquf] Description of whether the above studies constitute ALL
Phase II and above clinical trials sponsored by your organization for
this topic and an index outlining the relevant information in each
submitted file.
Your contribution is very beneficial to the Program. Materials
submitted must be publicly available or able to be made public.
Materials that are considered confidential; marketing materials; study
types not included in the review; or information on topics not included
in the review cannot be used by the EPC Program. This is a voluntary
request for 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: <a href="https://effectivehealthcare.ahrq.gov/email-updates">https://effectivehealthcare.ahrq.gov/email-updates</a>.
The review will answer the following questions. This information is
provided as background. AHRQ is not requesting that the public provide
answers to these questions.
Key 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............................... <bullet> Individuals of any age, <bullet> Those with
including pregnant or lactating women. diseases/health-related
<bullet> 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).
<bullet> Those with chronic
constipation (100% of
study population),
including functional
constipation.
<bullet> Study eligibility
criteria includes
``abnormal laxation'' as
defined by either a
minimum or maximum number
of defecations per week
(or equivalent).
<bullet> Those with other
gastrointestinal-related
conditions, symptoms,
diagnoses;
[cir] Including
diverticulosis.
<bullet> Those with
diseases/health-related
conditions or taking
medications that could
alter the gut microbiota
composition/diversity
(e.g., antibiotics).
<bullet> Those with cancer,
gastrointestinal disease,
undernutrition, or who
have had gut resection or
bariatric surgery.
<bullet> Those with acute
illness or injury.
<bullet> Pre-term babies
(gestational age <37
weeks), babies with low
birth weight (<2,500 g) or
small for gestational age
(per study criteria).
<bullet> Enteral/tube fed.
<bullet> Animal, in vitro,
or other non-human
studies.
Interventions............................ <bullet> Fiber intake, including <bullet> Diets (or other
different types and sources of fiber. interventions or
<bullet> 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 <bullet> 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).
<bullet> Combinations of
fiber supplements and
other entities (e.g.,
minerals, vitamins).
Comparators.............................. <bullet> Different levels (dosages) of <bullet> Other entities
fiber. with a purported effect on
<bullet> No added fiber or placebo. motility, digestion, or
<bullet> Different types or sources of microbiota (e.g.,
fiber. probiotic).
<bullet> Different formulations of <bullet> Alternative food
fiber. group diets (e.g., red
meat, fish, high protein).
Interventions vs. Comparators............ <bullet> Fiber (supplement) vs. no fiber <bullet> Fiber + probiotic
(supplement). (etc.) vs. no intervention
<bullet> Higher fiber (diet) vs. lower or placebo.
fiber (diet). <bullet> Fiber + probiotic
<bullet> Fiber vs. alternative fiber. (etc.) vs. same probiotic
<bullet> Fiber vs. alternative fiber (etc.).
dose. <bullet> Fiber vs.
<bullet> Fiber vs. alternative fiber probiotic (etc.).
formulation. <bullet> High-fiber diet
vs. red meat diet (etc.).
Outcomes................................. <bullet> Laxation (i.e., gut motility). <bullet> Other disease or
[cir] Fecal frequency (e.g., number of health outcomes.
defecations per week). <bullet> 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.................... <bullet> 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................................... <bullet> Randomized controlled trials. <bullet> Observational
[cir] Parallel or cross-over. studies.
<bullet> N >=10/group. <bullet> All other study
designs.
[[Page 21523]]
Timing................................... <bullet> Minimum duration of None.
intervention: 2 weeks.
<bullet> 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.................................. <bullet> General population. <bullet> Hospital or other
acute care settings.
Publication.............................. <bullet> English language. <bullet> Non-English
<bullet> Published in peer-reviewed language text.
journals. <bullet> 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
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