[Federal Register Volume 88, Number 127 (Wednesday, July 5, 2023)]
[Notices]
[Pages 42941-42943]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-14184]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Breastfeeding and
Health Outcomes for Infants and Children
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for supplemental evidence and data submissions.
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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 Breastfeeding
and Health Outcomes for Infants and Children, 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Access to published and unpublished pertinent scientific information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 August 4, 2023.
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 06E53A, 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
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evidence for Breastfeeding and Health Outcomes for Infants and
Children. AHRQ is conducting this systematic 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 Breastfeeding and Health Outcomes for Infants and
Children, including those that describe adverse events. The entire
research protocol is available online at: https://effectivehealthcare.ahrq.gov/products/breastfeeding-health-outcomes/protocol.
This is to notify the public that the EPC Program would find the
following information on Breastfeeding and Health Outcomes for Infants
and Children helpful:
[ssquf] A list of completed studies that your organization has
sponsored for this indication. 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: 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 indication. In the list, please provide the
ClinicalTrials.gov trial number or, if the trial is not registered, the
protocol for the study including 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 indication 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 indications 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 systematic 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)
This review will be guided by one Key Question (KQ 1) that
addresses the infant and child health outcomes associated with
breastfeeding and consuming human milk. One sub-KQ (KQ 1a) addresses
variation in the associations by important variables related to
breastfeeding and human milk consumption.
1. What is the association between breastfeeding/human milk
consumption and health outcomes among infants and children?
a. How do these associations vary by intensity (including
exclusivity), duration, and mode of feeding, and by source of human
milk?
Population, Intervention, Comparator, Outcome, Timing, Setting/Study
Design (PICOTS)
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PICOTS Inclusion Exclusion
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Populations............... Full term infants Studies exclusively
(>=37 and 0/7 weeks among:
gestation).
Preterm
(gestational age <37
weeks) infants \a\.
Low birth
weight (<2500 grams)
or small for
gestational age
infants.
Women with
medical conditions
contraindicated for
breastfeeding (e.g.,
breast cancer, HIV).
Exposures................. Any exposure to human Application of human
milk, including milk to skin
feeding at the
breast; consuming
expressed human
milk; or a
combination.
Comparators............... No exposure All other
to human milk. comparisons; no
comparison.
Less
intensive exposure
(e.g., mixed feeding
or commercial milk
formula consumption
vs. exclusive
consumption; lower
proportion of
feedings that are
human milk).
Shorter
duration of exposure.
Different
mechanism of
exposure (e.g.,
feeding at the
breast [direct
breastfeeding] vs.
feeding expressed
human milk).
Different
source of human milk
(e.g., milk from
lactating parent vs.
milk from donor).
Outcomes \b\.............. Health outcomes Any other outcome not
observed at any specified, including
point in the life maternal health
course, outcomes.
specifically:
Allergies,
specifically:
[cir] Atopic
dermatitis.
[cir] Allergic
rhinitis.
[cir] Food allergies.
Asthma......
Celiac
disease.
Cognitive
development (e.g.,
measures of IQ and
other cognitive
development
measures).
Childhood
cancer.
Cardiovascular
disease outcomes,
specifically:
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[cir] Blood lipid
levels,
hyperlipidemia.
[cir] Blood pressure,
elevated blood
pressure.
[cir] Arterial
stiffness, intima-
media thickness,
atherosclerosis.
[cir] Metabolic
syndrome.
[cir] Incidence and
prevalence of CVD.
[cir] CVD-related
mortality.
Diabetes,
specifically.
[cir] Type I.........
[cir] Type II........
Infectious
diseases,
specifically:
[cir] Otitis media...
[cir] Diarrhea/GI
infection.
[cir] Upper and lower
respiratory tract
infections including
COVID-19.
Oral health
outcomes,
specifically:
[cir] Dental caries..
[cir] Malocclusions..
Sudden
infant death
syndrome/sudden
unexpected infant
death.
Infant
mortality.
Inflammatory
bowel disease.
Weight-
related outcomes,
specifically:
[cir] Weight gain
velocity (birth to
24 months).
[cir] Obesity........
Country setting........... Studies conducted in Studies conducted in
a more developed other countries.
country, defined as
``very high'' on the
2021 human
development index
per the United
Nations Development
Programme \44\.
Study designs............. Existing All other designs,
systematic reviews including:
\c\.
Studies of
Observational breastfeeding
studies comparing support
health outcomes interventions
among 2 or more without
groups with observational follow-
different exposures up of health
to human milk, outcomes.
including cohort and Studies with
case-control \d\ no comparison
studies and studies groups.
with observational Cross-
follow-up of health sectional
outcomes from studies.\e\
randomized or non- Case series.
randomized clinical
trials of
breastfeeding
support
interventions.
Publication language...... Studies published in Studies published in
English. languages other than
English.
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Abbreviations: ADHD = attention deficit hyperactivity disorder; ASD =
autism spectrum disorder; COVID-19 = coronavirus disease 2019; GI =
gastrointestinal; HIV = human immunodeficiency virus; NICU = neonatal
intensive care unit.
\a\ The full report will contextually consider the unique feeding needs
of this population and will discuss what we know about the association
between breastfeeding and health outcomes for preterm infants. This
evidence will not be systematically reviewed.
\b\ The full report will contextually discuss potentially harmful
unintended consequences related to breastfeeding such as excessive
weight loss, hyperbilirubinemia, and hypoglycemia. This evidence will
not be systematically reviewed
\c\ Well-conducted systematic review, with or without meta-analysis,
that aligns with these PICOTS criteria and is not rated as
``critically low'' according to systematic review credibility criteria
using AMSTAR 2.\45\
\d\ Case-control studies will be considered only in cases in which the
outcome is rare (<1/1000) and/or this is the only evidence available
for that particular outcome.
\e\ Cross-sectional studies will be excluded except in cases in which
the study compares outcomes between twins or siblings with different
exposures.
Dated: June 29, 2023.
Marquita Cullom,
Associate Director.
[FR Doc. 2023-14184 Filed 7-3-23; 8:45 am]
BILLING CODE 4160-90-P