Supplemental Evidence and Data Request on Breastfeeding and Health Outcomes for Infants and Children, 42941-42943 [2023-14184]
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Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Breastfeeding and Health
Outcomes for Infants and Children
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for supplemental
evidence and data submissions.
AGENCY:
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unpublished pertinent scientific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: epc@
ahrq.hhs.gov.
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.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Kelly Carper, Telephone: 301–427–1656
or Email: epc@ahrq.hhs.gov.
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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42942
Federal Register / Vol. 88, No. 127 / Wednesday, July 5, 2023 / Notices
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:
D 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.
D 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.
D 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.
D 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)
PICOTS
Inclusion
Populations ..............
Full term infants (≥37 and 0/7 weeks 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).
Any exposure to human milk, including feeding at the
breast; consuming expressed human milk; or a combination.
• No exposure to human milk ...............................................
• 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).
Health outcomes observed at any point in the life course,
specifically:
• Allergies, specifically:
Æ Atopic dermatitis.
Æ Allergic rhinitis.
Æ Food allergies.
• Asthma.
• Celiac disease.
• Cognitive development (e.g., measures of IQ and other
cognitive development measures).
• Childhood cancer.
• Cardiovascular disease outcomes, specifically:
Exposures ................
Comparators ............
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Outcomes b ..............
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Exclusion
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Studies exclusively among:
Application of human milk to skin
All other comparisons; no comparison.
Any other outcome not specified, including maternal health
outcomes.
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Federal Register / Vol. 88, No. 127 / Wednesday, July 5, 2023 / Notices
42943
POPULATION, INTERVENTION, COMPARATOR, OUTCOME, TIMING, SETTING/STUDY DESIGN (PICOTS)—Continued
PICOTS
Inclusion
Exclusion
Æ
Æ
Æ
Æ
Æ
Æ
•
Æ
Æ
•
Æ
Æ
Æ
Country setting ........
Study designs ..........
Publication language
Blood lipid levels, hyperlipidemia.
Blood pressure, elevated blood pressure.
Arterial stiffness, intima-media thickness, atherosclerosis.
Metabolic syndrome.
Incidence and prevalence of CVD.
CVD-related mortality.
Diabetes, specifically.
Type I.
Type II.
Infectious diseases, specifically:
Otitis media.
Diarrhea/GI infection.
Upper and lower respiratory tract infections including
COVID–19.
• Oral health outcomes, specifically:
Æ Dental caries.
Æ Malocclusions.
• Sudden infant death syndrome/sudden unexpected infant
death.
• Infant mortality.
• Inflammatory bowel disease.
• Weight-related outcomes, specifically:
Æ Weight gain velocity (birth to 24 months).
Æ Obesity.
Studies conducted in a more developed country, defined as
‘‘very high’’ on the 2021 human development index per
the United Nations Development Programme 44.
• Existing systematic reviews c .............................................
• Observational studies comparing health outcomes among
2 or more groups with different exposures to human milk,
including cohort and case-control d studies and studies
with observational follow-up of health outcomes from randomized
or
non-randomized
clinical
trials
of
breastfeeding support interventions.
Studies published in English .................................................
Studies conducted in other countries.
All other designs, including:
• Studies of breastfeeding support interventions without
observational follow-up of health outcomes.
• Studies with no comparison groups.
• Cross-sectional studies.e
• Case series.
Studies published in languages other than English.
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.
ACTION:
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Solicitation of Nominations for
Appointment to the Board of Scientific
Counselors, National Center for Injury
Prevention and Control
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
AGENCY:
17:11 Jul 03, 2023
All nominations should be
emailed to ncipcbsc@cdc.gov.
ADDRESSES:
The Centers for Disease
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the Department of Health and Human
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Scientific Counselors, National Center
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[FR Doc. 2023–14184 Filed 7–3–23; 8:45 am]
VerDate Sep<11>2014
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PO 00000
Frm 00035
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FOR FURTHER INFORMATION CONTACT:
Christopher R. Harper, Ph.D.,
Designated Federal Officer, Board of
Scientific Counselors, National Center
for Injury Prevention and Control,
Centers for Disease Control and
Prevention, 4770 Buford Highway NE,
Mailstop S–1069, Atlanta, Georgia
30341. Telephone: (404) 718–8330.
Email: ncipcbsc@cdc.gov.
SUPPLEMENTARY INFORMATION:
Nominations are sought for individuals
who have expertise and qualifications
necessary to contribute to the
accomplishment of the objectives of the
Board of Scientific Counselors, National
Center for Injury Prevention and Control
(BSC, NCIPC). Nominees will be
E:\FR\FM\05JYN1.SGM
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]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 42942]]
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)
------------------------------------------------------------------------
PICOTS Inclusion Exclusion
------------------------------------------------------------------------
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:
[[Page 42943]]
[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.
------------------------------------------------------------------------
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
