[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Access to published and unpublished pertinent scientific information 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

[[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