[Federal Register Volume 85, Number 242 (Wednesday, December 16, 2020)]
[Notices]
[Pages 81475-81477]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27645]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Maternal and Childhood 
Outcomes Associated With the Special Supplemental Nutrition Program for 
Women, Infants and Children (WIC)

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 Maternal and 
Childhood Outcomes Associated with the Special Supplemental Nutrition 
Program for Women, Infants and Children (WIC), 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Access to published and unpublished pertinent scientific information 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 January 15, 2021.

ADDRESSES: Email submissions: <a href="/cdn-cgi/l/email-protection#cca9bcaf8cada4bebde2a4a4bfe2aba3ba"><span class="__cf_email__" data-cfemail="9cf9ecffdcfdf4eeedb2f4f4efb2fbf3ea">[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: Jenae Benns, Telephone: 301-427-1496 
or Email: <a href="/cdn-cgi/l/email-protection#d2b7a2b192b3baa0a3fcbabaa1fcb5bda4"><span class="__cf_email__" data-cfemail="fe9b8e9dbe9f968c8fd096968dd0999188">[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 Maternal and Childhood 
Outcomes Associated with the Special Supplemental Nutrition Program for 
Women, Infants and Children (WIC). 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 Maternal and Childhood Outcomes Associated with the 
Special Supplemental Nutrition Program for Women, Infants and Children 
(WIC), including those that describe adverse events. The entire 
research protocol is available online at: https://effectivehealthcare.ahrq.gov/products/outcomes-nutrition/protocol.
    This is to notify the public that the EPC Program would find the 
following information on Maternal and Childhood Outcomes Associated 
with the Special Supplemental Nutrition Program for Women, Infants and 
Children (WIC) 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 (KQs)

    KQ 1: Among women who are eligible to participate in WIC, how is 
WIC participation during pregnancy associated with maternal and infant 
birth outcomes?
    a. Does the association vary by gestational age at WIC enrollment 
or duration of mother's WIC participation?
    b. Does the association vary by participant factors such as:

i. Age of the mother at delivery
ii. Race/ethnicity of mother
iii. Geographic location (e.g. region, urban vs. rural)
iv. Education of the mother
v. Employment status of the mother
vi. Marital status
vii. Housing (e.g. public), homelessness

    KQ 2: Among infants and children eligible to participate in WIC, 
how is WIC participation associated with dietary and health outcomes in 
childhood?
    a. Does the association vary by age or duration of WIC 
participation?

[[Page 81476]]

    b. Does the association vary by participant factors such as:

i. Age of the mother at delivery
ii. Race/ethnicity of child
iii. Geographic location (e.g. region, urban vs. rural)
iv. Education of the mother
v. Employment status of the mother
vi. Marital status of the mother
vii. Housing (e.g. public, private), homelessness

   PICOTS (Populations, Interventions, Comparators, Outcomes, Timing,
                                Settings)
------------------------------------------------------------------------
      PICOTS elements                KQ 1                   KQ 2
------------------------------------------------------------------------
Population................  Women who              Infants/children who
                             participated in WIC    participated in WIC
                             during pregnancy and   (age from 29 days up
                             their infants at       to age 5).
                             birth up to 28 days.
                            Participant factors    Participant factors
                             include; age of        include; age of
                             mother at delivery,    mother at delivery,
                             race/ethnicity of      race/ethnicity of
                             mother, geographic     child (or mother),
                             location, education    geographic location,
                             of mother,             education of mother,
                             employment status of   employment status of
                             mother, marital        mother, marital
                             status of mother,      status of mother,
                             housing, parity, and   housing, parity of
                             maternal nutritional   mother, and maternal
                             status at enrollment.  and/or child
                                                    nutritional status
                                                    at enrollment.
Intervention..............  Participation in WIC   Participation in WIC
                             with service           with service
                             provisions from 2009   provisions from 2009
                             onwards (year and      onwards (year and
                             location), defined     location), defined
                             at a minimum as        at a minimum as
                             enrolling in WIC for   enrolling in WIC for
                             one month or more.     one month or more.
Comparison................  Women who were         Infants/children who
                             eligible for WIC,      were eligible for
                             but did not            WIC, but did not
                             participate during     participate at the
                             pregnancy, and their   age studied (ages
                             infants at birth up    from 29 days up to 5
                             to 28 days; duration   years); duration of
                             of WIC participation.  WIC participation.
Outcomes *................  Dietary practices of   Dietary practices of
                             infants and mothers,   infants and
                             diet quality,          children, diet
                             household food         quality, household
                             security, food         and child food
                             purchasing.            security, food
                                                    purchasing.
                            Anthropometric         Anthropometric
                             status: Weight         status: E.g. weight-
                             status (e.g. BMI,      for-age, length- or
                             underweight,           height-for-age,
                             obesity).              weight-for-length,
                            Maternal: E.g.          or weight-for-height
                             anemia, weight gain,   percentile or Z-
                             health care            score, BMI-for-age
                             utilization            percentile or Z-
                             (prenatal,             score, underweight,
                             postpartum), mode of   and obesity), growth
                             delivery, intra- and   velocity.
                             post-partum
                             complications,
                             morbidity and
                             mortality.
                            Infant birth           Infant and child
                             outcomes: E.g.         outcomes: Anemia,
                             gestational age,       iron deficiency
                             birth weight, small/   anemia, iron
                             large for              deficiency, primary
                             gestational age,       health care
                             birth complications    utilization,
                             such as preterm        immunization status,
                             delivery,              morbidity and
                             hospitalization.       mortality.
                                                   Child development/
                                                    school performance
                                                    (e.g., cognitive
                                                    development,
                                                    behavioral
                                                    development,
                                                    educational
                                                    performance, school-
                                                    related factors
                                                    (e.g. attendance,
                                                    behavior)).
Timing **.................  Studies published      Studies published
                             2009 onwards.          2009 onwards.
Setting...................  Any jurisdiction       Any jurisdiction
                             served by a WIC        served by a WIC
                             State or Local         State or Local
                             Agency.                Agency.
Study Design..............  Intervention trials    Intervention trials
                             (randomized and non-   (randomized and non-
                             randomized),           randomized),
                             observational          observational
                             studies, quasi-        studies, quasi-
                             experimental, before-  experimental, before-
                             after, interrupted     after, interrupted
                             time series.           time series.
------------------------------------------------------------------------
* Please see appendix A for the detailed list of outcomes.
** Only for specific key outcomes (maternal mortality, infant mortality,
  child development/school performance) will studies prior to 2009 be
  included.

Appendix A: Detailed List of Outcomes by Key Question

    Key Question 1: Among women who are eligible to participate in WIC, 
how is WIC participation during pregnancy associated with maternal and 
infant birth outcomes?

------------------------------------------------------------------------
             Outcomes                             Measures
------------------------------------------------------------------------
Maternal health outcomes [health
 risk] in:
    [rtarr8] Pregnancy.
    [rtarr8] Postpartum...........
    Anemia, Iron deficiency, Iron-
     deficiency anemia,
     Nutritional anemias.
    Gestational weight gain.......  Total gestational weight gain; IOM
                                     rec by BMI: under, within, over.
    Weight status (e.g., BMI,       Pregnancy, Postpartum obesity,
     underweight, overweight,        Postpartum weight retention.
     obesity).
    Health care utilization.......  Utilization of recommended prenatal
                                     care, postpartum care and other
                                     health maintenance recommendations
                                     Inter-pregnancy interval.
    Morbidity.....................  GDM, Pre-eclampsia, Gestational
                                     hypertension, Mental Health
                                     (symptoms), Smoking, alcohol, risk
                                     behaviors.
    Mode of delivery..............  Cesarean/Vaginal.
    Intra- and post-partum          Prolonged labor, PROM, Postpartum
     complications.                  hemorrhage, transfusion.
    Mortality.....................  Fetal death (stillbirth), pregnancy-
                                     related death (while pregnant or
                                     within a year of the pregnancy
                                     ending).
Dietary outcomes..................  Breastfeeding (intention,
Diet intake, practices and quality   initiation, and duration of any
 (infant and mother).                breastfeeding), Dietary intake
(Diet quality measure, Dietary       (nutrient intake); diet quality
 intake (method), Diet quality       measures (HEI, AHEI, DASH/Medical);
 score).                             glycemic load; servings of food
                                     groups, variety, adequacy and
                                     moderation components, SSB, sodium/
                                     salt, EFA); nutrient density (%
                                     fat, and by type; %CHO).
    Food purchasing behavior at     Benefit redemption, purchasing
     the participant level.          surveys.
    Household food security.......  E.g., 18-item USDA Household Food
                                     Security Scale.

[[Page 81477]]

 
Infant birth outcomes:
    Gestational age...............  Preterm, late preterm, early term,
                                     term and late term.
    Birth weight..................  Very low birth weight, Low birth
                                     weight, Normal birth weight, High
                                     birth weight.
    Small for gestational age.....
    Large for gestational age.....
    Birth complications...........  Preterm delivery, hospitalization,
                                     NICU stay, congenital
                                     malformations, neonatal (live birth
                                     and death within 28 days) or infant
                                     (within first year of life after
                                     live birth) death.
------------------------------------------------------------------------
BMI = Body mass index; GDM = Gestational diabetes mellitus; PIH =
  pregnancy-induced hypertension; PROM = Prelabor rupture of the
  membranes; USDA = United States Department of Agriculture; AHEI =
  Alternative Healthy Eating Index; DASH = Dietary, Approaches to Stop
  Hypertension; HEI = Healthy Eating Index; SSB = sugar-sweetened
  beverage; EFA = Essential Fatty Acids; CHO = Carbohydrates; NICU=
  Neonatal Intensive Care Unit; WIC = Special Supplemental Nutrition
  Program for Women, Infants and Children.

    Key Question 2: Among infants and children eligible to participate 
in WIC, how is WIC participation associated with dietary and health 
outcomes in childhood (to age 17 years)?

------------------------------------------------------------------------
             Outcomes                             Measures
------------------------------------------------------------------------
Health outcomes:
    Anemia, Iron deficiency
     anemia, nutritional anemias,
     iron deficiency.
    Child growth, anthropometric    Weight-for-age, length- or height-
     status.                         for-age, weight-for-length, or
                                     weight-for-height percentile or Z-
                                     score, BMI-for-age percentile or Z-
                                     score, underweight, overweight,
                                     obese; growth velocity (change in
                                     size/status or z-score over time).
    Healthcare Utilization........  Well child visits, Immunization
                                     status.
    Morbidity.....................  Otitis media, allergies,
                                     gastrointestinal respiratory
                                     infections, asthma, immunization
                                     status,
                                    Pre-diabetes, Diabetes mellitus,
                                     elevated blood pressure/
                                     hypertension, hyperlipidemia.
    Mortality.....................  Infant mortality.
                                    Child mortality.
Dietary outcomes:
    Dietary practices of infants    Infants: Maternal intention to
     and children.                   breastfeed; Ever breastfed or any
                                     breastfeeding; Exclusive
                                     breastfeeding (initiation and
                                     duration); Duration of any
                                     breastfeeding; introduction of
                                     formula (timing); timing of solids
                                     introduction (<4 months, <6
                                     months); cereal in the bottle;
                                     timing of cow's milk introduction
                                     (<12 months); food group servings;
                                     nutrient intakes.
                                    Children (1-2): Food group servings,
                                     groups for variety, adequacy and
                                     moderation; added sugars, SSB, type
                                     of milk; fruit juice; dietary
                                     diversity; nutrient intakes,
                                     nutrient density measures (iron,
                                     zinc, calcium, %fat (total and by
                                     type)) energy density.
    Diet quality..................  Children 2-5: [HEI, AHEI, food group
                                     servings (adequacy and moderation,
                                     added sugars, SSB), type of milk;
                                     fruit juice].
                                    Nutrient intakes and nutrient
                                     density measures (iron, zinc,
                                     calcium, %fat (total and by type))
                                     energy density.
    Food purchasing behavior at     Benefit redemption, purchasing
     the participant level.          surveys.
    Household and child food        18-item USDA Household Food Security
     security.                       Scale.
Child development/school
 performance:
    Academic development..........  Pre-school or Head Start (e.g.,
                                     attendance, behavior).
                                    K-12 educational performance, school-
                                     related factors (e.g. attendance,
                                     behavior).
                                    ADHD, conduct disorders, mental
                                     health.
    Child development (behavioral   BSID II/III; WPPSI, WISC, other
     development, cognitive          standardized measures or specific
     development; cognitive          constructs.
     performance).
------------------------------------------------------------------------
ADHD = Attention deficit hyperactivity disorder; AHEI = Alternative
  Healthy Eating Index; HEI = Healthy Eating Index; SSB = sugar-
  sweetened beverage; WISC = Wechsler Intelligence Scale for Children;
  BSID = Bayley Scales of Infant Development; WPPSI = Wechsler Preschool
  and Primary Scale of Intelligence.


    Dated: December 10, 2020.
Marquita Cullom,
Associate Director.
[FR Doc. 2020-27645 Filed 12-15-20; 8:45 am]
BILLING CODE 4160-90-P


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