[Federal Register Volume 87, Number 48 (Friday, March 11, 2022)]
[Notices]
[Pages 14011-14014]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-05141]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Postpartum Care for 
Women Up to One Year After Pregnancy

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 Postpartum Care 
for Women Up to One Year After Pregnancy, 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Access to published and unpublished pertinent scientific information 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 11, 2022.

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 06E77D, Rockville, 
MD 20857.

FOR FURTHER INFORMATION CONTACT: Jenae Benns, Telephone: 301-427-1496 
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 evidence for Postpartum Care for 
Women Up to One Year After Pregnancy. AHRQ is conducting this technical 
brief 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 Postpartum Care for Women Up to One Year After 
Pregnancy, including those that describe adverse events. The entire 
research protocol is available online at: https://effectivehealthcare.ahrq.gov/products/postpartum-care-one-year/protocol.
    This is to notify the public that the EPC Program would find the 
following information on Postpartum Care for Women Up to One Year After 
Pregnancy 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

[[Page 14012]]

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)

    KQ 1: What healthcare delivery strategies affect postpartum 
healthcare utilization and improve maternal outcomes within 1 year 
postpartum?
    a. Do the healthcare delivery strategies affect postpartum 
healthcare utilization and improve maternal outcomes within 3 months 
postpartum? Does this relationship differ by timing of outcomes, 
specifically within 6 days postpartum, between 1 to 6 weeks postpartum, 
and between 6 weeks and 3 months postpartum?
    b. Do the healthcare delivery strategies affect postpartum 
healthcare utilization and improve maternal outcomes between 3 months 
and 1 year postpartum?
    KQ 2: Does extension of health insurance coverage or improvements 
in access to healthcare affect postpartum healthcare utilization and 
improve maternal outcomes within 1 year postpartum?

PICOTSD (Populations, Interventions, Comparators, Outcomes, Timing, 
Settings, and Design)

Key Question 1 (Strategies for Healthcare Delivery)

Populations
 Individuals (of any age) who are in the postpartum period 
(defined as within 1 year after giving birth).
    [cir] For this review, ``giving birth'' is defined as a live birth, 
intrauterine fetal death (IUFD)/stillbirth, or induced abortion that 
occurred at 20 or more weeks of gestation (i.e., the duration of 
gestation that is commonly considered to denote the viability of the 
fetus).
 Eligible populations
    [cir] Healthy individuals (general population)
    [cir] Individuals at increased risk of postpartum complications due 
to pregnancy-related conditions (e.g., hypertensive disorders of 
pregnancy, gestational diabetes)
    [cir] Individuals at increased risk of postpartum complications due 
to incident or newly diagnosed conditions postpartum (e.g., postpartum 
hypertension, postpartum depression, new-onset diabetes)
 Exclude:
    [cir] Individuals with specific health conditions not typically 
managed by providers of pregnancy and postpartum care, (e.g., multiple 
sclerosis, HIV, cancer, substance use disorders other than tobacco).
    [cir] Individuals with diagnosed chronic conditions--pre-existing 
(non-gestational) diabetes, cardiac disease/risk factors (e.g., 
cardiomyopathy, pre-existing [non-gestational] hypertension), mood 
disorders (e.g., major depression, anxiety), stress urinary 
incontinence, and dyspareunia.

    Content of Interventions Provided (note that these are not the 
interventions being compared in the review).
    Categories of interventions include components of the ACOG 
Postpartum Care Plan: \18\

 Counseling, support, and education regarding
    [cir] Infant care and feeding
    [cir] Reproductive life planning and contraception
    [cir] Adverse pregnancy outcomes associated with cardiometabolic 
disease
    [cir] Risks and behaviors associated with poor postpartum health
 Screening or prevention of:
    [cir] Pregnancy complications
    [cir] Common chronic health conditions (e.g., hypertension, 
diabetes)
    [cir] Mental health conditions (e.g., depression, anxiety)
    [cir] Common gynecologic problems (e.g., sexually transmitted 
infections, cervical cancer)
    [cir] Common postpartum problems (e.g., stress urinary 
incontinence, dyspareunia)
 Exclude:
    [cir] Treatments for acute or emergency postpartum conditions 
(e.g., for mastitis, urinary tract infections, other infections)
    [cir] Treatments or other interventions for conditions unrelated to 
pregnancy (e.g., HIV, schizophrenia)
    [cir] Treatments or other interventions for acute conditions during 
pregnancy or occurring around the time of giving birth (e.g., for 
postpartum hemorrhage, preeclampsia with severe features)
    [cir] Treatments or other interventions directed at the infant 
(e.g., well-child visits, otitis media, colic)
    [cir] Referral-only interventions (e.g., lactation consultants for 
specific lactation problems)
Delivery Strategies
 Where healthcare is delivered--e.g., hospital, clinic, home 
visit, community health center, birth center, virtual care/telehealth, 
Women Infants and Children (WIC) program office/site
 How healthcare is delivered--e.g., dedicated postpartum care 
visit, as part of well-child visit, group visit
 When healthcare is delivered--e.g., timing before giving 
birth, after giving birth, or at postpartum visits
 Who provides healthcare/support
    [cir] Predominantly health system-based care--e.g., OB/GYN, 
midwife, pediatrician, family physician, internist, physician 
assistant, nurse practitioner, nurse, lactation consultant (when 
integrated as part of the care), clinical psychologist or other mental 
health professional
    [cir] Predominantly community-based care--e.g., doula support, 
community health worker, lay support, social worker/support, peer 
support, case manager
 Healthcare coordination and management of care--e.g., patient 
navigators, creation and implementation of post-birth care plans, 
strategies for continuity of care/care transitions, strategies to 
facilitate access to appointments/scheduling, postpartum specialty care 
clinics, multidisciplinary care models (e.g., maternal and child health 
centers, maternity care homes), evidence-based care protocols, 
incentives for care completion
 Information and communication technology--e.g., bidirectional 
telemedicine, virtual televisits, phone visits, bidirectional texting, 
real-time chat-bots, smartphone or computer applications designed to 
enhance provision of postpartum healthcare
    [cir] Exclude: Social media or support groups (without provider 
involvement), web or device applications aimed at general health 
maintenance
 Interventions targeted at healthcare providers or systems--
e.g., interventions to improve guideline-adherent care, clinical 
decision support tools, interventions to help reduce healthcare 
inequities (e.g., promoting respectful care)
 Exclude:
    [cir] Referral-only interventions (e.g., lactation consultants for 
specific lactation problems)

[[Page 14013]]

    [cir] Treatments for specific ailments or conditions (e.g., pelvic 
floor physical therapy, urinary incontinence treatment, contraception, 
pain treatment, cognitive behavioral therapy)
    [cir] Insurance extension (which is covered in KQ 2)
Comparator Delivery Strategies
 Standard delivery strategy
 Alternative delivery strategy

    Outcomes (* and bold font denotes important outcomes that will be 
used when developing Strength of Evidence tables)

 Intermediate and healthcare utilization outcomes
    [cir] Attendance at postpartum visits *
    [cir] Unplanned care utilization (e.g., unplanned readmissions, 
emergency room visits) *
    [cir] Adherence to condition-specific screening/testing (e.g., 
blood pressure monitoring, glucose tolerance testing) or treatment *
    [cir] Transition to primary care provider for long-term care *
 Clinical outcomes (as appropriate, outcomes include incidence, 
prevalence/continuation, severity, and resolution)
    [cir] Maternal mortality *
    [cir] Symptoms or diagnosis of mental health conditions (e.g., 
anxiety, depression, substance use) *
    [cir] Patient-reported outcomes
    [ssquf] Quality of life (using validated measures) *
    [ssquf] Perceived stress *
    [ssquf] Pain
    [ssquf] Sleep quality
    [ssquf] Fatigue
    [ssquf] Sexual well-being and satisfaction
    [ssquf] Awareness of risk factors for long-term ill health
    [cir] Physical health/medical outcomes
    [ssquf] Postpartum onset of preeclampsia or hypertension
    [ssquf] Infections (e.g., mastitis, wound infections)
    [ssquf] Severe maternal morbidity
    [cir] Cardiovascular disorders (e.g., cardiomyopathy)
    [cir] Cerebrovascular disorders (e.g., stroke)
    [cir] Bleeding
    [cir] Venous thromboembolism
    [cir] Other
    [cir] Interpregnancy interval
    [cir] Unintended pregnancies
    [cir] Contraceptive initiation and continuation
    [cir] Breastfeeding intention, initiation, duration, and 
exclusivity
    [cir] Reduction in health inequities (e.g., by race, ethnicity, 
geography, disability status)
 Harms
    [cir] Health inequities *
    [cir] Perceived discrimination *
    [cir] Over-utilization of healthcare
    [cir] Patient burden regarding postpartum care
Potential Effect Modifiers
 Patient-level factors
    [cir] Age
    [cir] Race/ethnicity
    [cir] Gender identity
    [cir] Sexual identity
    [cir] Physical disability status
    [cir] Socioeconomic status
    [cir] Immigration status
    [cir] Barriers to transportation to healthcare facility
    [cir] Paid family leave policies (e.g., presence versus absence, 
different durations of leave)
    [cir] Access to internet (for virtual care/telehealth questions)
    [cir] Substance use/substance use disorder
    [cir] Type of insurance coverage (insured versus uninsured, private 
versus public [e.g., Medicaid], insurance coverage of postpartum care, 
Medicaid insurance coverage extension or expansion)
    [cir] Presence versus absence of disorders of pregnancy (e.g., 
hypertensive, cardiovascular, gestational diabetes mellitus) or 
peripartum complications that increase risk of postpartum complications
    [cir] Preterm versus term delivery
    [cir] Live birth versus stillbirth/spontaneous abortion/induced 
abortion
    [cir] Number of infants (singleton versus twins/triplets, etc.)
    [cir] Presence versus absence of a supportive partner
    [cir] Infant health (e.g., neonatal intensive care unit [NICU] 
admission, congenital anomalies)
 Setting factors
    [cir] Country (U.S. versus other high-income countries)
    [cir] Geographic location (urban versus suburban versus rural)
    [cir] Different levels of neighborhood vulnerability (e.g., social 
vulnerability index)
    [cir] Volume of facility/hospital (high versus low)
    [cir] Type of facility/hospital (private versus public)
    [cir] Racial/ethnic concordance between provider and patient
    [cir] Language concordance between provider and patient
Timing
 Delivery strategy and comparator delivery strategy: Antenatal 
or postpartum (or both)
    [cir] If the service is delivered antenatally, the strategy must be 
aimed at postpartum health (not just that the outcome was measured 
during the postpartum period).
 Outcome measurement: For KQ 1a: Within 3 months after giving 
birth. For KQ 1b: 3 months to 1 year after giving birth (except 
interpregnancy interval, unintended pregnancies, and chronic diseases 
[e.g., diabetes, hypertension], which can be later)
Settings
 High-income countries (as classified by the World Bank--see 
https://datahelpdesk.worldbank.org/knowledgebase/articles/906519-world-bank-country-and-lending-groups)
 Outpatient care
 Exclude: Institutionalized settings (e.g., prisons)
Design
 Randomized controlled trials (N >=10 participants per group)
 Nonrandomized comparative studies, longitudinal (prospective 
or retrospective) (N >=30 participants per group)
 Case-control studies (N >=30 participants per group)
 Exclude: Single-group (noncomparative) studies, comparative 
cross-sectional studies (without a discernable time-period between 
implementation of strategy for intervention and measurement of 
outcomes), qualitative studies

Key Question 2 (Extension of Healthcare or Insurance Coverage)

Populations
 Individuals (of any age) who are in the postpartum period 
(defined as within 1 year after giving birth).
    [cir] For this review, ``giving birth'' is defined as a live birth, 
intrauterine fetal death (IUFD)/stillbirth, or induced abortion that 
occurred at 20 or more weeks of gestation (i.e., the duration of 
gestation that is commonly considered to denote the viability of the 
fetus).
 Eligible populations
    [cir] Healthy individuals (general population)
    [cir] Individuals at increased risk of postpartum complications due 
to pregnancy-related conditions (e.g., hypertensive disorders of 
pregnancy, gestational diabetes)
    [cir] Individuals at increased risk of postpartum complications due 
to incident or newly diagnosed conditions postpartum (e.g., postpartum 
hypertension,

[[Page 14014]]

postpartum depression, new-onset diabetes)
 Exclude:
    [cir] Individuals with specific health conditions not typically 
managed by providers of pregnancy and postpartum care, (e.g., multiple 
sclerosis, HIV, cancer, substance use disorders other than tobacco).
    [cir] Individuals with diagnosed chronic conditions--pre-existing 
(non-gestational) diabetes, cardiac disease/risk factors (e.g., 
cardiomyopathy, pre-existing [non-gestational] hypertension), mood 
disorders (e.g., major depression, anxiety), stress urinary 
incontinence, and dyspareunia.
Interventions
 More comprehensive insurance coverage
 Extended duration of insurance coverage
 More continuous insurance coverage
 Better/more continuous access to care as the result of a 
targeted program at the state, system, or provider level (e.g., 
Medicaid expansion)
Comparators
 Less comprehensive level of or no insurance coverage
 Less continuous insurance coverage
 Worse, less continuous, or no access to healthcare
    Outcomes (* and bold font denotes important outcomes that will be 
used when developing Strength of Evidence tables)
 Intermediate and healthcare utilization outcomes
    [cir] Attendance at postpartum visits *
    [cir] Unplanned care utilization (e.g., readmissions, emergency 
room visits) *
    [cir] Adherence to condition-specific screening/testing (e.g., 
blood pressure monitoring, glucose tolerance testing) or treatment *
    [cir] Transition to primary care provider for long-term care *
 Clinical outcomes (as appropriate, outcomes include incidence, 
prevalence/continuation, severity, and resolution)
    [cir] Maternal mortality *
    [cir] Symptoms or diagnosis of mental health conditions (e.g., 
anxiety, depression, substance use) *
    [cir] Patient-reported outcomes
    [ssquf] Quality of life (using validated measures) *
    [ssquf] Perceived stress *
    [ssquf] Pain
    [ssquf] Sleep quality
    [ssquf] Fatigue
    [ssquf] Sexual well-being and satisfaction
    [ssquf] Awareness of risk factors for long-term ill health
    [cir] Physical health/medical outcomes
    [ssquf] Postpartum onset of preeclampsia or hypertension
    [ssquf] Infections (e.g., mastitis, wound infections)
    [ssquf] Severe maternal morbidity
    [cir] Cardiovascular disorders (e.g., cardiomyopathy)
    [cir] Cerebrovascular disorders (e.g., stroke)
    [cir] Bleeding
    [cir] Venous thromboembolism
    [cir] Other
    [cir] Interpregnancy interval
    [cir] Unintended pregnancies
    [cir] Contraceptive initiation and continuation
    [cir] Breastfeeding intention, initiation, duration, and 
exclusivity
    [cir] Reduction in health inequities (e.g., by race, ethnicity, 
geography, disability status)
 Harms
    [cir] Health inequities *
    [cir] Perceived discrimination *
    [cir] Over-utilization of healthcare
    [cir] Patient burden regarding postpartum care
Potential Effect Modifiers
 Patient-level factors
    [cir] Age
    [cir] Race/ethnicity
    [cir] Gender identity
    [cir] Sexual identity
    [cir] Physical disability status
    [cir] Socioeconomic status
    [cir] Immigration status
    [cir] Barriers to transportation to healthcare facility
    [cir] Paid family leave policies (e.g., presence versus absence, 
different durations of leave)
    [cir] Substance use/substance use disorder
    [cir] Type of insurance coverage (insured versus uninsured, private 
versus public [e.g., Medicaid], insurance coverage of postpartum care, 
Medicaid insurance coverage extension or expansion)
    [cir] Presence versus absence of disorders of pregnancy (e.g., 
hypertensive, cardiovascular, gestational diabetes mellitus) or 
peripartum complications that increase risk of postpartum complications
    [cir] Preterm versus term delivery
    [cir] Live birth versus stillbirth/spontaneous abortion/induced 
abortion
    [cir] Number of infants (singleton versus twins/triplets, etc.)
    [cir] Presence versus absence of a supportive partner
    [cir] Infant health (e.g., neonatal intensive care unit [NICU] 
admission, congenital anomalies)
 Setting factors
    [cir] Geographic location (urban versus suburban versus rural)
    [cir] Different levels of neighborhood vulnerability (e.g., social 
vulnerability index)
    [cir] Volume of facility/hospital (high versus low)
    [cir] Type of facility/hospital (private versus public)
    [cir] Racial/ethnic concordance between provider and patient
    [cir] Language concordance between provider and patient
Timing
 Interventions and Comparators: Within 1 year after giving 
birth
 Outcome measurement: Up to 1 year after giving birth (except 
interpregnancy interval, unintended pregnancies, and chronic diseases 
[e.g., diabetes, hypertension], which can be later)
Settings
     U.S. only
     Outpatient care
     Exclude: Institutionalized settings (e.g., prisons)
Design
     Randomized controlled trials (N >=10 participants per 
group)
     Nonrandomized comparative studies, longitudinal 
(prospective or retrospective) or cross-sectional (N >=30 participants 
per group)
     Case-control studies (N >=30 participants per group)
     Exclude: Single-group (noncomparative) studies, 
comparative cross-sectional studies (without a discernable time-period 
between intervention and measurement of outcomes), qualitative studies

    Dated: March 7, 2022.
Marquita Cullom,
Associate Director.
[FR Doc. 2022-05141 Filed 3-10-22; 8:45 am]
BILLING CODE 4160-90-P