Notice2022-05141
Supplemental Evidence and Data Request on Postpartum Care for Women Up to One Year After Pregnancy
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 11, 2022
Issuing agencies
Health and Human Services DepartmentAgency for Healthcare Research and Quality
Abstract
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 Access to published and unpublished pertinent scientific information will improve the quality of this review.
Full Text
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<title>Federal Register, Volume 87 Issue 48 (Friday, March 11, 2022)</title>
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[Federal Register Volume 87, Number 48 (Friday, March 11, 2022)]
[Notices]
[Pages 14011-14014]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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Access to published and unpublished pertinent scientific information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: <a href="/cdn-cgi/l/email-protection#1673667556777e6467387e7e6538717960"><span class="__cf_email__" data-cfemail="cfaabfac8faea7bdbee1a7a7bce1a8a0b9">[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#0c697c6f4c6d647e7d2264647f226b637a"><span class="__cf_email__" data-cfemail="f3968390b3929b8182dd9b9b80dd949c85">[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 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: <a href="https://effectivehealthcare.ahrq.gov/products/postpartum-care-one-year/protocol">https://effectivehealthcare.ahrq.gov/products/postpartum-care-one-year/protocol</a>.
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 <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> along with the
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> trial number.
[ssquf] For completed studies that do not have results on
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>, 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
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> 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: <a href="https://www.effectivehealthcare.ahrq.gov/email-updates">https://www.effectivehealthcare.ahrq.gov/email-updates</a>.
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
<bullet> 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).
<bullet> 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)
<bullet> 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\
<bullet> 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
<bullet> 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)
<bullet> 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
<bullet> 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
<bullet> How healthcare is delivered--e.g., dedicated postpartum care
visit, as part of well-child visit, group visit
<bullet> When healthcare is delivered--e.g., timing before giving
birth, after giving birth, or at postpartum visits
<bullet> 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
<bullet> 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
<bullet> 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
<bullet> 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)
<bullet> 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
<bullet> Standard delivery strategy
<bullet> Alternative delivery strategy
Outcomes (* and bold font denotes important outcomes that will be
used when developing Strength of Evidence tables)
<bullet> 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 *
<bullet> 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)
<bullet> Harms
[cir] Health inequities *
[cir] Perceived discrimination *
[cir] Over-utilization of healthcare
[cir] Patient burden regarding postpartum care
Potential Effect Modifiers
<bullet> 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)
<bullet> 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
<bullet> 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).
<bullet> 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
<bullet> High-income countries (as classified by the World Bank--see
<a href="https://datahelpdesk.worldbank.org/knowledgebase/articles/906519-world-bank-country-and-lending-groups">https://datahelpdesk.worldbank.org/knowledgebase/articles/906519-world-bank-country-and-lending-groups</a>)
<bullet> Outpatient care
<bullet> Exclude: Institutionalized settings (e.g., prisons)
Design
<bullet> Randomized controlled trials (N >=10 participants per group)
<bullet> Nonrandomized comparative studies, longitudinal (prospective
or retrospective) (N >=30 participants per group)
<bullet> Case-control studies (N >=30 participants per group)
<bullet> 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
<bullet> 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).
<bullet> 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)
<bullet> 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
<bullet> More comprehensive insurance coverage
<bullet> Extended duration of insurance coverage
<bullet> More continuous insurance coverage
<bullet> 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
<bullet> Less comprehensive level of or no insurance coverage
<bullet> Less continuous insurance coverage
<bullet> 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)
<bullet> 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 *
<bullet> 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)
<bullet> Harms
[cir] Health inequities *
[cir] Perceived discrimination *
[cir] Over-utilization of healthcare
[cir] Patient burden regarding postpartum care
Potential Effect Modifiers
<bullet> 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)
<bullet> 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
<bullet> Interventions and Comparators: Within 1 year after giving
birth
<bullet> 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
<bullet> U.S. only
<bullet> Outpatient care
<bullet> Exclude: Institutionalized settings (e.g., prisons)
Design
<bullet> Randomized controlled trials (N >=10 participants per
group)
<bullet> Nonrandomized comparative studies, longitudinal
(prospective or retrospective) or cross-sectional (N >=30 participants
per group)
<bullet> Case-control studies (N >=30 participants per group)
<bullet> 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
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