Supplemental Evidence and Data Request on Respectful Maternity Care: Dissemination and Implementation of Perinatal Safety Culture To Improve Equitable Maternal Healthcare Delivery and Outcomes, 67478-67480 [2022-24384]
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[FR Doc. 2022–24372 Filed 11–7–22; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Respectful Maternity Care:
Dissemination and Implementation of
Perinatal Safety Culture To Improve
Equitable Maternal Healthcare Delivery
and Outcomes
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
Respectful Maternity Care:
Dissemination and Implementation of
Perinatal Safety Culture to Improve
Equitable Maternal Healthcare Delivery
and Outcomes, which is currently being
conducted by the AHRQ’s Evidencebased 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Access to published and unpublished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 December 8, 2022.
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 06E77D, Rockville, MD
20857.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Jenae Benns, Telephone: 301–427–1496
or Email: epc@ahrq.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency for Healthcare Research and
Quality has commissioned the
E:\FR\FM\08NON1.SGM
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Federal Register / Vol. 87, No. 215 / Tuesday, November 8, 2022 / Notices
Evidence-based Practice Center (EPC)
Program to complete a review of the
evidence for Respectful Maternity Care:
Dissemination and Implementation of
Perinatal Safety Culture to Improve
Equitable Maternal Healthcare Delivery
and Outcomes. 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 Respectful Maternity
Care: Dissemination and
Implementation of Perinatal Safety
Culture to Improve Equitable Maternal
Healthcare Delivery and Outcomes,
including those that describe adverse
events. The entire research protocol is
available online at: https://effective
healthcare.ahrq.gov/products/
respectful-maternity-care/protocol.
This is to notify the public that the
EPC Program would find the following
information on Respectful Maternity
Care: Dissemination and
Implementation of Perinatal Safety
Culture to Improve Equitable Maternal
Healthcare Delivery and Outcomes
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 (KQs)
KQ1. Which components of
Respectful Maternity Care (RMC) have
been examined using validated
measures? Are there validated tools to
measure RMC?
KQ2. What is the effectiveness of
strategies to implement RMC?
KQ3. What is the effectiveness of
RMCe on maternal health and
utilization outcomes?
a. How does effectiveness vary among
disadvantaged pregnant persons?
b. Which components of RMC are
associated with effectiveness?
c. Which (non-patient) factors are
associated with effectiveness?
KQ4. What is the effectiveness of
RMC on infant health outcomes?
a. How does effectiveness vary among
infants of disadvantaged pregnant
persons?
b. Which components of RMC are
associated with effectiveness?
c. Which (non-patient) factors are
associated with effectiveness?
For KQ 3a and 4a, ‘disadvantaged
pregnant persons’ may be defined by
geography, race/ethnicity, age,
disability, language, education, SES,
etc., as described in Cochrane’s
PROGRESS-Plus framework.1 In KQ 3c
and 4c, ‘non-patient factors’ could be
related to setting (type of hospital, rural/
urban, staffing ratios) or intervention
characteristics.
Contextual Question (CQ)
CQ1. How is RMC during labor and
delivery, and the immediate postpartum
period defined in the literature? Does
the literature define the essential/
critical components of RMC? For
example, is teamwork and
communication (amongst providers,
staff, patients and families) an essential
element of RMC?
PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, AND SETTINGS)
Inclusion
Population ................
lotter on DSK11XQN23PROD with NOTICES1
Interventions .............
Comparators .............
Outcomes .................
VerDate Sep<11>2014
Exclusion
KQ 1–4: Pregnant adolescents and adults admitted for
labor through discharge after delivery.
Subgroups of interest:
• KQ 3a and 4a: Disadvantaged individuals a.
KQ 1: Validated measures of RMC ......................................
KQ 2: Implementation strategies for RMC (e.g., patient/provider education, policies, payment, doula/patient advocate, practice facilitation).
KQ 3–4: RMC (any definition).
KQ 3b and 4b: Specific component of RMC.
KQ 1: Other tool(s), reference/gold standard or no tool to
measure RMC.
KQ 2: Other implementation strategies for RMC.
KQ 3–4: Routine maternity care.
Absence of a specific RMC component.
KQ 1:
• RMC as measured by a validated tool.
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67479
Non-pregnant populations.
Non-validated RMC measures.
No tool, measure, or comparison.
KQ4: Infant health outcomes >1 year.
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67480
Federal Register / Vol. 87, No. 215 / Tuesday, November 8, 2022 / Notices
PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, AND SETTINGS)—Continued
Inclusion
Timing .......................
Settings ....................
Study designs and
publication types.
Exclusion
KQ 2:
• RMC provider knowledge and/or practices.
• Rates of procedures and interventions.
KQ 3:
• Health outcomes for pregnant persons.
Æ Maternal morbidity.
Æ Maternal mortality.
Æ Mental health outcomes.
Æ Function, quality of life, patient satisfaction using
validated measures.
Æ Mental health outcomes based on validated measures (e.g., anxiety, depression).
Æ Harms.
• Utilization outcomes for pregnant persons.
Æ Length of stay.
Æ Healthcare utilization post-discharge.
Æ Rates of procedures.
KQ 4:
• Health outcomes for infants.
Æ Infant morbidity.
Æ Infant mortality.
Æ Harms.
• Utilization outcomes for infants.
Æ Length of stay.
Æ Healthcare utilization post-discharge.
• Intervention: Admission for labor through discharge after
delivery.
• Outcomes: from admission through one year postpartum
• KQ1, CQ: All countries in a hospital or birthing facility
setting (eg, birth centers).
• KQ 2–4: hospital or birthing facility in US or US relevant
countries.
• KQ 3c and 4c: hospital or birthing facility in US or US
relevant countries.
• KQ1–4: Trials (randomized and comparative nonrandomized), comparative observational studies.
Interventions: before labor, during prenatal care.
Outcomes: More than one year postpartum.
Home births.
KQ 1: Studies that do not describe psychometric properties/methods of determining validity of measures or
components.
KQ2–4: Case reports, case series (or similar single-arm
designs).
Publication types: Conference abstracts or proceedings,
editorials, letters, white papers, citations that have not
been peer-reviewed, single site reports of multi-site studies.
Abbreviations: CQ, contextual question; KQ, key question; RMC, respectful maternity care.
‘‘Disadvantaged persons’’ as defined by PROGRESS-plus framework.1
Reference
1. O’Neill J, Tabish H, Welch V, et al.
Applying an equity lens to interventions:
using PROGRESS ensures consideration
of socially stratifying factors to
illuminate inequities in health. J Clin
Epidemiol. 2014 Jan;67(1):56–64. doi:
10.1016/j.jclinepi.2013.08.005. PMID:
24189091.
Dated: November 2, 2022.
Marquita Cullom,
Associate Director.
lotter on DSK11XQN23PROD with NOTICES1
[FR Doc. 2022–24384 Filed 11–7–22; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Notice of Closed Meeting
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended, and the Determination of
the Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, CDC, pursuant to
Public Law 92–463.
PO 00000
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Name of Committee: Safety and
Occupational Health Study Section (SOHSS),
National Institute for Occupational Safety
and Health (NIOSH).
Dates: February 7–8, 2023.
Times: 11:00 a.m.–5:00 p.m., EST.
Place: Teleconference.
Agenda: The meeting will convene to
address matters related to the conduct of
Study Section business and for the Study
Section to consider safety and occupational
health-related grant applications.
For Further Information Contact: Michael
Goldcamp, Ph.D., Scientific Review Officer,
NIOSH, 1095 Willowdale Road, Morgantown,
West Virginia 26506; Telephone: (304) 285–
5951; Email: MGoldcamp@cdc.gov.
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
E:\FR\FM\08NON1.SGM
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]]>Agencies
[Federal Register Volume 87, Number 215 (Tuesday, November 8, 2022)]
[Notices]
[Pages 67478-67480]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-24384]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Respectful Maternity
Care: Dissemination and Implementation of Perinatal Safety Culture To
Improve Equitable Maternal Healthcare Delivery and Outcomes
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 Respectful
Maternity Care: Dissemination and Implementation of Perinatal Safety
Culture to Improve Equitable Maternal Healthcare Delivery and Outcomes,
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 December 8, 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
[[Page 67479]]
Evidence-based Practice Center (EPC) Program to complete a review of
the evidence for Respectful Maternity Care: Dissemination and
Implementation of Perinatal Safety Culture to Improve Equitable
Maternal Healthcare Delivery and Outcomes. 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 Respectful Maternity Care: Dissemination and
Implementation of Perinatal Safety Culture to Improve Equitable
Maternal Healthcare Delivery and Outcomes, including those that
describe adverse events. The entire research protocol is available
online at: https://effectivehealthcare.ahrq.gov/products/respectful-maternity-care/protocol.
This is to notify the public that the EPC Program would find the
following information on Respectful Maternity Care: Dissemination and
Implementation of Perinatal Safety Culture to Improve Equitable
Maternal Healthcare Delivery and Outcomes 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)
KQ1. Which components of Respectful Maternity Care (RMC) have been
examined using validated measures? Are there validated tools to measure
RMC?
KQ2. What is the effectiveness of strategies to implement RMC?
KQ3. What is the effectiveness of RMCe on maternal health and
utilization outcomes?
a. How does effectiveness vary among disadvantaged pregnant
persons?
b. Which components of RMC are associated with effectiveness?
c. Which (non-patient) factors are associated with effectiveness?
KQ4. What is the effectiveness of RMC on infant health outcomes?
a. How does effectiveness vary among infants of disadvantaged
pregnant persons?
b. Which components of RMC are associated with effectiveness?
c. Which (non-patient) factors are associated with effectiveness?
For KQ 3a and 4a, `disadvantaged pregnant persons' may be defined
by geography, race/ethnicity, age, disability, language, education,
SES, etc., as described in Cochrane's PROGRESS-Plus framework.\1\ In KQ
3c and 4c, `non-patient factors' could be related to setting (type of
hospital, rural/urban, staffing ratios) or intervention
characteristics.
Contextual Question (CQ)
CQ1. How is RMC during labor and delivery, and the immediate
postpartum period defined in the literature? Does the literature define
the essential/critical components of RMC? For example, is teamwork and
communication (amongst providers, staff, patients and families) an
essential element of RMC?
PICOTS (Populations, Interventions, Comparators, Outcomes, and Settings)
----------------------------------------------------------------------------------------------------------------
Inclusion Exclusion
----------------------------------------------------------------------------------------------------------------
Population......................... KQ 1-4: Pregnant adolescents and Non-pregnant populations.
adults admitted for labor through
discharge after delivery.
Subgroups of interest:...............
KQ 3a and 4a: Disadvantaged
individuals \a\..
Interventions...................... KQ 1: Validated measures of RMC...... Non-validated RMC measures.
KQ 2: Implementation strategies for
RMC (e.g., patient/provider
education, policies, payment, doula/
patient advocate, practice
facilitation).
KQ 3-4: RMC (any definition).........
KQ 3b and 4b: Specific component of
RMC.
Comparators........................ KQ 1: Other tool(s), reference/gold No tool, measure, or comparison.
standard or no tool to measure RMC.
KQ 2: Other implementation strategies
for RMC.
KQ 3-4: Routine maternity care.......
Absence of a specific RMC component..
Outcomes........................... KQ 1: KQ4: Infant health outcomes >1 year.
RMC as measured by a
validated tool.
[[Page 67480]]
KQ 2:
RMC provider knowledge and/
or practices..
Rates of procedures and
interventions.
KQ 3:
Health outcomes for pregnant
persons..
[cir] Maternal morbidity.............
[cir] Maternal mortality.............
[cir] Mental health outcomes.........
[cir] Function, quality of life,
patient satisfaction using validated
measures.
[cir] Mental health outcomes based on
validated measures (e.g., anxiety,
depression).
[cir] Harms..........................
Utilization outcomes for
pregnant persons.
[cir] Length of stay.................
[cir] Healthcare utilization post-
discharge..
[cir] Rates of procedures............
KQ 4:
Health outcomes for infants.
[cir] Infant morbidity...............
[cir] Infant mortality...............
[cir] Harms..........................
Utilization outcomes for
infants.
[cir] Length of stay.................
[cir] Healthcare utilization post-
discharge.
Timing............................. Intervention: Admission for Interventions: before labor, during
labor through discharge after prenatal care.
delivery. Outcomes: More than one year
Outcomes: from admission postpartum.
through one year postpartum.
Settings........................... KQ1, CQ: All countries in a Home births.
hospital or birthing facility
setting (eg, birth centers).
KQ 2-4: hospital or birthing
facility in US or US relevant
countries.
KQ 3c and 4c: hospital or
birthing facility in US or US
relevant countries.
Study designs and publication types KQ1-4: Trials (randomized KQ 1: Studies that do not describe
and comparative nonrandomized), psychometric properties/methods of
comparative observational studies. determining validity of measures or
components.
KQ2-4: Case reports, case series (or
similar single-arm designs).
Publication types: Conference
abstracts or proceedings,
editorials, letters, white papers,
citations that have not been peer-
reviewed, single site reports of
multi-site studies.
----------------------------------------------------------------------------------------------------------------
Abbreviations: CQ, contextual question; KQ, key question; RMC, respectful maternity care.
``Disadvantaged persons'' as defined by PROGRESS-plus framework.\1\
Reference
1. O'Neill J, Tabish H, Welch V, et al. Applying an equity lens to
interventions: using PROGRESS ensures consideration of socially
stratifying factors to illuminate inequities in health. J Clin
Epidemiol. 2014 Jan;67(1):56-64. doi: 10.1016/
j.jclinepi.2013.08.005. PMID: 24189091.
Dated: November 2, 2022.
Marquita Cullom,
Associate Director.
[FR Doc. 2022-24384 Filed 11-7-22; 8:45 am]
BILLING CODE 4160-90-P
