Notice2022-24384
Supplemental Evidence and Data Request on Respectful Maternity Care: Dissemination and Implementation of Perinatal Safety Culture To Improve Equitable Maternal Healthcare Delivery and Outcomes
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Published
November 8, 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 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 Access to published and unpublished pertinent scientific information will improve the quality of this review.
Full Text
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<title>Federal Register, Volume 87 Issue 215 (Tuesday, November 8, 2022)</title>
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[Federal Register Volume 87, Number 215 (Tuesday, November 8, 2022)]
[Notices]
[Pages 67478-67480]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-24384]
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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: 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 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 Access to published and unpublished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: <a href="/cdn-cgi/l/email-protection#1673667556777e6467387e7e6538717960"><span class="__cf_email__" data-cfemail="caafbaa98aaba2b8bbe4a2a2b9e4ada5bc">[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#0164716241606973702f6969722f666e77"><span class="__cf_email__" data-cfemail="781d081b3819100a095610100b561f170e">[email protected]</span></a>.
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: <a href="https://effectivehealthcare.ahrq.gov/products/respectful-maternity-care/protocol">https://effectivehealthcare.ahrq.gov/products/respectful-maternity-care/protocol</a>.
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 <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 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 (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)
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Inclusion Exclusion
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Population......................... KQ 1-4: Pregnant adolescents and Non-pregnant populations.
adults admitted for labor through
discharge after delivery.
Subgroups of interest:...............
<bullet> 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.
<bullet> RMC as measured by a
validated tool.
[[Page 67480]]
KQ 2:
<bullet> RMC provider knowledge and/
or practices..
<bullet> Rates of procedures and
interventions.
KQ 3:
<bullet> 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..........................
<bullet> Utilization outcomes for
pregnant persons.
[cir] Length of stay.................
[cir] Healthcare utilization post-
discharge..
[cir] Rates of procedures............
KQ 4:
<bullet> Health outcomes for infants.
[cir] Infant morbidity...............
[cir] Infant mortality...............
[cir] Harms..........................
<bullet> Utilization outcomes for
infants.
[cir] Length of stay.................
[cir] Healthcare utilization post-
discharge.
Timing............................. <bullet> Intervention: Admission for Interventions: before labor, during
labor through discharge after prenatal care.
delivery. Outcomes: More than one year
<bullet> Outcomes: from admission postpartum.
through one year postpartum.
Settings........................... <bullet> KQ1, CQ: All countries in a Home births.
hospital or birthing facility
setting (eg, birth centers).
<bullet> KQ 2-4: hospital or birthing
facility in US or US relevant
countries.
<bullet> KQ 3c and 4c: hospital or
birthing facility in US or US
relevant countries.
Study designs and publication types <bullet> 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.
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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
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