[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]


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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 Access to published and unpublished 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: [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