87 FR 215 pgs. 67478-67480 - Supplemental Evidence and Data Request on Respectful Maternity Care: Dissemination and Implementation of Perinatal Safety Culture To Improve Equitable Maternal Healthcare Delivery and Outcomes
Type: NOTICEVolume: 87Number: 215Pages: 67478 - 67480
Pages: 67478, 67479, 67480FR document: [FR Doc. 2022-24384 Filed 11-7-22; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Agency for Healthcare Research and Quality
Official PDF Version: PDF Version
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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.
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 Access to published and unpublished pertinent scientific information will improve the quality of this review.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: 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.
FOR FURTHER INFORMATION CONTACT:
Jenae Benns, Telephone: 301-427-1496 or Email: epc@ahrq.hhs.gov.
SUPPLEMENTARY INFORMATION:
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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:
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.
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.
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.
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?
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| Inclusion | Exclusion | |
|---|---|---|
| Population | KQ 1-4: Pregnant adolescents and adults admitted for labor through discharge after delivery Subgroups of interest: • KQ 3a and 4a: Disadvantaged individuals? a . | Non-pregnant populations. |
| 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 standard or no tool to measure RMC | No tool, measure, or comparison. |
| 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 | ||
| KQ 2: • RMC provider knowledge and/or practices. • Rates of procedures and interventions | ||
| KQ 3: • Health outcomes for pregnant persons. ? Maternal morbidity. ? Maternal mortality. ? Mental health outcomes. ? Function, quality of life, patient satisfaction using validated measures ? Mental health outcomes based on validated measures ( e.g., anxiety, depression) ? Harms | ||
| • Utilization outcomes for pregnant persons. ? Length of stay. ? Healthcare utilization post-discharge. ? Rates of procedures | ||
| KQ 4: • Health outcomes for infants. ? Infant morbidity. ? Infant mortality. ? Harms | ||
| • Utilization outcomes for infants. ? Length of stay. ? Healthcare utilization post-discharge | ||
| Timing | • Intervention: Admission for labor through discharge after delivery • Outcomes: from admission through one year postpartum | Interventions: before labor, during prenatal care. Outcomes: More than one year postpartum. |
| Settings | • KQ1, CQ: All countries in a hospital or birthing facility setting (eg, birth centers) | Home births. |
| • 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 and comparative nonrandomized), comparative observational studies | 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.
[FR Doc. 2022-24384 Filed 11-7-22; 8:45 am]
BILLING CODE 4160-90-P