Supplemental Evidence and Data Request on Schedule of Visits and Use of Telemedicine for Routine Antenatal Care, 47310-47312 [2021-18125]
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Federal Register / Vol. 86, No. 161 / Tuesday, August 24, 2021 / Notices
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[FR Doc. 2021–18198 Filed 8–23–21; 8:45 am]
BILLING CODE 6210–01–P
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Jkt 253001
Supplemental Evidence and Data
Request on Schedule of Visits and Use
of Telemedicine for Routine Antenatal
Care
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
Schedule of Visits and Use of
Telemedicine for Routine Antenatal
Care, 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Access to published and unpublished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 September 23, 2021.
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
Evidence-based Practice Centers (EPC)
Program to complete a review of the
evidence for Schedule of Visits and Use
of Telemedicine for Routine Antenatal
Care. 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
PO 00000
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Sfmt 4703
literature by requesting information
from the public (e.g., details of studies
conducted). We are looking for studies
that report on Schedule of Visits and
Use of Telemedicine for Routine
Antenatal Care, including those that
describe adverse events. The entire
research protocol is available online at:
https://effectivehealthcare.ahrq.gov/
products/schedule-visits-antenatal-care/
protocol.
This is to notify the public that the
EPC Program would find the following
information on Schedule of Visits and
Use of Telemedicine for Routine
Antenatal Care 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:
E:\FR\FM\24AUN1.SGM
24AUN1
Federal Register / Vol. 86, No. 161 / Tuesday, August 24, 2021 / Notices
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)
KQ 1: What are the benefits and harms
of different antenatal care schedules that
vary by number or timing of visits for
pregnancies requiring routine care and
monitoring?
47311
KQ 2: What are the benefits and harms
of telemedicine for providing routine
antenatal care during pregnancy?
KQ 3: What are patient, partner/
family, and provider perspectives,
preferences, and experiences related to
antenatal care visit schedules and use of
telemedicine for routine antenatal care?
PICOTS (POPULATION, INTERVENTION, COMPARATOR, OUTCOME, TIMING, SETTING)
Category
Definition
Population .......................................
KQ 1 & 2:
• Pregnant individuals receiving routine/standard/basic/traditional antenatal care.
• Allow studies of pregnant individuals at increased risk of poor outcomes (e.g., with gestational diabetes,
gestational hypertension, fetal growth restriction, those receiving part of their antenatal care by maternalfetal medicine [MFM] or other specialists), as long as the study pertains to their routine antenatal care
(i.e., not specifically to their enhanced care for their high-risk condition).
KQ3:
• Pregnant individuals.
• Postpartum individuals.
• Individuals considering or planning pregnancy.
• Partners/family.
• Providers of antenatal care (any profession or licensure).
Allow studies that include high-risk patients, as long as the interventions being assessed pertain to routine
care.
KQ1:
• Defined routine antenatal care schedules with focus on:
D Total number of planned visits.
D Overall schedule (timing, frequency, cadence).
D Number of planned in-person visits.
• Providers of routine antenatal visits include: Obstetricians/gynecologists, nurse practitioners, nurse midwives, nurses, physician assistants, family medicine clinicians.
• Include interventions designed to evaluate different types of providers (e.g., a nurse instead of a doctor)
if there is a concomitant comparison of different schedule of planned visits.
• Include interventions designed to evaluate group visits if the group visits replace individual visits and
there is a concomitant comparison of different schedule of planned visits.
• Include interventions designed to evaluate home visits if the home visits replace in-clinic visits and there
is a concomitant comparison of different schedule of planned visits.
KQ2:
• Antenatal care programs using telemedicine, including remote synchronous (real-time visits such as
video calls) and asynchronous interactions (e.g., portal email discussions).
Allow inclusion of devices designed to transmit information only if use of the devices are part of telemedicine interactions between patients and providers.
KQ3:
• Routine antenatal care, specific to interventions covered in KQ 1 and 2.
KQ1:
• Standard, routine, or alternative antenatal care schedule (as defined by the study).
KQ2:
• All in-person care, alternative telemedicine/remote care.
• No (explicit) comparator.
KQ3:
• Not applicable.
KQ1 & KQ2:
• Pregnancy complications:
D Maternal mortality.
D Antenatal pregnancy complications.
D Delivery-related complications.
• Other maternal health outcomes:
D Delivery outcomes.
D Inappropriate weight gain.
D Postpartum contraception—must be adjusted to account for patient preferences.
• Maternal psychosocial, preferences, and related outcomes:
D Quality of life measures.*
D Psychosocial measures.
D Mental health measures or diagnosis (e.g., anxiety, depression).*
D Patient satisfaction with antenatal care.*
D Patient preferences.
D Resources.
• Fetal/neonatal/infant outcomes:
D Delivery timing.
D Mortality.
D Perinatal morbidity (e.g., birth trauma).
Interventions ....................................
Comparators ...................................
lotter on DSK11XQN23PROD with NOTICES1
Outcomes (prioritized
have an asterisk).
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Federal Register / Vol. 86, No. 161 / Tuesday, August 24, 2021 / Notices
PICOTS (POPULATION, INTERVENTION, COMPARATOR, OUTCOME, TIMING, SETTING)—Continued
Category
Definition
Study Design ...................................
Timing .............................................
Setting .............................................
D Small for gestational age (e.g., birth weight <10% for similar age neonates),* low birth weight (e.g.,
<2.5 kg [5 lb, 8 oz]).*
D Abnormal Apgar score (threshold, e.g. <7).*
D Breastfeeding *—must be adjusted to account for patient preferences.
D Need for social services.
• Care utilization:
D Attendance at planned antenatal visits (adherence/compliance).
D Completion of ACOG recommended services.*
D Number of unplanned visits.*
D Number of referrals to other providers.
D Unplanned hospital admissions.
D Emergency room/triage visits.
D Neonatal intensive care unit [NICU] admissions */length of stay.
D Number of unplanned contacts (e.g., portal/phone messages).
• Provider outcomes:
D Provider satisfaction with antenatal care.
• Harms:
D Overdiagnosis (‘‘unnecessary’’ negative workups or misdiagnoses).
D Delayed diagnoses (e.g., gestational diabetes).*
D Harms to marginalized groups/equity outcomes.
KQ3:
• Perspectives and preferences related to interventions covered by KQ 1 and KQ 2.
• Barriers and facilitators related to interventions covered by KQ 1 and KQ 2.
KQ1 & KQ2:
• Comparative studies (comparisons of different interventions), including parallel design, pre-post studies,
and other comparisons.
D Randomized or observational (nonrandomized).
D Prospective or retrospective.
• Surveys that compare interventions (specifically for patient preferences and satisfaction).
• Registry (e.g., PRAMS [Pregnancy Risk Assessment Monitoring System], National family study) and
other retrospective data sources may be eligible, but only if the comparison is between different numbers of planned or scheduled visits (KQ1) or if there is a specific evaluation of telemedicine (KQ2).
• Single group studies (no direct comparison of interventions).
D Preference and satisfaction outcomes only.
• N ≥10 per intervention group.
• (Existing systematic reviews and guidelines will be used as sources of otherwise missed eligible studies).
KQ3:
• Qualitative studies.
• Interviews.
• Focus groups.
• Ethnographic studies.
• Surveys with open-ended questions amenable to qualitative analysis.
KQ1 & KQ2:
• Interventions: During antenatal period (excluding labor and delivery).
• Followup/Outcomes: Any (antenatal, peripartum, postpartum, or later).
KQ3:
• Any (as long as interventions of interest occurred during antenatal period).
All KQs:
• High income countries based on World Bank classifications.
• Outpatient care.
Dated: August 18, 2021.
Marquita Cullom,
Associate Director.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2021–18125 Filed 8–23–21; 8:45 am]
Agency for Healthcare Research and
Quality
BILLING CODE 4160–90–P
lotter on DSK11XQN23PROD with NOTICES1
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:
This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
SUMMARY:
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16:43 Aug 23, 2021
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that the Office of Management and
Budget (OMB) approve the renewal of
the information collection project
‘‘Medical Office Survey on Patient
Safety Culture Database.’’ This proposed
information collection was previously
published in the Federal Register on
May 3rd, 2021 and allowed 60 days for
public comment. AHRQ did not receive
any substantive comments from
members of the public. The purpose of
this notice is to allow an additional 30
days for public comment.
Comments on this notice must be
received by September 23, 2021.
DATES:
E:\FR\FM\24AUN1.SGM
24AUN1
]]>Agencies
[Federal Register Volume 86, Number 161 (Tuesday, August 24, 2021)]
[Notices]
[Pages 47310-47312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-18125]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Schedule of Visits and
Use of Telemedicine for Routine Antenatal Care
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 Schedule of
Visits and Use of Telemedicine for Routine Antenatal Care, 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 September 23, 2021.
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 Evidence-based Practice Centers (EPC)
Program to complete a review of the evidence for Schedule of Visits and
Use of Telemedicine for Routine Antenatal Care. 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 Schedule of Visits and Use of Telemedicine for Routine
Antenatal Care, including those that describe adverse events. The
entire research protocol is available online at: https://effectivehealthcare.ahrq.gov/products/schedule-visits-antenatal-care/protocol.
This is to notify the public that the EPC Program would find the
following information on Schedule of Visits and Use of Telemedicine for
Routine Antenatal Care 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:
[[Page 47311]]
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)
KQ 1: What are the benefits and harms of different antenatal care
schedules that vary by number or timing of visits for pregnancies
requiring routine care and monitoring?
KQ 2: What are the benefits and harms of telemedicine for providing
routine antenatal care during pregnancy?
KQ 3: What are patient, partner/family, and provider perspectives,
preferences, and experiences related to antenatal care visit schedules
and use of telemedicine for routine antenatal care?
PICOTS (Population, Intervention, Comparator, Outcome, Timing, Setting)
------------------------------------------------------------------------
Category Definition
------------------------------------------------------------------------
Population........................ KQ 1 & 2:
Pregnant individuals
receiving routine/standard/basic/
traditional antenatal care.
Allow studies of pregnant
individuals at increased risk of
poor outcomes (e.g., with
gestational diabetes, gestational
hypertension, fetal growth
restriction, those receiving part
of their antenatal care by maternal-
fetal medicine [MFM] or other
specialists), as long as the study
pertains to their routine antenatal
care (i.e., not specifically to
their enhanced care for their high-
risk condition).
KQ3:
Pregnant individuals.
Postpartum individuals.
Individuals considering or
planning pregnancy.
Partners/family.
Providers of antenatal care
(any profession or licensure).
Allow studies that include high-risk
patients, as long as the
interventions being assessed
pertain to routine care.
Interventions..................... KQ1:
Defined routine antenatal
care schedules with focus on:
[ssquf] Total number of planned
visits.
[ssquf] Overall schedule (timing,
frequency, cadence).
[ssquf] Number of planned in-
person visits.
Providers of routine
antenatal visits include:
Obstetricians/gynecologists, nurse
practitioners, nurse midwives,
nurses, physician assistants,
family medicine clinicians.
Include interventions
designed to evaluate different
types of providers (e.g., a nurse
instead of a doctor) if there is a
concomitant comparison of different
schedule of planned visits.
Include interventions
designed to evaluate group visits
if the group visits replace
individual visits and there is a
concomitant comparison of different
schedule of planned visits.
Include interventions
designed to evaluate home visits if
the home visits replace in-clinic
visits and there is a concomitant
comparison of different schedule of
planned visits.
KQ2:
Antenatal care programs
using telemedicine, including
remote synchronous (real-time
visits such as video calls) and
asynchronous interactions (e.g.,
portal email discussions).
Allow inclusion of devices designed
to transmit information only if use
of the devices are part of
telemedicine interactions between
patients and providers.
KQ3:
Routine antenatal care,
specific to interventions covered
in KQ 1 and 2.
Comparators....................... KQ1:
Standard, routine, or
alternative antenatal care schedule
(as defined by the study).
KQ2:
All in-person care,
alternative telemedicine/remote
care.
No (explicit) comparator.
KQ3:
Not applicable.
Outcomes (prioritized outcomes KQ1 & KQ2:
have an asterisk). Pregnancy complications:
[ssquf] Maternal mortality.
[ssquf] Antenatal pregnancy
complications.
[ssquf] Delivery-related
complications.
Other maternal health
outcomes:
[ssquf] Delivery outcomes.
[ssquf] Inappropriate weight
gain.
[ssquf] Postpartum contraception--
must be adjusted to account for
patient preferences.
Maternal psychosocial,
preferences, and related outcomes:
[ssquf] Quality of life
measures.*
[ssquf] Psychosocial measures.
[ssquf] Mental health measures or
diagnosis (e.g., anxiety,
depression).*
[ssquf] Patient satisfaction with
antenatal care.*
[ssquf] Patient preferences.
[ssquf] Resources.
Fetal/neonatal/infant
outcomes:
[ssquf] Delivery timing.
[ssquf] Mortality.
[ssquf] Perinatal morbidity
(e.g., birth trauma).
[[Page 47312]]
[ssquf] Small for gestational age
(e.g., birth weight <10% for
similar age neonates),* low
birth weight (e.g., <2.5 kg [5
lb, 8 oz]).*
[ssquf] Abnormal Apgar score
(threshold, e.g. <7).*
[ssquf] Breastfeeding *--must be
adjusted to account for patient
preferences.
[ssquf] Need for social services.
Care utilization:
[ssquf] Attendance at planned
antenatal visits (adherence/
compliance).
[ssquf] Completion of ACOG
recommended services.*
[ssquf] Number of unplanned
visits.*
[ssquf] Number of referrals to
other providers.
[ssquf] Unplanned hospital
admissions.
[ssquf] Emergency room/triage
visits.
[ssquf] Neonatal intensive care
unit [NICU] admissions */length
of stay.
[ssquf] Number of unplanned
contacts (e.g., portal/phone
messages).
Provider outcomes:
[ssquf] Provider satisfaction
with antenatal care.
Harms:
[ssquf] Overdiagnosis
(``unnecessary'' negative
workups or misdiagnoses).
[ssquf] Delayed diagnoses (e.g.,
gestational diabetes).*
[ssquf] Harms to marginalized
groups/equity outcomes.
KQ3:
Perspectives and
preferences related to
interventions covered by KQ 1 and
KQ 2.
Barriers and facilitators
related to interventions covered by
KQ 1 and KQ 2.
Study Design...................... KQ1 & KQ2:
Comparative studies
(comparisons of different
interventions), including parallel
design, pre-post studies, and other
comparisons.
[ssquf] Randomized or
observational (nonrandomized).
[ssquf] Prospective or
retrospective.
Surveys that compare
interventions (specifically for
patient preferences and
satisfaction).
Registry (e.g., PRAMS
[Pregnancy Risk Assessment
Monitoring System], National family
study) and other retrospective data
sources may be eligible, but only
if the comparison is between
different numbers of planned or
scheduled visits (KQ1) or if there
is a specific evaluation of
telemedicine (KQ2).
Single group studies (no
direct comparison of
interventions).
[ssquf] Preference and
satisfaction outcomes only.
N >=10 per intervention
group.
(Existing systematic
reviews and guidelines will be used
as sources of otherwise missed
eligible studies).
KQ3:
Qualitative studies.
Interviews.
Focus groups.
Ethnographic studies.
Surveys with open-ended
questions amenable to qualitative
analysis.
Timing............................ KQ1 & KQ2:
Interventions: During
antenatal period (excluding labor
and delivery).
Followup/Outcomes: Any
(antenatal, peripartum, postpartum,
or later).
KQ3:
Any (as long as
interventions of interest occurred
during antenatal period).
Setting........................... All KQs:
High income countries based
on World Bank classifications.
Outpatient care.
------------------------------------------------------------------------
Dated: August 18, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021-18125 Filed 8-23-21; 8:45 am]
BILLING CODE 4160-90-P
