Notice2021-18125
Supplemental Evidence and Data Request on Schedule of Visits and Use of Telemedicine for Routine Antenatal Care
Primary source
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Published
August 24, 2021
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 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 Access to published and unpublished pertinent scientific information will improve the quality of this review.
Full Text
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<title>Federal Register, Volume 86 Issue 161 (Tuesday, August 24, 2021)</title>
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[Federal Register Volume 86, Number 161 (Tuesday, August 24, 2021)]
[Notices]
[Pages 47310-47312]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-18125]
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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.
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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 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 Access to published and unpublished pertinent scientific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: <a href="/cdn-cgi/l/email-protection#ed889d8ead8c859f9cc385859ec38a829b"><span class="__cf_email__" data-cfemail="afcadfccefcec7ddde81c7c7dc81c8c0d9">[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#2d485d4e6d4c455f5c0345455e034a425b"><span class="__cf_email__" data-cfemail="1a7f6a795a7b72686b34727269347d756c">[email protected]</span></a>.
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: <a href="https://effectivehealthcare.ahrq.gov/products/schedule-visits-antenatal-care/protocol">https://effectivehealthcare.ahrq.gov/products/schedule-visits-antenatal-care/protocol</a>.
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 <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:
[[Page 47311]]
<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)
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)
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Category Definition
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Population........................ KQ 1 & 2:
<bullet> Pregnant individuals
receiving routine/standard/basic/
traditional antenatal care.
<bullet> 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:
<bullet> Pregnant individuals.
<bullet> Postpartum individuals.
<bullet> Individuals considering or
planning pregnancy.
<bullet> Partners/family.
<bullet> 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:
<bullet> 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.
<bullet> Providers of routine
antenatal visits include:
Obstetricians/gynecologists, nurse
practitioners, nurse midwives,
nurses, physician assistants,
family medicine clinicians.
<bullet> 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.
<bullet> 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.
<bullet> 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:
<bullet> 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:
<bullet> Routine antenatal care,
specific to interventions covered
in KQ 1 and 2.
Comparators....................... KQ1:
<bullet> Standard, routine, or
alternative antenatal care schedule
(as defined by the study).
KQ2:
<bullet> All in-person care,
alternative telemedicine/remote
care.
<bullet> No (explicit) comparator.
KQ3:
<bullet> Not applicable.
Outcomes (prioritized outcomes KQ1 & KQ2:
have an asterisk). <bullet> Pregnancy complications:
[ssquf] Maternal mortality.
[ssquf] Antenatal pregnancy
complications.
[ssquf] Delivery-related
complications.
<bullet> Other maternal health
outcomes:
[ssquf] Delivery outcomes.
[ssquf] Inappropriate weight
gain.
[ssquf] Postpartum contraception--
must be adjusted to account for
patient preferences.
<bullet> 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.
<bullet> 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.
<bullet> 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).
<bullet> Provider outcomes:
[ssquf] Provider satisfaction
with antenatal care.
<bullet> Harms:
[ssquf] Overdiagnosis
(``unnecessary'' negative
workups or misdiagnoses).
[ssquf] Delayed diagnoses (e.g.,
gestational diabetes).*
[ssquf] Harms to marginalized
groups/equity outcomes.
KQ3:
<bullet> Perspectives and
preferences related to
interventions covered by KQ 1 and
KQ 2.
<bullet> Barriers and facilitators
related to interventions covered by
KQ 1 and KQ 2.
Study Design...................... KQ1 & KQ2:
<bullet> Comparative studies
(comparisons of different
interventions), including parallel
design, pre-post studies, and other
comparisons.
[ssquf] Randomized or
observational (nonrandomized).
[ssquf] Prospective or
retrospective.
<bullet> Surveys that compare
interventions (specifically for
patient preferences and
satisfaction).
<bullet> 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).
<bullet> Single group studies (no
direct comparison of
interventions).
[ssquf] Preference and
satisfaction outcomes only.
<bullet> N >=10 per intervention
group.
<bullet> (Existing systematic
reviews and guidelines will be used
as sources of otherwise missed
eligible studies).
KQ3:
<bullet> Qualitative studies.
<bullet> Interviews.
<bullet> Focus groups.
<bullet> Ethnographic studies.
<bullet> Surveys with open-ended
questions amenable to qualitative
analysis.
Timing............................ KQ1 & KQ2:
<bullet> Interventions: During
antenatal period (excluding labor
and delivery).
<bullet> Followup/Outcomes: Any
(antenatal, peripartum, postpartum,
or later).
KQ3:
<bullet> Any (as long as
interventions of interest occurred
during antenatal period).
Setting........................... All KQs:
<bullet> High income countries based
on World Bank classifications.
<bullet> 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
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