[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]


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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 Access to published and unpublished pertinent scientific 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: [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)
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             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.
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    Dated: August 18, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021-18125 Filed 8-23-21; 8:45 am]
BILLING CODE 4160-90-P