[Federal Register Volume 87, Number 60 (Tuesday, March 29, 2022)]
[Notices]
[Pages 18018-18021]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06532]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Postpartum Home Blood 
Pressure Monitoring, Postpartum Treatment of Hypertensive Disorders of 
Pregnancy, and Peripartum Magnesium Sulfate Regimens for Preeclampsia 
With Severe Features

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 Postpartum Home 
Blood Pressure Monitoring, Postpartum Treatment of Hypertensive 
Disorders of Pregnancy, and Peripartum Magnesium Sulfate Regimens for 
Preeclampsia With Severe Features, 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published and unpublished pertinent scientific information will improve 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 April 28, 2022.

ADDRESSES:
    Email submissions: <a href="/cdn-cgi/l/email-protection#8aeffae9caebe2f8fba4e2e2f9a4ede5fc"><span class="__cf_email__" data-cfemail="f5908596b5949d8784db9d9d86db929a83">[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#5237223112333a20237c3a3a217c353d24"><span class="__cf_email__" data-cfemail="781d081b3819100a095610100b561f170e">[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 Postpartum Home Blood 
Pressure Monitoring, Postpartum Treatment of Hypertensive Disorders of 
Pregnancy, and Peripartum Magnesium Sulfate Regimens for Preeclampsia 
With Severe Features. 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 Postpartum Home Blood Pressure Monitoring, Postpartum 
Treatment of Hypertensive Disorders of Pregnancy, and Peripartum 
Magnesium Sulfate Regimens for Preeclampsia With Severe Features, 
including those that describe adverse events. The entire research 
protocol is available online at: https://effectivehealthcare.ahrq.gov/products/hypertensive-disorders-pregnancy/protocol.
    This is to notify the public that the EPC Program would find the 
following information on Postpartum Home Blood Pressure Monitoring, 
Postpartum Treatment of Hypertensive Disorders of Pregnancy, and 
Peripartum Magnesium Sulfate Regimens for Preeclampsia With Severe 
Features 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.

[[Page 18019]]

Key Questions (KQ)

    KQ 1: What are the effectiveness, comparative effectiveness, and 
harms of home blood pressure monitoring/telemonitoring in postpartum 
individuals?
    KQ 2: What are the effectiveness, comparative effectiveness, and 
harms of pharmacological treatments for hypertensive disorders of 
pregnancy in postpartum individuals?
    KQ 3: What are the comparative effectiveness and harms of 
alternative magnesium sulfate (MgSO<INF>4</INF>) treatment regimens to 
treat preeclampsia with severe features during the peripartum period?
    3.a. Are there harms associated with the concomitant use of 
particular antihypertensive medications during treatment with 
MgSO<INF>4</INF>?
    For all Key Questions, how do the findings vary by race, ethnicity, 
HDP subgroup, maternal age, parity, singleton/multiple pregnancies, 
mode of delivery, co-occurring conditions (e.g., obesity), and social 
determinants of health (e.g., postpartum insurance coverage, English 
proficiency, income, educational attainment)?

Contextual Question (CQ)

    CQ 1: How are race, ethnicity, and social determinants of health 
related to disparities associated with incidence of HDP, detection, 
access to care, management, followup care, and clinical outcomes in 
individuals with postpartum hypertensive disorders of pregnancy?

Study Eligibility Criteria

Key Question 1 (Home BP Monitoring)

Population
<bullet> Postpartum individuals (with or without a prior HDP diagnosis)
Modifiers/Subgroups of Interest
<bullet> Subgroups defined by ACOG HDP classification (some of which 
may arise de novo in the postpartum period)
    [cir] chronic HTN
    [cir] gestational HTN
    [cir] preeclampsia (may be superimposed on chronic HTN)
    [cir] preeclampsia with severe features (as defined by study 
authors)
    [cir] de novo HTN postpartum
<bullet> Subgroups defined by BP diagnostic threshold(s)
<bullet> Race, ethnicity
<bullet> Maternal age, parity, singleton/multiple pregnancy, delivery 
(e.g., cesarean versus vaginal delivery, preterm versus term)
<bullet> Co-occurring disorders (e.g., obesity, diabetes)
<bullet> Subgroups defined by potential indicators of social 
determinants of health (e.g., insurance coverage, English proficiency, 
income, educational attainment)
<bullet> Access to technology (e.g., broadband internet, smartphone)
Interventions and Intervention Components
<bullet> Postpartum home BP monitoring interventions
    [cir] Electronic, digital monitors, any
    [cir] With or without web-based connectivity and communication
    [cir] With or without education or training in use of monitor
    [cir] With or without validation of accuracy of patient's monitor
<bullet> Exclude: Ambulatory BP monitoring (e.g.,24- or 48-hour 
continuous monitoring)
<bullet> Exclude: Monitors with manual inflation and auscultation
<bullet> Exclude: BP monitoring only by third parties, such as home 
health aides, visiting nurses
<bullet> Exclude: Very limited use of monitoring (e.g., single reading 
or single day)
<bullet> Exclude: Use of device only in laboratory or clinic setting
Comparators
<bullet> No home BP monitoring (e.g., usual care with clinic-only BP 
monitoring)
<bullet> Alternative non-clinic-based BP monitoring approaches (e.g., 
kiosks, pharmacy-based BP monitoring, home health aide visits)
<bullet> Alternative education modalities about self-monitoring BP 
(e.g., demonstration of correct use, confirmation of appropriate cuff 
size)
<bullet> Alternative home BP monitor characteristics (e.g., direct 
transmission of results, prompts for communication of symptoms)
<bullet> Alternative home BP monitoring regimen (e.g., BP measurement 
frequency, duration)
<bullet> Alternative instructions for when to communicate results 
immediately (e.g., different BP threshold alerts)
<bullet> Alternative mode of communicating results (e.g., during clinic 
visit, automatic web-based, via text/email/portal/phone)
<bullet> Alternative clinician feedback processes
<bullet> No use of validation of accuracy of patient's monitor
Outcomes (prioritized outcomes have an asterisk and are in bold font)
<bullet> Blood pressure
    [cir] Ascertainment of elevated BP or new onset HDP *
    [ssquf] Time to clinical recognition of elevated BP
    [cir] Treatment *
    [ssquf] Initiation or discontinuation of antihypertensive 
medications
    [ssquf] Increase or decrease in dose (or number) of 
antihypertensive medications
    [ssquf] BP control (e.g., BP normalization)
    [cir] Documentation of BP after discharge
    [cir] Recognition of white coat HTN
<bullet> Severe maternal outcomes
    [cir] Maternal mortality, including pregnancy-related mortality *
    [cir] Severe maternal morbidity * (e.g., stroke *, eclampsia, 
pulmonary edema)
<bullet> Patient reported outcomes
    [cir] Patient reported experience measures (PREMs) for example
    [ssquf] Satisfaction with postpartum care *
    [ssquf] Ease of access to care
    [ssquf] Quality of communication
    [ssquf] Support to manage HTN
    [ssquf] Patient Reported Experience Measure of Obstetric racism 
(PREM-OB Scale)
    [cir] Patient reported outcome measures (PROMs), for example
    [ssquf] Global Quality of life *, e.g., SF-36
    [ssquf] Psychosocial distress
    <bullet> Anxiety *, e.g., State-Trait Anxiety Inventory (STAI)
    <bullet> Depression *, e.g., Edinburgh Postnatal Depression Score 
(EPDS)
<bullet> Healthcare utilization
    [cir] Length of postpartum hospital stay *
    [cir] Unplanned obstetrical triage area or clinic visits *
    [cir] Emergency department visits *
    [cir] Re-hospitalization after discharge *
<bullet> Reduction of health disparities * (increase in disparities 
included under Harms)
<bullet> Other Harms
    [cir] Generation or exacerbation of health disparities *
    [cir] Anxiety associated with use of monitoring technology
Study Design
<bullet> Comparative studies (comparisons of different interventions or 
regimens)
    [cir] Randomized controlled trials (N >=10 per group)
    [cir] Nonrandomized comparative studies (prospective or 
retrospective) that use statistical techniques (e.g., regression 
adjustment, propensity score matching, inverse probability weighting) 
to reduce bias due to confounding)
<bullet> Any publication language (unless cannot be translated)
<bullet> Exclude
    [cir] Single group (noncomparative) studies

[[Page 18020]]

    [cir] Case-control studies
    [cir] Claims database analyses
    [cir] Feasibility studies
    [cir] Device validation studies (not including validation of 
patients' monitors in the clinic)
    [cir] Qualitative studies
    [cir] Conference abstracts prior to 2020 (without subsequent, 
eligible peer-reviewed publication)
Timing
<bullet> Intervention: Day of birth through 1 year postpartum
    [cir] Self-monitoring may start antenatal, in hospital, or 
postpartum, but must continue postpartum
<bullet> Outcomes: Any (postpartum)
Setting
<bullet> Outpatient postpartum management (although training and 
initiation may start in hospital or at clinic)
<bullet> Any publication date
<bullet> Any country

Key Question 2 (Treatment of HDP)

Population
<bullet> Postpartum individuals with diagnosed HDP (whether diagnosed 
antenatal, peripartum, or postpartum)
Modifiers/Subgroups of Interest
<bullet> Subgroups defined by ACOG HDP classification (these may arise 
de novo in the postpartum period)
    [cir] chronic HTN
    [cir] gestational HTN
    [cir] preeclampsia (may be superimposed on chronic HTN)
    [cir] preeclampsia with severe features (as defined by study 
authors)
    [cir] de novo HTN postpartum
<bullet> Subgroups defined by BP thresholds/categories
<bullet> Race, ethnicity
<bullet> Maternal age, parity, singleton/multiple pregnancy, mode of 
delivery (e.g., cesarean versus vaginal delivery, preterm versus term)
<bullet> Co-occurring disorders (e.g., obesity, diabetes)
<bullet> Subgroups defined by potential indicators of social 
determinants of health (e.g., insurance coverage, English proficiency, 
income, educational attainment)
<bullet> Use of home monitoring
Interventions
<bullet> Pharmacological treatments for HTN or HDP administered 
postpartum
    [cir] Antihypertensive medications (single or combination 
therapies)
    [cir] Loop diuretics (alone or in combination with antihypertensive 
medications)
<bullet> Exclude:
    [cir] Medication not available for use in the U.S.
    [cir] Nonpharmacological treatments (e.g., uterine curettage)
    [cir] Corticosteroids (e.g., for HELLP)
    [cir] Interventions to prevent preeclampsia (e.g., low-dose 
aspirin)
    [cir] Treatments not used to treat HDP (e.g., NSAIDs)
    [cir] Behavioral modification (e.g., diet, exercise)
    [cir] Non-medical interventions (e.g., traditional medicine, 
complementary and alternative medicine, meditation, mindfulness)
Comparators
<bullet> Alternative specific treatments (e.g., alternative 
antihypertensive medication(s) or combinations of medications, 
alternative diuretic)
<bullet> Alternative treatment regimen (e.g., alternative dose, 
duration of treatment)
<bullet> Alternative blood pressure targets
<bullet> No treatment (or placebo)
<bullet> Exclude: Excluded interventions
Outcomes (prioritized outcomes have an asterisk and are in bold font)
<bullet> Intermediate outcomes
    [cir] Blood pressure control *
    [cir] Measures of end-organ function
    [ssquf] Cardiovascular measures (e.g., echocardiographic 
measurements of diastolic function and hypertrophy)
    [ssquf] Kidney function (e.g., estimated glomerular filtration 
rate)
<bullet> Severe maternal outcomes
    [cir] Maternal mortality, including pregnancy-related mortality *
    [cir] Severe maternal morbidity * (e.g., stroke *, eclampsia, 
pulmonary edema)
<bullet> Patient reported outcomes
    [cir] Patient reported experience measures (PREMs), for example
    [ssquf] Satisfaction with postpartum care *
    [ssquf] Ease of access to care
    [ssquf] Quality of communication
    [ssquf] Support to manage HTN
    [cir] Patient reported outcome measures (PROMs), for example
    [ssquf] Global Quality of life *, e.g., SF-36
    [ssquf] Maternal-neonatal bonding, e.g., Postpartum Bonding 
Questionnaire
    [ssquf] Psychosocial distress
<bullet> Anxiety *, e.g., State-Trait Anxiety Inventory (STAI)
<bullet> Depression *, e.g., Edinburgh Postnatal Depression Score 
(EPDS)
<bullet> Healthcare utilization
    [cir] Length of postpartum hospital stay *
    [cir] Unplanned obstetrical triage area or clinic visits *
    [cir] Emergency department visits *
    [cir] Re-hospitalization after discharge *
<bullet> Infant health outcomes
    [cir] Breastfeeding outcomes (e.g., initiation, success, duration) 
*
<bullet> Reduction of health disparities * (increase in disparities 
included under Harms)
<bullet> Harms
    [cir] Severe adverse events * (e.g., electrolyte abnormalities, 
severe hypotension)
    [cir] Infant morbidities * (e.g., hypotension, other symptoms 
attributed to medication exposure via breast milk)
    [cir] Generation or exacerbation of health disparities *
    [cir] Adverse interactions with other medications
Study Design
<bullet> Comparative studies (comparisons of different interventions or 
regimens)
    [cir] Randomized controlled trials (N >=10 per group)
    [cir] Nonrandomized comparative studies (prospective or 
retrospective) that use statistical techniques (e.g., regression 
adjustment, propensity score matching, inverse probability weighting) 
to reduce bias due to confounding
<bullet> Any publication language (unless cannot be translated)
<bullet> Exclude
    [cir] Single group (noncomparative) studies
    [cir] Case-control studies
    [cir] Claims database analyses
    [cir] Feasibility studies
    [cir] Qualitative studies
    [cir] Conference abstracts prior to 2020 (without subsequent, 
eligible peer-reviewed publication)
Timing
<bullet> Intervention: Day of birth up to 1 year postpartum
    [cir] Intervention may start antenatal, in hospital, or postpartum, 
but must continue postpartum
<bullet> Outcomes: Any (postpartum)
Setting
<bullet> Outpatient, non-acute management (treatment may start 
inpatient)
<bullet> Any publication date
<bullet> Any country

Key Question 3 (MgSO4 for Preeclampsia With Severe Features)

Population
<bullet> Individuals who have preeclampsia with severe features (as 
defined by study authors) during the peripartum period (prior to and/or 
after delivery)
<bullet> Exclude: Pregnant patients who are treated with MgSO4 with the 
goal of suppressing premature labor, for fetal neuroprotection, or for 
other reasons

[[Page 18021]]

Modifiers/Subgroups of Interest
<bullet> Race, ethnicity
<bullet> Maternal age, parity, singleton/multiple pregnancy, mode of 
delivery (e.g., cesarean versus vaginal delivery, preterm versus term)
<bullet> Co-occurring disorders (e.g., obesity, diabetes)
<bullet> Subgroups defined by potential indicators of social 
determinants of health (e.g., insurance coverage, English proficiency, 
income, educational attainment)
<bullet> Timing of MgSO<INF>4</INF> administration or onset of 
preeclampsia with severe features with respect to delivery
    [cir] Antepartum
    [cir] Intrapartum
    [cir] Postpartum
<bullet> Individuals with reduced kidney function
Interventions
<bullet> Peripartum MgSO<INF>4</INF> administration
    [cir] Any dose, route (except oral), timing, duration of treatment, 
concomitant treatment, or regimen
<bullet> Exclude: Oral magnesium supplementation
Comparators
<bullet> Alternative MgSO<INF>4</INF> regimens
    [cir] Different criteria for initiation of treatment
    [cir] Different criteria for stopping (or continuing) treatment
    [cir] Different criteria for altering dosing during treatment
    [cir] Different loading dose
    [cir] Different planned total dose
    [cir] Different route
    [cir] Different planned duration of treatment
    [cir] Tailored interventions based on pharmacokinetic monitoring 
(i.e., based on serum Mg levels)
    [cir] Combined treatment with antihypertensive medications 
(including regimens with alternative antihypertensive medications)
    [cir] Other variations in regimens
<bullet> Exclude: No MgSO<INF>4</INF> treatment (either placebo, no 
treatment, or non-MgSO<INF>4</INF> comparators)
    [cir] Except retain RCTs with placebo, no treatment, or non-
MgSO<INF>4</INF> comparators and NRCSs comparing MgSO<INF>4</INF> with 
no MgSO<INF>4</INF> for postpartum preeclampsia with severe features 
These may be included in network meta-analyses to indirectly compare 
alternative MgSO<INF>4</INF> regimens.
Outcomes (prioritized outcomes have an asterisk and are in bold font)
<bullet> Severe maternal health outcomes
    [cir] Maternal mortality, including pregnancy-related mortality *
    [cir] Severe maternal morbidity * (e.g., eclampsia *, stroke)
<bullet> Newborn/child outcomes
    [cir] Infant morbidities * (e.g., respiratory depression, Apgar 
score)
    [cir] Breastfeeding outcomes * (e.g., initiation, success, 
duration)
    [cir] Fetal/neonatal mortality
    [cir] Cognitive function
<bullet> Healthcare utilization and functional status
    [cir] Length of postpartum hospital stay
    [cir] Time to ambulation
<bullet> Patient reported outcomes
    [cir] Patient reported experience measures (PREMs), for example
    [ssquf] Satisfaction with care *
    [ssquf] Quality of communication
    [ssquf] Support to manage preeclampsia treatment
    [cir] Patient reported outcome measures (PROMs), for example
    [ssquf] Global Quality of life *, e.g., SF-36
    [ssquf] Specific to postpartum population*, e.g., Mother-Generated 
Index, Functional Status After Childbirth scales
    [ssquf] Psychosocial distress
    <bullet> Anxiety *, e.g., State-Trait Anxiety Inventory (STAI)
    <bullet> Depression *, e.g., Edinburgh Postnatal Depression Score 
(EPDS)
    <bullet> Stress *, e.g., Impact of Event Scale
    [ssquf] Maternal-neonatal bonding *, e.g., Postpartum Bonding 
Questionnaire
<bullet> Reduction of health disparities * (increase in disparities 
included under Harms)
<bullet> Maternal harms/adverse events
    [cir] Magnesium-related toxicity * (respiratory depression, loss of 
reflexes, reduced urine output, need for calcium infusion) *
    [cir] Other clinically important adverse events* (e.g., 
hypotension, neuromuscular blockade)
    [cir] Adverse drug interactions * (e.g., with antihypertensive 
medications)
    [cir] Generation or exacerbation of health disparities *
    [cir] Other serious (e.g., severe flushing)
Study Design
<bullet> Comparative studies (comparisons of different interventions)
    [cir] Randomized controlled trials N >=10 per group
    [ssquf] Comparisons between MgSO<INF>4</INF> and placebo/no 
treatment or non-MgSO<INF>4</INF> treatments must be randomized (for 
potential network meta-analyses)
    [cir] Nonrandomized comparative studies (prospective or 
retrospective) that use statistical techniques (e.g., regression 
adjustment, propensity score matching, inverse probability weighting) 
to reduce bias due to confounding
<bullet> Any publication language (unless cannot be translated)
<bullet> Exclude
    [cir] Single group (noncomparative) studies
    [cir] Case-control studies
    [cir] Claims database analyses
    [cir] Feasibility studies
    [cir] Qualitative studies
    [cir] Conference abstracts prior to 2020 (without subsequent, 
eligible peer-reviewed publication)
Timing
<bullet> Intervention: Peripartum (antenatal, during delivery 
hospitalization, postpartum)
<bullet> Outcomes: Any
Setting
<bullet> Inpatient management
<bullet> Any publication date
<bullet> Any country

    Dated: March 23, 2022.
Marquita Cullom,
Associate Director.
[FR Doc. 2022-06532 Filed 3-28-22; 8:45 am]
BILLING CODE 4160-90-P


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