Supplemental Evidence and Data Request on Maternal and Fetal Effects of Mental Health Treatments in Pregnant and Breastfeeding Women: A Systematic Review of Pharmacological Interventions, 67462-67464 [2019-26510]
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Federal Register / Vol. 84, No. 237 / Tuesday, December 10, 2019 / Notices
DEPARTMENT OF HEALTH AND
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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
Maternal and Fetal Effects of Mental
Health Treatments in Pregnant and
Breastfeeding Women: A Systematic
Review of Pharmacological
Interventions, 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Access to published and unpublished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 30 days after date of publication.
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:
Notice.
FOR FURTHER INFORMATION CONTACT:
Supplemental Evidence and Data
Request on Maternal and Fetal Effects
of Mental Health Treatments in
Pregnant and Breastfeeding Women: A
Systematic Review of Pharmacological
Interventions
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 Maternal and Fetal Effects
of Mental Health Treatments in
Pregnant and Breastfeeding Women: A
Systematic Review of Pharmacological
Interventions. AHRQ is conducting this
systematic review pursuant to Section
902(a) of the Public Health Service Act,
42 U.S.C. 299a(a).
PO 00000
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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 Maternal and Fetal Effects
of Mental Health Treatments in
Pregnant and Breastfeeding Women: A
Systematic Review of Pharmacological
Interventions, including those that
describe adverse events. The entire
research protocol, including the key
questions, is also available online at:
https://effectivehealthcare.ahrq.gov/
topics/mental-health-pregnancy/
protocol.
This is to notify the public that the
EPC Program would find the following
information on Maternal and Fetal
Effects of Mental Health Treatments in
Pregnant and Breastfeeding Women: A
Systematic Review of Pharmacological
Interventions 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
E:\FR\FM\10DEN1.SGM
10DEN1
Federal Register / Vol. 84, No. 237 / Tuesday, December 10, 2019 / Notices
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 four 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.
The Key Questions
Key Question 1: Among pregnant and
postpartum women, what is the
effectiveness of pharmacologic
interventions on maternal outcomes?
a. Among those with a new or
preexisting anxiety disorder?
b. Among those with a new or
preexisting depressive disorder?
c. Among those with a new or
preexisting bipolar disorder?
d. Among those with new or
preexisting schizophrenia?
Key Question 2: Among pregnant and
postpartum women, what is the
comparative effectiveness of
pharmacologic interventions on
maternal outcomes?
a. Among those with a new or
preexisting anxiety disorder?
b. Among those with a new or
preexisting depressive disorder?
c. Among those with a new or
preexisting bipolar disorder?
d. Among those with new or
preexisting schizophrenia?
67463
Key Question 3: Among reproductiveaged women with any mental health
disorder, what are the maternal and fetal
harms associated with pharmacologic
interventions for a mental health
disorder during preconception,
pregnancy, and postpartum?
Key Question 4: Among reproductiveaged women with any mental health
disorder, what are the comparative
maternal and fetal harms of
pharmacologic interventions for a
mental health disorder during
preconception, pregnancy, and
postpartum?
Contextual Question 1: Among
women who are preconceptional,
pregnant, or postpartum, within a given
disorder, what are the harms of NOT
treating or stopping a pharmacological
treatment, or of switching medications?
TABLE 1—PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, SETTINGS) AND INCLUSION/
EXCLUSION CRITERIA
PICOTS
Inclusion
Exclusion
Population ....
KQ 1, KQ 2: Women who are pregnant or postpartum with new or preexisting diagnosis of anxiety, depression, bipolar disorder, or schizophrenia.
• Anxiety disorders include DSM 5 and DSM–IV diagnoses (including generalized anxiety disorder, panic disorder, social anxiety disorder [social phobia], obsessive compulsive disorder [OCD]; and
posttraumatic stress disorder).
• Depressive disorders include major depressive disorder
KQ 3, KQ 4: Reproductive-aged women (15–44 years old during preconception [≤12 weeks before pregnancy], pregnancy, and postpartum
[through 1 year]) with any mental health disorder (new or preexisting).
KQs 1, 2: Studies of women with disorders other than anxiety (including
PTSD and OCD), depression, bipolar disorder, and schizophrenia.
KQs 3, 4: <90% of reproductive age (15–44).
KQs 1–4: Studies with 100% substance use disorders.
jbell on DSKJLSW7X2PROD with NOTICES
Intervention †
Pharmacologic interventions for a mental health disorder including: ...
• Antipsychotics
(haloperidol,
chlorpromazine,
aripiprazole,
quetiapine, olanzapine, risperidone, clozapine, lurasidone,
paliperidone, fluphenazine, perphenazine, iloperidone, asenapine,
brexpiprazole, and ziprasidone).
• SSRIs and serotonin modulators (citalopram, escitalopram,
fluoxetine, fluvoxamine, nefazodone, paroxetine, sertraline,
trazodone, vilazodone, and vortioxetine).
• SNRIs (venlafaxine, desvenlafaxine, milnacipran, and duloxetine).
• Tricyclic antidepressants (amitriptyline, amoxapine, desipramine,
doxepin, imipramine, nortriptyline, protriptyline, and trimipramine).
• Other antidepressants (bupropion, mirtazapine).
• Mood stabilizers (lithium).
• Antianxiety agent (benzodiazepines [alprazolam, clobazam,
clonazepam, clorazepate, clonidine, chlordiazepoxide, diazepam,
lorazepam, temazepam, and triazolam] and buspirone).
• Anticonvulsants (valproate, carbamazepine, oxcarbazepine,
topiramate, and lamotrigine).
• Other medications for a mental health disorder (gabapentin,
zolpidem, eszopiclone, zaleplon, ramelteon, diphenhydramine,
lisdexamfetamine, and hydroxyzine).
All other interventions.
Comparator ..
KQ 1, KQ 3: Placebo or no treatment .........................................................
KQ 2, KQ 4: Other pharmacologic interventions, any psychotherapy,
combined pharmacotherapy, and psychotherapy.
KQ 1, KQ 3: Active comparators, no comparators
KQ 2, KQ 4:
• Treatments other than pharmacologic interventions or psychotherapy
(e.g., yoga, mindfulness, self-care, nutritional or herbal supplements)
• No comparators
• Placebo or no treatment comparators.
Outcomes ‡ ..
KQ 1, KQ 2: Effectiveness ...........................................................................
• Final health outcomes (maternal benefits).
• Symptoms (response/remission/relapse, suicidal ideation).
• Functional capacity *.
• Quality of life *.
• Peripartum events (delivery mode, breastfeeding, weight change).
• Adherence to treatment/care/discontinuation.
Suicidal events.
KQ 3, KQ 4: Harms.
• Maternal harms.
All other outcomes
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Federal Register / Vol. 84, No. 237 / Tuesday, December 10, 2019 / Notices
TABLE 1—PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, SETTINGS) AND INCLUSION/
EXCLUSION CRITERIA—Continued
PICOTS
Inclusion
Exclusion
Æ Harms specific to pregnancy and breastfeeding (infertility,
miscarriage,
abruption,
preterm
labor/preterm
birth,
preeclampsia, gestational hypertensive disorders, glucose intolerance/gestational diabetes mellitus, reduced milk production in breastfeeding/undesired weaning).
Æ Danger to self or infant.
Æ Misuse of prescription medication.
Æ Serious adverse events related to treatment.
Æ Death.
• Fetal/infant/child harms.
Æ Preterm birth/small for gestational age or large for gestational
age.
Æ Congenital anomalies.
Æ Perinatal complications (low APGAR, withdrawal, respiratory
distress, neonatal intensive care unit time, persistent pulmonary hypertension).
Æ Poor infant attachment/bonding *†.
Æ Delayed social, emotional, and cognitive development *.
Æ Death.
Time frame ...
Followup .......................................................................................................
KQ 1, KQ 2: From conception up to 1 year postpartum for maternal outcomes.
KQ 3, KQ 4: All ............................................................................................
Followup
• KQ 1, KQ 2: More than 12 weeks preconception for maternal preconception outcomes, more than 1 year for maternal postpartum outcomes
• KQ 3, KQ 4: None.
Settings § .....
Clinical setting ..............................................................................................
All settings ....................................................................................................
Clinical setting
None.
Study design
• RCTs, CCTs, case-control studies, cohort studies with comparison
arms.
• Reference lists of relevant systematic reviews published in 2013 or
later will be used to ensure our search strategies captured all relevant
studies.
All other designs and studies using included designs that do not meet the
sample size criterion.
Language .....
Studies published in English ........................................................................
Studies published in languages other than English.
* We will limit included outcomes to those using validated measures. Another potential exclusion, depending on volume of yield, includes studies that fail to control
for confounding.
† Drugs such as brexanolone that are awaiting FDA approval will be included in the review once they are approved
‡ We will focus strength of evidence (SOE) grades on outcomes prioritized by the Technical Expert Panel (TEP).
§ Depending on volume, we may limit the primary analysis to studies from geographic settings with resources comparable or applicable to the United States.
Dated: December 4, 2019.
Virginia Mackay-Smith,
Associate Director.
[FR Doc. 2019–26510 Filed 12–9–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Toxic Substances and
Disease Registry
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Statement of Organization, Functions,
and Delegations of Authority
Part J (Agency for Toxic Substances
and Disease Registry) of the Statement
of Organization, Functions, and
Delegations of Authority of the
Department of Health and Human
Services (50 FR 25129–25130, dated
June 17, 1985, as amended most
recently at 82 FR 42555, dated
September 8, 2017) is amended to
reflect the Order of Succession for the
Agency for Toxic Substances and
Disease Registry.
Section J–C, Order of Succession:
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Delete in its entirety the Section J–C,
Order of Succession, and insert the
following:
During the absence or disability of the
Administrator, Agency for Toxic
Substances and Disease Registry
(ATSDR), or in the event of a vacancy
in that office, the first official listed
below who is available shall act as
Administrator, except during a planned
period of absence, the Administrator
may specify a different order of
succession:
1. Assistant Administrator, ATSDR
2. Deputy Director for Non-Infectious
Diseases
3. Principal Deputy Director
4. Chief Medical Officer
5. Director, Center for Preparedness and
Response
Sherri A. Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2019–26494 Filed 12–9–19; 8:45 am]
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[Document Identifiers: CMS–10221, CMS–
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ACTION: Notice.
AGENCY:
The Centers for Medicare &
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an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
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(PRA), federal agencies are required to
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concerning each proposed collection of
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]]>Agencies
[Federal Register Volume 84, Number 237 (Tuesday, December 10, 2019)]
[Notices]
[Pages 67462-67464]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26510]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Maternal and Fetal
Effects of Mental Health Treatments in Pregnant and Breastfeeding
Women: A Systematic Review of Pharmacological Interventions
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 Maternal and
Fetal Effects of Mental Health Treatments in Pregnant and Breastfeeding
Women: A Systematic Review of Pharmacological Interventions, 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 30 days after date of
publication.
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 Maternal and Fetal
Effects of Mental Health Treatments in Pregnant and Breastfeeding
Women: A Systematic Review of Pharmacological Interventions. AHRQ is
conducting this systematic review pursuant to Section 902(a) of the
Public Health Service Act, 42 U.S.C. 299a(a).
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 Maternal and Fetal Effects of Mental Health Treatments
in Pregnant and Breastfeeding Women: A Systematic Review of
Pharmacological Interventions, including those that describe adverse
events. The entire research protocol, including the key questions, is
also available online at: https://effectivehealthcare.ahrq.gov/topics/mental-health-pregnancy/protocol.
This is to notify the public that the EPC Program would find the
following information on Maternal and Fetal Effects of Mental Health
Treatments in Pregnant and Breastfeeding Women: A Systematic Review of
Pharmacological Interventions 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
[[Page 67463]]
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 four 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.
The Key Questions
Key Question 1: Among pregnant and postpartum women, what is the
effectiveness of pharmacologic interventions on maternal outcomes?
a. Among those with a new or preexisting anxiety disorder?
b. Among those with a new or preexisting depressive disorder?
c. Among those with a new or preexisting bipolar disorder?
d. Among those with new or preexisting schizophrenia?
Key Question 2: Among pregnant and postpartum women, what is the
comparative effectiveness of pharmacologic interventions on maternal
outcomes?
a. Among those with a new or preexisting anxiety disorder?
b. Among those with a new or preexisting depressive disorder?
c. Among those with a new or preexisting bipolar disorder?
d. Among those with new or preexisting schizophrenia?
Key Question 3: Among reproductive-aged women with any mental
health disorder, what are the maternal and fetal harms associated with
pharmacologic interventions for a mental health disorder during
preconception, pregnancy, and postpartum?
Key Question 4: Among reproductive-aged women with any mental
health disorder, what are the comparative maternal and fetal harms of
pharmacologic interventions for a mental health disorder during
preconception, pregnancy, and postpartum?
Contextual Question 1: Among women who are preconceptional,
pregnant, or postpartum, within a given disorder, what are the harms of
NOT treating or stopping a pharmacological treatment, or of switching
medications?
Table 1--PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, Settings) and Inclusion/Exclusion
Criteria
----------------------------------------------------------------------------------------------------------------
PICOTS Inclusion Exclusion
----------------------------------------------------------------------------------------------------------------
Population......................... KQ 1, KQ 2: Women who are pregnant or KQs 1, 2: Studies of women with
postpartum with new or preexisting disorders other than anxiety
diagnosis of anxiety, depression, (including PTSD and OCD),
bipolar disorder, or schizophrenia. depression, bipolar disorder, and
Anxiety disorders include schizophrenia.
DSM 5 and DSM-IV diagnoses KQs 3, 4: <90% of reproductive age
(including generalized anxiety (15-44).
disorder, panic disorder, social KQs 1-4: Studies with 100% substance
anxiety disorder [social phobia], use disorders.
obsessive compulsive disorder [OCD];
and posttraumatic stress disorder)..
Depressive disorders include
major depressive disorder.
KQ 3, KQ 4: Reproductive-aged women
(15-44 years old during
preconception [<=12 weeks before
pregnancy], pregnancy, and
postpartum [through 1 year]) with
any mental health disorder (new or
preexisting).
----------------------------------------------------------------------------------------------------------------
Intervention [dagger].............. Pharmacologic interventions for a All other interventions.
mental health disorder including:.
Antipsychotics
(haloperidol, chlorpromazine,
aripiprazole, quetiapine,
olanzapine, risperidone,
clozapine, lurasidone,
paliperidone, fluphenazine,
perphenazine, iloperidone,
asenapine, brexpiprazole, and
ziprasidone).
SSRIs and serotonin
modulators (citalopram,
escitalopram, fluoxetine,
fluvoxamine, nefazodone,
paroxetine, sertraline,
trazodone, vilazodone, and
vortioxetine).
SNRIs (venlafaxine,
desvenlafaxine, milnacipran, and
duloxetine).
Tricyclic antidepressants
(amitriptyline, amoxapine,
desipramine, doxepin, imipramine,
nortriptyline, protriptyline, and
trimipramine).
Other antidepressants
(bupropion, mirtazapine).
Mood stabilizers
(lithium).
Antianxiety agent
(benzodiazepines [alprazolam,
clobazam, clonazepam,
clorazepate, clonidine,
chlordiazepoxide, diazepam,
lorazepam, temazepam, and
triazolam] and buspirone).
Anticonvulsants
(valproate, carbamazepine,
oxcarbazepine, topiramate, and
lamotrigine).
Other medications for a
mental health disorder
(gabapentin, zolpidem,
eszopiclone, zaleplon, ramelteon,
diphenhydramine,
lisdexamfetamine, and
hydroxyzine).
----------------------------------------------------------------------------------------------------------------
Comparator......................... KQ 1, KQ 3: Placebo or no treatment.. KQ 1, KQ 3: Active comparators, no
KQ 2, KQ 4: Other pharmacologic comparators
interventions, any psychotherapy, KQ 2, KQ 4:
combined pharmacotherapy, and Treatments other than
psychotherapy. pharmacologic interventions or
psychotherapy (e.g., yoga,
mindfulness, self-care, nutritional
or herbal supplements)
No comparators
Placebo or no treatment
comparators.
----------------------------------------------------------------------------------------------------------------
Outcomes [Dagger].................. KQ 1, KQ 2: Effectiveness............ All other outcomes
Final health outcomes
(maternal benefits).
Symptoms (response/
remission/relapse, suicidal
ideation).
Functional capacity *....
Quality of life *........
Peripartum events
(delivery mode, breastfeeding,
weight change).
Adherence to treatment/
care/discontinuation.
Suicidal events......................
KQ 3, KQ 4: Harms....................
Maternal harms...........
[[Page 67464]]
[cir] Harms specific to
pregnancy and breastfeeding
(infertility, miscarriage,
abruption, preterm labor/
preterm birth, preeclampsia,
gestational hypertensive
disorders, glucose intolerance/
gestational diabetes mellitus,
reduced milk production in
breastfeeding/undesired
weaning).
[cir] Danger to self or infant..
[cir] Misuse of prescription
medication.
[cir] Serious adverse events
related to treatment.
[cir] Death.....................
Fetal/infant/child
harms.
[cir] Preterm birth/small for
gestational age or large for
gestational age.
[cir] Congenital anomalies......
[cir] Perinatal complications
(low APGAR, withdrawal,
respiratory distress, neonatal
intensive care unit time,
persistent pulmonary
hypertension).
[cir] Poor infant attachment/
bonding *[dagger].
[cir] Delayed social, emotional,
and cognitive development *.
[cir] Death.....................
----------------------------------------------------------------------------------------------------------------
Time frame......................... Followup............................. Followup
KQ 1, KQ 2: From conception up to 1 KQ 1, KQ 2: More than 12
year postpartum for maternal weeks preconception for maternal
outcomes. preconception outcomes, more than 1
KQ 3, KQ 4: All...................... year for maternal postpartum
outcomes
KQ 3, KQ 4: None.
----------------------------------------------------------------------------------------------------------------
Settings Sec. .................... Clinical setting..................... Clinical setting
All settings......................... None.
----------------------------------------------------------------------------------------------------------------
Study design....................... RCTs, CCTs, case-control All other designs and studies using
studies, cohort studies with included designs that do not meet
comparison arms. the sample size criterion.
Reference lists of relevant
systematic reviews published in 2013
or later will be used to ensure our
search strategies captured all
relevant studies.
----------------------------------------------------------------------------------------------------------------
Language........................... Studies published in English......... Studies published in languages other
than English.
----------------------------------------------------------------------------------------------------------------
* We will limit included outcomes to those using validated measures. Another potential exclusion, depending on
volume of yield, includes studies that fail to control for confounding.
[dagger] Drugs such as brexanolone that are awaiting FDA approval will be included in the review once they are
approved
[Dagger] We will focus strength of evidence (SOE) grades on outcomes prioritized by the Technical Expert Panel
(TEP).
Sec. Depending on volume, we may limit the primary analysis to studies from geographic settings with resources
comparable or applicable to the United States.
Dated: December 4, 2019.
Virginia Mackay-Smith,
Associate Director.
[FR Doc. 2019-26510 Filed 12-9-19; 8:45 am]
BILLING CODE 4160-90-P
