[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]
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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.
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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 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 Access to published and unpublished pertinent scientific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
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PICOTS Inclusion Exclusion
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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).
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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).
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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.
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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.....................
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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.
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Settings Sec. .................... Clinical setting..................... Clinical setting
All settings......................... None.
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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.
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Language........................... Studies published in English......... Studies published in languages other
than English.
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* 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