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

 
CONTENT
Federal Register, Volume 84 Issue 237 (Tuesday, December 10, 2019)
[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 Access to published and unpublished pertinent scientific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:  Depressive disorders include
                                      major depressive disorder.
                                     KQ 3, KQ 4: Reproductive-aged women
                                      (15-44 years old during
                                      preconception [ 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