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]

Download as PDF 67462 Federal Register / Vol. 84, No. 237 / Tuesday, December 10, 2019 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2019–26593 Filed 12–9–19; 8:45 am] BILLING CODE 8070–01–C Agency for Healthcare Research and Quality GENERAL SERVICES ADMINISTRATION [Notice–MA–2019–10; Docket No. 2019– 0002; Sequence No. 32] Relocation Allowances: Taxes on Travel, Transportation, and Relocation Expenses Office of Government-wide Policy (OGP), General Services Administration (GSA). AGENCY: ACTION: The purpose of this notice is to inform Federal agencies that FTR Bulletin 20–02, pertaining to travel, transportation, and relocation allowances impacted by recent changes to Federal tax law, has been published and is now available online at www.gsa.gov/ftrbulletin. This bulletin contains certain examples and tables that were removed from the FTR as a result of FTR Amendment 2020–02, published by GSA on November 25, 2019, and issued as a direct final rule. 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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 Access to published and unpublished pertinent scientific information will improve the quality of this review.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 Frm 00040 Fmt 4703 Sfmt 4703 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 VerDate Sep<11>2014 17:08 Dec 09, 2019 Jkt 250001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\10DEN1.SGM 10DEN1 67464 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. 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[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.

-----------------------------------------------------------------------

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