Supplemental Evidence and Data Request on Psychological and Pharmacological Treatments for Adults With Posttraumatic Stress Disorder (PTSD): A Systematic Review Update, 29085-29087 [2017-13394]
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Federal Register / Vol. 82, No. 122 / Tuesday, June 27, 2017 / Notices
Settings
Inclusion
All KQs: Outpatients.
Exclusion
Inpatients.
Country Setting
Inclusion
All KQs: Any geographic area.
Exclusion
None.
Study Designs
Inclusion
I. For all KQs (i.e., benefits and harms
overall [KQs 1, 2, 3] and among
subgroups [KQ 4]), we will include
head-to head RCTs and nRCTs;
prospective, controlled cohort
studies (N ≥ 100); double-blinded,
placebo-controlled trials for
network meta-analysis; and SRs for
identification of additional
references only.
II. For studies of harms (i.e., overall [KQ
3] and among subgroups [KQ 4]),
we will also include any other
observational study (e.g., cohort,
case-control, large case series, post
marketing surveillance) (N ≥ 100).
Exclusion
All other designs not listed.
Publication Language
Inclusion
All KQs: English.
Exclusion
Languages other than English.
Sharon B. Arnold,
Deputy Director.
[FR Doc. 2017–13395 Filed 6–26–17; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
mstockstill on DSK30JT082PROD with NOTICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Psychological and
Pharmacological Treatments for Adults
With Posttraumatic Stress Disorder
(PTSD): A Systematic Review Update
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
SUMMARY:
VerDate Sep<11>2014
18:33 Jun 26, 2017
Jkt 241001
scientific information submissions from
the public. Scientific information is
being solicited to inform our review of
Psychological and Pharmacological
Treatments for Adults with
Posttraumatic Stress Disorder (PTSD): A
Systematic Review Update, 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published and unpublished pertinent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 July 27, 2017.
ADDRESSES:
Email submissions: SEADS@epcsrc.org.
Print submissions:
Mailing Address: Portland VA
Research Foundation, Scientific
Resource Center, ATTN: Scientific
Information Packet Coordinator, P.O.
Box 69539, Portland, OR 97239.
Shipping Address (FedEx, UPS, etc.):
Portland VA Research Foundation,
Scientific Resource Center, ATTN:
Scientific Information Packet
Coordinator, 3710 SW U.S. Veterans
Hospital Road, Mail Code: R&D 71,
Portland, OR 97239.
FOR FURTHER INFORMATION CONTACT:
Ryan McKenna, Telephone: 503–220–
8262 ext. 51723 or Email: SEADS@epcsrc.org.
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 Psychological and
Pharmacological Treatments for Adults
with Posttraumatic Stress Disorder
(PTSD): A Systematic Review Update.
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 Psychological and
Pharmacological Treatments for Adults
with Posttraumatic Stress Disorder
(PTSD): A Systematic Review Update,
including those that describe adverse
events. The entire research protocol,
including the key questions, is also
available online at: https://
effectivehealthcare.ahrq.gov/index.cfm/
search-for-guides-reviews-and-reports/?
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
29085
pageaction=displayproduct&
productid=2478.
This is to notify the public that the
EPC Program would find helpful the
following information on Psychological
and Pharmacological Treatments for
Adults with Posttraumatic Stress
Disorder (PTSD): A Systematic Review
Update:
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,
please provide 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 will be very
beneficial to the EPC Program. Materials
submitted must be publicly available or
able to be made public. Materials that
are considered confidential; marketing
materials; study types not included in
the review; or information on
indications not included in the review
cannot be used by the EPC Program.
This is a voluntary request for
information, and all costs for complying
with this request must be borne by the
submitter.
The draft of this review will be posted
on AHRQ’s EPC Program Web site and
available for public comment for a
period of 4 weeks. If you would like to
be notified when the draft is posted,
please sign up for the email list at:
https://www.effectivehealthcare.
ahrq.gov/index.cfm/join-theemail-list1/.
The systematic review will answer the
following questions. This information is
E:\FR\FM\27JNN1.SGM
27JNN1
29086
Federal Register / Vol. 82, No. 122 / Tuesday, June 27, 2017 / Notices
provided as background. AHRQ is not
requesting that the public provide
answers to these questions.
The Key Questions
Key Question (KQ) 1. What is the
comparative effectiveness of different
psychological treatments for adults
diagnosed with PTSD?
I. How does comparative effectiveness
vary by patient characteristics or type of
trauma experienced?
KQ 2. What is the comparative
effectiveness of different
pharmacological treatments for adults
diagnosed with PTSD?
I. How does comparative effectiveness
vary by patient characteristics or type of
trauma experienced?
KQ 3. What is the comparative
effectiveness of different psychological
treatments and pharmacological
treatments for adults diagnosed with
PTSD?
I. How does comparative effectiveness
vary by patient characteristics or type of
trauma experienced?
KQ 4. What adverse events (AEs) are
associated with treatments for adults
diagnosed with PTSD?
Contextual Question (CQ)
CQ 1a. What are the components of
effective psychological treatments (e.g.,
frequency or intensity of therapy, and/
or aspects of the therapeutic modality)?
CQ 1b. For psychological
interventions that are effective in trial
settings, what is the degree of fidelity
when implemented in clinical practice
settings?
PICOTS (Populations, Interventions,
Comparators, Outcomes, Timing,
Settings)
Populations
mstockstill on DSK30JT082PROD with NOTICES
Inclusion
I. Adults 18 years or older with PTSD
based on any DSM diagnostic criteria.
II. Subgroups of interest (KQs 1a, 2a,
3a) include those distinguished by
patient characteristics (e.g., gender, age,
race/ethnicity, comorbid mental and
physical health conditions, employment
types requiring trauma exposure [for
example, first responders], severity of
trauma experienced, different symptoms
of PTSD, dissociation, and/or psychosis,
PTSD symptom chronicity or severity)
or type of trauma experienced (e.g.,
military/combat, natural disaster, war,
political instability, relational [physical,
emotional, or sexual abuse or exposure
to domestic violence], repeat
victimizations, cumulative).
Exclusion
All other.
VerDate Sep<11>2014
18:33 Jun 26, 2017
Jkt 241001
Intervention
Inclusion
I. Psychological interventions: Brief
eclectic psychotherapy, CBT including
cognitive restructuring, cognitive
processing therapy, exposure-based
therapy, coping skills therapy (e.g.,
stress inoculation therapy, assertiveness
training, biofeedback, relaxation
training), psychodynamic therapy,
EMDR, IPT, group therapy, hypnosis or
hypnotherapy, and energy psychology
(including EFT).
II. Pharmacological interventions:
SSRIs (citalopram, escitalopram,
fluoxetine, fluvoxamine, paroxetine,
and sertraline), SNRIs (desvenlafaxine,
venlafaxine, and duloxetine), tricyclic
antidepressants (imipramine,
amitriptyline, and desipramine), other
second-generation antidepressants
(bupropion, mirtazapine, nefazodone,
and trazodone), alpha blockers
(prazosin), atypical antipsychotics
(olanzapine, risperidone, ziprasidone,
aripiprazole and quetiapine),
benzodiazepines (alprazolam, diazepam,
lorazepam, and clonazepam),
anticonvulsants/mood stabilizers
(topiramate, tiagabine, lamotrigine,
carbamazepine, and divalproex).
Exclusion
(i.e., no longer having symptoms or loss
of PTSD diagnosis), quality of life,
disability or functional impairment,
return to work or active duty status
II. KQ 4: Overall and specific AEs
(e.g., disturbed sleep, increased
agitation, sedation, weight gain,
metabolic side effects, and mortality),
withdrawals due to AEs.
Exclusion
All other outcomes.
Time Frame
Inclusion
I. Studies published from 2012 to the
present will be searched to identify new
studies meeting the review criteria.
Findings of these newly identified
studies will be synthesized with those
from studies included in the prior
review that continue to meet the new
review criteria.
II. At least 4 weeks study duration
after randomization.
Exclusion
Less than 4 weeks.
Settings
Inclusion
I. Complementary and alternative
medicine approaches.
II. Psychological or pharmacological
interventions not listed as included.
Comparator
Outpatient and inpatient primary care
or specialty mental health care;
community settings e.g., churches,
community health centers, rape crisis
centers), military settings.
Inclusion
Exclusion
I. KQ 1 (1a): Psychological
interventions listed above compared
with one another, waiting list
assignment, usual care (as defined by
the study), no intervention, or sham.
II. KQ 2 (2a): Pharmacological
interventions listed above compared
with one another or placebo.
III. KQ 3 (3a): Psychological
interventions listed above compared
with pharmacological interventions
listed above.
IV. KQ 4: Any intervention listed
above.
Exclusion
All other comparisons
Outcomes
I. KQs 1–3: PTSD symptom reduction,
prevention or reduction of comorbid
medical or psychiatric conditions (e.g.,
coronary artery disease; depressive
symptoms; anxiety symptoms; suicidal
ideation/plans/attempts; and substance
use, abuse, or dependence), remission
Frm 00065
Study Design
Inclusion
I. KQs 1–3: Randomized controlled
trials (RCTs) of any sample size,
systematic reviews (for references).
II. KQ 4: AE data from trials for KQs
1–3, systematic reviews and metaanalyses (for references),
nonrandomized controlled trials,
prospective cohort studies with an
eligible comparison group and a sample
size of at least 500, case-control studies
with a sample size of at least 500.
Exclusion
Inclusion
PO 00000
Other settings.
Fmt 4703
Sfmt 4703
All other designs and studies using
included designs that do not meet the
sample size criterion.
Language
Inclusion
Studies published in English.
E:\FR\FM\27JNN1.SGM
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29087
Federal Register / Vol. 82, No. 122 / Tuesday, June 27, 2017 / Notices
Exclusion
Studies published in languages other
than English.
Sharon B. Arnold,
Deputy Director.
[FR Doc. 2017–13394 Filed 6–26–17; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30 Day–17–0729]
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Prevention (CDC) has submitted the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995. The notice for
the proposed information collection is
published to obtain comments from the
public and affected agencies.
Written comments and suggestions
from the public and affected agencies
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information are encouraged. Your
comments should address any of the
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information, including the validity of
the methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected; (d) Minimize the burden of
the collection of information on those
who are to respond, including through
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and (e) Assess information
collection costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. Direct
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Proposed Project
Customer Surveys Generic Clearance
for the National Center for Health
Statistics (0920–0729, Expiration 05/31/
2017)—Reinstatement—National Center
for Health Statistics (NCHS), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Section 306 of the Public Health
Service (PHS) Act (42 U.S.C. 242k), as
amended, authorizes that the Secretary
of Health and Human Services (DHHS),
acting through NCHS, shall collect
statistics on ‘‘the extent and nature of
illness and disability of the population
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reinstatement request for a generic
approval from OMB to conduct
customer surveys over the next three
years at an overall burden rate of 4000
hours.
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the National Center for Health Statistics
(NCHS) plans to continue to assess its
customers’ satisfaction with the content,
quality and relevance of the information
it produces. NCHS will conduct
voluntary customer surveys to assess
strengths in agency products and
services and to evaluate how well it
addresses the emerging needs of its data
users. Results of these surveys will be
used in future planning initiatives.
The data will be collected using a
combination of methodologies
appropriate to each survey. These may
include: Evaluation forms, mail surveys,
focus groups, automated and electronic
technology (e.g., email, Web-based
surveys), and telephone surveys.
Systematic surveys of several groups
will be folded into the program. Among
these are Federal customers and policy
makers, state and local officials who
rely on NCHS data, the broader
educational, research, and public health
community, and other data users.
Respondents may include data users
who register for and/or attend NCHS
sponsored conferences; persons who
access the NCHS Web site and the
detailed data available through it;
consultants; and others. Respondent
data items may include (in broad
categories) information regarding
respondent’s gender, age, occupation,
affiliation, location, etc., to be used to
characterize responses only. Other
questions will attempt to obtain
information that will characterize the
respondents’ familiarity with and use of
NCHS data, their assessment of data
content and usefulness, general
satisfaction with available services and
products, and suggestions for
improvement of surveys, services and
products.
In order to capture anticipated
additional feedback opportunities, this
reinstatement request allows for the
potential increase in both respondents
and time per response for a total
estimated annual burden total of 4,000
hours. There is no cost to respondents
other than their time to participate in
the survey. The resulting information
will be for NCHS internal use.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondent
mstockstill on DSK30JT082PROD with NOTICES
Questionnaire for conference registrants/
attendees.
Focus groups ..................................................
Web-based ......................................................
Other customer surveys ..................................
VerDate Sep<11>2014
18:33 Jun 26, 2017
Number of
respondents
Form name
Jkt 241001
Public/private
others.
Public/private
others.
Public/private
others.
Public/private
others.
PO 00000
Frm 00066
Number of
responses per
respondent
Average
burden per
response
(hours)
researchers, Consultants, and
6,000
1
15/60
researchers, Consultants, and
500
1
1
researchers, Consultants, and
6,000
1
15/60
researchers, Consultants, and
2,000
1
15/60
Fmt 4703
Sfmt 4703
E:\FR\FM\27JNN1.SGM
27JNN1
]]>Agencies
[Federal Register Volume 82, Number 122 (Tuesday, June 27, 2017)]
[Notices]
[Pages 29085-29087]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-13394]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Psychological and
Pharmacological Treatments for Adults With Posttraumatic Stress
Disorder (PTSD): A Systematic Review Update
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 of Psychological
and Pharmacological Treatments for Adults with Posttraumatic Stress
Disorder (PTSD): A Systematic Review Update, 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 July 27, 2017.
ADDRESSES:
Email submissions: src.org">SEADS@epc-src.org.
Print submissions:
Mailing Address: Portland VA Research Foundation, Scientific
Resource Center, ATTN: Scientific Information Packet Coordinator, P.O.
Box 69539, Portland, OR 97239.
Shipping Address (FedEx, UPS, etc.): Portland VA Research
Foundation, Scientific Resource Center, ATTN: Scientific Information
Packet Coordinator, 3710 SW U.S. Veterans Hospital Road, Mail Code: R&D
71, Portland, OR 97239.
FOR FURTHER INFORMATION CONTACT: Ryan McKenna, Telephone: 503-220-8262
ext. 51723 or Email: src.org">SEADS@epc-src.org.
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 Psychological and
Pharmacological Treatments for Adults with Posttraumatic Stress
Disorder (PTSD): A Systematic Review Update. 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 Psychological and Pharmacological Treatments for Adults
with Posttraumatic Stress Disorder (PTSD): A Systematic Review Update,
including those that describe adverse events. The entire research
protocol, including the key questions, is also available online at:
https://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productid=2478.
This is to notify the public that the EPC Program would find
helpful the following information on Psychological and Pharmacological
Treatments for Adults with Posttraumatic Stress Disorder (PTSD): A
Systematic Review Update:
[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, please provide 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 will be very beneficial to the EPC Program.
Materials submitted must be publicly available or able to be made
public. Materials that are considered confidential; marketing
materials; study types not included in the review; or information on
indications not included in the review cannot be used by the EPC
Program. This is a voluntary request for information, and all costs for
complying with this request must be borne by the submitter.
The draft of this review will be posted on AHRQ's EPC Program Web
site and available for public comment for a period of 4 weeks. If you
would like to be notified when the draft is posted, please sign up for
the email list at: https://www.effectivehealthcare.ahrq.gov/index.cfm/join-the-email-list1/.
The systematic review will answer the following questions. This
information is
[[Page 29086]]
provided as background. AHRQ is not requesting that the public provide
answers to these questions.
The Key Questions
Key Question (KQ) 1. What is the comparative effectiveness of
different psychological treatments for adults diagnosed with PTSD?
I. How does comparative effectiveness vary by patient
characteristics or type of trauma experienced?
KQ 2. What is the comparative effectiveness of different
pharmacological treatments for adults diagnosed with PTSD?
I. How does comparative effectiveness vary by patient
characteristics or type of trauma experienced?
KQ 3. What is the comparative effectiveness of different
psychological treatments and pharmacological treatments for adults
diagnosed with PTSD?
I. How does comparative effectiveness vary by patient
characteristics or type of trauma experienced?
KQ 4. What adverse events (AEs) are associated with treatments for
adults diagnosed with PTSD?
Contextual Question (CQ)
CQ 1a. What are the components of effective psychological
treatments (e.g., frequency or intensity of therapy, and/or aspects of
the therapeutic modality)?
CQ 1b. For psychological interventions that are effective in trial
settings, what is the degree of fidelity when implemented in clinical
practice settings?
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing,
Settings)
Populations
Inclusion
I. Adults 18 years or older with PTSD based on any DSM diagnostic
criteria.
II. Subgroups of interest (KQs 1a, 2a, 3a) include those
distinguished by patient characteristics (e.g., gender, age, race/
ethnicity, comorbid mental and physical health conditions, employment
types requiring trauma exposure [for example, first responders],
severity of trauma experienced, different symptoms of PTSD,
dissociation, and/or psychosis, PTSD symptom chronicity or severity) or
type of trauma experienced (e.g., military/combat, natural disaster,
war, political instability, relational [physical, emotional, or sexual
abuse or exposure to domestic violence], repeat victimizations,
cumulative).
Exclusion
All other.
Intervention
Inclusion
I. Psychological interventions: Brief eclectic psychotherapy, CBT
including cognitive restructuring, cognitive processing therapy,
exposure-based therapy, coping skills therapy (e.g., stress inoculation
therapy, assertiveness training, biofeedback, relaxation training),
psychodynamic therapy, EMDR, IPT, group therapy, hypnosis or
hypnotherapy, and energy psychology (including EFT).
II. Pharmacological interventions: SSRIs (citalopram, escitalopram,
fluoxetine, fluvoxamine, paroxetine, and sertraline), SNRIs
(desvenlafaxine, venlafaxine, and duloxetine), tricyclic
antidepressants (imipramine, amitriptyline, and desipramine), other
second-generation antidepressants (bupropion, mirtazapine, nefazodone,
and trazodone), alpha blockers (prazosin), atypical antipsychotics
(olanzapine, risperidone, ziprasidone, aripiprazole and quetiapine),
benzodiazepines (alprazolam, diazepam, lorazepam, and clonazepam),
anticonvulsants/mood stabilizers (topiramate, tiagabine, lamotrigine,
carbamazepine, and divalproex).
Exclusion
I. Complementary and alternative medicine approaches.
II. Psychological or pharmacological interventions not listed as
included.
Comparator
Inclusion
I. KQ 1 (1a): Psychological interventions listed above compared
with one another, waiting list assignment, usual care (as defined by
the study), no intervention, or sham.
II. KQ 2 (2a): Pharmacological interventions listed above compared
with one another or placebo.
III. KQ 3 (3a): Psychological interventions listed above compared
with pharmacological interventions listed above.
IV. KQ 4: Any intervention listed above.
Exclusion
All other comparisons
Outcomes
Inclusion
I. KQs 1-3: PTSD symptom reduction, prevention or reduction of
comorbid medical or psychiatric conditions (e.g., coronary artery
disease; depressive symptoms; anxiety symptoms; suicidal ideation/
plans/attempts; and substance use, abuse, or dependence), remission
(i.e., no longer having symptoms or loss of PTSD diagnosis), quality of
life, disability or functional impairment, return to work or active
duty status
II. KQ 4: Overall and specific AEs (e.g., disturbed sleep,
increased agitation, sedation, weight gain, metabolic side effects, and
mortality), withdrawals due to AEs.
Exclusion
All other outcomes.
Time Frame
Inclusion
I. Studies published from 2012 to the present will be searched to
identify new studies meeting the review criteria. Findings of these
newly identified studies will be synthesized with those from studies
included in the prior review that continue to meet the new review
criteria.
II. At least 4 weeks study duration after randomization.
Exclusion
Less than 4 weeks.
Settings
Inclusion
Outpatient and inpatient primary care or specialty mental health
care; community settings e.g., churches, community health centers, rape
crisis centers), military settings.
Exclusion
Other settings.
Study Design
Inclusion
I. KQs 1-3: Randomized controlled trials (RCTs) of any sample size,
systematic reviews (for references).
II. KQ 4: AE data from trials for KQs 1-3, systematic reviews and
meta-analyses (for references), nonrandomized controlled trials,
prospective cohort studies with an eligible comparison group and a
sample size of at least 500, case-control studies with a sample size of
at least 500.
Exclusion
All other designs and studies using included designs that do not
meet the sample size criterion.
Language
Inclusion
Studies published in English.
[[Page 29087]]
Exclusion
Studies published in languages other than English.
Sharon B. Arnold,
Deputy Director.
[FR Doc. 2017-13394 Filed 6-26-17; 8:45 am]
BILLING CODE 4160-90-P
