82 FR 29085 - Supplemental Evidence and Data Request on Psychological and Pharmacological Treatments for Adults With Posttraumatic Stress Disorder (PTSD): A Systematic Review Update

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality

Federal Register Volume 82, Issue 122 (June 27, 2017)

Page Range		29085-29087
FR Document		2017-13394

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 Access to published and unpublished pertinent scientific information will improve the quality of this review.

Federal Register, Volume 82 Issue 122 (Tuesday, June 27, 2017)

[Federal Register Volume 82, Number 122 (Tuesday, June 27, 2017)]
[Notices]
[Pages 29085-29087]
From the Federal Register Online [www.thefederalregister.org]
[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Access to published and unpublished pertinent scientific information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

29086 Federal Register / Vol. 82, No. 122 / Tuesday, June 27, 2017 / Notices

provided as background. AHRQ is not Intervention (i.e., no longer having symptoms or loss
requesting that the public provide of PTSD diagnosis), quality of life,
Inclusion
answers to these questions. disability or functional impairment,
I. Psychological interventions: Brief return to work or active duty status
The Key Questions eclectic psychotherapy, CBT including
II. KQ 4: Overall and specific AEs
Key Question (KQ) 1. What is the cognitive restructuring, cognitive
(e.g., disturbed sleep, increased
comparative effectiveness of different processing therapy, exposure-based
psychological treatments for adults agitation, sedation, weight gain,
therapy, coping skills therapy (e.g.,
diagnosed with PTSD? stress inoculation therapy, assertiveness metabolic side effects, and mortality),
I. How does comparative effectiveness training, biofeedback, relaxation withdrawals due to AEs.
vary by patient characteristics or type of training), psychodynamic therapy, Exclusion
trauma experienced? EMDR, IPT, group therapy, hypnosis or
KQ 2. What is the comparative hypnotherapy, and energy psychology All other outcomes.
effectiveness of different (including EFT).
pharmacological treatments for adults Time Frame
II. Pharmacological interventions:
diagnosed with PTSD? SSRIs (citalopram, escitalopram, Inclusion
I. How does comparative effectiveness fluoxetine, fluvoxamine, paroxetine,
vary by patient characteristics or type of and sertraline), SNRIs (desvenlafaxine, I. Studies published from 2012 to the
trauma experienced? venlafaxine, and duloxetine), tricyclic present will be searched to identify new
KQ 3. What is the comparative antidepressants (imipramine, studies meeting the review criteria.
effectiveness of different psychological amitriptyline, and desipramine), other Findings of these newly identified
treatments and pharmacological second-generation antidepressants studies will be synthesized with those
treatments for adults diagnosed with (bupropion, mirtazapine, nefazodone, from studies included in the prior
PTSD? and trazodone), alpha blockers review that continue to meet the new
I. How does comparative effectiveness (prazosin), atypical antipsychotics review criteria.
vary by patient characteristics or type of (olanzapine, risperidone, ziprasidone, II. At least 4 weeks study duration
trauma experienced? aripiprazole and quetiapine), after randomization.
KQ 4. What adverse events (AEs) are benzodiazepines (alprazolam, diazepam,
associated with treatments for adults lorazepam, and clonazepam), Exclusion
diagnosed with PTSD? anticonvulsants/mood stabilizers
(topiramate, tiagabine, lamotrigine, Less than 4 weeks.
Contextual Question (CQ)
carbamazepine, and divalproex). Settings
CQ 1a. What are the components of
effective psychological treatments (e.g., Exclusion Inclusion
frequency or intensity of therapy, and/ I. Complementary and alternative
or aspects of the therapeutic modality)? medicine approaches. Outpatient and inpatient primary care
CQ 1b. For psychological II. Psychological or pharmacological or specialty mental health care;
interventions that are effective in trial interventions not listed as included. community settings e.g., churches,
settings, what is the degree of fidelity community health centers, rape crisis
when implemented in clinical practice Comparator centers), military settings.
settings? Inclusion Exclusion
PICOTS (Populations, Interventions, I. KQ 1 (1a): Psychological
Comparators, Outcomes, Timing, interventions listed above compared Other settings.
Settings) with one another, waiting list Study Design
Populations assignment, usual care (as defined by
the study), no intervention, or sham. Inclusion
Inclusion II. KQ 2 (2a): Pharmacological
I. KQs 1–3: Randomized controlled
I. Adults 18 years or older with PTSD interventions listed above compared
with one another or placebo. trials (RCTs) of any sample size,
based on any DSM diagnostic criteria. systematic reviews (for references).
II. Subgroups of interest (KQs 1a, 2a, III. KQ 3 (3a): Psychological
3a) include those distinguished by interventions listed above compared II. KQ 4: AE data from trials for KQs
patient characteristics (e.g., gender, age, with pharmacological interventions 1–3, systematic reviews and meta-
race/ethnicity, comorbid mental and listed above. analyses (for references),
physical health conditions, employment IV. KQ 4: Any intervention listed nonrandomized controlled trials,
types requiring trauma exposure [for above. prospective cohort studies with an
example, first responders], severity of eligible comparison group and a sample
Exclusion
trauma experienced, different symptoms size of at least 500, case-control studies
All other comparisons with a sample size of at least 500.
of PTSD, dissociation, and/or psychosis,
PTSD symptom chronicity or severity) Outcomes Exclusion
or type of trauma experienced (e.g.,
Inclusion
military/combat, natural disaster, war, All other designs and studies using
mstockstill on DSK30JT082PROD with NOTICES

political instability, relational [physical, I. KQs 1–3: PTSD symptom reduction, included designs that do not meet the
emotional, or sexual abuse or exposure prevention or reduction of comorbid sample size criterion.
to domestic violence], repeat medical or psychiatric conditions (e.g.,
victimizations, cumulative). coronary artery disease; depressive Language
symptoms; anxiety symptoms; suicidal Inclusion
Exclusion ideation/plans/attempts; and substance
All other. use, abuse, or dependence), remission Studies published in English.

VerDate Sep<11>2014 18:33 Jun 26, 2017 Jkt 241001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 E:\FR\FM\27JNN1.SGM 27JNN1

Federal Register / Vol. 82, No. 122 / Tuesday, June 27, 2017 / Notices 29087

Exclusion the use of appropriate automated, strengths in agency products and
Studies published in languages other electronic, mechanical, or other services and to evaluate how well it
than English. technological collection techniques or addresses the emerging needs of its data
other forms of information technology, users. Results of these surveys will be
Sharon B. Arnold, e.g., permitting electronic submission of used in future planning initiatives.
Deputy Director. responses; and (e) Assess information The data will be collected using a
[FR Doc. 2017–13394 Filed 6–26–17; 8:45 am] collection costs. combination of methodologies
BILLING CODE 4160–90–P To request additional information on appropriate to each survey. These may
the proposed project or to obtain a copy include: Evaluation forms, mail surveys,
of the information collection plan and focus groups, automated and electronic
DEPARTMENT OF HEALTH AND instruments, call (404) 639–7570 or technology (e.g., email, Web-based
HUMAN SERVICES send an email to omb@cdc.gov. Direct surveys), and telephone surveys.
written comments and/or suggestions Systematic surveys of several groups
Centers for Disease Control and regarding the items contained in this will be folded into the program. Among
Prevention notice to the Attention: CDC Desk these are Federal customers and policy
[30 Day–17–0729] Officer, Office of Management and makers, state and local officials who
Budget, Washington, DC 20503 or by fax rely on NCHS data, the broader
Agency Forms Undergoing Paperwork to (202) 395–5806. Written comments educational, research, and public health
Reduction Act Review should be received within 30 days of community, and other data users.
this notice. Respondents may include data users
The Centers for Disease Control and
Prevention (CDC) has submitted the Proposed Project who register for and/or attend NCHS
following information collection request sponsored conferences; persons who
Customer Surveys Generic Clearance
to the Office of Management and Budget access the NCHS Web site and the
for the National Center for Health
(OMB) for review and approval in detailed data available through it;
Statistics (0920–0729, Expiration 05/31/
accordance with the Paperwork consultants; and others. Respondent
2017)—Reinstatement—National Center
Reduction Act of 1995. The notice for data items may include (in broad
for Health Statistics (NCHS), Centers for
the proposed information collection is categories) information regarding
Disease Control and Prevention (CDC).
published to obtain comments from the respondent’s gender, age, occupation,
public and affected agencies. Background and Brief Description affiliation, location, etc., to be used to
Written comments and suggestions Section 306 of the Public Health characterize responses only. Other
from the public and affected agencies Service (PHS) Act (42 U.S.C. 242k), as questions will attempt to obtain
concerning the proposed collection of amended, authorizes that the Secretary information that will characterize the
information are encouraged. Your of Health and Human Services (DHHS), respondents’ familiarity with and use of
comments should address any of the acting through NCHS, shall collect NCHS data, their assessment of data
following: (a) Evaluate whether the statistics on ‘‘the extent and nature of content and usefulness, general
proposed collection of information is illness and disability of the population satisfaction with available services and
necessary for the proper performance of of the United States.’’ This is a products, and suggestions for
the functions of the agency, including reinstatement request for a generic improvement of surveys, services and
whether the information will have approval from OMB to conduct products.
practical utility; (b) Evaluate the customer surveys over the next three In order to capture anticipated
accuracy of the agencies estimate of the years at an overall burden rate of 4000 additional feedback opportunities, this
burden of the proposed collection of hours. reinstatement request allows for the
information, including the validity of As part of a comprehensive program, potential increase in both respondents
the methodology and assumptions used; the National Center for Health Statistics and time per response for a total
(c) Enhance the quality, utility, and (NCHS) plans to continue to assess its estimated annual burden total of 4,000
clarity of the information to be customers’ satisfaction with the content, hours. There is no cost to respondents
collected; (d) Minimize the burden of quality and relevance of the information other than their time to participate in
the collection of information on those it produces. NCHS will conduct the survey. The resulting information
who are to respond, including through voluntary customer surveys to assess will be for NCHS internal use.

ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondent Form name responses per
respondents response
respondent (hours)

Questionnaire for conference registrants/ Public/private researchers, Consultants, and 6,000 1 15/60
attendees. others.
Focus groups .................................................. Public/private researchers, Consultants, and 500 1 1
others.
Web-based ...................................................... Public/private researchers, Consultants, and 6,000 1 15/60
mstockstill on DSK30JT082PROD with NOTICES

others.
Other customer surveys .................................. Public/private researchers, Consultants, and 2,000 1 15/60
others.

VerDate Sep<11>2014 18:33 Jun 26, 2017 Jkt 241001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 E:\FR\FM\27JNN1.SGM 27JNN1

Document Created: 2018-11-14 10:14:42
Document Modified: 2018-11-14 10:14:42

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Request for supplemental evidence and data submissions.
Dates		Submission Deadline on or before July 27, 2017.
Contact		Ryan McKenna, Telephone: 503-220-8262 ext. 51723 or Email: [email protected]
FR Citation		82 FR 29085

82 FR 29085 - Supplemental Evidence and Data Request on Psychological and Pharmacological Treatments for Adults With Posttraumatic Stress Disorder (PTSD): A Systematic Review Update

DEPARTMENT OF HEALTH AND HUMAN SERVICESAgency for Healthcare Research and Quality

Federal Register Volume 82, Issue 122 (June 27, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality