Supplemental Evidence and Data Request on Antipsychotics for the Prevention and Treatment of Delirium: A Systematic Review, 49386-49388 [2018-21242]
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instructions to reflect the changes to the
financial disclosure regulation.
Specifically, OGE proposes to: Revise
the reporting period for termination
reports to include the entire preceding
calendar year if a required annual report
has not been filed; revise the income
disclosure requirement to include only
received income; revise the ‘‘widely
diversified’’ criterion for purposes of
determining whether a fund qualifies as
an ‘‘excepted investment fund;’’ add a
new feature (checkbox) for purposes of
managing early termination report filing
on the Integrity version of the Form
278e; clarify the Definition section of
Part 2; clarify when a source of
compensation need not be disclosed and
the method for disclosing the existence
of such sources; and eliminate the
disclosure of transactions that occurred
before the reporting individual became
subject to the public financial disclosure
requirements.
OGE is also proposing to update the
Privacy Act statement in accordance
with changes to the applicable system of
records and to make certain minor
formatting changes and corrections to
the instructions and one of the data
entry fields.
OGE published a first round notice of
its intent to request paperwork
clearance for a modified OGE Form 278e
Executive Branch Personnel Public
Financial Disclosure Report. See 83 FR
32122 (July 11, 2018). OGE received
three responses to that notice. The first
response was unrelated to the notice
and did not address the information
collection.
The second comment suggested
eliminating the requirement to report
diversified mutual funds. The financial
disclosure requirements are dictated by
the Ethics in Government Act (EIGA), 5
U.S.C. app. sec. 102, as amended. The
commenter’s suggested change could
not be made without revisions to the
EIGA. Accordingly, OGE declines to
adopt this suggestion as a modification
of the OGE Form 278e.
The third comment was from an
individual identifying himself as a
former nominee to a Presidentiallyappointed, Senate-confirmed position.
The commenter made several
suggestions about how the government
should address potential conflicts of
interest identified through the financial
disclosure review and certification
process, as well as ways that the
government could make that process
more efficient. These matters are beyond
the scope of the information collection
and cannot be addressed through the
modification of the OGE Form 278e. The
commenter also made suggestions
regarding the detail with which filers
VerDate Sep<11>2014
17:50 Sep 28, 2018
Jkt 247001
are required to report certain assets,
suggesting that the form requires
excessive reporting of ‘‘low value’’ data.
As discussed above, the financial
disclosure requirements are dictated by
the EIGA. Therefore, OGE cannot make
substantive changes to the financial
disclosure reporting requirements
through a modification of the OGE Form
278e.
Finally, the third commenter also
stated that the government’s estimate of
the reporting burden vastly understates
the actual burden for candidates with
extensive or complicated financial
holdings. In addressing this issue, the
commenter noted that completing the
form required ‘‘at least 40 hours of
work’’ by him and his family. He also
noted that the government’s cumulative
response time during the review and
certification process was 114 days. As
an initial matter, OGE notes that its
estimate of the average reporting burden
for the 278e is currently ten hours, not
three as stated by the commenter.
Moreover, the estimated burden
properly does not include the time
spent by the government in reviewing
and responding to the filers’ completed
forms. OGE’s estimated time per
response is an average based on the
estimated burden on all types of filers—
those with complicated financial
holdings and those with simpler
financial holdings. While OGE
recognizes that the burden for a filer
with extensive or complicated financial
holdings may be significantly more than
ten hours, the estimated burden for the
majority of filers is fewer than five
hours. Accordingly, OGE declines to
revise its estimated burden at this time.
Request for Comments: Agency and
public comment is again invited
specifically on the need for and
practical utility of this information
collection, the accuracy of OGE’s
burden estimate, the enhancement of
quality, utility, and clarity of the
information collected, and the
minimization of burden (including the
use of information technology).
Comments received in response to this
notice may be included with the OGE
request for approval of the modified
information collection. The comments
will also become a matter of public
record.
Approved: September 26, 2018.
Diana Veilleux,
Chief, Legal, External Affairs and
Performance Branch, Office of Government
Ethics.
[FR Doc. 2018–21270 Filed 9–28–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Antipsychotics for the
Prevention and Treatment of Delirium:
A Systematic Review
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
scientific information submissions from
the public. Scientific information is
being solicited to inform our review of
Antipsychotics for the Prevention and
Treatment of Delirium: A Systematic
Review, 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 October 31, 2018.
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:
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 Antipsychotics for the
Prevention and Treatment of Delirium:
A Systematic Review. 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
E:\FR\FM\01OCN1.SGM
01OCN1
amozie on DSK3GDR082PROD with NOTICES
Federal Register / Vol. 83, No. 190 / Monday, October 1, 2018 / Notices
literature by requesting information
from the public (e.g., details of studies
conducted). We are looking for studies
that report on Antipsychotics for the
Prevention and Treatment of Delirium:
A Systematic Review, including those
that describe adverse events. The entire
research protocol, including the key
questions, is also available online at:
https://effectivehealthcare.ahrq.gov/
topics/antipsychotics/research-protocol.
This is to notify the public that the
EPC Program would find the following
information on Antipsychotics for the
Prevention and Treatment of Delirium:
A Systematic Review 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,
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 website and
available for public comment for a
period of 4 weeks. If you would like to
VerDate Sep<11>2014
17:50 Sep 28, 2018
Jkt 247001
be notified when the draft is posted,
please sign up for the email list at:
https://www.effectivehea
lthcare.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
I. What are the benefits and harms for
antipsychotics compared to each other,
placebo, or non-drug approaches to
prevent delirium?
A. What are the benefits and harms
for antipsychotics compared to each
other, placebo, or non-drug approaches
to prevent delirium in persons aged 65
years or older?
B. What are the benefits and harms for
antipsychotics compared to each other,
placebo, or non-drug approaches to
prevent delirium in persons with
dementia?
C. What are the benefits and harms for
antipsychotics compared to each other,
placebo, or non-drug approaches to
prevent delirium in patients in an
intensive care unit?
D. What are the benefits and harms for
antipsychotics compared to each other,
placebo, or non-drug approaches to
prevent delirium in patients in a postacute care facility?
E. What are the benefits and harms for
antipsychotics compared to each other,
placebo, or non-drug approaches to
prevent delirium in patients in
palliative or hospice care?
F. What are the benefits and harms for
antipsychotics compared to each other,
placebo, or non-drug approaches to
prevent delirium in patients in postoperative care?
II. What are the benefits and harms for
antipsychotics compared to each other,
placebo, or non-drug approaches to treat
delirium?
A. What are the benefits and harms
for antipsychotics compared to each
other, placebo, or non-drug approaches
to treat delirium in persons aged 65
years or older?
B. What are the benefits and harms for
antipsychotics compared to each other,
placebo, or non-drug approaches to treat
delirium in persons with dementia?
C. What are the benefits and harms for
antipsychotics compared to each other,
placebo, or non-drug approaches to treat
delirium in patients in an intensive care
unit?
D. What are the benefits and harms for
antipsychotics compared to each other,
placebo, or non-drug approaches to treat
delirium in patients in a post-acute care
facility?
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49387
E. What are the benefits and harms for
antipsychotics compared to each other,
placebo, or non-drug approaches to treat
delirium in patients in palliative or
hospice care?
F. What are the benefits and harms for
antipsychotics compared to each other,
placebo, or non-drug approaches to treat
delirium in patients in post-operative
care?
PICOTS (Populations, Interventions,
Comparators, Outcomes, Timing,
Settings)
Population(s):
I. KQ 1: Hospitalized adults, adults in
post-acute care, adults in palliative
or hospice care, or adults in postoperative care
II. KQ 2: Hospitalized adults, adults in
post-acute care, adults in palliative
or hospice care, or adults in postoperative care who have been
diagnosed with delirium using a
validated instrument
Interventions:
I. Antipsychotic drugs, including
A. Any first-generation agent
(chlorpromazine, droperidol,
fluphenazine, haloperidol,
loxapine, molindone, perphenazine,
pimozide, prochlorperazine,
thiothixene, thioridazine,
trifluoperazine)
B. Any second-generation agent
(aripiprazole, asenapine,
brexpiprazole, cariprazine,
clozapine, iloperidone, lurasidone,
olanzapine, paliperidone,
quetiapine, risperidone,
ziprasidone)
II. We will only include studies where
the effects of the antipsychotic drugs
can be isolated.
Comparators
I. KQ 1: Non-drug approaches to
preventing delirium, placebo, active
control, usual care
II. KQ 2: Non-drug approaches to
treating delirium, placebo, active
control, usual care
Outcomes:
I. Intermediate outcomes
A. Short-term delirium symptoms
B. Delirium severity
C. Delirium-free, coma-free days alive
D. Duration of delirium
E. Patient distress
F. Use of rescue therapy
G. Use of physical restraint
II. Final health or patient-centered
outcomes
A. Mortality
B. Quality of life
C. Cognitive and emotional
functioning (includes functioning
related to memory, communication,
concentration, and understanding
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Federal Register / Vol. 83, No. 190 / Monday, October 1, 2018 / Notices
instructions)
D. Long-term cognitive impairment
(Change in cognition after delirium
that has a long-term duration or is
possibly permanent)
E. Institutionalization (living in an
assisted living facility or nursing
home)
F. Caregiver burden/strain
G. Falls
H. Memory of patient distress
III. Resource utilization
A. Re-admissions to hospital or ICU
B. Length of stay in ICU
C. Length of stay in hospital
D. Length of stay in skilled nursing
facility
E. Sitter use
F. Hospice enrollment
IV. Adverse effects of intervention(s)
A. Sedation
B. Weight gain
C. Changes in appetite
D. Cardiac effects
E. Neurologic effects
F. Paradoxical reactions
G. Hypersensitivity reactions
H. Inappropriate continuation of
antipsychotic medication
I. Swallowing difficulties
J. Aspiration pneumonia
III. Timing
A. Any duration of follow-up
IV. Settings
A. Hospital setting
B. Post-acute care setting
C. Palliative care setting
[FR Doc. 2018–21242 Filed 9–28–18; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. CDC–2018–0093; NIOSH–320]
Self-Contained Breathing Apparatus
Compressed Breathing Gas
Containers; Request for Information
Centers for Disease Control and
Prevention, HHS.
ACTION: Request for information.
AGENCY:
In October 2017, the
Department of Transportation (DOT)
issued a special permit to the Digital
Wave Corporation, allowing the
company to extend the service life of
certain carbon-fiber reinforced
aluminum-lined cylinders. Some
stakeholders, including respirator and
cylinder manufacturers, have expressed
concern to the National Institute for
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17:50 Sep 28, 2018
Jkt 247001
ADDRESSES:
Written comments: You may submit
comments by any of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments to
the docket.
• Mail: NIOSH Docket Office, Robert
A. Taft Laboratories, MS–C34, 1090
Tusculum Avenue, Cincinnati, OH
45226.
Instructions: All submissions received
must include the agency name (Centers
for Disease Control and Prevention,
HHS) and docket number (CDC–2018–
0093; NIOSH–320) for this action. All
relevant comments, including any
personal information provided, will be
posted without change to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
The
Department of Transportation approves
certain carbon-fiber reinforced
aluminum-lined cylinders (hereinafter
‘‘DOT–CFFC’’), which are commonly
used to provide breathing air in the selfcontained breathing apparatus (SCBA)
respirators typically carried by
firefighters and other industrial workers
to protect them in atmospheres
immediately dangerous to life and
health. Currently, all DOT–CFFC
approved cylinders that are a subcomponent of NIOSH-approved SCBA
have a service life of 15 years; DOT
regulations require ‘‘requalification’’
every 5 years to ensure that each
cylinder can hold its rated pressure for
the duration of the 15-year service life.
In October 2017, the DOT Pipeline
and Hazardous Materials Safety
Administration issued special permit,
DOT–SP 16320 (Third Revision), to
Digital Wave Corporation of Centennial,
SUPPLEMENTARY INFORMATION:
Centers for Disease Control and
Prevention
VerDate Sep<11>2014
Comments must be received by
November 30, 2018.
DATES:
Jeffrey Peterson, NIOSH National
Personal Protective Technology
Laboratory, 626 Cochrans Mill Road,
Pittsburgh, PA 15236; 1–888–654–2294
(this is a toll-free number);
PPEconcerns@cdc.gov.
Francis D. Chesley, Jr.,
Deputy Director.
SUMMARY:
Occupational Safety and Health
(NIOSH), within the Centers for Disease
Control and Prevention, about the safety
of cylinders extended beyond the
manufacturers’ stated service life.
NIOSH is seeking information about the
potential effect of the special permit, as
it may relate to the safety of selfcontained breathing apparatus
respirators approved by NIOSH for use
in U.S. workplaces.
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CO.1 Digital Wave Corporation
manufactures ultrasonic examination
cylinder testing equipment, modal
acoustic emission testing equipment,
and provides associated inspection
services, including the requalification of
carbon-fiber reinforced aluminum-lined
cylinders. Pursuant to DOT–SP 16320,
modal acoustic emission requalification
testing allows DOT–CFFC cylinders to
be authorized for use for 5 years after
the original 15-year service life;
cylinders could be requalified three
times beyond the original 15-year
service life, for a total service life of 30
years.
Modal acoustic emission testing is an
advanced, non-destructive evaluation of
carbon-fiber reinforced aluminum-lined
cylinders that detects structural damage
which can compromise burst pressure
strength in a composite overwrapped
pressure vessel. The modal acoustic
emission waveforms can be used to
identify damage such as fiber breakage
and delamination. Some stakeholders
have expressed concerns regarding
potential cylinder failure when the
service life is extended past the service
life identified on the original special
permit. Since DOT–SP 16320 was
issued, more than 3,500 carbon-fiber
reinforced aluminum-lined cylinders
have been requalified beyond their
original 15-year service life using the
modal acoustic emission method.
NIOSH has published guidance
advising SCBA users who may be
concerned about using modal acoustic
emission-requalified cylinders as part of
their NIOSH-approved SCBA
configuration to review the user
instructions, supplemental
informational inserts, safety
precautions, and SCBA warranty
information provided by the NIOSH
approval holder.2 The guidance further
encourages approval holders to provide
respiratory protection program
administrators and SCBA users with
current recommendations regarding the
DOT–SP 16320 requalification method
with regard to service life limitations or
other relevant matters.
NIOSH seeks to better understand the
use of modal acoustic emission testing
to requalify DOT–CFFC cylinders
beyond the original 15-year service life,
as permitted by DOT–SP 16320, as well
as the safety and health concerns of
users in industrial settings, including
the fire service and first responders.
1 DOT Pipeline and Hazardous Materials Safety
Administration, DOT–SP 16320, https://
www.phmsa.dot.gov/approvals-and-permits/
hazmat/file-serve/offer/SP16320.pdf/offerserver/
SP16320.
2 https://www.cdc.gov/niosh/npptl/resources/
pressrel/letters/respprotect/CA-2018-1006.html.
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]]>Agencies
[Federal Register Volume 83, Number 190 (Monday, October 1, 2018)]
[Notices]
[Pages 49386-49388]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21242]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Antipsychotics for the
Prevention and Treatment of Delirium: A Systematic Review
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 Antipsychotics
for the Prevention and Treatment of Delirium: A Systematic Review,
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 October 31, 2018.
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 Antipsychotics for the
Prevention and Treatment of Delirium: A Systematic Review. 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
[[Page 49387]]
literature by requesting information from the public (e.g., details of
studies conducted). We are looking for studies that report on
Antipsychotics for the Prevention and Treatment of Delirium: A
Systematic Review, including those that describe adverse events. The
entire research protocol, including the key questions, is also
available online at: https://effectivehealthcare.ahrq.gov/topics/antipsychotics/research-protocol.
This is to notify the public that the EPC Program would find the
following information on Antipsychotics for the Prevention and
Treatment of Delirium: A Systematic Review 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, 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
website 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/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
I. What are the benefits and harms for antipsychotics compared to
each other, placebo, or non-drug approaches to prevent delirium?
A. What are the benefits and harms for antipsychotics compared to
each other, placebo, or non-drug approaches to prevent delirium in
persons aged 65 years or older?
B. What are the benefits and harms for antipsychotics compared to
each other, placebo, or non-drug approaches to prevent delirium in
persons with dementia?
C. What are the benefits and harms for antipsychotics compared to
each other, placebo, or non-drug approaches to prevent delirium in
patients in an intensive care unit?
D. What are the benefits and harms for antipsychotics compared to
each other, placebo, or non-drug approaches to prevent delirium in
patients in a post-acute care facility?
E. What are the benefits and harms for antipsychotics compared to
each other, placebo, or non-drug approaches to prevent delirium in
patients in palliative or hospice care?
F. What are the benefits and harms for antipsychotics compared to
each other, placebo, or non-drug approaches to prevent delirium in
patients in post-operative care?
II. What are the benefits and harms for antipsychotics compared to
each other, placebo, or non-drug approaches to treat delirium?
A. What are the benefits and harms for antipsychotics compared to
each other, placebo, or non-drug approaches to treat delirium in
persons aged 65 years or older?
B. What are the benefits and harms for antipsychotics compared to
each other, placebo, or non-drug approaches to treat delirium in
persons with dementia?
C. What are the benefits and harms for antipsychotics compared to
each other, placebo, or non-drug approaches to treat delirium in
patients in an intensive care unit?
D. What are the benefits and harms for antipsychotics compared to
each other, placebo, or non-drug approaches to treat delirium in
patients in a post-acute care facility?
E. What are the benefits and harms for antipsychotics compared to
each other, placebo, or non-drug approaches to treat delirium in
patients in palliative or hospice care?
F. What are the benefits and harms for antipsychotics compared to
each other, placebo, or non-drug approaches to treat delirium in
patients in post-operative care?
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing,
Settings)
Population(s):
I. KQ 1: Hospitalized adults, adults in post-acute care, adults in
palliative or hospice care, or adults in post-operative care
II. KQ 2: Hospitalized adults, adults in post-acute care, adults in
palliative or hospice care, or adults in post-operative care who have
been diagnosed with delirium using a validated instrument
Interventions:
I. Antipsychotic drugs, including
A. Any first-generation agent (chlorpromazine, droperidol,
fluphenazine, haloperidol, loxapine, molindone, perphenazine, pimozide,
prochlorperazine, thiothixene, thioridazine, trifluoperazine)
B. Any second-generation agent (aripiprazole, asenapine,
brexpiprazole, cariprazine, clozapine, iloperidone, lurasidone,
olanzapine, paliperidone, quetiapine, risperidone, ziprasidone)
II. We will only include studies where the effects of the
antipsychotic drugs can be isolated.
Comparators
I. KQ 1: Non-drug approaches to preventing delirium, placebo, active
control, usual care
II. KQ 2: Non-drug approaches to treating delirium, placebo, active
control, usual care
Outcomes:
I. Intermediate outcomes
A. Short-term delirium symptoms
B. Delirium severity
C. Delirium-free, coma-free days alive
D. Duration of delirium
E. Patient distress
F. Use of rescue therapy
G. Use of physical restraint
II. Final health or patient-centered outcomes
A. Mortality
B. Quality of life
C. Cognitive and emotional functioning (includes functioning
related to memory, communication, concentration, and understanding
[[Page 49388]]
instructions)
D. Long-term cognitive impairment (Change in cognition after
delirium that has a long-term duration or is possibly permanent)
E. Institutionalization (living in an assisted living facility or
nursing home)
F. Caregiver burden/strain
G. Falls
H. Memory of patient distress
III. Resource utilization
A. Re-admissions to hospital or ICU
B. Length of stay in ICU
C. Length of stay in hospital
D. Length of stay in skilled nursing facility
E. Sitter use
F. Hospice enrollment
IV. Adverse effects of intervention(s)
A. Sedation
B. Weight gain
C. Changes in appetite
D. Cardiac effects
E. Neurologic effects
F. Paradoxical reactions
G. Hypersensitivity reactions
H. Inappropriate continuation of antipsychotic medication
I. Swallowing difficulties
J. Aspiration pneumonia
III. Timing
A. Any duration of follow-up
IV. Settings
A. Hospital setting
B. Post-acute care setting
C. Palliative care setting
Francis D. Chesley, Jr.,
Deputy Director.
[FR Doc. 2018-21242 Filed 9-28-18; 8:45 am]
BILLING CODE 4160-90-P
