Supplemental Evidence and Data Request on Prehospital Airway Management, 12559-12561 [2020-04253]
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Federal Register / Vol. 85, No. 42 / Tuesday, March 3, 2020 / Notices
BLS) mechanism. While ICLS supported
only lines used to provide traditional
voice service (including voice service
bundled with broadband service), CAF–
BLS also supports consumer broadbandonly loops. In March 2016, the
Commission adopted the Rate-of-Return
Reform Order to continue modernizing
the universal service support
mechanisms for rate-of-return carriers.
The Rate-of-Return Reform Order
replaced the Interstate Common Line
Support (ICLS) mechanism with the
Connect America Fund—Broadband
Loop Support (CAF–BLS) mechanism.
While ICLS supported only lines used to
provide traditional voice service
(including voice service bundled with
broadband service), CAF–BLS also
supports consumer broadband-only
loops. For the purposes of calculating
and monitoring CAF–BLS, rate-of-return
carriers that receive CAF–BLS must file
common line and consumer broadbandonly loop counts on FCC Form 507,
forecasted common line and consumer
broadband-only loop costs and revenues
on FCC Form 508, and actual common
line and consumer broadband-only loop
costs and revenues on FCC Form 509.
See 47 CFR 54.903(a).
In December 2018, the Commission
adopted the December 2018 Rate-ofReturn Reform Order to require rate-ofreturn carriers that receive Alternative
Connect American Model (A–CAM) or
Alaska Plan support to file line count
data on FCC Form 507 as a condition of
high-cost support. Historically, all rateof-return carriers received CAF BLS or,
prior to that, ICLS, and were required to
file line count data on FCC Form 507 as
a condition of that support. In recent
years, some rate-of-return carriers have
elected to receive A–CAM I, A–CAM II,
or Alaska Plan instead, and those
carriers were not required to file line
count data because the requirement to
file applied only to rate-of-return
carriers receiving CAF BLS. In order to
restore a data set that the Commission
relied on to evaluate the effectiveness of
its high-cost universal service programs,
the Commission revised its rules in that
Order to require all rate-of-return
carriers to file that data. While carriers
receiving CAF–BLS must file the line
count data on March 31 for line counts
as of the prior December 31, the A–CAM
I, A–CAM II, and Alaska Plan carriers
will be required to file on July 1 of each
year to coincide with other existing
requirements in OMB Control No. 3060–
0986. Connect America Fund et al., WC
Docket No. 10–90 et al., Report and
Order, Further Notice of Proposed
Rulemaking and Order on
Reconsideration, 33 FCC Rcd 11893
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(2018) (2018 Rate-of-Return Reform
Order). See also 47 CFR 54.313(f)(5).
The Commission therefore proposes
to revise this information collection. We
also propose to increase the burdens
associated with existing reporting
requirements to account for additional
carriers that will be subject to those
requirements.
Sarah Cudahy,
General Counsel.
Federal Communications Commission.
Marlene Dortch,
Secretary, Office of the Secretary.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2020–04330 Filed 3–2–20; 8:45 am]
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[FR Doc. 2020–04261 Filed 3–2–20; 8:45 am]
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Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Prehospital Airway
Management
FEDERAL MEDIATION AND
CONCILIATION SERVICE
SUMMARY:
all FMCS guidance documents currently
in effect, which may be accessed at
https://www.fmcs.gov/guidance-portal/.
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 on
Prehospital Airway Management, 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 the date of
publication of this notice.
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 Prehospital Airway
Management. AHRQ is conducting this
systematic review pursuant to Section
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Federal Register / Vol. 85, No. 42 / Tuesday, March 3, 2020 / Notices
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 Prehospital Airway
Management, including those that
describe adverse events. The entire
research protocol is available online at:
https://effectivehealthcare.ahrq.gov/
products/prehospital-airwaymanagement/protocol.
This is to notify the public that the
EPC Program would find the following
information on Prehospital Airway
Management 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
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.
Key Questions (KQ)
Key Question 1
a. What are the comparative benefits
and harms of bag valve mask versus
supraglottic airway for patients
requiring prehospital ventilatory
support or airway protection?
b. Are the comparative benefits and
harms modified by:
i. Techniques or devices used?
ii. Characteristics of emergency
medical services personnel (including
training, proficiency, experience, etc.)?
iii. Patient characteristics?
Key Question 2
a. What are the comparative benefits
and harms of bag valve mask versus
endotracheal intubation for patients
requiring prehospital ventilatory
support or airway protection?
b. Are the comparative benefits and
harms modified by:
i. Techniques or devices used?
ii. Characteristics of emergency
medical services personnel (including
training, proficiency, experience, etc.)?
iii. Patient characteristics?
Key Question 3
a. What are the comparative benefits
and harms of supraglottic airway versus
endotracheal intubation for patients
requiring prehospital ventilatory
support or airway protection?
b. Are the comparative benefits and
harms modified by:
i. Techniques or devices used?
ii. Characteristics of emergency
medical services personnel (including
training, proficiency, experience, etc.)?
iii. Patient characteristics?
Key Question 4
What are the comparative benefits and
harms of the following variations of any
one of the three included airway
interventions (bag valve mask,
supraglottic airways, or endotracheal
intubation) for patients requiring
prehospital ventilatory support or
airway protection:
i. Techniques or devices used?
ii. Characteristics of emergency
medical services personnel (including
training, proficiency, experience, etc.)?
iii. Patient characteristics?
PICOS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, SETTINGS, STUDY DESIGN SETTINGS)
PICOS
Inclusion criteria
Exclusion criteria
Populations ......................................
Patients requiring prehospital ventilatory support or airway protection
who are treated in the prehospital setting by emergency medical
services personnel (paramedic, advanced emergency medical technician, emergency medical technician, emergency medical responder, etc.).
• Bag valve mask ventilation ................................................................
• Supraglottic airway insertion, including dual-lumen airways.
• Endotracheal intubation.
Æ Via direct laryngoscopy with or without RSI or DSI.
Æ Via video laryngoscopy with or without RSI or DSI.
KQ1: bag valve mask vs. supraglottic airway .......................................
KQ2: bag valve mask vs. endotracheal intubation.
KQ3: supraglottic airway vs. endotracheal intubation.
KQ4: different techniques for any one of the three included types of
airways.
• Patients treated with naloxone
to reverse opioid-related respiratory failure.
• Patients cared for in other than
the prehospital setting.
• Nasotracheal intubation.
• Percutaneous devices.
• Surgical airway procedures.
• CPAP and BiPAP.
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Interventions ....................................
Comparators ....................................
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PICOS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, SETTINGS, STUDY DESIGN SETTINGS)—Continued
PICOS
Inclusion criteria
Exclusion criteria
Outcomes ........................................
Patient Health Outcomes (highest priority) ...........................................
• Mortality/survival.
Æ To arrival at hospital.
Æ To hospital discharge.
Æ Any period less than or equal to 30 days post-injury.
• Morbidity.
Æ Glasgow Outcome Scale, Glasgow Outcome Scale Extended,
Modified Rankin Scale, Cerebral Performance Category.
Æ Pneumothorax.
Æ Aspiration pneumonia.
• Length of Stay.
Æ Hospital length of stay (days).
Æ ICU length of stay (days).
Æ ICU-free days.
Intermediate Outcomes (secondary priority).
• Overall success rate.
• First pass success rate.
• Number of prehospital attempts to secure an airway.
• EtCO2 values.
• Effective oxygenation.
• Effective ventilation.
• Definitive Airway Sans Hypoxia/Hypotension on First Attempt
(DASH–1A).
Adverse Events/Harms.
• Vomiting.
• Gastric content aspiration.
• Hypoxia (SpO2<90%).
• Hyperventilation (EtCO2<35).
• Hypoventilation (EtCO2>45).
• Hypotension.
• Oral trauma, airway trauma.
• Barotrauma.
• Misplaced tube.
• Need for additional airway interventions.
• Prehospital .........................................................................................
• ED only if needed to fill important gaps where there are no
prehospital studies.
• International studies in English language.
Long-term outcomes (more than
30 days post-injury).
Setting .............................................
Study Design ...................................
• RCTs ..................................................................................................
If RCTs do not provide sufficient evidence, the following designs will
be included:
• Prospective comparative studies.
• Retrospective comparative studies.
• Case control studies.
Airway studies conducted in cadaver labs, or simulated environments; operating rooms; or
inpatient.
ED
studies
if
prehospital studies of the topic
are available.
• Systematic reviews (we will use
reference lists to identify studies
for possible inclusion).
• Case series.
• Descriptive studies.
• Letters to the editor.
• Opinion papers.
• Studies published prior to 1990.
BiPAP = bilevel positive airway pressure; CPAP = continuous positive airway pressure; DSI = delayed sequence intubation; ED = emergency
department; ICU = intensive care unit; KQ = Key Question; RCT = randomized controlled trial; RSI = rapid sequence intubation
Dated: 26 February 2020.
Virginia L. Mackay-Smith,
Associate Director, Office of the Director,
AHRQ.
[FR Doc. 2020–04253 Filed 3–2–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
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Agency for Healthcare Research and
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Meeting of the National Advisory
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Quality
Agency for Healthcare Research
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ACTION: Notice of public meeting.
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AGENCY:
This notice announces a
meeting of the National Advisory
Council for Healthcare Research and
Quality.
SUMMARY:
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The meeting will be held on
Thursday, March 26, 2020, from 8:30
a.m. to 2:45 p.m.
DATES:
The meeting will be held at
AHRQ, 5600 Fishers Lane, Rockville,
Maryland 20857.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Jaime Zimmerman, Designated
Management Official, at the Agency for
Healthcare Research and Quality, 5600
Fishers Lane, Mail Stop 06E37A,
Rockville, Maryland 20857, (301) 427–
1456. For press-related information,
please contact Bruce Seeman at (301)
427–1998 or Bruce.Seeman@
AHRQ.hhs.gov.
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[Federal Register Volume 85, Number 42 (Tuesday, March 3, 2020)]
[Notices]
[Pages 12559-12561]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04253]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Prehospital Airway
Management
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 Prehospital
Airway Management, 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 the date of
publication of this notice.
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 Prehospital Airway
Management. AHRQ is conducting this systematic review pursuant to
Section
[[Page 12560]]
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 Prehospital Airway Management, including those that
describe adverse events. The entire research protocol is available
online at: https://effectivehealthcare.ahrq.gov/products/prehospital-airway-management/protocol.
This is to notify the public that the EPC Program would find the
following information on Prehospital Airway Management 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 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.
Key Questions (KQ)
Key Question 1
a. What are the comparative benefits and harms of bag valve mask
versus supraglottic airway for patients requiring prehospital
ventilatory support or airway protection?
b. Are the comparative benefits and harms modified by:
i. Techniques or devices used?
ii. Characteristics of emergency medical services personnel
(including training, proficiency, experience, etc.)?
iii. Patient characteristics?
Key Question 2
a. What are the comparative benefits and harms of bag valve mask
versus endotracheal intubation for patients requiring prehospital
ventilatory support or airway protection?
b. Are the comparative benefits and harms modified by:
i. Techniques or devices used?
ii. Characteristics of emergency medical services personnel
(including training, proficiency, experience, etc.)?
iii. Patient characteristics?
Key Question 3
a. What are the comparative benefits and harms of supraglottic
airway versus endotracheal intubation for patients requiring
prehospital ventilatory support or airway protection?
b. Are the comparative benefits and harms modified by:
i. Techniques or devices used?
ii. Characteristics of emergency medical services personnel
(including training, proficiency, experience, etc.)?
iii. Patient characteristics?
Key Question 4
What are the comparative benefits and harms of the following
variations of any one of the three included airway interventions (bag
valve mask, supraglottic airways, or endotracheal intubation) for
patients requiring prehospital ventilatory support or airway
protection:
i. Techniques or devices used?
ii. Characteristics of emergency medical services personnel
(including training, proficiency, experience, etc.)?
iii. Patient characteristics?
PICOS (Populations, Interventions, Comparators, Outcomes, Settings,
Study Design Settings)
------------------------------------------------------------------------
Exclusion
PICOS Inclusion criteria criteria
------------------------------------------------------------------------
Populations................... Patients requiring
prehospital Patients
ventilatory support treated with
or airway protection naloxone to
who are treated in reverse opioid-
the prehospital related
setting by emergency respiratory
medical services failure.
personnel (paramedic,
advanced emergency Patients cared
medical technician, for in other
emergency medical than the
technician, emergency prehospital
medical responder, setting.
etc.).
Interventions................. Bag valve
mask ventilation. Nasotracheal
Supraglottic intubation.
airway insertion,
including dual-lumen Percutaneous
airways.. devices.
Endotracheal
intubation.. Surgical airway
[cir] Via direct procedures.
laryngoscopy with or CPAP
without RSI or DSI.. and BiPAP.
[cir] Via video
laryngoscopy with or
without RSI or DSI..
Comparators................... KQ1: bag valve mask No
vs. supraglottic airway
airway. management.
KQ2: bag valve mask
vs. endotracheal
intubation..
KQ3: supraglottic
airway vs.
endotracheal
intubation..
KQ4: different
techniques for any
one of the three
included types of
airways..
[[Page 12561]]
Outcomes...................... Patient Health Long-term
Outcomes (highest outcomes (more
priority). than 30 days
Mortality/ post-injury).
survival..
[cir] To arrival at
hospital..
[cir] To hospital
discharge..
[cir] Any period less
than or equal to 30
days post-injury..
Morbidity.
[cir] Glasgow
Outcome Scale,
Glasgow Outcome
Scale Extended,
Modified Rankin
Scale, Cerebral
Performance
Category..
[cir] Pneumothorax.
[cir] Aspiration
pneumonia..
Length of
Stay.
[cir] Hospital
length of stay
(days)..
[cir] ICU length of
stay (days)..
[cir] ICU-free
days..
Intermediate Outcomes
(secondary priority).
Overall
success rate.
First pass
success rate.
Number of
prehospital attempts
to secure an airway.
EtCO2 values.
Effective
oxygenation.
Effective
ventilation.
Definitive
Airway Sans Hypoxia/
Hypotension on First
Attempt (DASH-1A).
Adverse Events/Harms..
Vomiting.
Gastric
content aspiration.
Hypoxia
(SpO2<90%).
Hyperventilation
(EtCO2<35).
Hypoventilation
(EtCO2>45).
Hypotension.
Oral trauma,
airway trauma.
Barotrauma.
Misplaced
tube.
Need for
additional airway
interventions.
Setting....................... Prehospital.. Airway studies
ED only if conducted in
needed to fill cadaver labs,
important gaps where or simulated
there are no environments;
prehospital studies.. operating
International rooms; or
studies in English inpatient. ED
language.. studies if
prehospital
studies of the
topic are
available.
Study Design.................. RCTs.........
If RCTs do not provide Systematic
sufficient evidence, reviews (we
the following designs will use
will be included:. reference lists
Prospective to identify
comparative studies.. studies for
Retrospective possible
comparative studies.. inclusion).
Case control Case
studies.. series.
Descriptive
studies.
Letters
to the editor.
Opinion
papers.
Studies
published prior
to 1990.
------------------------------------------------------------------------
BiPAP = bilevel positive airway pressure; CPAP = continuous positive
airway pressure; DSI = delayed sequence intubation; ED = emergency
department; ICU = intensive care unit; KQ = Key Question; RCT =
randomized controlled trial; RSI = rapid sequence intubation
Dated: 26 February 2020.
Virginia L. Mackay-Smith,
Associate Director, Office of the Director, AHRQ.
[FR Doc. 2020-04253 Filed 3-2-20; 8:45 am]
BILLING CODE 4160-90-P
