Supplemental Evidence and Data Request on Prehospital EMS Blood Transfusion and Fluid Interventions for Hemorrhagic Shock, 93293-93296 [2024-27679]
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Federal Register / Vol. 89, No. 228 / Tuesday, November 26, 2024 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Prehospital EMS Blood
Transfusion and Fluid Interventions for
Hemorrhagic Shock
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for Supplemental
Evidence and Data Submission
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 EMS Blood Transfusion and
Fluid Interventions for Hemorrhagic
Shock, 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Access to published and unpublished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 December 26, 2024.
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:
lotter on DSK11XQN23PROD with NOTICES1
FOR FURTHER INFORMATION CONTACT:
Kelly Carper, Telephone: 301–427–1656
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 EMS Blood
Transfusion and Fluid Interventions for
Hemorrhagic Shock. AHRQ is
conducting this review pursuant to
Section 902 of the Public Health Service
Act, 42 U.S.C. 299a.
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
VerDate Sep<11>2014
18:03 Nov 25, 2024
Jkt 265001
from the public (e.g., details of studies
conducted). We are looking for studies
that report on Prehospital EMS Blood
Transfusion and Fluid Interventions for
Hemorrhagic Shock. The entire research
protocol is available online at: https://
effectivehealthcare.ahrq.gov/products/
ems-blood-transfusion/protocol.
This is to notify the public that the
EPC Program would find the following
information on Prehospital EMS Blood
Transfusion and Fluid Interventions for
Hemorrhagic Shock helpful:
D A list of completed studies that
your organization has sponsored for this
topic. 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, if relevant: 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
topic. In the list, please provide the
ClinicalTrials.gov trial number or, if the
trial is not registered, the protocol for
the study including, if relevant, 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 topic 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 topics 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://effectivehealthcare.ahrq.gov/
email-updates.
PO 00000
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93293
The 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)
KQ 1
a. What are the benefits and harms of
transfusion of whole blood for patients
requiring prehospital hemorrhagic
shock resuscitation?
b. Are the benefits and harms
modified by:
i. EMS protocols (including but not
limited to transfusion volume, adjuvant
medication coadministration such as
tranexamic acid [TXA] and calcium
salts, or crystalloid fluid coinfusion;
transfusion equipment, and transfusion
route)?
ii. Patient characteristics (including
but not limited to age, sex,
comorbidities, preexisting medications
[anti-platelets, anti-coagulants, heart
rate control medications], or mechanism
of injury/condition)?
iii. Characteristics of the EMS system
(including air/helicopter medical
ambulance, ground ambulance, EMS
clinician certification, or service
delivery model [such as fire-based,
private, third service], and logistics
related to blood administrations
[intercept model, blood stored on
ambulance])?
KQ 2
a. What are the benefits and harms of
transfusion of PRBCs for patients
requiring prehospital hemorrhagic
shock resuscitation?
b. Are the benefits and harms
modified by:
i. EMS protocols (including but not
limited to transfusion volume, adjuvant
medication coadministration such as
TXA and calcium salts, or crystalloid
fluid coinfusion; transfusion equipment,
and transfusion route)?
ii. Patient characteristics (including
but not limited to age, sex,
comorbidities, preexisting medications
[anti-platelets, anti-coagulants, heart
rate control medications], or mechanism
of injury/condition)?
iii. Characteristics of the EMS system
(including air/helicopter medical
ambulance, ground ambulance, EMS
clinician certification, or service
delivery model [such as fire-based,
private, third service], and logistics
related to blood administrations
[intercept model, blood stored on
ambulance])?
KQ 3
a. What are the benefits and harms of
transfusion of plasma for patients
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26NON1
93294
Federal Register / Vol. 89, No. 228 / Tuesday, November 26, 2024 / Notices
requiring prehospital hemorrhagic
shock resuscitation?
b. Are the benefits and harms
modified by:
i. EMS protocols (including but not
limited to transfusion volume, adjuvant
medication coadministration such as
TXA and calcium salts, or crystalloid
fluid coinfusion, transfusion equipment,
and transfusion route)?
ii. Patient characteristics (including
but not limited to age, sex,
comorbidities, preexisting medications
[anti-platelets, anti-coagulants, heart
rate control medications], or mechanism
of injury/condition)?
iii. Characteristics of the EMS system
(including air/helicopter medical
ambulance, ground ambulance, EMS
clinician certification, or service
delivery model [such as fire-based,
private, third service], logistics related
to blood administrations [intercept
model, blood stored on ambulance])?
KQ 4
a. What are the benefits and harms of
infusion of crystalloid fluids for patients
requiring prehospital hemorrhagic
shock resuscitation?
b. Are the benefits and harms
modified by:
i. EMS protocols (including but not
limited to volume infused, or adjuvant
medication coadministration such as
TXA and calcium salts, or transfusion
equipment and transfusion route)?
ii. Patient characteristics (including
but not limited to age, sex,
comorbidities, preexisting medications
[anti-platelets, anti-coagulants, heart
rate control medications], or mechanism
of injury/condition)?
iii. Characteristics of the EMS system
(such as air/helicopter medical
ambulance, ground ambulance,
personnel certification, or service
delivery model [such as fire-based,
private, third service], and logistics
related to blood administrations
[intercept model, blood stored on
ambulance])?
KQ 5
a. What are the benefits and harms of
different strategies (therapeutic,
logistical, or both combined) and
interventions (whole blood, PRBCs,
plasma, and crystalloid fluid) for
patients requiring prehospital
hemorrhagic shock resuscitation?
b. Are the benefits and harms
modified by:
i. EMS protocol (including but not
limited to transfusion volume, adjuvant
medication coadministration such as
TXA and calcium salts, or crystalloid
fluid coinfusion, and transfusion
equipment and transfusion route)?
ii. Patient characteristics (including
but not limited to age, sex, nature of
illness, comorbidities, preexisting
medications [anti-platelets, anticoagulants, heart rate control
medications], or mechanism of injury/
condition)?
iii. Characteristics of the EMS system
(including air/helicopter medical
ambulance, ground ambulance, EMS
clinician certification, or service
delivery model [such as fire-based,
private, third service], logistics related
to blood administrations [intercept
model, blood stored on ambulance])?
KQ 6
What specific areas of future research
are essential for closing existing
evidence gaps surrounding prehospital
hemorrhagic shock resuscitation and
prehospital blood transfusion? What are
the precise scientific questions, optimal
study designs, targeted study
populations, and the various transfusion
intervention protocols that need to be
studied?
Contextual Question (CQ)
CQ 1
What are the barriers to and
facilitators of implementation of
effective prehospital blood product
transfusion programs utilizing a
systems-level approach? Barriers and
facilitators could include EMS agency
costs, EMS agency reimbursement, cost
effectiveness, blood product
maintenance and logistics, partnerships
with blood banks, medical oversight
including real-time medical direction,
and diagnostic tools.
PICOTS (Populations, Interventions,
Comparators, Outcomes, Timing, and
Setting)
PRELIMINARY PICOTS CRITERIA
PICOTS
Inclusion criteria
Exclusion criteria
Populations ......................................
• Patients requiring prehospital hemorrhagic shock resuscitation
treated in the prehospital setting by emergency medical services
clinicians.
Intervention ......................................
•
•
•
•
•
•
•
•
• Individuals who do not require
prehospital hemorrhagic shock
resuscitation.
• Individuals not treated by emergency medical services clinicians.
• Other types of resuscitation.
lotter on DSK11XQN23PROD with NOTICES1
Comparator .....................................
Outcomes ........................................
KQ1: whole blood ..............................................................................
KQ2: PRBCs.
KQ3: plasma (e.g., fresh frozen, liquid, dried, etc.).
KQ4: crystalloid fluids.
KQ5: strategies as specified in each publication.
KQ6: NA.
CQ1: NA.
KQ1 to 4 .............................................................................................
Æ Head-to-head comparisons between transfusion options to
treat prehospital hemorrhagic shock patients.
Æ Comparison to usual care as specified in each publication in
another group or time period.
• KQ5: strategies as specified in each publication.
• KQ6: NA.
• CQ1: NA.
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-emergency.
• Morbidity after discharge.
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• KQ1 to KQ5: no comparison.
• Cost-effectiveness,
comes.
26NON1
other
out-
Federal Register / Vol. 89, No. 228 / Tuesday, November 26, 2024 / Notices
93295
PRELIMINARY PICOTS CRITERIA—Continued
PICOTS
Inclusion criteria
Exclusion criteria
Timing ..............................................
Æ Glasgow Outcome Scale, Glasgow Outcome Scale Extended,
Modified Rankin Scale, Cerebral Performance Category.
• Length of stay.
Æ Hospital free days.
Æ ICU free days.
Intermediate Outcomes in the prehospital or ED setting.
• Physiological indicators (including but not limited to the following).
Æ Systolic blood pressure.
Æ Diastolic blood pressure.
Æ Mean arterial pressure.
Æ Heart rate.
Æ Respiratory rate.
Æ Respiratory failure.
Æ ROSC.
Æ Shock index.
Æ Body temperature.
Æ End tidal CO2 (EtCO2).
Æ Level of Consciousness.
D GCS.
D AVPU.
Æ Blood lactate level.
Process Outcomes.
• Time from EMS arrival to initial transfusion of blood product or infusion of crystalloid fluid.
• Amount of blood product transfused or crystalloid fluid infused
(total: prehospital and hospital) vs. (hospital only).
Adverse Events/Harms (including but not limited to the following).
• Allergic reaction.
• Febrile nonhemolytic reaction.
• Acute hemolytic reaction.
• Transfusion-related acute lung injury [TRALI].
• Transfusion-associated circulatory overload [TACO].
• Infection.
• Fluid overload.
• Citrate toxicity.
• Delay to definitive care based on arrival time.
• Isoimmunization.
• Hemolysis.
• Harms related to the method of administration.
• Risk of clotting when Ringer’s lactate solution combined with blood.
• Outcomes up to 30 days post-injury ..................................................
Setting .............................................
• Prehospital .........................................................................................
• US and International studies published in English language from
Very High and High HDI a countries..
Study Design ...................................
• RCTs ..................................................................................................
•
•
•
•
•
Prospective comparative studies .......................................................
Retrospective comparative studies ....................................................
Case control studies ..........................................................................
Before/after studies ............................................................................
Time series ........................................................................................
lotter on DSK11XQN23PROD with NOTICES1
• For CQ1 only: qualitative studies that specifically collect data about
barriers to and facilitators of implementing prehospital blood product transfusion programs (e.g., descriptive case studies, evaluations, QI reports), interviews, focus groups.
• Outcomes more than 30 days
post-injury.
• ED.
• Inpatient, surgery.
• Studies conducted in countries
rated less than High in the
HDI a.
• 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,
to focus on contemporary evidence and practices relevant to
current prehospital hemorrhagic
shock resuscitation protocols.
Abbreviations: AVPU = Alert, Voice, Pain, Unresponsive; CQ = Contextual Question; ED = emergency department; EMS = emergency medical
services; GCS = Glasgow Coma Scale; HDI = Human Development Index; ICU = intensive care unit; KQ = Key Question; NA = not applicable;
PICOTS = population, interventions, comparators, outcomes, timing, and setting; PRBC = packed red blood cell; QI = quality improvement; RCT
= randomized controlled trial; ROSC = return of spontaneous circulation.
a United Nations Development Programme. Human Development Index. Retrieved from https://hdr.undp.org/data-center/human-developmentindex#/indicies/HDI.
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93296
Federal Register / Vol. 89, No. 228 / Tuesday, November 26, 2024 / Notices
Dated: November 21, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024–27679 Filed 11–25–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60 Day–25–0728; Docket No. CDC–2024–
0095]
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This data collection provides the official
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identified by Docket No. CDC–2024–
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the information collection plan and
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ADDRESSES:
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Information Collection Review Office,
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]]>Agencies
[Federal Register Volume 89, Number 228 (Tuesday, November 26, 2024)]
[Notices]
[Pages 93293-93296]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-27679]
[[Page 93293]]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Prehospital EMS Blood
Transfusion and Fluid Interventions for Hemorrhagic Shock
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for Supplemental Evidence and Data Submission
-----------------------------------------------------------------------
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 EMS
Blood Transfusion and Fluid Interventions for Hemorrhagic Shock, 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 December 26, 2024.
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: Kelly Carper, Telephone: 301-427-1656
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 EMS Blood
Transfusion and Fluid Interventions for Hemorrhagic Shock. AHRQ is
conducting this review pursuant to Section 902 of the Public Health
Service Act, 42 U.S.C. 299a.
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 EMS Blood Transfusion and Fluid
Interventions for Hemorrhagic Shock. The entire research protocol is
available online at: https://effectivehealthcare.ahrq.gov/products/ems-blood-transfusion/protocol.
This is to notify the public that the EPC Program would find the
following information on Prehospital EMS Blood Transfusion and Fluid
Interventions for Hemorrhagic Shock helpful:
[ssquf] A list of completed studies that your organization has
sponsored for this topic. 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, if
relevant: 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 topic. In the list, please provide the
ClinicalTrials.gov trial number or, if the trial is not registered, the
protocol for the study including, if relevant, 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 topic 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 topics 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://effectivehealthcare.ahrq.gov/email-updates.
The 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)
KQ 1
a. What are the benefits and harms of transfusion of whole blood
for patients requiring prehospital hemorrhagic shock resuscitation?
b. Are the benefits and harms modified by:
i. EMS protocols (including but not limited to transfusion volume,
adjuvant medication coadministration such as tranexamic acid [TXA] and
calcium salts, or crystalloid fluid coinfusion; transfusion equipment,
and transfusion route)?
ii. Patient characteristics (including but not limited to age, sex,
comorbidities, preexisting medications [anti-platelets, anti-
coagulants, heart rate control medications], or mechanism of injury/
condition)?
iii. Characteristics of the EMS system (including air/helicopter
medical ambulance, ground ambulance, EMS clinician certification, or
service delivery model [such as fire-based, private, third service],
and logistics related to blood administrations [intercept model, blood
stored on ambulance])?
KQ 2
a. What are the benefits and harms of transfusion of PRBCs for
patients requiring prehospital hemorrhagic shock resuscitation?
b. Are the benefits and harms modified by:
i. EMS protocols (including but not limited to transfusion volume,
adjuvant medication coadministration such as TXA and calcium salts, or
crystalloid fluid coinfusion; transfusion equipment, and transfusion
route)?
ii. Patient characteristics (including but not limited to age, sex,
comorbidities, preexisting medications [anti-platelets, anti-
coagulants, heart rate control medications], or mechanism of injury/
condition)?
iii. Characteristics of the EMS system (including air/helicopter
medical ambulance, ground ambulance, EMS clinician certification, or
service delivery model [such as fire-based, private, third service],
and logistics related to blood administrations [intercept model, blood
stored on ambulance])?
KQ 3
a. What are the benefits and harms of transfusion of plasma for
patients
[[Page 93294]]
requiring prehospital hemorrhagic shock resuscitation?
b. Are the benefits and harms modified by:
i. EMS protocols (including but not limited to transfusion volume,
adjuvant medication coadministration such as TXA and calcium salts, or
crystalloid fluid coinfusion, transfusion equipment, and transfusion
route)?
ii. Patient characteristics (including but not limited to age, sex,
comorbidities, preexisting medications [anti-platelets, anti-
coagulants, heart rate control medications], or mechanism of injury/
condition)?
iii. Characteristics of the EMS system (including air/helicopter
medical ambulance, ground ambulance, EMS clinician certification, or
service delivery model [such as fire-based, private, third service],
logistics related to blood administrations [intercept model, blood
stored on ambulance])?
KQ 4
a. What are the benefits and harms of infusion of crystalloid
fluids for patients requiring prehospital hemorrhagic shock
resuscitation?
b. Are the benefits and harms modified by:
i. EMS protocols (including but not limited to volume infused, or
adjuvant medication coadministration such as TXA and calcium salts, or
transfusion equipment and transfusion route)?
ii. Patient characteristics (including but not limited to age, sex,
comorbidities, preexisting medications [anti-platelets, anti-
coagulants, heart rate control medications], or mechanism of injury/
condition)?
iii. Characteristics of the EMS system (such as air/helicopter
medical ambulance, ground ambulance, personnel certification, or
service delivery model [such as fire-based, private, third service],
and logistics related to blood administrations [intercept model, blood
stored on ambulance])?
KQ 5
a. What are the benefits and harms of different strategies
(therapeutic, logistical, or both combined) and interventions (whole
blood, PRBCs, plasma, and crystalloid fluid) for patients requiring
prehospital hemorrhagic shock resuscitation?
b. Are the benefits and harms modified by:
i. EMS protocol (including but not limited to transfusion volume,
adjuvant medication coadministration such as TXA and calcium salts, or
crystalloid fluid coinfusion, and transfusion equipment and transfusion
route)?
ii. Patient characteristics (including but not limited to age, sex,
nature of illness, comorbidities, preexisting medications [anti-
platelets, anti-coagulants, heart rate control medications], or
mechanism of injury/condition)?
iii. Characteristics of the EMS system (including air/helicopter
medical ambulance, ground ambulance, EMS clinician certification, or
service delivery model [such as fire-based, private, third service],
logistics related to blood administrations [intercept model, blood
stored on ambulance])?
KQ 6
What specific areas of future research are essential for closing
existing evidence gaps surrounding prehospital hemorrhagic shock
resuscitation and prehospital blood transfusion? What are the precise
scientific questions, optimal study designs, targeted study
populations, and the various transfusion intervention protocols that
need to be studied?
Contextual Question (CQ)
CQ 1
What are the barriers to and facilitators of implementation of
effective prehospital blood product transfusion programs utilizing a
systems-level approach? Barriers and facilitators could include EMS
agency costs, EMS agency reimbursement, cost effectiveness, blood
product maintenance and logistics, partnerships with blood banks,
medical oversight including real-time medical direction, and diagnostic
tools.
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and
Setting)
Preliminary PICOTS Criteria
------------------------------------------------------------------------
Exclusion
PICOTS Inclusion criteria criteria
------------------------------------------------------------------------
Populations................... Patients
requiring prehospital Individuals who
hemorrhagic shock do not require
resuscitation treated prehospital
in the prehospital hemorrhagic
setting by emergency shock
medical services resuscitation.
clinicians.
Individuals not
treated by
emergency
medical
services
clinicians.
Intervention.................. KQ1: whole Other
blood. types of
resuscitation.
KQ2: PRBCs...
KQ3: plasma
(e.g., fresh frozen,
liquid, dried, etc.).
KQ4:
crystalloid fluids.
KQ5:
strategies as
specified in each
publication.
KQ6: NA......
CQ1: NA......
Comparator.................... KQ1 to 4..... KQ1 to
KQ5: no
comparison.
[cir] Head-to-head
comparisons
between
transfusion
options to treat
prehospital
hemorrhagic shock
patients.
[cir] Comparison to
usual care as
specified in each
publication in
another group or
time period.
KQ5:
strategies as
specified in each
publication.
KQ6: NA......
CQ1: NA......
Outcomes...................... Patient Health Cost-
Outcomes (highest effectiveness,
priority). other outcomes.
Mortality/
survival.
[cir] To arrival at
hospital.
[cir] To hospital
discharge.
[cir] Any period
less than or equal
to 30 days post-
emergency.
Morbidity
after discharge.
[[Page 93295]]
[cir] Glasgow
Outcome Scale,
Glasgow Outcome
Scale Extended,
Modified Rankin
Scale, Cerebral
Performance
Category.
Length of
stay.
[cir] Hospital free
days.
[cir] ICU free days
Intermediate Outcomes
in the prehospital or
ED setting.
Physiological
indicators (including
but not limited to
the following).
[cir] Systolic
blood pressure.
[cir] Diastolic
blood pressure.
[cir] Mean arterial
pressure.
[cir] Heart rate...
[cir] Respiratory
rate.
[cir] Respiratory
failure.
[cir] ROSC.........
[cir] Shock index..
[cir] Body
temperature.
[cir] End tidal CO2
(EtCO2).
[cir] Level of
Consciousness.
[ssquf] GCS......
[ssquf] AVPU.....
[cir] Blood lactate
level.
Process Outcomes......
Time from EMS
arrival to initial
transfusion of blood
product or infusion
of crystalloid fluid.
Amount of
blood product
transfused or
crystalloid fluid
infused (total:
prehospital and
hospital) vs.
(hospital only).
Adverse Events/Harms
(including but not
limited to the
following).
Allergic
reaction.
Febrile
nonhemolytic reaction.
Acute
hemolytic reaction.
Transfusion-
related acute lung
injury [TRALI].
Transfusion-
associated
circulatory overload
[TACO].
Infection....
Fluid
overload.
Citrate
toxicity.
Delay to
definitive care based
on arrival time.
Isoimmunization.
Hemolysis....
Harms related
to the method of
administration.
Risk of
clotting when
Ringer's lactate
solution combined
with blood.
Timing........................ Outcomes up
to 30 days post- Outcomes more
injury. than 30 days
post-injury.
Setting....................... Prehospital.. ED.
US and
International studies Inpatient,
published in English surgery.
language from Very Studies
High and High HDI \a\ conducted in
countries.. countries rated
less than High
in the HDI \a\.
Study Design.................. RCTs.........
Systematic
reviews (we
will use
reference lists
to identify
studies for
possible
inclusion).
Prospective Case
comparative studies. series.
Retrospective
comparative studies. Descriptive
studies.
Case control Letters
studies. to the editor.
Before/after Opinion
studies. papers.
Time series.. Studies
published prior
to 1990, to
focus on
contemporary
evidence and
practices
relevant to
current
prehospital
hemorrhagic
shock
resuscitation
protocols.
For CQ1 only:
qualitative studies
that specifically
collect data about
barriers to and
facilitators of
implementing
prehospital blood
product transfusion
programs (e.g.,
descriptive case
studies, evaluations,
QI reports),
interviews, focus
groups.
------------------------------------------------------------------------
Abbreviations: AVPU = Alert, Voice, Pain, Unresponsive; CQ = Contextual
Question; ED = emergency department; EMS = emergency medical services;
GCS = Glasgow Coma Scale; HDI = Human Development Index; ICU =
intensive care unit; KQ = Key Question; NA = not applicable; PICOTS =
population, interventions, comparators, outcomes, timing, and setting;
PRBC = packed red blood cell; QI = quality improvement; RCT =
randomized controlled trial; ROSC = return of spontaneous circulation.
\a\ United Nations Development Programme. Human Development Index.
Retrieved from https://hdr.undp.org/data-center/human-development-index#/indicies/HDI.
[[Page 93296]]
Dated: November 21, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024-27679 Filed 11-25-24; 8:45 am]
BILLING CODE 4160-90-P
