Notice2024-27679
Supplemental Evidence and Data Request on Prehospital EMS Blood Transfusion and Fluid Interventions for Hemorrhagic Shock
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Published
November 26, 2024
Issuing agencies
Health and Human Services DepartmentAgency for Healthcare Research and Quality
Abstract
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 Access to published and unpublished pertinent scientific information will improve the quality of this review.
Full Text
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<title>Federal Register, Volume 89 Issue 228 (Tuesday, November 26, 2024)</title>
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[Federal Register Volume 89, Number 228 (Tuesday, November 26, 2024)]
[Notices]
[Pages 93293-93296]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-27679]
[[Page 93293]]
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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 Access to published and unpublished pertinent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: <a href="/cdn-cgi/l/email-protection#0f6a7f6c4f6e677d7e2167677c21686079"><span class="__cf_email__" data-cfemail="eb8e9b88ab8a83999ac5838398c58c849d">[email protected]</span></a>
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: <a href="/cdn-cgi/l/email-protection#0b6e7b684b6a63797a25636378256c647d"><span class="__cf_email__" data-cfemail="96f3e6f5d6f7fee4e7b8fefee5b8f1f9e0">[email protected]</span></a>.
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: <a href="https://effectivehealthcare.ahrq.gov/products/ems-blood-transfusion/protocol">https://effectivehealthcare.ahrq.gov/products/ems-blood-transfusion/protocol</a>.
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 <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> along with the <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>
trial number.
[ssquf] For completed studies that do not have results on
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>, 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
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> 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: <a href="https://effectivehealthcare.ahrq.gov/email-updates">https://effectivehealthcare.ahrq.gov/email-updates</a>.
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................... <bullet> Patients <bullet>
requiring prehospital Individuals who
hemorrhagic shock do not require
resuscitation treated prehospital
in the prehospital hemorrhagic
setting by emergency shock
medical services resuscitation.
clinicians. <bullet>
Individuals not
treated by
emergency
medical
services
clinicians.
Intervention.................. <bullet> KQ1: whole <bullet> Other
blood. types of
resuscitation.
<bullet> KQ2: PRBCs...
<bullet> KQ3: plasma
(e.g., fresh frozen,
liquid, dried, etc.).
<bullet> KQ4:
crystalloid fluids.
<bullet> KQ5:
strategies as
specified in each
publication.
<bullet> KQ6: NA......
<bullet> CQ1: NA......
Comparator.................... <bullet> KQ1 to 4..... <bullet> 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.
<bullet> KQ5:
strategies as
specified in each
publication.
<bullet> KQ6: NA......
<bullet> CQ1: NA......
Outcomes...................... Patient Health <bullet> Cost-
Outcomes (highest effectiveness,
priority). other outcomes.
<bullet> Mortality/
survival.
[cir] To arrival at
hospital.
[cir] To hospital
discharge.
[cir] Any period
less than or equal
to 30 days post-
emergency.
<bullet> Morbidity
after discharge.
[[Page 93295]]
[cir] Glasgow
Outcome Scale,
Glasgow Outcome
Scale Extended,
Modified Rankin
Scale, Cerebral
Performance
Category.
<bullet> Length of
stay.
[cir] Hospital free
days.
[cir] ICU free days
Intermediate Outcomes
in the prehospital or
ED setting.
<bullet> 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......
<bullet> Time from EMS
arrival to initial
transfusion of blood
product or infusion
of crystalloid fluid.
<bullet> 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).
<bullet> Allergic
reaction.
<bullet> Febrile
nonhemolytic reaction.
<bullet> Acute
hemolytic reaction.
<bullet> Transfusion-
related acute lung
injury [TRALI].
<bullet> Transfusion-
associated
circulatory overload
[TACO].
<bullet> Infection....
<bullet> Fluid
overload.
<bullet> Citrate
toxicity.
<bullet> Delay to
definitive care based
on arrival time.
<bullet>
Isoimmunization.
<bullet> Hemolysis....
<bullet> Harms related
to the method of
administration.
<bullet> Risk of
clotting when
Ringer's lactate
solution combined
with blood.
Timing........................ <bullet> Outcomes up <bullet>
to 30 days post- Outcomes more
injury. than 30 days
post-injury.
Setting....................... <bullet> Prehospital.. <bullet> ED.
<bullet> US and <bullet>
International studies Inpatient,
published in English surgery.
language from Very <bullet> Studies
High and High HDI \a\ conducted in
countries.. countries rated
less than High
in the HDI \a\.
Study Design.................. <bullet> RCTs......... <bullet>
Systematic
reviews (we
will use
reference lists
to identify
studies for
possible
inclusion).
<bullet> Prospective <bullet> Case
comparative studies. series.
<bullet> Retrospective <bullet>
comparative studies. Descriptive
studies.
<bullet> Case control <bullet> Letters
studies. to the editor.
<bullet> Before/after <bullet> Opinion
studies. papers.
<bullet> Time series.. <bullet> Studies
published prior
to 1990, to
focus on
contemporary
evidence and
practices
relevant to
current
prehospital
hemorrhagic
shock
resuscitation
protocols.
<bullet> 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 <a href="https://hdr.undp.org/data-center/human-development-index#/indicies/HDI">https://hdr.undp.org/data-center/human-development-index#/indicies/HDI</a>.
[[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
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