[Federal Register Volume 82, Number 60 (Thursday, March 30, 2017)]
[Notices]
[Pages 15707-15709]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-06232]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Physiologic Predictors 
of the Need for Trauma Center Care: A Systematic Review

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Request for Supplemental Evidence and Data Submissions.

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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 Physiologic 
Predictors of the Need for Trauma Center Care: 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 Access to published and unpublished 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 May 1, 2017.

ADDRESSES: 
    Email submissions: src.org">SEADS@epc-src.org.
    Print submissions:
    Mailing Address: Portland VA Research Foundation, Scientific 
Resource Center, ATTN: Scientific Information Packet Coordinator,PO Box 
69539, Portland, OR 97239.
    Shipping Address (FedEx, UPS, etc.): Portland VA Research 
Foundation, Scientific Resource Center, ATTN: Scientific Information 
Packet Coordinator, 3710 SW., U.S. Veterans Hospital Road, Mail Code: 
R&D 71, Portland, OR 97239.

FOR FURTHER INFORMATION CONTACT: Ryan McKenna, Telephone: 503-220-8262 
ext. 51723 or Email: src.org">SEADS@epc-src.org.

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality (AHRQ) has commissioned the Evidence-based Practice Centers 
(EPC) Program to complete a review of the evidence for Physiologic 
Predictors of the Need for Trauma Center Care: 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 literature by requesting information from the 
public (e.g., details of studies conducted). We are looking for studies 
that report on Physiologic Predictors of the Need for Trauma Center 
Care: A Systematic Review, including those that describe adverse 
events. The entire research protocol, including the key questions, is 
also available online at: https://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productid=2435
    This is to notify the public that the EPC Program would find the 
following information on Physiologic Predictors of the Need for Trauma 
Center Care: 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. The 
contents of all submissions will be made available to the public upon 
request so materials submitted must be publicly available or able to be 
made public. Materials that are considered

[[Page 15708]]

confidential; marketing materials; study types not included in the 
review; or information on indications not included in the review cannot 
be used by the EPC Program. This is a voluntary request for 
information, and all costs for complying with this request must be 
borne by the submitter.
    The draft of this review will be posted on AHRQ's EPC Program Web 
site and available for public comment for a period of 4 weeks. If you 
would like to be notified when the draft is posted, please sign up for 
the email list at: https://www.effectivehealthcare.ahrq.gov/index.cfm/join-the-email-list1/.
    The systematic review will answer the following questions. This 
information is provided as background. AHRQ is not requesting that the 
public provide answers to these questions.

The Key Questions

Key Question 1

    For patients with known or suspected trauma who are treated out-of-
hospital by Emergency Medical System (EMS) personnel, what is the 
predictive utility of measures of circulatory compromise (e.g., 
systolic blood pressure, mean arterial pressure, heart rate, heart rate 
complexity/variability) or derivative measures (e.g., the shock index) 
for predicting serious injury requiring transport to the highest level 
trauma center available?
    I. How does the predictive utility of the studied measures of 
circulatory compromise vary across age groups (e.g., children or the 
elderly)? Specifically, what age ranges and values for the different 
age ranges are supported by the evidence?

Key Question 2

    For patients with known or suspected trauma who are treated out-of-
hospital by EMS personnel, what is the predictive utility of measures 
of respiratory compromise, (e.g., ventilatory support, respiration 
rate, tissue O2 saturation, respiratory effort, measures of acidemia 
such as end-tidal CO2, lactate, or base deficit) for predicting serious 
injury requiring transport to the highest level trauma center 
available?
    I. How does the predictive utility of the studied measures of 
respiratory compromise vary across age groups (e.g., children or the 
elderly)? Specifically, what age ranges and values for the different 
age ranges are supported by the evidence?

Key Question 3

    For patients with known or suspected trauma who are treated out of 
the hospital by EMS personnel, what is the predictive utility for 
combinations of measures of respiratory and circulatory compromise 
together with or without measures of altered levels of consciousness 
(as defined by Glasgow coma scale or its components), for predicting 
serious injury requiring transport to the highest level trauma center 
available?
    I. How does the predictive utility of combinations of measures vary 
across age groups (e.g., children or the elderly)? Specifically, what 
age ranges and values for the different age ranges are supported by the 
evidence?
    Using the PICOTS (Populations, Interventions, Comparators, 
Outcomes, Timing, Settings) framework and a graphical analytic 
framework required adapting these tools as they were designed for and 
usually used for intervention studies. Our approach is informed by 
guidance related to frameworks in the Methods Guide for Systematic 
Reviews of Diagnostic Tests in addition to the Methods Guide for 
Effectiveness and Comparative Effectiveness Reviews. We have included 
the standard PICOTS terms, but added detail to explain how we are using 
them for this review and we have added a legend and text to the 
graphical framework.

PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, 
Settings)

Population(s)

    Population refers to the patients who are the subjects in the 
studies to be included.
    Include: Studies of patients of any age with known or suspected 
trauma who require assessment of physiologic compromise by EMS out of 
the hospital.
    Exclude: Studies of patients with nontrauma conditions or 
illnesses, patients with burns or chemical exposures, healthy people, 
and animal studies. Studies of patients in which other assessments are 
used (e.g., type of injury) or in which the patient population is 
limited to a subgroup of patients defined as seriously injured.

     Studies in which the patient population is a priori 
restricted to patients with serious traumatic injuries.
     Studies in which all patients have injuries that can be 
assessed or would be defined as serious based on direct observation 
(e.g., an amputation).

Interventions (Physiologic Measures)

    The intervention is usually the treatment or health service of 
interest that is being evaluated in terms of its impact on the 
population. In this review the physiologic measures are what are 
evaluated. This review will include any measure of circulatory or 
respiratory compromise or combination measures. Examples are provided 
for each Key Question; however, additional measures may be identified 
by the search.
    Include:
    I. Key Question 1: Physiologic measures of circulatory compromise, 
including but not limited to systolic blood pressure, mean arterial 
pressure, heart rate, heart rate complexity/variability, or derivative 
measures such as the shock index.
    II. Key Question 2: Physiologic measures of respiratory compromise 
or effort, including but not limited to respiration rate, tissue O2 
saturation, respiratory effort, measure of acidemia (e.g., end-tidal 
CO2, lactate, base deficit), or advanced out-of-hospital airway 
intervention.
    III. Key Question 3: Combinations of measures of respiratory and 
circulatory compromise with or without measures of altered levels of 
consciousness (as defined by Glasgow coma scale or its components).
    IV. All Key Questions: Additional measures may be identified during 
the search and included based on input from clinical experts. Studies 
of newer devices that provide these or other measurements will be 
included if available and relevant.
    In all cases measurement can be for a single point in time, change 
over time, or can be trends in the measure evaluated by a person or 
technology.
    Exclude: Clinical assessment or indicator of health status that is 
not a separate indicator or a combination indicator including a measure 
of circulatory or respiratory compromise (e.g., temperature, 
consciousness, eye tracking, musculoskeletal soundness, balance, blood 
glucose, orientation).

Comparisons and Outcomes

    As this is not a review of intervention studies, the structure of 
the questions for the review as well as the questions posed by included 
studies are different. The Key Questions address how well measures of 
physiologic compromise identify trauma patients likely to have a 
serious injury requiring high-level trauma care.
    We include two types of evaluations of measures: (1) Studies of how 
well single measures predict severe injury; and (2) studies that 
compare the performance of two or more measures directly (head-to-head 
studies).
    The end points or ``outcomes'' of interest are the predictive 
utility of the measures. We include three different approaches to 
assessing predictive

[[Page 15709]]

utility: (1) Adjusted risk estimates (e.g., odds ratio, relative risk, 
hazards ratio); (2) discrimination (e.g., area under the receiver 
operating characteristic curve [AUROC]); and (3) measures of diagnostic 
accuracy (e.g., sensitivity, specificity, positive predictive values, 
and negative predictive values).
    The predictive utility is defined in terms of the physiologic 
measure's ability to identify patients who have severe injury. Defining 
and operationalizing what ``severe injury'' means is challenging for 
several reasons. Whether a patient had a serious injury at the time of 
field triage cannot be determined conclusively and we expect that 
clinical outcomes (e.g., death or disability) are affected by out-of-
hospital and in-hospital treatment (i.e., a person can have a serious 
injury and recover). For this reason, we accept several indicators that 
a patient was seriously injured. These include outcomes, such as death, 
whether the patient required treatments and interventions used for 
serious injury, or whether the injury is rated as severe using accepted 
rating scales. It is possible the review will identify additional 
indicators that a patient had a severe injury; however the following 
list includes those that have been used in prior research.
Indicators of Serious Injury
    I. In-hospital mortality.
    II. Resource use/intervention standards or lists.
    a. Published Consensus-Based Criterion Standard--This list defines 
need for trauma center care as any one of the following 10 specific 
indicators: Major surgery, advanced airway, blood products, admission 
for spinal cord injury, thoracotomy, pericardiocentesis, cesarean 
delivery, intracranial pressure monitoring, interventional radiology, 
and in-hospital death.
    b. Need For Life-Saving Interventions--Lists used by the U.S. 
military that include angioembolization, blood transfusion, 
cardiopulmonary resuscitation, chest tube, intubation, needle 
decompression, surgical cricothyrotomy or thoracotomy, 
pericardiocentesis, angiography with embolization, angiography without 
and surgical intervention.
    c. Major Surgery--Not including orthopedic surgery.
    d. Ratings of Injury Severity--Injury Severity Score (ISS) >15, as 
this is a commonly used threshold for high risk patients, but other 
cut-offs will be considered if used in included studies. The ISS score 
is based on an assessment that divides the body into nine regions, 
classifies the level of injury in each of the three most severely 
injured regions on a scale of 1 to 6, squares these values, and adds 
them together.

Timing

    Physiological measures upon the arrival of EMS personnel to the 
scene of injury, during treatment in the field, and during transport 
(referred to as out-of-hospital or in the field). Studies with measures 
taken upon arrival at an emergency department will be considered. 
Details about timing of measurement will be recorded in data 
abstraction if they are reported.

Settings

    Include:

I. Studies measuring physiologic compromise in the field/out of 
hospital
II. Studies of initial ED measurement as indirect evidence only if out 
of hospital evidence is not available and the measure is deemed 
clinically relevant
III. Studies conducted in civilian or military settings

    Exclude:

I. Inpatient, clinic, or emergency department (ED)
II. Studies conducted in developing countries with out-of-hospital care 
systems that differ from those in the United States

Study Designs

    Include:

I. Any study that assesses the predictive utility of included measures 
either individually or that compares two or more measures. Designs may 
include trials and prospective and retrospective observational studies
    a. Systematic reviews

    Exclude:

I. Nonsystematic reviews, commentaries, and letters
II. Descriptions of the properties or performance of measures that do 
not include predictive utility

Sharon B. Arnold,
Acting Director.
[FR Doc. 2017-06232 Filed 3-29-17; 8:45 am]
BILLING CODE 4160-90-P