Development and Testing of a Pediatric Cervical Spine Injury Risk Assessment Tool
Conditions: Cervical Spine Injury
Sponsor: Julie Leonard

Development and Testing of a Pediatric Cervical
Spine Injury Risk Assessment Tool
(C-Spine)
PECARN Protocol Number 042
Pediatric Emergency Care Applied Research Network
National Institute for Child Health and Human Development
(NICHD)
Protocol Version 1.04
Version Date: December 22, 2020
Printing Date: March 8, 2021

Copyright c⃝2018-2023. University of Utah School of Medicine on behalf of the
Principal Investigator, Julie C. Leonard, MD, MPH and the Pediatric Emergency Care
Applied Research Network (PECARN). All rights reserved.
This protocol is PECARN Protocol Number 042, and has been authored by Julie
C. Leonard, MD, MPH, Nationwide Children’s Hospital, for implementation with the
PECARN investigators. This study is supported by R01-HD091347-01A1 awarded to
Nationwide Children’s Hospital (PI:Julie C. Leonard, MD, MPH) by the Eunice Kennedy
Shriver National Institute for Child Health and Human Development (NICHD).
The PECARN Research Node Centers are the University of Utah, Nationwide Chil-
dren’s Hospital, Cincinnati Children’s Hospital Medical Center, Columbia University
Medical Center, University of California Davis Medical center, University of Arizona
Health Sciences Center, Children’s National Health System, and medical College of
Wisconsin and are supported by Cooperative Agreements U03-MC00008, U03-MC00003,
U03-MC22684, U03-MC00007, U03-MC00001, U03-MC28845, U03-MC00006, and H3-
MC26201 from the Emergency Medical Services for Children (EMSC) Program, Maternal
and Child Health Bureau, Health Resources and Services Administration.
This document was prepared by the PECARN Data Coordinating Center (DCC)
located at the University of Utah School of Medicine, Salt Lake City, Utah. The document
was written and typeset using LATEX2ε. The DCC at the University of Utah is supported
by Cooperative Agreement U03-MC00008 from the Emergency Medical Services for
Children (EMSC) Program, Maternal and Child Health Bureau, Health Resources and
Services Administration.

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PROTOCOL TITLE:
Development and Testing of a Pediatric Cervical Spine Injury Risk Assessment Tool
Short Title: C-Spine
PECARN Protocol Number: 042
Lead Investigator and Author:
Julie C. Leonard, MD, MPH
Nationwide Children’s Hospital
Protocol Version: 1.04
Version Date: December 22, 2020
I conﬁrm that I have read this protocol, I understand it, and I will conduct the study
according to the protocol. I will also work consistently with the ethical principles that have
their origin in the Declaration of Helsinki and will adhere to the Ethical and Regulatory
Considerations as stated. I conﬁrm that if I or any of my staﬀare members of the Insti-
tutional Review Board, we will abstain from voting on this protocol, its future renewals,
and its future amendments.
Principal Investigator Name:
Principal Investigator Signature:
Date:
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Contents
1
Study Summary
8
1.1
Speciﬁc Aims . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
9
1.2
Subject Eligibility, Accrual and Study Duration . . . . . . . . . . . . . .
10
2
Rationale and Background
10
2.1
Introduction and Study Rationale . . . . . . . . . . . . . . . . . . . . . .
10
2.2
Preliminary Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
14
3
Overall Study Design
18
4
Study Procedures and Data Collection:
Prospective Observational Study
21
4.1
Subject Identiﬁcation . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
21
4.2
Study Workﬂow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
21
4.3
Observational Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
23
4.4
Follow-up Assessment(s) . . . . . . . . . . . . . . . . . . . . . . . . . . .
25
4.5
Medical Record Review . . . . . . . . . . . . . . . . . . . . . . . . . . . .
25
4.6
Withdrawal from Study
. . . . . . . . . . . . . . . . . . . . . . . . . . .
26
5
Study Procedures and Data Collection:
User-Centered Design Activities
26
5.1
Subject Identiﬁcation . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
27
5.2
Study Workﬂow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
27
5.2.1
Applied Cognitive Task Analysis
. . . . . . . . . . . . . . . . . .
27
5.2.2
Iterative Design . . . . . . . . . . . . . . . . . . . . . . . . . . . .
30
5.2.3
Summative Testing . . . . . . . . . . . . . . . . . . . . . . . . . .
30
5.3
Data Collection Methods/Tools . . . . . . . . . . . . . . . . . . . . . . .
30
5.3.1
Applied Cognitive Task Analysis
. . . . . . . . . . . . . . . . . .
30
5.3.2
Iterative Design . . . . . . . . . . . . . . . . . . . . . . . . . . . .
31
5.3.3
Summative Testing . . . . . . . . . . . . . . . . . . . . . . . . . .
31
5.4
Withdrawal from Study Activities . . . . . . . . . . . . . . . . . . . . . .
32
6
Study Procedures and Data Collection:
Diversity Supplement
32
6.1
Diversity Supplement Study Summary
. . . . . . . . . . . . . . . . . . .
32
6.2
Diversity Supplement Speciﬁc Aims . . . . . . . . . . . . . . . . . . . . .
32
6.3
Diversity Supplement - Subject Eligibility, Accrual and Study Duration .
33
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6.4
Diversity Supplement - Rational and Background
. . . . . . . . . . . . .
33
6.5
Diversity Supplement - Overall Study Design . . . . . . . . . . . . . . . .
34
6.6
Diversity Supplement - Subject Identiﬁcation . . . . . . . . . . . . . . . .
35
6.7
Diversity Supplement - Study Workﬂow . . . . . . . . . . . . . . . . . . .
36
6.8
Diversity Supplement - Medical Record Review
. . . . . . . . . . . . . .
37
6.9
Diversity Supplement - Telephone Follow-up Assessment
. . . . . . . . .
37
6.10 Diversity Supplement - Withdrawal from Study
. . . . . . . . . . . . . .
38
6.11 Diversity Supplement - Data Analysis . . . . . . . . . . . . . . . . . . . .
39
6.12 Diversity Supplement - Consent Procedures
. . . . . . . . . . . . . . . .
39
7
Data Management
41
8
Data Analysis
42
8.1
Speciﬁc Aim Analyses
. . . . . . . . . . . . . . . . . . . . . . . . . . . .
43
9
Study Training
46
9.1
Study Training
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
46
9.2
Study Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
46
9.2.1
Site Monitoring Plan . . . . . . . . . . . . . . . . . . . . . . . . .
46
10 Protection of Human Subjects
47
10.1 Institutional Review Board (IRB) Approval
. . . . . . . . . . . . . . . .
47
10.2 Potential Risks
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
47
10.2.1 Improper Disclosure of Medical Information
. . . . . . . . . . . .
48
10.2.2 Medical Risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
48
10.2.3 Protections Against Risk . . . . . . . . . . . . . . . . . . . . . . .
48
10.3 Potential Beneﬁts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
49
10.4 Waiver of Informed Consent . . . . . . . . . . . . . . . . . . . . . . . . .
49
10.5 Health Insurance Portability and Accountability Act
. . . . . . . . . . .
51
10.6 Inclusion of Women and Minorities . . . . . . . . . . . . . . . . . . . . .
51
10.7 ClinicalTrials.gov Requirements . . . . . . . . . . . . . . . . . . . . . . .
52
10.8 Retention of Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
52
10.9 Public Use Data Set
. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
52
List of Tables
1
Prospective test accuracies of pediatric CSI risk factors . . . . . . . . . .
16
2
Rates of spinal precautions and imaging
. . . . . . . . . . . . . . . . . .
17
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3
User-Centered Design Subject Sampling Strategy
. . . . . . . . . . . . .
28
List of Figures
1
Evaluation of children for CSI following blunt trauma
. . . . . . . . . .
12
2
User-centered Approach to Tool Design
. . . . . . . . . . . . . . . . . .
18
3
Study Population . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
19
4
Study Workﬂow
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
24
5
User-Centered Approach Study Workﬂow
. . . . . . . . . . . . . . . . .
29
6
Consent Procedures for Study Population
. . . . . . . . . . . . . . . . .
36
7
Study Workﬂow and Consent Procedures
. . . . . . . . . . . . . . . . .
37
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Abstract
Cervical spine injuries (CSI) are serious, but rare events in children. In contrast,
use of spinal precautions for trauma transport and radiographic evaluation for
CSI in the emergency department (ED) are common and associated with adverse
eﬀects. As a result, millions of children who have no CSI are exposed to harm
with no demonstrable beneﬁt. The nation’s EMS systems need a Pediatric CSI
Risk Assessment Tool that can be used to reduce the number of children who are
transported in spinal precautions and irradiated unnecessarily. Leonard et al. and
the Pediatric Emergency Care Applied Research Network (PECARN) retrospectively
identiﬁed 8 risk factors that predict CSI in children. Leonard et al. also established
the infrastructure to prospectively collect paired observations from EMS and ED
providers and determined the test accuracies of the PECARN CSI risk factors. This
study proposes to develop and test a Pediatric CSI Risk Assessment Tool that can
be used by EMS and ED providers to determine which children warrant spinal
precautions and cervical spine imaging after blunt trauma.
Leonard et al. will conduct this work at approximately 18 PECARN trauma
centers and collect prospective observational data from EMS and ED providers
regarding CSI risk factors for children who undergo emergency evaluation after blunt
trauma and follow enrolled subjects for 28 days to determine CSI status. The study
will occur in two phases: development (13,333 children; 240 children with CSI) and
validation (8,889 children; 160 children with CSI). The study will also capitalize on
the research infrastructure to conduct an Applied Cognitive Task Analysis (ACTA)
and tool prototype testing that will inform the iterative tool design to ensure that
the tool is useable by EMS and ED providers. With data from the development
cohort, a useable clinical decision support tool will be constructed that achieves >
95% sensitivity, as well as adequate speciﬁcity (> 40%) in the prediction of CSI.
Subsequently, Leonard et al. will determine the performance characteristics of the
tool in the independent validation cohort and in a cohort that has EMS provider
observations. The ultimate output from this project will be a set of speciﬁcations for
the Pediatric CSI Risk Assessment Tool that will include a validated clinical decision
rule, validated tool designs and functions, and recommendations for implementation.
An accurate, validated, and ultimately ﬁeld-tested Pediatric CSI Risk Assessment
Tool will safely limit unnecessary spinal precautions and radiographic testing for
millions of children while helping identify those children who are truly at risk for
CSI.
1
Study Summary
Cervical spine injuries (CSI) are serious, but rare events in children.1, 2 Spinal precautions
(rigid cervical collar and immobilization on a longboard) in the prehospital setting
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may be beneﬁcial for children with CSI, but are poorly studied.3–6 In contrast, spinal
precautions for pediatric trauma patients without CSI are common and may be associated
with harm.5, 7–32
Spinal precautions result in well-documented adverse physical and
physiological sequelae.5, 7–31 Of substantial concern is that the mere presence of prehospital
spinal precautions may lead to a cascade of events (see conceptual model, Figure 1)
that results in the increased use of inappropriate radiographic testing in the emergency
department (ED) to evaluate children for CSI and thus an unnecessary, increased exposure
to ionizing radiation and lifetime risk of cancer.29–31, 33–56 Most children who receive
spinal precautions and/or are imaged for potential CSI, and particularly those imaged
with computed tomography (CT), are exposed to potential harm with no demonstrable
beneﬁt. Therefore, there is an urgent need to develop a Pediatric CSI Risk Assessment
Tool that can be used in the prehospital and ED settings to reduce the number of children
who receive prehospital spinal precautions inappropriately and are imaged unnecessarily
while identifying all children who are truly at risk for CSI.6, 57–68
1.1
Speciﬁc Aims
The goal of the current project is to develop and test a Pediatric CSI Risk Assessment Tool
that can be used by EMS and ED providers to determine which children warrant spinal
precautions and cervical spine imaging after blunt trauma. We will use the R21-established
research infrastructure to conduct a larger multi-center, prospective observational cohort
study and an applied cognitive task analysis to inform a process of iterative tool design
that has the following Speciﬁc Aims:
Speciﬁc Aim 1. Develop the Pediatric CSI Risk Assessment Tool in children with blunt
trauma using prospective observational data obtained from ED providers.
Speciﬁc Aim 2. Validate the Pediatric CSI Risk Assessment Tool in a separate popula-
tion of children with blunt trauma using prospective observational data obtained
from ED providers.
Speciﬁc Aim 3. Validate the Pediatric CSI Risk Assessment Tool in a population of
children with blunt trauma using prospective observational data obtained from EMS
providers.
1.2
Subject Eligibility, Accrual and Study Duration
Eligible participants will be identiﬁed by study staﬀ. Patients will be enrolled in the
study if they meet the following inclusion criteria:
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1. Age 0-17 years; AND
2. Known or suspected exposure to blunt trauma regardless of whether or not injuries
were sustained; AND
3. One of the following:
(a) Undergoing trauma team evaluation; OR
(b) Transported from the scene to site facility by EMS; OR
(c) Undergoing cervical spine imaging at site facility; OR
(d) Transferred to site facility with cervical spine imaging.
Patients will be excluded from enrollment if they meet the following exclusion criteria:
1. Exposed to solely penetrating trauma mechanism (example: gunshot or stab wound)*
*Note that children that have sustained penetrating injuries as a result of or
in addition to a blunt trauma mechanism are not excluded from eligibility.
2
Rationale and Background
2.1
Introduction and Study Rationale
Spinal precautions are the standard of care for trauma patients but have
questionable eﬃcacy. Historically, spinal precautions were recommended for all trauma
patients meeting criteria for transport to a trauma center with the belief that maintaining
the spine in a neutral position and minimizing spinal motion during transport will
prevent or limit neurological injury.3 This practice, however, is poorly studied and may
be harmful. Even for the rare child who has sustained a CSI, the eﬃcacy of spinal
precautions in limiting neurological injury during emergency medical services (EMS)
transport is unknown.4 A Cochrane review concluded that “the eﬀect of prehospital
spinal immobilization on mortality, neurological injury, spinal stability and adverse eﬀects
in trauma patients remains uncertainthe possibility that immobilization may increase
mortality and morbidity cannot be excluded.”4 In fact, there is evidence that challenges the
eﬃcacy of spinal precautions in providing neutral positioning and in limiting neurological
injury for those patients with CSI.4, 5, 7–14 Furthermore, for those at greatest risk of CSI,
spinal precautions are associated with adverse side eﬀects including encumbered airway
management and ventilation, elevated intracranial pressure and decubitus ulcers.15–25
Thus, while spinal precautions for trauma transport are considered the standard of care,
there is no evidence supporting their use and some evidence illustrating adverse eﬀects.
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Spinal precautions cause harm for those children at low risk for CSI by
increasing self-reported pain and prompting reliance on radiographic studies
to evaluate for CSI. EMS providers use spinal precautions somewhat indiscriminately
which is concerning as spinal precautions are associated with adverse eﬀects.32 The most
common adverse eﬀect of spinal precautions is musculoskeletal pain. Immobilization on a
rigid longboard and placement of a rigid cervical collar causes substantial pain, which may
last well beyond the immediate period of immobilization.26–31 The pain caused by spinal
precautions may be confused with pain caused by injury leading to unnecessary diagnostic
evaluations.30, 31 Additionally, the presence of spinal precautions at the time of evaluation
may heighten physician concern for CSI and/or interrupt a useful neck examination.30
Further magnifying the situation is that 70% of children are cared for by adult-oriented
trauma surgeons and general emergency medicine providers when the trauma system is
activated and there is an impulse to use neck CT for CSI screening, a practice that is
supported in the adult trauma patient.33 Thus, given the lack of established guidelines
for clinical clearance of CSI in children, ED and other providers may overly rely on
radiographic imaging for diagnostic evaluation.30, 33–35 This cascade of events, prehospital
spinal precautions followed by use of radiographic imaging for clearance of CSI (Figure 1
on the following page), results in potential harm for most children who present for care
following blunt trauma.
Reliance on CT scanning to evaluate the cervical spine in children who
are at low risk for CSI results in substantial exposure to ionizing radiation
and increased risk of cancer. Due to a general apprehension that the immaturity
of the pediatric spine will limit the interpretability of plain radiographs and that some
important injuries may be missed, CT scanning, which is associated with substantial
exposure to radiation, is frequently used to evaluate children for potential CSI.33–38
Children are more susceptible to radiation-induced cancers due to an intrinsic sensitivity to
ionizing radiation and a longer life expectancy during which the cancer may manifest.39–42
It is estimated that, depending on age, pediatric CT increases the population risk of
fatal cancer by 4-6 cases per 10,000 pediatric CT scans.43–49
Furthermore, for each
radiation-induced lethal malignancy, as many as 5-10 non-lethal malignancies will be
induced.43–49, 56 CT scans of the neck are of particular concern in children because of a
well-documented, age-related radiation sensitivity of the thyroid due to its size relative to
surrounding structures, proportion of dividing cells, and concentration by iodine.50–55 A
single CT scan of the cervical spine in childhood is associated with signiﬁcant thyroid
irradiation, increasing a child's lifetime risk of thyroid cancer by 78%.56
Adult CSI screening criteria have been derived and validated for use in
limiting radiographic imaging during ED trauma evaluation.
Due to both
the risk of irradiation during cervical spine evaluation and its cost, there have been
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Figure 1: Evaluation of children for CSI following blunt trauma
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considerable eﬀorts to limit radiographic clearance of adult trauma patients. The National
Emergency X-ray Utilization Study (NEXUS) collaboration developed a predication rule
with ﬁve clinical screening criteria (posterior midline cervical tenderness, altered alertness,
distracting injury, intoxication, and focal neurological ﬁndings), which has 100% sensitivity
for CSI and exhibited good inter-rater agreement among emergency physicians.69–72 In
addition, the Canadian C-spine Rule (ambulatory, ability to sit upright, time to onset of
neck pain, midline cervical tenderness, ability to rotate neck, paresthesia, age older versus
younger than 65 years, and dangerous mechanism versus simple rear-end collision) has
been reported to have nearly 100% sensitivity for CSI in alert and stable adult trauma
patients.73–76 Neither of these studies, however, focused on children. The NEXUS study
had only 30 children with CSI and the Canadian study excluded pediatric patients.
EMS prehospital providers can appropriately apply adult CSI screening
criteria, but their reliability in assessing CSI screening criteria has not been
demonstrated. Early studies suggest that when adult screening criteria are applied in
the prehospital setting by EMS providers, the criteria result in a signiﬁcant reduction (up
to 50%) in overall spinal immobilization without missing clinically important CSI.77–80
Despite these promising results, there are indications that EMS prehospital providers
diﬀer in their ascertainment of clinical screening criteria. Prospective studies evaluating
the agreement between EMS providers and emergency physicians for adult CSI risk are
inconclusive with kappa statistics ranging from poor to excellent.81, 82 These ﬁndings
highlight the limitations associated with developing clinical decision rules exclusively
in the ED setting that are intended to also be applied in the prehospital environment.
Involvement of EMS prehospital providers early in the development and/or reﬁnement of
clinical decision rules will help ensure that the rules can be applied appropriately in the
prehospital setting.83–86
Clinical screening criteria for CSI in children are lacking. While clinical
screening criteria provide promising results in adult trauma patients, these ﬁndings should
not be applied to children due to diﬀering injury patterns, anatomic variance, and age-
related diﬀerences in the ability to localize pain. Clinical risk stratiﬁcation criteria for CSI
have yet to be adequately identiﬁed and evaluated in a prospective fashion in children.
Early attempts at deﬁning pediatric clinical screening criteria have tended to agree with
the ﬁndings in adult patients, but are not generalizable due to small sample sizes that are
not geographically, demographically, or clinically representative.2, 87–89 Particularly under
represented in previous studies are pre-verbal children who rarely experience CSI, but
are potentially at greatest risk from inappropriate immobilization and imaging.2, 87–89 As
a result, more than eight million injured children in the U.S. annually are evaluated for
potential CSI and may be subject to spinal precautions and/or radiographic imaging yet
fewer than one percent will actually have CSI.2, 58
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In sum, there has been insuﬃcient research in CSI evaluation and management in
injured children in both the prehospital and ED settings. In particular, there are no
established clinical screening criteria for CSI in children, and as a result, many children
are exposed to spinal precautions and radiographic evaluation unnecessarily. Because
of this, and the alarming increase in CT use in children, there is an urgent need to
develop and implement a Pediatric CSI Risk Assessment Tool that can be
used by EMS and ED providers to determine which children warrant spinal
precautions and cervical spine imaging after blunt trauma.
2.2
Preliminary Studies
With federal funding, Pediatric Emergency Care Applied Research Network (PECARN)
investigators, led by this study's Principal Investigator (PI), conducted a large retro-
spective case-control study of children with CSI which allowed us to identify a set of
risk factors that are signiﬁcantly associated with CSI.90, 91 These factors; altered mental
status, focal neurological deﬁcits, self-report of neck pain, torticollis, substantial injury to
the torso, predisposing condition, high-risk motor vehicle crash, and diving mechanism;
had greater than 98% sensitivity for identifying all children with CSI in the cohort. If
these mechanistic and clinical factors were used as clinical screening criteria for CSI, radio-
graphic imaging for CSI in the cohort would have been reduced by more than 25%. These
factors, however, need prospective evaluation and reﬁnement prior to implementation as
a risk assessment tool that guides management. In order to develop a risk assessment
tool for CSI in children, a large prospective cohort of children experiencing blunt trauma
is required due to the rarity of CSI.
As a prerequisite for a large, prospective multi-center study to develop and validate
a Pediatric CSI Risk Assessment Tool, we conducted a NICHD R21-funded, 4-center
(Washington University in St. Louis, Medical College of Wisconsin, Cincinnati Children's
Hospital Medical Center and Nationwide Children's Hospital) pilot study aimed at
developing the infrastructure (materials, methods and procedures) necessary for collecting
prospective data from prehospital EMS providers and ED providers who care for children
after blunt trauma.92
We developed a web-based, branch-logic questionnaire using
Research Electronic Data Capture (REDCap) that was administered via a tablet computer
to ED providers (attending or fellow pediatric emergency medicine, emergency medicine or
hospitalist physicians, or advanced practice nurses or physician assistants) during their ED
evaluation of children with blunt trauma, and if applicable, to the EMS providers who had
rendered scene response care.92, 93 The questionnaire assessed factors determined a priori
to be associated with CSI in children, including those from our retrospective case-control
study.69, 73, 90, 91, 94, 95 We collected data in the ED under waiver of informed consent;
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however we provided parents/guardians a study information sheet with instructions for
withdrawal from further phone follow-up.92, 96–99 For children who had cervical spine
imaging, we determined presence of CSI by review of the imaging reports by the Site PI
with veriﬁcation of the CSI through review of the spine surgeon's consultation notes. For
those children who did not undergo cervical spine imaging in the ED, we made telephone
follow-up calls 21-28 days after the ED visit to conﬁrm that the child was free of CSI. To
determine whether or not our cohort was representative of all children meeting inclusion
criteria, we reviewed daily ED census reports to identify missed eligible children and
gathered a limited data set.
Preliminary results from this pilot study support the feasibility of conducting a larger
investigation using these established methods. We enrolled 4091 children over 18 months;
84.9% of eligible subjects during enrollment hours and 70.9% of all eligible subjects.92
The characteristics of those children that we enrolled were comparable to those that were
missed.92 We captured the EMS provider's observations 60.2% of the time for those
that arrived as a scene response. Importantly, there were 74 children within the cohort
ultimately diagnosed with CSI (1.1 injuries per site per month; CSI incidence of 1.8%).92
Table 1 on the next page demonstrates the prospective performance of our retrospectively-
identiﬁed risk factors in identifying all children with CSI.94, 95 For each candidate risk
factor, we calculated bivariable relative risks. We explored the PECARN model for CSI as
a predictor set and considered children with at least one positive risk factor test positive
for CSI risk. The PECARN model risk factors were 90.5% sensitive and 45.6% speciﬁc
for CSI in the cohort. Retrospective medical record review of the 7 children missed by
the PECARN model revealed that all either had a PECARN model risk factor that was
not captured in the observational data (n=6; altered mental status and complaint of
neck pain) and/or had one of the other observed candidate risk factors (n=5; axial load
biomechanics, loss of consciousness, other signs of substantial head injury- skull fracture,
upper thoracic tenderness and pain). These ﬁndings conﬁrm our previously-identiﬁed risk
factors for CSI in children.
There are several other candidate risk factors (axial load, loss of consciousness, skull
fracture, hypoxia, respiratory distress/failure, or intubation) which provide opportunities
to improve the PECARN model.90, 91, 94, 95 Our pilot work supports the prospective
reﬁnement of a decision rule based on these risk factors that will serve as the basis for a
risk assessment tool for CSI in children after blunt trauma.
While it is reassuring that the PECARN model risk factors performed well when
applied to the subsample of patients that had EMS provider observations (Page 16),
inter-observer agreement between EMS and ED provider observations was variable and
aﬀected by observer group bias and risk factor prevalence.100, 101 Prehospital use of a
pediatric CSI risk assessment tool may be feasible; however agreement on infrequently
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Table 1: Prospective test accuracies of pediatric CSI risk factors
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Table 2: Rates of spinal precautions and imaging
encountered factors and on patients whose histories and examinations change over time is
complicated. Our pilot work demonstrates that a pediatric CSI decision rule that will be
used in the prehospital setting needs to be validated with EMS assessments and supports
the need to continue the inclusion of EMS provider's observations in future studies.
Finally, our pilot study established the baseline use of spinal precautions and cervical
spine imaging in children after blunt trauma (Table 2). Clinicians used imaging to
screen 75.7% of children for CSI after blunt trauma including 15.8% screened by CT.
This conﬁrms our concern for some indiscriminate use of cervical spine imaging but also
establishes the feasibility of a decision rule that can serve as the basis for a tool that
reduces imaging, particularly CT. Rates of CT use were higher for children evaluated at
outlying hospitals prior to presenting in the study site EDs (27.3%) with most undergoing
imaging prior to transfer. This is important because 90% of children in the U.S. are
evaluated in general EDs after blunt trauma and not pediatric EDs.101, 102 Based on
conservative estimates, use of the PECARN risk factors to determine the need for imaging
within our pilot study cohort would have reduced overall imaging rates by more than
25% and would have reduced CT use by up to 50%. A tool based on a reﬁned decision
rule and that stratiﬁes children by risk to speciﬁc imaging strategies, once implemented,
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Figure 2: User-centered Approach to Tool Design
would likely result in even further reductions in imaging.
3
Overall Study Design
Our project will follow a comprehensive user-centered design approach (Figure 2) that
will engage representative clinical end-users in a sequence of activities that provides the
following: 1) a decision rule comprised of a parsimonious set of risk factors that predict
CSI in children after blunt trauma and that meet the analytic hypotheses tied to our
speciﬁc aims, 2) deﬁned relevant clinical roles associated with evaluating children for
CSI, 3) descriptions of the clinical scenarios in which children are evaluated for CSI, 4)
a detailed cognitive task analysis of the clinical workﬂow involving all clinical roles and
scenarios, 5) decision tool prototypes suitable for user testing, and 6) iterative user testing
and redesign of the decision tool prototypes. The ﬁnal products of this work will be
a set of validated and highly detailed design speciﬁcations for the Pediatric CSI Risk
Assessment Tool(s) and clinical process ﬂow diagrams for evaluating children after blunt
trauma.103, 104 Together, these outputs lay the groundwork for rapidly implementing the
tool across the entire clinical spectrum of care for children experiencing blunt trauma.
We will use two methodologies to gather data. We will conduct a prospective ob-
servational study of children 0-17 years old who present to the ED for care following
known or suspected exposure to blunt trauma regardless of whether or not injuries were
sustained. Children will be included if they meet any one of the following: (a) undergoing
trauma team evaluation, (b) transported from the scene to site facility by EMS, (c)
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Figure 3: Study Population
undergoing cervical spine imaging at site facility, or (d) transferred to site facility with
cervical spine imaging. We will exclude children if they are exposed to a solely penetrating
trauma mechanism. Figures 3 and 4 on page 24 represent the study population and study
workﬂow.
CSI, the outcome of interest, is deﬁned as vertebral fracture, ligamentous injury,
intraspinal hemorrhage, or spinal cord injury (on either MRI or spinal cord injury without
radiographic association) involving the cervical region of the spine (occiput to the 7th
cervical vertebra including ligamentous structures attaching the 7th vertebra to the 1st
thoracic vertebra). Presence of CSI will be determined by review of study site cervical
spine imaging reports and if applicable spine surgeon consultation notes and phone
follow-up. At 21 days after the ED visit for injury, the study site medical records will
be reviewed for cervical spine imaging and spine surgeon consultation. Children will be
considered to have CSI if after cervical spine imaging and if applicable consultation with a
spine surgeon; they are determined to have CSI. If imaging report diagnoses conﬂict with
spine surgeon consultation, the treating spine surgeon will be contacted for clariﬁcation.
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To ensure that there are not missed CSI for those children not undergoing cervical spine
imaging, we will review the medical record for follow-up encounters and if necessary,
conduct phone follow-up 21-28 days post study enrollment. We will also collect data on
patients that are eligible for the study but are not enrolled (missed eligibles).
We estimate that it will require a total observation of at least 22,000 children who
are evaluated after blunt trauma to adequately assess our study aims. Enrollment will
incorporate a staggered site enrollment plan to allow for an iterative process for the study
tool design to meet the study speciﬁc aims and objectives. Study objectives include:
1. Develop the Pediatric CSI Risk Assessment Tool in children with blunt trauma
using prospective observational data obtained from ED providers; AND
2. Validate the Pediatric CSI Risk Assessment Tool in a separate population of children
with blunt trauma using prospective observational data obtained from ED providers;
AND
3. Validate the Pediatric CSI Risk Assessment Tool using prospective observational
data obtained from EMS providers.
In parallel with the prospective observational study, we will capitalize on the research
infrastructure to characterize the clinicians' decision-making relative to screening children
for CSI by conducting an Applied Cognitive Task Analysis (ACTA).105 Task analysis has
been applied to system design for nearly 100 years starting with the work of Frederick
Taylor's time and motion studies to improve worker productivity.106 These methods
have evolved to the more contemporary cognitive task analysis and now include methods
for identifying the cognitive skills or mental demands needed to perform a task proﬁ-
ciently.105, 107 For our project, we will apply a more streamlined, practical approach to
performing a cognitive task analysis, the ACTA, which is based on three basic interview
methods designed to produce results that can be applied to system design: task diagram
interview, 2) knowledge audit, 3) simulation interview.105 We will perform each interview
method with representative end-users (EMS, ED personnel, and surgical staﬀaﬃliated
with participating study sites and their aﬃliated outlying hospitals and agencies) and
subject matter experts (i.e. the research team).
Together, the prospective observational study and the ACTA will inform the iterative
design of a Pediatric CSI Risk Assessment Tool (Figure 2 on page 18).
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4
Study Procedures and Data Collection:
Prospective Observational Study
Figure 3 on page 19 depicts the study population relative to consent procedures. This
study will include the collection of observational data from EMS providers, ED providers,
and surgical providers and review of the medical record. These activities will be conducted
under waiver of informed consent/parental permission and waiver of authorization. This
is a minimal risk prospective observational study with no therapeutic interventions. Legal
guardians of patients will be given a Consent, Parental permission, and Authorization
cover letter that provides information regarding the study and information that they may
be contacted for a brief telephone follow-up observational assessment if their child did not
have imaging of their head/neck at time of their child's hospital visit at the study site or
it's aﬃliated facilities.
4.1
Subject Identiﬁcation
Potential subjects will be identiﬁed through research staﬀstructured screening of real-time
electronic medical records, in particular the ED tracking system. Patients will be screened
for eligibility if they present for evaluation after known or suspected exposure to blunt
trauma regardless of whether or not injuries were sustained. A screened patient is eligible
if the patient meets one of the following criteria: (a) undergoing trauma team evaluation,
(b) transported from the scene to site facility by EMS, (c) undergoing cervical spine
imaging at site facility, or (d) transferred to site facility with cervical spine imaging. Once
a potential patient is identiﬁed, the patient will be enrolled in the study as long as they
meet the eligibility criteria in Section 1.2.
To identify missed eligible children, we will review the previous day's ED census reports.
Children meeting inclusion criteria are screened and general demographic information is
obtained.
4.2
Study Workﬂow
Figure 4 represents the study workﬂow relative to the study population for the prospective
observational study. The numbers within the ﬁgure correspond to the following study
tasks:
1. A patient arrives in the emergency department (ED) by emergency medical services
(EMS) or private vehicle.
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(a) RC identiﬁes patient: The RC is notiﬁed of the potential subject and reviews
the patient chart to verify the patient has known or suspected blunt trauma
and is being evaluated as described in section 4.1. If the patient meets criteria
the RC completes the Screening Form and continues to step 2.
(b) RC does not identify patient: On a regular basis, the RC reviews the ED census
reports for potential patients not identiﬁed at point of ED arrival/treatment.
For patients who meet inclusion criteria, the RC completes the Missed Eligible
Form.
2. RC launches the appropriate provider forms for eligible subjects based on patient
presentation to the ED.
(a) For patients who arrive by EMS from the scene of the injury: The EMS provider
transfers patient care to the ED provider, and is approached by the RC to
participate in the study. If the EMS provider agrees to participate, the RC
launches the EMS Provider Form for the provider to complete. Once the form
is complete, or if the EMS provider declines or is not available to approach,
the RC continues to step 3.
(b) For patients who arrive by private vehicle, EMS transfer, or other means: The
RC continues to step 3.
3. The ED provider completes the initial physical exam and history on the patient and
the RC launches the ED Provider From for the provider to start. If the ED provider
conﬁrms the patient is eligible, the observational section of the form is completed
and the RC continues to step 4. If the patient is not eligible, the form ends and no
further action is required.
4. For eligible subjects, if a surgical provider is available and agrees to participate in
the study, the RC launches the Surgical Provider Form for the provider to complete.
Once the form is completed, or a provider is not available or does not agree to
participate, the RC continues to step 5.
5. For children that did not get imaging: Prior to the patient leaving the ED, the
RC provides the family with the Consent, Parental permission, and Authorization
cover letter. Sites will have the option to send this via mail if the RC cannot make
contact before the subject leaves the ED. The RC then completes the Demographics
and Disposition Form and the RC continues to step 6.
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6. On days 21-28 post ED enrollment, the RC reviews the patient's medical record and
completes the Patient Outcome Form. The RC also reviews the chart for cervical
spinal imaging and completes the appropriate form.
(a) If cervical spine imaging is NOT documented in the record: The RC conducts
a phone interview and completes the Phone Follow-Up Form.
(b) If cervical spine imaging is documented in the record: The RC and the PI com-
plete the Imagining/Consultation/Surgery Form.
7. For subjects who had abnormal cervical spine imaging, the study adjudicator
completes the Patient Diagnosis Form.
4.3
Observational Data
This study will use an electronic tablet system that will be managed by the research coordi-
nator (RC) to gather observational data. The RC will verify patient's inclusion/exclusion
criteria based on information available and/or documentation during the time of enroll-
ment through prompted questions. EMS and ED Provider Forms will automatically
launch providing observational questions for both providers if the patient is eligible. The
RC will be responsible for managing the tablet operated observational data system to
verify the correct questions launch and that it is completed by the correct provider.
• EMS Providers: RCs must verify the correct form has been launched prior to
administering the observational assessment to the EMS provider. The form will
be available if the patient arrived by EMS directly from the scene of injury and
the EMS Provider who provided the patient's assessment is available and willing
to ﬁll out form. EMS Providers complete the EMS observational data assessment
following the transition of care to the ED providers and prior to leaving the hospital.
Once the EMS Provider Form is complete they return the tablet to the RC and
returns to service.
• ED Providers: RCs must verify the correct form has been launched prior to
administering the observational assessment to the ED provider. The ED Provider
Form should be completed by the ED Provider who performed/or was present
during the assessments on the patient to verify eligibility and complete the ED
Provider Form. If the patient arrives by private vehicle (or other means), arrives as
a transfer from another facility, or does not directly arrive from the scene of injury
by EMS the study RC will launch the observational assessment for the ED Provider
to conﬁrm patient eligibility and complete the ED Provider Form.
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Figure 4: Study Workﬂow
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• Surgical Providers: RCs must verify the correct form has been launched prior to
administering the observational assessment to the Surgical provider. The Surgical
Provider Form should be completed by a Surgical Provider who assessed the patient
in the ED. Once the Surgical Provider Form is complete they return the tablet to
the RC and returns to service.
4.4
Follow-up Assessment(s)
Legal guardians of patients who did not get cervical spine imaging will be given a Consent,
Parental permission, and Authorization cover letter that provides information regarding
the study and information that they may be contacted for a brief telephone follow-up
assessment. Patients that do not receive cervical spine imaging at the study site or its
aﬃliated facilities within 21 days of their child's hospital visit, unless the legal guardian
refuses, will receive a telephone call assessment from the RC to discuss injury status.
Verbal consent will be obtained from a parent or legal guardian to determine if the patient
had a delayed diagnosis of cervical spine injury. Assessments must be completed between
21 and 28 days after ED enrollment.
We selected 21-28 days for record review and phone follow-up because previous studies
demonstrated that patients' with CSIs missed on their initial visit are usually diagnosed
within 3 weeks of injury.108, 109 PECARN has used this method of identifying missed
injuries in previous studies.92, 96, 97
4.5
Medical Record Review
The research staﬀwill review the patient's medical record to determine eligibility, conﬁrm
basic demographic information and determine CSI status. If the RC deems the patient is
eligible based on existing documentation, he or she will launch the EMS, ED, or Surgical
Provider Forms in REDCap as appropriate. Each study site will have diﬀerent electronic
medical records for patients. The following study forms will be completed through review
of the patient's electronic medical record for those who are eligible for the study:
• Demographics and Disposition Form
• Imaging/Consultation/Surgery Form
• Patient Outcome Form
• Diagnosis Form
• PHI Form (site use only)
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• Missed Eligible Form (if applicable)
Data will be collected in REDCap. REDCap protects PHI through ﬁlters to limit
access to site data to the site research team. For example, the PI of the protocol, data
manager and the bio statistical team has access to all the de-identiﬁed information of
participants enrolled. Site-speciﬁc research team members only have access to their site's
data which are not de-identiﬁed. Each study site will use REDCap, and the data will be
securely collected at diﬀerent locations but managed within the same system at the DCC.
4.6
Withdrawal from Study
Parents may withdraw their child from participation in the phone follow-up call if
applicable. We will not contact the family to collect new information about their child.
However, we will use information obtained through prospective observational methods
and retrospective chart review as these activities are covered under waiver of informed
consent. There are no penalties nor beneﬁts lost to the patient if the legal guardian
decides to withdraw their child's data. The RC will notify the DCC of the participants
request to have their information removed from REDCap. The DCC data manager will
remove the participants data upon receiving a request from the study site's RC.
5
Study Procedures and Data Collection:
User-Centered Design Activities
In parallel to the prospective cohort study which is aimed at deriving and validating a
decision rule, we will perform activities which will inform the design of implementation
ready Pediatric CSI Risk Assessment Tool. Participation in ACTA activities are voluntary
and participants will be provided a Provider Consent cover letter that explains the
activities to be performed. At the time of participation, each participant will be assigned
a study identiﬁcation number. This number will be used on study materials and in the
study database instead of names and other private information. A separate list that links
each participant's name to the study identiﬁcation number will be maintained for future
reference and communication. Access to this list will be restricted to speciﬁc study team
members.
Interviews will be audio-recorded. The audio-recordings will be deleted from the
recording device immediately after they are saved to computer. Computer ﬁles will be
stored on a password protected computer system in a secure location. The key linking
the participant's name to responses will be removed from the computer system after the
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study has closed. An unidentiﬁed dataset and back-up copies will remain on an encrypted
remote back-up system. The tapes will be reviewed and relevant information transcribed
into text. Participant names and any other identifying information will be omitted to
assure conﬁdentiality.
5.1
Subject Identiﬁcation
We will rely on information obtained from subject matter experts (the research team)
and the tools clinical end-users; EMS, ED personnel, and surgeons that are representative
of trauma systems across the U.S. The subject matter experts will be responsible for
identifying clinical end-users within their hospitals catchment areas. Table 3 outlines
important provider attributes for sampling to ensure that participants are representative
of all potential tool users. Our plan is to engage 3-5 clinical end-users per each provider
type (clinical end-users), strategically sampling to ensure representation across ED and
agency attributes.
5.2
Study Workﬂow
We will engage the subject matter experts and clinical end-users in qualitative and
quantitative methods that will be conducted in three phases:(1) Applied Cognitive Task
Analysis (ACTA) comprised of three interview activities to capture and represent subject
workﬂow and knowledge; (2) Iterative design where clinical end-users participate in a
process of assessing the tool design utilizing mock-ups and formative user testing; and (3)
Summative testing where clinical end-users participate in a detailed simulation scenario-
based usability testing to validate the tool design. The alignment of these activities with
the prospective observational study is illustrated in Figure 5.
5.2.1
Applied Cognitive Task Analysis
The applied cognitive task analysis (ACTA) is an established human factors method to
describe complex processes in terms of the user task ﬂow, but also cognitive factors such
as knowledge, goals and decisions critical to the design of an eﬀective tool. The ACTA
consists of three semi-structured interviews to elicit and represent knowledge: (1) Task
Diagram. (2) Knowledge Audit. (3) Simulation interview. The task diagram interview
will provide an initial presentation of the workﬂow and cognitive tasks. The knowledge
audit will capture details of subject knowledge and expertise. The simulation interview
will involve subject responses to complex and challenging patient scenarios. Clinical
end-users representing each of the three cohorts will be purposively sampled from each
site to participate in these interviews.
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Table 3: User-Centered Design Subject Sampling Strategy
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Figure 5: User-Centered Approach Study Workﬂow
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5.2.2
Iterative Design
Using the results of the ACTA we will create a set of scenario-based mockups of the
tool. In this phase, purposively sampled subjects from each end-user group will react to
and provide suggestions regarding tool mockups that will be presented in the context of
realistic clinical scenarios. Topics explored will be based on our conceptual model derived
from the ACTA for how a CSI tool may improve the process of care and patient outcomes.
An iterative process will be used in which the topics discovered will be applied to mockup
reﬁnement or redesign and subsequent re-testing until objectives are achieved.
5.2.3
Summative Testing
We will conduct a simulation-based usability study in which a purposive sample from each
of the three cohorts will attempt to perform a series of tasks with a functioning prototype
of the tool. The usability of the system will be assessed quantitatively and qualitatively.
Quantitative measurements include task completion, error rate and time on task.
5.3
Data Collection Methods/Tools
5.3.1
Applied Cognitive Task Analysis
While the content of the three ACTA interviews will diﬀer, and use unique interview guides
based on the end-user group, the procedure will be the same. All subjects will receive a
Provider Consent cover letter. For each ACTA interview subjects will be instructed on the
purpose and format of the interview and will complete a short demographic questionnaire.
Subjects will be audio recorded as they respond to open ended questions from the interview
guide developed to elicit their knowledge and tasks associated with the diagnosis and
treatment of patients with a suspected CSI with the three ACTA interviews sequentially
capturing more detailed information. The audio ﬁles of the interviews will be reviewed
and relevant information transcribed into text.
We will compile the information from all three interview processes into a cognitive
demands table which itemizes each diﬃcult cognitive element by relevant end-user, why
it is diﬃcult, common errors, and cues and strategies used to avoid errors. The cognitive
demands table will help the research team achieve the projects goals by providing them
information and requirements that will aid the development of a useable Pediatrics CSI
Risk Assessment Tool and content to facilitate the subsequent implementation of the tool
into various settings. We will conﬁrm the information obtained during the interviews
through questions incorporated into the real-time electronic provider assessment form
and structured review of the electronic medical record.
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5.3.2
Iterative Design
Clinical end-users will be instructed on the purpose and format of the design review.
After receiving a Provider Consent cover letter, they will be asked to ﬁll out a short
demographic questionnaire. Clinical end-users will then be presented realistic patient
scenarios in which a child should be screened for CSI following blunt trauma along with
tool mockups related to each patient scenario. At each page or screen of the mockup
the clinical end-users will be asked what actions they might perform with the tool (e.g.
clicking a particular option or ﬁlling in data ﬁeld). The test facilitator will record whether
or not the subject completed the desired actions. At the end of the session the subject
will ﬁll out a questionnaire with a series of questions rating the functionality, usability and
utility of the tool. All data from these sessions will be entered into a Redcap database
using the subject’s identiﬁcation number.
The results of the testing sessions will be applied to reﬁning or redesigning the mockups
and the user testing procedure will be repeated. This entire process will be iterated until
satisfactory results of the mockups are obtained. We estimate a set of three iterations
will be performed.
5.3.3
Summative Testing
Clinical end-users will be instructed on the purpose and format of the simulation-based
usability test, will receive a Provider Consent cover letter and will complete a short
demographic questionnaire.
Realistic patient scenarios will once again be used and
presented. It will be stressed to each subject that the purpose of the review is to evaluate
the system and not the users' capabilities, and that any diﬃculties discovered in the
test will reveal issues with system design, not the subject’s skills or competency. The
evaluation will be based on a mix of qualitative and quantitative data as they interact
with the tool prototypes via patient scenarios. This data will be used to assess three
primary aspects of the tool. (1) Support decision making. (2) System utility. (3) System
usability. Though we anticipate the Formative Design phase will address any serious
defects, if initial testing reveals issues that are consistent and severe, we will modify
the prototype and test the changes with new subject. We will conﬁrm the information
obtained during the interviews through questions incorporated into the real-time electronic
provider assessment form and structured review of the electronic medical record.
5.4
Withdrawal from Study Activities
Subject matter experts and clinical end-users may withdraw from participation in user-
centered design activities at any time without prejudice to their employment status. It
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will be documented whether or not each subject completes the study.
6
Study Procedures and Data Collection:
Diversity Supplement
6.1
Diversity Supplement Study Summary
This diversity supplement will build oﬀa currently enrolling multi-center prospective
observational study of children who have sustained blunt trauma and may be at risk of
cervical spine injury (CSI). The investigators of the parent study aim to develop and
test a pediatric cervical spine injury risk assessment tool that can be used by EMS and
ED providers to determine which children warrant spinal precautions and cervical spine
imaging after blunt trauma. Addressing the social factors to reduce health inequities is a
global health care priority, but the nature of their association with pediatric treatment
and outcomes of CSI remains unstudied. We propose to expand the aims of the parent
grant by examining social factors with hypothesized CSI care associations in the patients
and families who are enrolled in the current study. Our study is signiﬁcant because it
aims to identify modiﬁable health care disparities that can be reduced through targeted
interventions.
6.2
Diversity Supplement Speciﬁc Aims
Our study aims to identify modiﬁable health care disparities that can be reduced through
targeted interventions and has the Speciﬁc Aims below:
• Speciﬁc Aim 1. Determine social factors associated with pediatric CSI risk using
census tract data from the American Community Survey and other geographic data.
• Speciﬁc Aim 2. Determine social factors aﬀecting disparities in health care delivery,
post-injury care management, and functional outcomes in children with CSIs via
structured interviews.
6.3
Diversity Supplement - Subject Eligibility, Accrual and Study
Duration
Eligible participants will be identiﬁed by study staﬀ. Patients will be enrolled in the
study if they meet the following inclusion criteria:
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• Enrolled in the parent grant and has a CSI as determined by the study neurosurgeon
CSI, the outcome of interest, is deﬁned in the parent grant as vertebral fracture,
ligamentous injury, intraspinal hemorrhage, or spinal cord injury (on either MRI or spinal
cord injury without radiographic association) involving the cervical region of the spine
(occiput to the 7th cervical vertebra including ligamentous structures attaching the 7th
vertebra to the 1st thoracic vertebra). Presence of CSI will be determined by review of
study site cervical spine imaging reports and through applicable spine surgeon consultation
notes and phone follow-up. Children will be considered to have CSI if after cervical spine
imaging and if applicable consultation with a spine surgeon; they are determined to have
CSI. If imaging report diagnoses conﬂict with spine surgeon consultation, the treating
spine surgeon will be contacted for clariﬁcation.
Our study will enroll all pediatric patients diagnosed with CSI identiﬁed in the parent
grant for medical record review and will attempt telephone follow-up survey for each
patient during the 24-month enrollment period of the supplement. The parent grant will
identify at least 360 pediatric patients diagnosed with CSI following blunt trauma. Based
on prior studies using similar methodology, we expect that at least half of these families
will agree to participate in the follow-up survey.
6.4
Diversity Supplement - Rational and Background
Injury is the leading cause of morbidity and mortality in children, and there are vast
disparities within childhood trauma that are both multifactorial and poorly understood.110
Furthermore, there is a paucity of literature regarding the social factors related to pediatric
cervical spine injury risk. The evidence for disparities within pediatric trauma patients is
sparse and incomplete within the literature1. Elucidating the speciﬁc social factors that
are related to CSI risk and poor outcomes has the potential to inform new strategies in
prevention and post-injury interventions for at-risk youth. Although pediatric CSIs are
uncommon events, over 1300 new cases occur every year and the injuries contribute to
signiﬁcant morbidity and mortality.111, 112 Examining the role of social factors in pediatric
CSI will ﬁll two major gaps in the present literature: (1) While there is considerable
evidence of racial and ethnic health disparities in the adult trauma literature,113–116 little
is known about such disparities in children or about how social factors contribute to
pediatric CSI risk and outcomes. African-American children have been independently
identiﬁed as having increased morbidity, mortality and functional deﬁcit after traumatic
brain injury compared to equivalently injured Caucasian children.116, 117 Although these
studies clarify the relationship between trauma and disparities in general, the focus of
the studies was not pediatric CSI. (2) There is a paucity of literature that addresses the
disparities in health care delivery and functional outcomes in children with CSIs. To our
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knowledge, no researchers have prospectively examined how social factors are associated
with pediatric cervical spine post-injury care and functional outcomes.
6.5
Diversity Supplement - Overall Study Design
The proposed research will investigate how social factors are associated with pediatric
cervical spine injury (CSI) risk, post-injury care and functional outcomes. Our project will
use two methodologies to gather data: (1) retrospective review of the electronic medical
record and structured medical billing data prepared for the Pediatric Health Information
System (PHIS) and (2) ﬁxed-response telephone-administered questionnaire. The ﬁnal
products of this work will lay the groundwork for future studies to create targeted
interventions for injury prevention and health care facilitation to improve functional
outcomes for at-risk youth.
Children will be included if they were enrolled in the parent grant and sustained a
CSI as conﬁrmed by the study neurosurgeon. From the parent study, we will be able
to obtain information about the type of CSI diagnosis and acute care interventions as
related to the CSI. Our study will conduct an extended chart review for pediatric CSI
patients to richly describe social factors present in CSI patients, to further ascertain acute
care intervention information and resources at the time of discharge. Additionally, we
will also request PHIS IDs to review medical billing data for the incident visit and any
subsequent visit within 30 days of the incident visit. PHIS includes patients from over
45 children’s hospitals, to which all study sites in the parent grant participates. We will
compare CSI patients with the overall population of children in the United States (US) by
utilizing census data. Census tract data will be obtained from the American Community
Survey. We will retrieve the home zip code at the time of injury for each patient and link
in several secondary data sources to capture the social and physical characteristics of the
neighborhood/community environment.
In parallel, we will use validated survey tools to assess social factors, health care
delivery and functional outcomes of children with CSIs. The child’s parent or legal
guardian will be contacted via telephone to participate in a ﬁxed-response telephone-
administered questionnaire. Social factors will be assessed utilizing the Protocol for
Responding to and Assessing Patient’s Assets, Risks and Experiences (PRAPARE) and
functional outcomes will be assessed through the National Institutes of Health Common
Funds Patient-Reported Outcomes Measurement Instrument System (PROMIS) tool.
Healthcare utilization and needs will be assessed based on health care services received in
the cognitive, physical and socioemotional domains by standardized responses adapted
from National Health Interview Survey. Phone calls will be made at least 1 month after
initial diagnosis. The time since injury will be collected and included in the analysis. The
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surveys are expected to take 15 minutes, and families will receive monetary compensation
for participation. We will also include in the analysis retrospective data collected during
Aim 1 chart review that includes acute care interventions and discharge resources.
Diversity Supplement The activities for Aim 1 will be conducted under waiver
of consent and the activities for Aim 2 will be conducted under waiver of written
documentation of consent.
This is a minimal risk retrospective chart review study
with no therapeutic interventions. Legal guardians of eligible subjects will be given a
Consent, Parental permission, and Authorization cover letter that provides information
regarding the study and information that they will be contacted for a telephone follow-up
observational assessment if their child sustained a CSI.
6.6
Diversity Supplement - Subject Identiﬁcation
Subjects for this study will be identiﬁed using resources from the parent grant. The
eligibility criteria, data collection activities and consent methodologies for each aim are
explained below.
• Aim 1. Children with CSI will be identiﬁed by the parent grant Data Manager
(reference Section 1.2 of the parent grant eligibility criteria). The Data Manager
will provide each participating site a list of subject ID’s for those children with CSI.
These will be the subjects for which we perform a limited chart review and request
PHIS participant ID’s.
• Aim 2. Subjects from Aim 1 that are conversant in English or Spanish will receive
a Consent and Authorization Cover Letter from the study management team at
the DCC. This list of subjects will be sent to a limited group of study personnel at
Nationwide Children’s Hospital (Dr. Leonard, Dr. Wells and a research coordinator
(RC)). If a legal guardian contacts the study management team at the DCC to
opt out, they will not be contacted by the team at Nationwide Children’s for the
telephone follow-up. Figures 6 and 7 represent two consent methodologies for the
study
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Figure 6: Consent Procedures for Study Population
6.7
Diversity Supplement - Study Workﬂow
This study contains two data collection methodologies conducted under separate consent
procedures based on the respective speciﬁc aim.
Aim 1. Medical Record Review conducted under waiver of consent
• The parent grant Data Manager will identify subjects with adjudicated CSI.
• The research staﬀat each study site will perform a limited medical record review for
subjects with adjudicated CSI and provide the requested PHIS ID’s for the incident
visit and any visit within 30 days of the incident visit.
Aim 2. Telephone Follow-up Assessment conducted under waiver of written docu-
mentation of consent
• Based upon the limited medical record review, parents/guardians conversant in
English or Spanish will be eligible to receive a cover letter.
• The DCC will mail consent the Consent, Parental permission, and Authorization
cover letter to the family.
• Eligible parents/legal guardians who are sent a cover letter will be contacted at least
30 days post-ED enrollment by Dr. Wells or RC to complete the Phone Consent
form unless the parent/legal guardian chose to opt out.
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Figure 7: Study Workﬂow and Consent Procedures
6.8
Diversity Supplement - Medical Record Review
The parent grant Data Manager at the Data Coordinating Center (DCC) will identify
eligible subjects based on CSI adjudication.
They will provide a list of participant
ID’s for eligible subjects to each study site. The site will complete a supplemental
demographic form (limited medical record review) and submit the PHIS ID’s to REDCap.
All participating study sites prepare and submit billing data to PHIS.
Each study site will use REDCap, and the data will be securely collected at diﬀerent
locations but managed within the same system at the DCC. REDCap protects PHI through
ﬁlters to limit access to identiﬁable information. For example, only key study personnel
(study PI and parent grant Data Manager) and site-speciﬁc research team members only
have access to their site’s data which are not deidentiﬁed. Data management for PHIS
medical billing data will be conducted centrally at Nationwide Children’s Hospital, the
lead study site, by the Nationwide Children’s Hospital PHIS Data Manager. For the
medical billing data, patient encounters will be assigned a unique study identiﬁcation
number by PHIS that will be associated with the study participant number. A deidentiﬁed
dataset will be used for statistical analyses. The electronic data will be deleted within
seven years following the last publication stemming from the study.
6.9
Diversity Supplement - Telephone Follow-up Assessment
Legal guardians of patients with CSI who have been identiﬁed as conversant in English
or Spanish will be mailed a Consent, Parental Permission, and Authorization Cover
Letter. This cover letter provides information regarding the study and information that
they will be contacted for a telephone follow-up assessment. This cover letter will also
include instructions for how to opt out of telephone follow-up. Unless the legal guardian
has contacted the Project Manager at the DCC and elected to opt out of the telephone
follow-up, they will receive a phone call from either Dr. Wells or a RC at least 30 days after
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ED enrollment into the parent study. At the beginning of this call, the interviewer will
explain the study and obtain verbal consent. At this time, the legal guardian can decline
participation or continue with the phone interview. If participation in the phone interview
is declined, all subsequent attempts for contact and recruitment will be terminated. If
the legal guardian consents to participation, the interviewer will administer a structured
questionnaire that assesses the patient’s demographics, functional outcome, resources
needed upon discharge and ongoing healthcare needs.
If initial telephone attempts to contact the legal guardian are unsuccessful, subsequent
attempts will be limited to three total attempts. If voicemail is encountered, we will
leave a message and callback information for the legal guardian to assist with arranging
follow-up. If the telephone number is a disconnected line, all subsequent attempts for
contact to that telephone number will be terminated. Our ﬁnal attempt to contact a
family for telephone follow-up will be a mailed letter notifying them that attempts to
contact for participation in the survey had been made, provide contact information should
they want to participate and conﬁrm no further contact will be attempted.
For time and inconvenience, legal guardians will receive $50.00 for completing the
phone interview. Funds will be issued on a debit card specially designed for clinical
research, ClinCard. The ClinCard Research Stipends Payment System is designed to
deliver electronic payments to program participants for time associated with clinical
trials. In order to process the payment, we will need to verify their mailing information,
patient’s name and date of birth, legal guardian’s name, and telephone number. When
the interview is completed, funds will be approved, automatically loaded onto the card
and mailed to the legal guardian’s home address.
We selected 30 days for telephone follow-up because previous studies demonstrated
that patients with CSI missed on their initial visit are usually diagnosed within 3 weeks
of injury.108, 109 PECARN has used this method of identifying missed injuries in previous
studies.92, 96, 97 Additionally, a benchmark for care per the Centers for Medicare and
Medicaid Services is the 30-day readmission rate, therefore we plan to gather information
within 30 days of the initial ED visit. Finally, this would give enough time for eligible
subjects in the parent grant to complete the adjudication process for CSI.
6.10
Diversity Supplement - Withdrawal from Study
Parents may withdraw their child from participation in the telephone follow-up. We will
not contact the family to collect new information about their child if they opt out or ask
to withdraw from the telephone follow-up. However, we will use information obtained
through prospective observational methods (see 4 in parent grant) and retrospective chart
review as these activities are covered under waiver of informed consent. There are no
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penalties nor beneﬁts lost to the patient if the legal guardian decides to withdraw their
child’s data.
6.11
Diversity Supplement - Data Analysis
This study has two methodologies for data analysis based upon the speciﬁc aims.
• Speciﬁc Aim 1. Determine social factors associated with pediatric CSI risk using
census tract data from the American Community Survey and other geographic data.
Standard descriptive summaries (e.g. means and standard deviations for continuous
variables such as age and percentage for categorical variables such as gender) will be
used to summarize demographic variables. To analyze whether the distribution of
social factors in the CSI population diﬀers from that in the general population we
will calculate a standardized incidence ratio based on population level data from the
American Community Survey. The methodology compares the observed distribution
of social factors in the study’s CSI population to what would be expected in the
general population based on a synthetic cohort from census data.
• Speciﬁc Aim 2. Determine social factors aﬀecting disparities in health care delivery,
post-injury care management, and functional outcomes in children with CSIs via
structured interviews.
Univariate analysis using chi-square testing and multivariate logistic regression
will be used to determine the association between social factors and inequities
in healthcare delivery and functional outcome for children with CSI including
school performance, accessibility of healthcare resources, ED visits, and unplanned
readmissions.
6.12
Diversity Supplement - Consent Procedures
This study has two methodologies for consent procedures based upon the speciﬁc aims.
Aim 1. Medical Record Review Waiver of Consent Process
We are requesting a waiver of consent based on the following qualiﬁcations: the
research is limited to existing data; the data involves no more than minimal risk to the
subject; waiver of consent will not adversely aﬀect the rights and welfare of subjects,
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and the research could not be practicably carried out without the waiver. The proposed
study meets all regulatory requirements for a waiver, as outlined in the Code of Federal
Regulations Title 45 Part 46, “Protection of Human Subjects”. Justiﬁcation is provided
below.
• See 45 C.F.R. 46.116 (d)(1) See 10.4 The research activity proposed in this applica-
tion is retrospective chart review and minimal risk.
• See 45 C.F.R. 46.116 (d)(2) See 10.4 Beyond medical record review, there are no
activities or interventions outside of routine clinical care. Nothing proposed in the
research will adversely aﬀect the rights and welfare of the subject.
• See 45 C.F.R. 46.116 (d)(3) See 10.4 The research proposed in this application
would be impracticable to conduct if informed consent is required. Eligible subjects
enrolled in our study are identiﬁed through the parent grant which currently operates
with a waiver of informed consent. In addition, PHIS data sets are derived from over
45 hospitals throughout the United States; therefore, data collection and reporting
would not be feasible if the waiver of HIPAA authorization was not carried out. We
are requesting a waiver of HIPAA authorization based on the following qualiﬁcations:
the use or disclosure of PHI involves no more than minimal risk, the research could
not practicably be conducted without the waiver or alteration, and the research
could not practicably be conducted without access to and use of PHI. The protected
health information will not be reused or disclosed to any other person or entity,
except as required by law or for authorized oversight of the research project.
• See 45 C.F.R. 46.116 (d)(4) See 10.4 The research activity proposed in this appli-
cation is retrospective chart review, so no additional pertinent information will be
provided to the subjects.
Aim 2. Telephone Follow-up Assessments Waiver of Written Documentation of Consent
We are requesting a waiver of written documentation of consent. The proposed
study meets all regulatory requirements for a waiver, as outlined in the Code of Federal
Regulations Title 45 Part 46, “Protection of Human Subjects”. Justiﬁcation is provided
below.
• 21 CFR 56.109(c)(1) and 45 C.F.R. 46.117 (c)(1)(ii) Research presents
no more than minimal risk of harm to subjects and involves no pro-
cedures for which written consent is normally required outside of the
research context.
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The research activity proposed in this application is a telephone interview which is a
minimal risk activity. Beyond the interview, there are no activities or interventions
outside of routine clinical care.
• See 45 C.F.R. 46.116 (d)(1) See 10.4 The research activity proposed in this applica-
tion is retrospective chart review and minimal risk.
• See 45 C.F.R. 46.116 (d)(2) See 10.4 Beyond medical record review, there are no
activities or interventions outside of routine clinical care. Nothing proposed in the
research will adversely aﬀect the rights and welfare of the subject.
• See 45 C.F.R. 46.116 (d)(3) See 10.4 The research proposed in this application
would be impracticable to conduct if written informed consent is required as eligible
subjects are recruited through a national, multi-center trial study across the country
for telephone follow-up assessment.
• See 45 C.F.R. 46.116 (d)(4) See 10.4 Guardians of eligible children will be provided
a Consent, Parental Permission, and Authorization Cover Letter from the DCC
regarding the study. This handout will be mailed to the legal guardian’s home
address if the legal guardian is conversant in English or Spanish languages. A
follow-up call will be made to the legal guardian. At the time of the phone call, Dr.
Wells or RC will conﬁrm that the legal guardian has received the cover letter and
obtain verbal consent for the phone follow-up questions.
Figure 6 represents the proposed research activity and respective requested waivers of
consent for the study population
7
Data Management
We will collect data using structured observational assessment forms regarding factors that
have been shown previously to be associated with risk for CSI in children.90 Relevant data
will be collected by two methods: (1) Electronic questionnaires using tablets and wireless
technologies during the visit and (2) Detailed demographic and clinical information
from the medical records will be extracted at each institution. This information will be
integrated using an existing informatics infrastructure at the DCC.
The RCs will administer the observational assessment forms to the EMS, ED, and
surgical providers through a secure web-based, public interface to the data management
system via a tablet. The real-time data entry increases the time for review and data
analysis and potentially reduces missed or erroneous responses. The electronic version
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of the observational assessment forms will be available using a tablet, oﬀering these
advantages: (a) improved data quality and completeness by providing safeguards against
question omission and inconsistent response; (b) skip patterns and algorithms will be
programmed to customize the next questions asked based on previous answers; (c)
elimination of manual data entry errors since the data will be transmitted wirelessly
and automatically incorporated into REDCap, web-based clinical database management
system; (d) a user-friendly and engaging touchscreen interface; and (e) restricts access
to PHI. Using REDCap, the data will be securely collected at diﬀerent locations but
managed within the same system.
REDCap is a web-based application designed to support data capture for research
studies, providing:
• user authentication and role-based security
• collaborative access to data across academic departments and institutions
• intuitive electronic case report forms (CRFs)
• real-time data validation, integrity checks and other mechanisms for ensuring data
quality (e.g. double-data entry options)
• data attribution and audit capabilities
• protocol document storage and sharing
• central data storage and backups
• data export functions for common statistical packages
• data import functions to facilitate bulk import of data from other systems
8
Data Analysis
Tool Development and Evaluation
Figure 2 on page 18 illustrates the iterative
process of tool development and validation. This process relies on continuous monitoring
of clinical data with interim analyses to model and evaluate potential decision rules in
parallel with the Applied Cognitive Task Analysis which will inform the design of the
Pediatric CSI Risk Assessment Tool prototypes. We will evaluate the study progress
and data collection at multiple time points during the study collection period. The data
analysis will use interim evaluations to measure progress towards achieving the study
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speciﬁc aims. This process of reﬁnement will use qualitative and quantitative methods
to solicit input regarding the tool attributes from subject matter experts and clinical
end-users, in particular practicing EMS, ED, and surgical personnel.
8.1
Speciﬁc Aim Analyses
Speciﬁc Aim 1. Develop the Pediatric CSI Risk Assessment Tool in children with blunt
trauma using prospective observational data obtained from ED providers.
The ﬁrst step in tool development is the reﬁnement of the original PECARN model
into a decision rule that has very high sensitivity for identifying CSI in children with
blunt trauma and suﬃcient speciﬁcity to result in a meaningful reduction in the use
of spinal precautions and radiographic imaging. To evaluate Aim 1 we will use the
prospective observational data obtained from ED providers to reﬁne a clinical decision
support tool that has near perfect sensitivity (lower 95% conﬁdence limit >95%) and
adequate speciﬁcity to reduce unnecessary interventions (lower 95% conﬁdence limit
>40%) when screening children for CSIs. To develop the decision rule, we will use binary
recursive partitioning on a study population consisting of approximately 13,333 subjects
collected from eight PECARN sites.
We will use multiple analytic techniques to reﬁne the decision rule that will serve
as the basis for the Pediatric CSI Risk Assessment Tool. We will use both CART 7.0.0
(San Diego, CA) to perform recursive partitioning for the purpose of building a clinical
decision tree and multivariable logistic regression modeling using SAS 9.4 (Cary, NC) to
develop a risk model. This is important because each method will result in a tool that has
diﬀerent characteristics. As an example, we will use regression analysis if we determine
that the optimal tool is a “risk calculator” in which a child's risk for CSI is calculated
based on the child's individual constellation of ﬁndings and guidance for CSI evaluation
(e.g. nothing versus plain radiographs versus CT) is set for various risk thresholds. We
can use regression analysis, as was performed in our pilot work, to determine a set of
variables that has suﬃcient performance characteristics for use as a simple tool in which
the presence of any one ﬁnding would identify the child as at non-negligible risk for CSI
and therefore requiring further evaluation.90, 94, 95 Recursive partitioning results in a
clinical decision tree in which the resultant tool is a patient care algorithm, with each
terminus resulting in a risk estimate on which we base clinical decisions regarding CSI
evaluation.96, 97 Our ACTA will help determine which type of tool and therefore which
analytic techniques for decision rule reﬁnement will be most useful for tool design. It may
be that ultimate implementation requires multiple diﬀerent tools based on various patient
scenarios which diﬀer by parameters such as setting, provider type, point of entry into
the health care system, and timing within the patient's clinical course.
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Using the results of our ACTA, we will develop conceptual prototypes of the Pediatric
CSI Risk Assessment Tool suitable for user testing. We will perform a series of iterative
formative usability tests to evaluate the tool prototypes.118–120 Prototype assessment will
be scenario-based and designed to address the various clinical roles and workﬂows. At
each iterative testing period, we will assess the prototypes in terms of usability, utility
and eﬀectiveness, but also in supporting the desired outcome of the decision rule. We will
modify the prototypes, or if necessary redesign and retest to address the results. With each
iteration, the prototypes will increase in the level of detail and functionality they represent.
The development and user testing of conceptual system prototypes is well-established
in general usability science and moreover in the development of health information
technology solutions.103, 104, 118, 121, 122 Team members have experience using dedicated
software, such as Axure (Axure Software Solutions, San Diego, CA) to support rapid,
interactive prototyping of clinical decision support systems suitable for user testing.123–126
We will include all children that present to the study site EDs, regardless of point of
entry into the health care system. While this is important in terms of building a tool
that is representative of the full spectrum of children with CSI, this has the potential
for resulting in ascertainment bias on the part of the ED providers responding to the
assessment forms. In order to address this potential bias, we will determine the operating
characteristics of our prediction tool for the entire cohort as well as key sub-samples
of children, including those without cervical spine imaging prior to presentation at the
study site, those who do not have a trauma team activation, those who arrive via scene
response EMS, and those who arrive via private motor vehicle. For any subgroup with
poor performance, we will conduct an exploratory analysis by deriving separate rules.
As a standard quality measure for observational studies such as this, we will compare
the demographic characteristics of enrolled children to those that were eligible and not
enrolled.
In addition, when conducting our analyses, we will examine the operating charac-
teristics of the prediction rule for several high-risk groups including young children (<8
years), children with injuries that require either surgical stabilization or stabilization
with an orthotic device for >30 days, children with medical conditions that predispose to
CSIs and children who are victims of abusive trauma. For any high-risk group with poor
performance, we will conduct an exploratory analysis by deriving separate rules.
While every eﬀort will be made to ensure data quality, we will conduct several analyses
to assess the eﬀect of the quality of the data. CART automatically selects surrogate
variables in the event that a splitting variable has a missing or unknown value. For
regression modeling, we will use multiple imputations to allow for inclusion of records
where the provider failed to assess the patient for the clinical ﬁnding. Further, if a
risk factor in the tool has low prevalence or poor kappa for EMS-ED and ED-Surgical
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provider paired observations(lower 95% conﬁdence interval <0.4), the analyses will be
re-run excluding the variables for comparison.
Speciﬁc Aim 2. Validate the Pediatric CSI Risk Assessment Tool in a separate popula-
tion of children with blunt trauma using prospective observational data obtained
from ED providers.
To validate the Pediatric CSI Risk Assessment Tool, we hypothesized that the Pediatric
CSI Risk Assessment Tool will retain adequate sensitivity (lower 95% conﬁdence limit
>95%) and speciﬁcity (lower 95% conﬁdence limit >40%) in an independent sample of
children presenting for to the ED evaluation following blunt trauma. To evaluate this
aim, we will enroll patients from PECARN sites not involved in enrollment for Speciﬁc
Aim 1. Using a population of 8,889 collected from the prime site and an additional seven
diﬀerent PECARN sites and the prime, we will report standard performance measures to
describe the accuracy of the rule: sensitivity, speciﬁcity, positive predictive value, negative
predictive value, and positive and negative likelihood ratios. We will also report 95% CIs
for all above measures. In addition to evaluating the validity of the decision rule, we will
continue to perform and report formative testing on the Pediatric CSI Risk Assessment
Tool prototypes. If performance of the rule or provider acceptance is low at our interim
analysis, we will return to the training set in Aim 1 and approach reﬁning the decision rule
using a diﬀerent process and revalidate. We will report the demographic characteristics
of the validation study cohort using means and medians as appropriate for continuous
measures and frequencies and percentages for categorical measures.
Speciﬁc Aim 3. Validate the Pediatric CSI Risk Assessment Tool in a population of
children with blunt trauma using prospective observational data obtained from EMS
providers.
Using a set of patients who have data from both EMS and ED providers collected
throughout the both the derivation and validation phases of the study we will evaluate
the performance of the rule using EMS variables. Additionally, we will assess agreement
between EMS and ED providers using the kappa statistics. It is expected that there will
be a minimum of 7,444 subjects with data from both EMS and ED providers available
for this aim. As in Aims 1 and 2 we will report the decision rules performance based on
standard measures: sensitivity, speciﬁcity, positive predictive value, negative predictive
value, and positive and negative likelihood ratios. We will also report 95% CIs for all
above measures. If performance of the rule derived in Aim 1 is poor we will derive an
EMS speciﬁc rule using similar methods described above.
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9
Study Training
9.1
Study Training
A formal training program for investigators and research staﬀwill be held prior to the
start of enrollment. The training program will cover regulatory topics and review the
National Institutes of Health (NIH) required Good Clinical Practice standards. The
training will also provide in depth explanations regarding study procedures, clinical care,
data entry procedures, quality assurance, and site monitoring procedures. Upon return
to their home site, each investigator and research coordinator will train the remaining
study staﬀat their site on the protocol and all research-related duties and functions.
Documentation of this training will be required by the PI prior to any site being allowed
to initiate the study. A manual of operations will be provided to each investigator
prior to the start of enrollment. The manual will detail speciﬁc information about the
study procedures, regulatory information, protection of human research subjects, and
other necessary information. Updates and revisions to the manual will be made available
electronically. The Data Coordinating Center, in collaboration with the study investigators
will be the main contact for study questions.
9.2
Study Monitoring
The investigators recognize the importance of ensuring data of excellent quality. Study
monitoring is critical to this process. Monitoring has been a very eﬀective tool for
maintaining data quality in previous Pediatric Emergency Care Applied Research Network
studies, and we will utilize this process to ensure excellent quality data in the proposed
study. The DCC utilizes risk-based methodology to identify and correct problems that
may arise at sites. The risk-based approach to monitoring focuses on oversight activities
and preventing or mitigating key risks to data quality, as well as to processes critical to
human subject protection and integrity of the trial or study.
Study monitors must be provided with appropriate access to study materials and the
medical records for study subjects. If the medical records are in electronic form, the
clinical investigator or an authorized individual must provide any assistance necessary to
facilitate the study monitor’s review of data in the electronic medical record.
9.2.1
Site Monitoring Plan
A supplemental study-speciﬁc risk-based monitoring plan, separate from the protocol
will be completed which outlines speciﬁc criteria for monitoring. This plan may include
the number of planned site visits, criteria for focused visits, additional visits or remote
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monitoring, a plan for chart review and a follow up plan for non-compliant sites. The
monitoring plan also describes the type of monitoring that will take place (e.g., sample
of all subjects within a site; key data or all data), the schedule of visits, how they are
reported and a time frame to resolve any issues found.
10
Protection of Human Subjects
Human Subjects Involvement, Characteristics, and Design:
This is a prospec-
tive observational study of children who have sustained blunt trauma. The proposed
population was selected as it represents the population of children who may be at risk for
CSI and in whom there are not clinical guidelines for evaluation and management. We
will be observing the cohort of children younger than 18 years old who present to the 18
Pediatric Emergency Care Applied Research Network (PECARN)-aﬃliated Emergency
Departments for evaluation following blunt trauma. In addition, participants must have
one of the following: transported from the ﬁeld by EMS using spinal precautions, un-
dergoing trauma team evaluation, or undergoing cervical spine imaging to evaluate for
potential CSI (includes patients transferred with imaging). Our goal is to enroll 22,222
consecutive patients to meet the speciﬁc aims of our study. Given the rarity of CSI in
children, approximately 18 performance sites are necessary in order to establish the cohort
within our speciﬁed timeframe. All key personnel involved in conducting the research
will receive required education on the protection of human research participants prior to
engaging in the research; this includes good clinical practices, human subjects protection
and Health Insurance Portability Accountability Act (HIPAA) training. Institutional
Review Board approval will be obtained prior to initiating the study.
10.1
Institutional Review Board (IRB) Approval
A central IRB (cIRB) at the University of Utah will be used for this study.
The
Data Coordinating Center will track IRB approval status and will not permit subject
enrollment without documentation of initial IRB approval and maintenance of that
approval throughout subsequent years of the project.
10.2
Potential Risks
The risk to the subjects that participate in this study is the loss of privacy or conﬁdentiality
through accidental disclosure of private health information. The aforementioned safe-
guards will be implemented to protect against this potential risk. Due to these precautions,
the likelihood of a loss of privacy or conﬁdentially is minimal.
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10.2.1
Improper Disclosure of Medical Information
The data will be obtained from up to six sources: treating EMS prehospital provider,
treating ED provider, treating Surgical provider (which can include trauma surgeon
or spine surgeon), medical record and legal guardian. No biological specimens will be
obtained in this study. We will maintain the paper subject records for at least three years
after the last Federal Financial Report is submitted to the National Institute of Health.
10.2.2
Medical Risks
There are no known or anticipated additional medical risks from participating in the trial.
10.2.3
Protections Against Risk
Research Personnel who will have access to identiﬁable private information are the research
personnel (a site principal investigator and their authorized research staﬀ(RCs/RAs) at
the study site where the subject was enrolled. Data collection will be electronic; using
password protected computing devices that wirelessly transmit data to a secure network
drive. These devices will be kept in locked cabinets, in locked suites when not in use.
Each subject will be assigned a unique patient identiﬁer for purposes of analysis, and
this will be used to link any paper records to an electronic research record within the
analytic database. Study site personnel will be responsible for entering the data through
the electronic interface into a secure, web-based data management system hosted at the
PECARN DCC; thus, the analytic database will be maintained in a secure encrypted
HIPAA compliant computing system. Most research results will be presented in aggregate
fashion. HIPAA identiﬁers will be stripped from ﬁndings that reference individual subjects.
While the majority of the data will be stored electronically, there is a chance that we will
need to retain some information on paper records. All paper research records with patient
identiﬁers, if any, will be kept at the site from which they were obtained in locked cabinets,
in a locked oﬃce, within a locked oﬃce suite. Patient identiﬁers will not be part of the an-
alytic database. Any paper subject records will be destroyed upon completion of analysis.
Due to these precautions the likelihood of a loss of privacy or conﬁdentially is very minimal.
All personnel involved with the DCC have signed conﬁdentiality agreements concerning
data encountered in the course of their daily work. All personnel (including administrative
staﬀ) have received Human Subjects Protection and Health Information Portability and
Accountability Act (HIPAA) education. We require all users to sign speciﬁc agreements
concerning security, conﬁdentiality, and use of our information systems, before access is
provided.
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10.3
Potential Beneﬁts
There is no immediate potential beneﬁt to the human subjects involved in the study.
There is future beneﬁt to human subjects by improving the care of injured children
through the knowledge that is gained by the study.
This study will develop and validate a pediatric CSI risk assessment tool that can be
used by ED providers to determine which children can safely forgo spinal precautions and
cervical spine imaging after blunt trauma. It will also lay the groundwork for determining
the validity of this tool when used by other health care providers and for a subsequent
implementation trial. A rigorously-tested risk assessment tool for CSI in children has
the potential for substantially reducing the number of children who receive unnecessary
spinal precautions for trauma transport and/or who receive radiographic clearance of
their cervical spine. This could lead to signiﬁcant changes in recommendations for the
treatment and transport of injured children worldwide.
10.4
Waiver of Informed Consent
This study is a prospective observational study.
We will be obtaining observations
from clinicians regarding factors that place children at risk for CSI. To ensure that
these observations are not biased, we must try to obtain the surveys before diagnostic
imaging is performed. The decision to obtain diagnostic testing will not be inﬂuenced by
enrollment in the study. Diagnostic testing for these children should not be delayed for
study procedures. The proposed study meets all regulatory requirements for a waiver,
as outlined in the Code of Federal Regulations Title 45 Part 46, “Protection of Human
Subjects”. Justiﬁcation is provided below.
45 C.F.R. 46.116 (d)(1) The research involves no more than minimal risk to
the subjects
The research activities proposed in this application are 1) collection of
observational data from ED and EMS personnel and 2) review of medical record data.
Both of these are minimal risk activities.
45 C.F.R. 46.116 (d)(2) The waiver or alteration will not adversely aﬀect the
rights and welfare of the subjects
Beyond collection of observational data, there
are no activities or interventions outside of routine clinical care. Nothing proposed in the
research will adversely aﬀect the rights and welfare of the subject.
45 C.F.R. 46.116 (d)(3) The research could not practicably be carried out
without the waiver or alteration
The research proposed in this application would
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be impracticable to conduct if informed consent is required. This study investigates a rare
disease, cervical spine injury (CSI). CSI occurs in less than 2% of children who sustain
blunt trauma. We determined the feasibility of the proposed project's sample size 22,222
by using the enrollment rates and incidence of CSI in the pilot study and applying it to
information regarding this study’s participating sites obtained from PECARN’s core data
project.92, 127
Prior similar PECARN work in children with head injury and abdominal trauma has
demonstrated that we are able to achieve enrollment rates of 80% only with waiver of
consent.96, 97 If written informed consent had been required for these prospective cohort
participants, enrollment would have decreased by 45% due to lack of an available parent
or legal guardian (LAR) during the emergency visit.98, 99 Further, we have concern that
the established cohort would not be representative of the spectrum of children at risk
for CSI and thus would result in ascertainment bias. Our prior work has demonstrated
that those patients at highest risk for severe injury will be more diﬃcult to consent (e.g.
absent guardian, time critical injuries, etc.) while lower risk patients will be easier to
consent (e.g. arrive with guardian, stable injuries etc.).98, 99 Additional considerations
regarding the impact of written informed consent on the study’s scientiﬁc integrity:
• Pivotal to the scientiﬁc integrity of developing a decision tool is that observational
data collected from proxies is collected before diagnostic testing is obtained and/or
reviewed. Observational data obtained after the ED provider is aware of testing
results introduces recall bias. It would be unethical, however, to delay patient care
in order to obtain written informed consent for collection of observational assessment
data from EMS and ED providers. Thus, either we delay collection of observational
assessment data for the written informed consent and risk the introduction of recall
bias OR we conduct the collection of observational assessment data under waiver of
consent.
• In trauma situations, parents may be under considerable duress given the critical
nature of their child’s injuries. While it is not uncommon for parents/patients
to be approached for consent under these circumstances, particularly for studies
and clinical procedures that may have substantial beneﬁt to the patient, it would
be inappropriate to solicit informed consent for a minimal risk study during this
sensitive period of time when parents are facing more pressing decisions.
• Data are to be collected from EMS prehospital personnel, who are required to
return to service within 30 minutes or sooner of hospital arrival. It is implausible
that we would be able to obtain written informed consent from a parent or legal
guardian prior to EMS departure from the ED. Thus, we would be unable to collect
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prospective information from the EMS provider which threatens an important aim
of the study.
• For missed eligible subjects, we will not know who is eligible until review of the ED
daily census reports, at which juncture, the patient will no longer be in the ED
making consent procedures impossible.
45 C.F.R. 46.116 (d)(4) Whenever appropriate, the subjects will be provided
with additional pertinent information after participation
Guardians of eligible
children will be provided a Consent, Parental Permission, and Authorization cover letter
from the enrolling physician or research coordinator regarding the study. This handout
will be provided in the ED, if the legal guardian is present. If the child does not undergo
cervical spine imaging in the ED, a follow-up call will be made to the legal guardian to
conﬁrm absence of CSI. At the time of the phone call, the Research Coordinator will
conﬁrm that the legal guardian has received the cover letter and obtain verbal consent
for the phone follow-up questions.
10.5
Health Insurance Portability and Accountability Act
Data elements collected include the date of birth and date of admission. Prior to statistical
analyses, dates will be used to calculate patient age at the time of the study events. The
ﬁnal data sets (used for study analyses and archived at the end of the study) will be
de–identiﬁed, and will exclude these speciﬁc dates.
Data elements for race, ethnicity, and gender are also being collected. These demo-
graphic data are required for Federal reporting purposes to delineate subject accrual by
race, ethnicity, and gender.
For purposes of the DCC handling potential protected health information (PHI) and
producing the de–identiﬁed research data sets that will be used for analyses, all study sites
have been oﬀered a Business Associate Agreement with the University of Utah. Copies of
executed Business Associate Agreements are maintained at the DCC.
10.6
Inclusion of Women and Minorities
The proposed subject criteria were selected to represent the population of children who
may be at risk for CSI and in whom there are not clinical guidelines for evaluation and
management. The gender, race and ethnicity of the study cohort will be demographically
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representative of children who experience blunt trauma and who are cared for at the
participating study sites. The PHS Inclusion Enrollment Report represents the expected
demographic breakdown of the study population by gender, race and ethnicity. There will
be no sex/gender, racial or ethnic group excluded for any reason. As such, no outreach
programs are proposed for the purpose of recruiting speciﬁc sex/gender, racial, or ethnic
group members.
10.7
ClinicalTrials.gov Requirements
This study will not be registered at ClinicalTrials.gov as it is not an interventional trial.
10.8
Retention of Records
For federally funded studies subject to the Common Rule, records relating to the research
conducted shall be retained for at least 3 years after completion of the research. Completion
of the research for this protocol should be anticipated to include planned primary and
secondary analyses, as well as subsequent derivative analyses. Completion of the research
also entails completion of all publications relating to the research. All records shall be
accessible for inspection and copying by authorized representatives of the regulatory
authorities at reasonable times and in a reasonable manner [45 CFR §46.115(b)].
10.9
Public Use Data Set
After subject enrollment and follow up have been completed, the DCC will prepare a
ﬁnal study dataset for analysis. A releasable database will be produced and completely
de-identiﬁed in accordance with the deﬁnitions provided in the Health insurance Portabil-
ity and Accountability Act (HIPAA). Namely, all identiﬁers speciﬁed in HIPAA will be
recoded in a manner that will make it impossible to deduce or impute the speciﬁc identity
of any patient. The database will not contain any institutional identiﬁers.
The DCC will also prepare a data dictionary that provides a concise deﬁnition of every
data element included in the database. If speciﬁc data elements have idiosyncrasies that
might aﬀect interpretation or analysis, this will be discussed in the dictionary document.
In accordance with policies determined by the investigators and funding sponsors, the
releasable database will be provided to users in electronic form.
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