A Pragmatic Strategy Empowering Paramedics to Assess Low-Risk Trauma Patients With the Canadian C-Spine Rule and Selectively Transport Them Without Immobilization
Phase: NA
Conditions: Neck Injuries
Sponsor: Ottawa Hospital Research Institute

 
A Pragmatic Strategy 
Empowering Paramedics to 
Assess Low-Risk Trauma 
Patients with the Canadian    
C-Spine Rule and Selectively 
Transport them Without 
Immobilization 
      
Ottawa Hospital Research Institute 
Dr. Christian Vaillancourt 
 
 
 

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Contents 
Section 1: Administrative Information .......................................................................................................... 3 
1.1 
Study Title ..................................................................................................................................... 3 
1.2 Trial Registration and Data Set ........................................................................................................... 3 
1.3 Protocol Version and History of Changes ........................................................................................... 5 
1.4 Funding ............................................................................................................................................... 5 
1.5 Roles and Responsibilities in Protocol Development ......................................................................... 5 
1.6 Sponsor Contact Information .............................................................................................................. 6 
1.7 Roles and Responsibilities – Sponsor and Funder .............................................................................. 6 
1.8 Roles and Responsibilities – Committees ........................................................................................... 6 
Section 2. Introduction ................................................................................................................................. 8 
2.1 Background ......................................................................................................................................... 8 
2.2 Objectives.......................................................................................................................................... 10 
2.3 Trial Design ........................................................................................................................................ 11 
Section 3. Methods: Participants, Interventions and Outcomes ................................................................ 12 
3.1 Study Setting ..................................................................................................................................... 12 
3.2 Eligibility Criteria ............................................................................................................................... 12 
3.3 Interventions ..................................................................................................................................... 12 
3.4 Outcomes .......................................................................................................................................... 13 
3.5 Participant Timeline .......................................................................................................................... 14 
3.6 Sample Size ....................................................................................................................................... 14 
3.7 Recruitment ...................................................................................................................................... 14 
Section 4: Methods: Assignment of Interventions ..................................................................................... 15 
Section 5: Methods: Data Collection, Management, and Analysis ............................................................. 15 
5.1 Data Collection Methods .................................................................................................................. 15 
5.2 Data Collection Methods – Retention ............................................................................................... 15 
5.3 Data Management ............................................................................................................................ 16 
5.4 Statistical Methods ........................................................................................................................... 16 
Section 6. Methods: Monitoring ................................................................................................................. 17 
6.1 Data Monitoring ................................................................................................................................ 17 
6.2 Data Monitoring – Interim Analyses ................................................................................................. 18 
6.3 Harms ................................................................................................................................................ 18 

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6.4 Auditing ............................................................................................................................................. 19 
Section 7. Ethics and Dissemination ........................................................................................................... 19 
7.1 Research Ethics Approval .................................................................................................................. 19 
7.2 Protocol Amendments ...................................................................................................................... 19 
7.3 Consent ............................................................................................................................................. 19 
7.4 Confidentiality ................................................................................................................................... 20 
7.5 Declaration of Interests .................................................................................................................... 20 
7.6 Access to Data ................................................................................................................................... 20 
7.7 Dissemination ................................................................................................................................... 20 
Section 8. References .................................................................................................................................. 21 
Section 9. Appendices ................................................................................................................................. 23 
Appendix 1. C-Spine Study Team Membership, Roles and Affiliations ................................................... 23 
Appendix 2. Steering Committee Terms of Reference ........................................................................... 25 
Appendix 3. Publications Committee Terms of Reference ..................................................................... 27 
Appendix 4. Paramedic Committee Terms of Reference ........................................................................ 28 
Appendix 5. Patient Committee Terms of Reference ............................................................................. 30 
Appendix 6. Paramedic Data Collection Form ........................................................................................ 31 
Appendix 7. Study Data Collection Form ................................................................................................ 32 
Appendix 8. Data Safety Monitoring Board Terms of Reference ........................................................... 33 
 
 
 

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Study Protocol 
The information included in this report follows the Standard Protocol Items: Recommendations for 
Interventional Trials (SPIRIT) Guidance for recommended items to include and address in a clinical trial 
protocol (1, 2). 
Section 1: Administrative Information 
1.1 Study Title 
A pragmatic strategy empowering paramedics to assess low-risk trauma patients with the Canadian C-
Spine Rule (CCR) and selectively transport them without immobilization. 
1.2 Trial Registration and Data Set 
The trial has been registered at ClinicalTrials.gov. The ClinicalTrials.gov identifier assigned to this study 
is: NCT02786966. Table 1 (below) contains information on the recommended items from the WHO Trial 
Registration Data Set (http://www.who.int/ictrp/network/trds/en/) (1, 2). When items from Table 1 are 
updated in this protocol, the trial registry at ClinicalTrials.gov will be updated accordingly. 
 
 

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Table 1. C-Spine Study Registration Data Set 
Item 
Information 
Primary registry and trial 
identifying number 
ClinicalTrials.gov, NCT02786966 
Date of registration in primary 
registry 
May 31, 2016 
Secondary identifying numbers 
N/A 
Source(s) of monetary or 
material support 
Ontario SPOR SUPPORT Unit (OSSU) 
Primary sponsor 
Ottawa Hospital Research Institute 
Secondary sponsor(s) 
none 
Contact for public queries 
Manya Charette, Study Coordinator, email: mancharette@ohri.ca 
Contact for scientific queries 
Dr. Christian Vaillancourt, Principal Investigator, email: 
cvaillancourt@ohri.ca 
Public Title 
A pragmatic strategy empowering paramedics to assess low-risk 
trauma patients with the Canadian C-Spine Rule (CCR) and selectively 
transport them without immobilization. 
Scientific Title 
Can a strategy allowing paramedics to assess selective low-risk 
trauma patients with the Canadian C-Spine Rule and transport them 
without immobilization be safe, cost-effective, and result in significant 
health service benefits for patients, Emergency Medical Services, and 
Emergency Departments? – A Cluster Randomized Pragmatic 
Multicentre Trial. 
Countries of recruitment 
Canada (Ontario only) 
Health condition(s) or 
problem(s) studies 
Stable trauma patients with a potential neck injury requiring 
assessment by Emergency Medical Services (EMS) 
Intervention(s) 
Application of a decision rule – CCR – to determine the need for spinal 
immobilization 
Key inclusion and exclusion 
criteria 
Included: consecutive, alert (able to follow commands), stable 
(normal vital signs) patients evaluated by paramedics following acute 
blunt trauma (within 48 hours). 
Excluded: Patients with penetrating trauma, acute paralysis, known 
vertebral disease, those referred from another hospital and 
transported between facilities, and those younger than 8 years of age. 
Study type 
Stepped wedge, cluster randomized trial 
Date of first enrolment 
To be determined 
Target sample size 
7,200  
Recruitment status 
Not yet recruiting 
Primary outcome(s) 
Proportion of patients immobilized 
Proportion of patients feeling comfortable (co-primary outcome) 
Key secondary outcomes 
Proportion of patients with a pain score ≤ 4/10 
Time from EMS arrival to ED discharge or admission to hospital 
Patient radiation exposure from diagnostic imaging 
Number of skin pressure injuries 
Number of missed c-spine injuries 
Time spent in the field by paramedics before arrival to hospital 
Time spend in-hospital by paramedics before transfer of care 

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ED length of stay 
Number of subsequent ED visits within 30 days 
Number of subsequent clinical/family physician visits within 30 days 
Frequency of c-spine diagnostic imaging performed within 30 days 
Incremental cost per one immobilization avoided 
1.3 Protocol Version and History of Changes 
Any changes to the protocol that are more substantive than simply the correction of typographical 
errors will be recorded in Table 2. The revised protocol will be given a new version number, and a 
summary of the revisions made to the previous protocol version will be listed. The current protocol 
version number and effective date will also be displayed in the footer at the bottom of each page in the 
protocol and should match the version number on the cover sheet and in Table 2. 
 
Table 2. Description of Protocol Revisions 
 
Protocol 
Version # 
Effective 
Date 
Summary of Revisions 
1 
March 2016 
N/A 
2 
May 2016 
1.2 Trial Registration and Data Set – addition of registry number 
Table 1 – Trial Registration Information 
2.1 Background – addition of ILCOR reference 
3 – clarification regarding number of sites 
3.2 Eligibility Criteria – clarification of penetrating trauma, 
modification to stable vital signs 
Appendix 6 – Paramedic Data Collection Form – new version 
6.1 Data Monitoring – additional information on DSMB 
Appendix 4 – Paramedic Committee Terms of Reference 
Appendix 8 – addition of DSMB Terms of Reference 
 
 
 
 
 
 
1.4 Funding 
This study has received funding through the Ontario SPOR SUPPORT Unit (OSSU’s) IMPACT Awards 
competition. OSSU, which receives funding from the Canadian Institutes of Health Research and the 
Province of Ontario, has agreed to provide funding in the amount of $1,456,990 for the period June 2, 
2015 to September 30, 2018. The funding will be used to cover the direct costs required to implement 
and run this multicenter study. Indirect funding will be provided by the sponsor organization – the 
Ottawa Hospital Research Institute. Participating EMS Services have all agreed to provide paramedic 
training time for this study in-kind. 
1.5 Roles and Responsibilities in Protocol Development 
CV = Dr. Christian Vaillancourt, Ottawa Hospital Research Institute 
MC = Manya Charette, Ottawa Hospital Research Institute 
MT = Dr. Monica Taljaard, Ottawa Hospital Research Institute 
KT = Dr. Kednapa Thavorn, Ottawa Hospital Research Institute 
AP = Dr. Amy Plint, Children’s Hospital of Eastern Ontario 
 

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CV conceived of the study and drafted the IMPACT Awards Application. MC initiated the drafting of the 
study protocol using the IMPACT Awards Application as a template. MC will be responsible for 
maintaining the protocol going forward. MT provided statistical expertise into both the Application and 
the Protocol. KT provided expertise on the Health Economic components of the project. AP is 
coordinating the pediatric component of the project and provided input on these sections of the 
Application and the Protocol. All study team members (see Appendix 1. C-Spine Study Team 
Membership, Roles and Affiliations) contributed to the grant application. Members of the Steering 
Committee (see section 1.8.1 Steering Committee) reviewed the complete draft study protocol. 
1.6 Sponsor Contact Information 
Study Sponsor: Ottawa Hospital Research Institute 
Contact Name: Dr. Duncan Stewart, Chief Executive Officer; Ms. Nancy Camack, Director, Research 
Administration; Dr. Dean Fergusson, Director, Clinical Epidemiology Program 
Address: 725 Parkdale Avenue, Ottawa, ON K1Y 4E9 
Phone: 613-761-4395 
Email: info@ohri.ca  
 
1.7 Roles and Responsibilities – Sponsor and Funder 
Neither the Sponsor nor the Funder had any role in the design of this study. The Funder will be kept up-
to-date on study progress and activities, but will not have any direct role in the execution, analysis, 
interpretation or publication of study results.  
1.8 Roles and Responsibilities – Committees 
1.8.1 Steering Committee 
Chair: Dr. Christian Vaillancourt 
Membership: (to be confirmed) Dr. Amy Plint, Elizabeth Hall (patient representative), paramedic 
representative, Dr. Monica Taljaard, Dr. Kednapa Thavorn, one representative from each OSSU Partner 
(Ottawa Methods Centre, Institute for Clinical Evaluative Sciences, Ontario Child Health SUPPORT Unit, 
Women’s College Hospital Women’s Xchange, OSSU Ontario Francophone Communities Working Group, 
Clinical Trials Ontario), study support staff 
Responsibilities: 
 
Approve the main study protocol and any subsequent amendments 
 
Monitor and supervise the trial towards interim and overall objectives 
 
Review relevant information from other sources, including information from related studies that 
could impact the main study protocol 
 
Review recommendations and requests from participating Research Ethics Boards, as well as the 
Data Safety Monitoring Board 
 
Review activity of study subcommittees, including, but not limited to the Publications 
Committee, the Paramedic Committee, and the Patient Engagement Committee.  
 
Terms of Reference: appended, please see  
 

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Appendix 2. Steering Committee Terms of Reference.  
 
1.8.2 Publications Committee 
Chair: Dr. Christian Vaillancourt 
Membership: to be decided 
Responsibilities: 
 
Promote publication of study findings and activities in peer-reviewed, MEDLINE-indexed 
journals 
 
Support broad and equitable participation by study team members and investigators in 
presentations and publications 
 
Define rules and guidelines for writing group membership for manuscripts 
 
Review manuscript proposals, assign writing groups and prioritize publications and 
presentations 
 
Provide editorial support and timely review of presentations and publications. 
 
Terms of Reference: will be appended to Appendix 3. Publications Committee Terms of Reference when 
finalized.  
1.8.3 Operations Committee 
Chair: Dr. Christian Vaillancourt 
Membership: Manya Charette, other study support staff 
Responsibilities: day-to-day trial logistics and operations 
1.8.4 Paramedic Committee 
Chair: Brent McLeod, paramedic representative 
Membership: one representative from each participating EMS Service and each supporting Base Hospital 
Program, study Principal Investigator, study support staff 
Responsibilities:  
 
To help develop, review and approve study training materials, data collection forms and study 
advertisements 
 
To provide feedback to the Steering Committee on the EMS logistics of proposed study activities 
and processes 
 
Review and provide feedback on the main study protocol and any subsequent amendments 
 
Develop a strategy to communicate the study requirements, activities and study progress to 
each participating EMS service. 
 
Terms of Reference: appended, please see   
 

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Appendix 4. Paramedic Committee Terms of Reference. 
1.8.5 Patient Committee 
Chair: to be decided 
Membership: Elizabeth Hall, a second patient representative, a pediatric representative from CHEO, plus 
others to be confirmed 
Responsibilities: to be finalized following development of Terms of Reference 
Terms of Reference: will be appended to Appendix 5. Patient Committee Terms of Reference.  
1.8.6 Data Safety Monitoring Board 
Please see Section 6. Methods: Monitoring for details on the study Data Safety Monitoring Board.  
Section 2. Introduction 
2.1 Background 
Problem: Ontario Emergency Medical Services (EMS) annually transport half a million patients with a 
potential neck (cervical/c-spine) injury, from falls or motor vehicle collisions, to local emergency 
departments (ED). Ninety-five percent of those patients are alert and stable and at low risk of c-spine 
injury. Less than 1% actually have a c-spine fracture, and even less (0.5%) have a spinal cord injury. 
Spinal cord injuries result from moderate to severe blunt traumas and not from minor movements 
occurring during transport to hospital. Regardless, current EMS practice is to transport all such trauma 
victims (with or without c-spine injury) by ambulance using backboards, collars, and head immobilizers. 
These patients stay fully immobilized until an ED bed is made available, sometimes for as long as 3 
hours. This prolonged immobilization is often unnecessary and increases patient discomfort, contributes 
to ED crowding, prolongs EMS intervention times, and adds a heavy financial burden to our healthcare 
system.  
 
Why C-Spine Immobilization of Low-Risk Patients May Be Unwarranted: Not only is immobilization 
often unnecessary, its potential for clinical adverse effects and discomfort are well documented (3). 
Chest straps used in immobilization can have a pulmonary restrictive effect, even in healthy non-
smokers. Immobilization on a board leads to progressively worse pain in the head, neck, and back area, 
often resulting in the necessity to perform diagnostic imaging on an otherwise normal spine in the ED. 
The presence of a c-spine immobilization collar has been associated with hyperextension, actually 
causing spinal cord injury in patients suffering from ankylosing spondylitis. In addition, c-spine collars 
can cause neck vein compression and increased intra-cranial pressure for patients with head injury, 
difficulty swallowing, and local skin necrosis. 
 
We have identified three systematic reviews relevant to c-spine immobilization. Work published by 
Abram in 2010 (32 studies) (3) suggested there was a growing body of evidence documenting the “risks 
and complications of routine spinal immobilization”, and that there was a “possibility that 
immobilization could be contributing to mortality and morbidity in some patients.” A more recent review 
by Sundstrom et al (220 studies) (4)  concludes there is limited evidence supporting current c-spine 
immobilization practices, that large definitive randomized trials are lacking, that the benefit on 
neurological injury and spinal stability is uncertain, and that there is a growing body of opinions against 
the use of c-spine collars. The International Liaison Committee on Resuscitation (ILCOR) provides 

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international guidelines on cardiac arrest and trauma resuscitation. In November 2015, ILCOR published 
a recommendation not to use routine application of c-spine collars for adult and children with blunt 
suspected traumatic c-spine injury (based on very low quality of evidence from 29 studies) (5). 
 
Effect on Overburdened EMS Systems, and Crowded EDs: Because trauma victims need to be seen 
rapidly at the hospital, paramedics are given only 15-20 minutes to evaluate and treat them in the field 
before transport. Even for minor trauma victims, c-spine immobilization takes greater than 5 minutes to 
apply, or up to 30% of the allotted field time. Unlike minor trauma victims coming to the ED by their 
own means of transport and commonly triaged to the waiting room area, minor trauma victims 
immobilized and transported by paramedics can wait up to 3 hours until an ED stretcher becomes 
available, also holding up the EMS crew who then become unavailable for the next community 
emergency. In 2013, the U.S. National Association of Emergency Medical Services Physicians took a 
position in favor of a judicious immobilization strategy (6). 
 
Once on an ED stretcher, it is not unusual for these patients to remain fully immobilized for several 
hours until physician assessment and c-spine diagnostic imaging can be performed and interpreted. This 
consumes valuable time for physicians, nurses, and radiology technicians and distracts them from other 
urgent responsibilities. These delays compound the burden of our crowded Canadian EDs in an era when 
they are under unprecedented pressures. The median length of stay for a patient evaluated in the 
stretcher area is approximately 8-12 hours, whereas similar minor trauma victims arriving without 
immobilization can be evaluated and discharged in less than 4 hours. 
 
The Canadian C-Spine Rule: We have derived, validated, and implemented the Canadian C-Spine Rule 
(CCR) to be used by physicians (7-9), triage nurses (10), and paramedics (11) in more than 40,000 alert 
and stable trauma patients. The CCR (Figure 1) directs that immobilization is unnecessary if the patient 
has no high-risk criteria, has at least one low-risk criterion, and can voluntarily rotate their neck 45’ left 
and right. Physicians and nurses already use the CCR in the ED to safely remove immobilization devices 
without the need for imaging and with no documented adverse outcomes. We recently completed a 
pilot implementation study with Ottawa paramedics where selective patients were transported without 
immobilization. We have recruited 3,854 patients, and paramedics have identified all clinically 
significant injuries (100% sensitivity) without negative consequence when the CCR determined that 
immobilization was not required (68% specificity). Approximately 60% of immobilizations were avoided. 
 
C-Spine Evaluation in Children: The NEXUS decision instrument for use in adults and children was 
validated in 2,160 children aged 8 to 17 (12) and identified all significant injuries. The CCR’s performance 
was superior to that of the NEXUS decision instrument when prospectively compared in an adult 
population (13), but has yet to be implemented for use in children. A case-control study of children 
younger than 16 with c-spine injuries identified 8 risk factors for significant injuries, 7 of which are 
included in the CCR (14). 
 
Based on information provided by our EMS stakeholders, we estimate there are ≥4,000 children aged 8 
to 16 transported with immobilization each year in Ontario. In a survey of physicians, 85% stated they 
would use the CCR if it were properly evaluated for use in the pediatric population (15). 
 
Rationale for This Study: Minor trauma is very common and these patients are usually transported to 
the ED by EMS, but rarely do they have a fracture or spinal cord damage. Current immobilization and 
transport practice guidelines are not evidence-based, and there is a growing body of evidence testifying 
to the deleterious effects and consequences of this practice on patients, EMS systems, EDs, and the 

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health care system. We have successfully derived, validated, and implemented the CCR for use by 
physicians, nurses, and, more recently, by paramedics in a pilot project. Patient groups, EMS 
stakeholders, ethics board members, and the Medical Advisory Committee for the Ontario Ministry of 
Health and Long-Term Care Emergency Health Services Branch (MOHLTC-EHS) are all supportive of this 
multicentre implementation evaluation study. We now need a large pragmatic study to evaluate the 
feasibility, benefits, and safety of implementing the CCR in geographically and socially diverse 
prehospital communities. We are encouraged that most EMS services would only participate in the 
study if we adopted a design that would guarantee, at some point, an opportunity for them to be 
assigned to the intervention arm and expand the scope of their paramedics’ practice. 
 
Figure 1. The Canadian C-Spine Rule Adapted for Use by Paramedics 
 
2.2 Objectives 
The overall goals and impacts of this study are to improve patient care and health system efficiency and 
outcomes by allowing paramedics to assess eligible low-risk trauma patients with the CCR and 
selectively transport them without immobilization to the ED. 
 
 
The Canadian C-Spine Rule 

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We conservatively estimate that, in Ontario, more than 60% of all eligible trauma patients (300,000 
annually) could be transported safely and comfortably, without c-spine immobilization devices.  This will 
significantly reduce patient pain and discomfort, EMS intervention times, and ED length of stay, 
therefore improving access to EMS and ED care. This could be achieved rapidly and with lower 
healthcare costs compared to current practices (possible cost saving of $36 per immobilization, or 
$10,656,000 per year). 
 
 
In addition, this project will facilitate a new paradigm in prehospital research by integrating paramedics 
and patients actively into the research and knowledge translation process. It will offer the added 
benefits of consolidating a network of EMS research partners and of facilitating future collaborative 
projects. It will also make innovative use of data provided by the Institute for Clinical Evaluative Sciences 
(ICES) to streamline and decrease the cost of conducting prehospital research, and, with the help of our 
new OSSU partners, foster collaborative efforts to measure and possibly correct health inequities in 
prehospital care. Lastly, this project could lead to the use of the CCR by paramedics from across Ontario 
and Canada and to immediate health care benefits/savings on a national scale. 
 
PICOT Question: Does allowing paramedics to assess selective low-risk trauma patients with the 
Canadian C-Spine Rule (CCR) and transporting them without immobilization result in significant and 
immediate health service benefits for patients, Emergency Medical Services, and Emergency 
Departments, in a safe, cost-effective manner? 
2.3 Trial Design 
The multicentre implementation of the CCR by paramedics is designed as a stepped wedge cluster 
randomized trial with three steps, involving a total of 13 Ontario EMS Services. Our 36-month study will 
consist of a 12-month set-up and training period (Year 1), followed by the stepped wedge trial (Year 2), 
and a 12-month period for study completion, analyses, and knowledge translation and exchange (see 
Figure 2). EMS services in each step will cross from the control condition (usual care) to the intervention 
condition (CCR implementation) at intervals of 3 months until all communities have crossed to the 
intervention. Data will be collected on all eligible patients in each EMS service for a total duration of 12 
months.  
  
Figure 2: Diagram of the Study and Stepped Wedge Design 
Year 1 
 
Months 1-9 
Months 10-12 
Study set-up 
ePlatform programming for EMS data collection 
Preparation of study material and site visits 
Paramedic 
training 
Year 2 
Step 
Months 1-3 
Months 4-6 
Months 7-9 
Months 10-12 
1 (4 EMS services) 
Usual Care 
CCR 
CCR  
CCR 
2 (4 EMS services) 
Usual Care 
Usual Care 
CCR 
CCR 
3 (4 EMS services) 
Usual Care 
Usual Care 
Usual Care 
CCR 
Year 3 
 
Months 1-6 
Months 7-9 
Months 10-12 
Study completion 
Data linkage with ICES 
Data cleaning 
Data analyses 
Reports and 
manuscripts 
writing; KTE 

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Section 3. Methods: Participants, Interventions and Outcomes 
3.1 Study Setting 
The study will take place in the province of Ontario. Up to 12 new Ontario Emergency Medical Services 
will participate. Ottawa will also participate, but only provide data for the pediatric cohort, since the CCR 
has already been implemented within their practice. The 12 new EMS services vary in terms of size, 
population served and geographical location. A list of the participating EMS Services is located in 
Appendix 1. C-Spine Study Team Membership, Roles and Affiliations).  Each EMS Service in Ontario is 
affiliated with a Base Hospital. There are eight Regional Base Hospitals in Ontario which provide medical 
direction, leadership, and advice in the provision of prehospital emergency care. Although the Base 
Hospital Programs will not be participating directly in the study as separate sites, they will be assisting 
with start-up, implementation and follow-up. A list of the seven involved Base Hospital Programs is 
included in Appendix 1. C-Spine Study Team Membership, Roles and Affiliations). 
3.2 Eligibility Criteria 
All consecutive, alert (able to follow commands), stable patients (normal vital signs) evaluated by the 
paramedics employed by a participating EMS Service for potential cervical spine injury after sustaining 
acute blunt trauma (within 48 hours). These are patients for whom standard Ontario EMS trauma 
protocols usually require immobilization. As in prior CCR studies, patients will be excluded if they do not 
require immobilization as per the standard Ontario EMS trauma protocol, have a Glasgow Coma Scale 
score less than 15 or are intubated, or have unstable vital signs (systolic blood pressure < 90 mmHG; 
respiratory rate <10 or >24 breaths/minute). Patients will also be excluded if: their injury occurred more 
than 48 hours previously; they have penetrating trauma from stabbing or gunshot wound to the neck, 
acute paralysis, or known vertebral disease (specifically ankylosing spondylitis, rheumatoid arthritis, 
spinal stenosis or previous cervical spine surgery); they were referred from another hospital and 
transported between facilities; or they are younger than 8 years. 
3.3 Interventions 
Paramedics will be trained in the use of the CCR prior to the start of the trial. We have conducted an 
Ottawa EMS CCR implementation pilot study and have designed our training program to address 
barriers identified in the pilot. The training entails one hour of education: 30 minutes of self-review of a 
teaching video addressing the background and scientific development of the CCR, and a 30-minute in-
class teaching video reviewing the specific steps involved in using the CCR, complete with a 
demonstration and question and answer period with a certified trainer. Paramedics will be “certified” to 
clear the cervical spine by medical directive if they have: a) successfully completed the initial training 
sessions, and b) successfully completed (score of ≥80%) a written quiz. Paramedics failing the written 
quiz would be required to attend a remedial session and review all wrong answers with their certified 
trainer. Of note, Ottawa paramedics all successfully completed their training. 
 
 
The stepped wedge trial will begin after paramedic training has been completed (see Figure 2). During 
the Usual Care phase, paramedics will complete the CCR data collection form for all eligible patients, but 
will continue to immobilize them all before transport to the receiving hospital. Once a community has 
crossed to the intervention CCR phase, paramedics will be permitted by medical directive to implement 
the CCR. Paramedics will then transport selected patients without immobilization according to the CCR. 
Although following the medical directive will be mandatory for paramedics, they will be encouraged and 
allowed to immobilize patients if they are uncomfortable with the CCR’s recommendation to not 
immobilize them. 

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During the study set-up time period (Figure 2), each participating service will designate a local 
paramedic study champion. These individuals will be in close contact with staff at the Study 
Coordinating Centre and will receive further information about the study, the methodology and the 
implementation of the CCR. These individuals will be heavily involved in delivering the study training 
material at their particular location and will serve as a first point of contact throughout the 
implementation. Paramedics with questions about specific aspects of the CCR, or the application of the 
CCR for unusual scenarios will be able to communicate directly with a peer in an effort to promote 
adherence to the protocol.  
 
 
 
Paramedics will be encouraged to ask questions during the training sessions, speak directly with their 
study champion, add comments to study forms, or communicate with study staff via the study website 
or through social media. These questions and concerns will be compiled and distributed back to study 
champions to disseminate to local staff. Staff at the study coordinating centre will regularly provide 
updates and reminders to study champions. 
 
3.4 Outcomes 
The outcomes of interest are divided into three categories: measures of patient and health system 
benefit, measures of patient benefit and measures of health system benefit. 
3.4.1 Measures of  Patient and Health System Benefit 
a) proportion of patients transported with immobilization (primary outcome of interest) 
3.4.2 Measures of Patient Benefit 
a) Proportion of patients feeling comfortable (score ≤4 on a 10-point Likert scale) (co-primary outcome 
of interest), 
b) Proportion of patients with a pain score ≤4 on a 10-point Likert scale upon arrival at the Emergency 
Department (ED),  
c) Time from EMS arrival to ED discharge or admission to hospital, 
d) Patient radiation exposure (in millisieverts) from diagnostic imaging of the spine, 
e) Number of skin pressure injuries, and 
f) Number of missed clinically important c-spine injuries. A clinically important c-spine injury includes 
any injury other than the following defined unimportant injuries which require neither specialized 
treatment nor follow-up: isolated avulsion fracture of osteophyte, isolated fracture of transverse 
process not involving the body or facet joint, isolated fracture of the spinous process not involving the 
lamina, isolated simple compression fracture <25% of body height. 
3.4.3 Measures of Health System Benefit 
a) Time spent in the field by paramedics before arrival to hospital, 
b) Time spent in-hospital by paramedics before transfer of care to the ED team, 
c) ED length of stay until discharge or admission to hospital, 
d) Number of subsequent ED visits or admission to hospital within 30 days of ED discharge, 

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e) Number of subsequent clinic/family physician visits within 30 days of ED discharge, 
f) Frequency of c-spine diagnostic imaging performed within 30 days of ED discharge, and  
g) Incremental cost per one immobilization avoided (including cost of training, equipment, paramedic 
time, ED utilization, diagnostic imaging, and follow-up visits). 
3.5 Participant Timeline 
Patients with the potential for a c-spine injury will be enrolled in the study and evaluated with the CCR 
at the time of first contact with a paramedic. The paramedic documentation, as well as a completed 
study form will be reviewed by study staff to obtain the necessary information on the outcomes of 
interest. We will be partnering with the Institute for Clinical Evaluative Sciences (ICES) to obtain 
information on the initial ED visit, as well as any subsequent health care utilization within 30 days 
following the initial injury. 
3.6 Sample Size 
Our sample size for this study is determined mainly by pragmatic considerations: we need a large 
number of sites from across Ontario to evaluate safety and generalizability of implementation in this 
multicenter setting, while accounting for between-site differences such as size and setting. Power 
calculations were carried out for the stepped wedge trial. Using data from a previous study in these 
communities, we expect approximately 600 patients per EMS service per year (or 150 patients per 3 
month time interval). A total of 12 EMS services (7,200 patients) evaluated across 4 time intervals in a 
stepped wedge design will provide at least 90% power to detect minimally important differences of 10% 
in our two co-primary outcomes using two-sided tests at the 2.5% level of significance. In particular, for 
our primary outcome we will have >99.9% power to detect a minimally important absolute reduction of 
10% in the proportion of patients immobilized assuming a control arm proportion of 100%. For our co-
primary outcome we will have 90% power to detect a minimally important increase of 10% in the 
proportion of patients feeling comfortable assuming a conservative control arm proportion of 50%. In 
these calculations, we have assumed a commonly used intracluster correlation coefficient (ICC) of 0.05, 
added 2 EMS services to account for variation in the number of patients across sites, and a further 2 
EMS services to account for potential attrition. 
3.7 Recruitment 
Based on the volume of immobilized patients transported in each of the 12 new proposed participating 
centers, we expect there could be 8,129 eligible cases over the proposed 12-month evaluative period 
(required sample size is 7,200). We are confident that the required sample size can be obtained with the 
participation of the proposed centers, and we have accounted for unlikely attrition in our study design 
and sample size calculation. 
 
 
We also plan to employ a number of strategies during the enrollment phase of the study in order to 
meet our recruitment goals. We have specifically approached Ontario EMS Services that have previously 
and successfully participated in prehospital research. These paramedics will be familiar with completing 
specific study paperwork. We will be approaching the vendors of the software used by EMS Services in 
order to develop a study form that is easy to access, complete and submit. We will employ a local study 
champion at each EMS Service who will be accessible to the front-line paramedics to answer questions, 
deliver updates and reminders and provide feedback regarding certain cases or applications of the CCR. 

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Lastly, we will develop a study website, and utilize social media to keep the participating EMS Services 
and their staff engaged in the study. 
Section 4: Methods: Assignment of Interventions  
The 12 new participating EMS Services will be randomized using the technique of covariate constrained 
allocation to protect against chance imbalances in the following prognostic factors: catchment area 
(km2), number of immobilizations per month, average response time and staff make-up (advanced care 
paramedics and primary care paramedics) . Due to the relatively small number of allocation units, it is 
particularly important to use an allocation technique that minimizes the risk of chance imbalances. In 
the stepped-wedge design, randomization is with respect to the timing of implementation of the 
intervention. Effective randomization is essential to protect the internal validity of the trial, including the 
ability to obtain a valid estimate of any secular trend, as well as a valid estimate of the intervention 
effect. Covariate constrained allocation was selected as it was found to be superior to simple 
stratification and matching in a recent simulation study (16). In covariate constrained allocation, all 
possible allocations of sites will be considered (a total of 34,650 possible allocations), and those that are 
acceptable – in that they meet a set of balance constraints – will be identified. One of the allocations will 
then be randomly selected from among the set of acceptable allocations. To protect the validity of the 
randomization, the number of times that any given pair of sites receives the same allocation will be 
counted and constraints will be relaxaed if the design is found to be overly constrained. The allocation 
will be performed using a SAS macro developed for this purpose, by an independent statistician not 
associated with the trial. Allocations will be securely kept by the independent statistician and will be 
concealed from the study investigators and all participating sites, until one month before the allocated 
start time of a particular site. 
Section 5: Methods: Data Collection, Management, and Analysis 
5.1 Data Collection Methods 
Once training of paramedic staff has been completed, paramedics will begin evaluating eligible patients 
with the CCR. Each time an eligible patient is assessed using the CCR, the paramedic treating that patient 
will complete and submit an electronic CCR (see Appendix 6. Paramedic Data Collection Form). The 
paramedic will also record patient-reported comfort level and pain level on this form. Staff at the study 
coordinating centre will receive the electronic EMS-completed CCR, as well as a copy of the Paramedic 
Care Record (ePCR). Study staff will review the paramedic documentation in order to assess compliance 
with the study protocol and application of the CCR. Information on patient age, gender, mechanism of 
injury, field time, offload time and immobilization status are contained in the ePCR and will be recorded 
from there (see Appendix 7. Study Data Collection Form). 
We will link the information obtained from paramedic care records to provincial administrative 
databases housed at ICES. This linkage will allow us to obtain information related to the initial ED visit, c-
spine diagnostic imaging, hospitalization, and subsequent ED/clinic/family physician visits within 30 days 
of injury.  
5.2 Data Collection Methods – Retention 
We will employ a number of methods to minimize the number of missed cases and amount of missing 
information on EMS-completed data forms. We will work closely with local Study Champions to ensure 
that there are regular study updates, visible study advertisements and electronic reminders. Paramedics 

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will be able to connect with their local study champion, or remotely with study staff via e-mail, website 
communication or social media. We will provide feedback to services on aspects of the study that are 
going well, as well as areas where improvement may be needed. We will provide regular progress 
reports to participating sites, as well as Base Hospitals. Ultimately though, this study has been designed 
as a pragmatic trial. We will do our utmost to keep the study at the forefront using the methods 
described above, but we will not have the time nor the resources to locate and follow-up on missed 
cases (i.e. those cases where the CCR was not used but should have been). 
5.3 Data Management 
Data will be entered centrally at the study coordinating centre by trained study staff. Staff will receive 
training on the study protocol, definition of data elements, application of the CCR and elements of the 
ePCR. A complete list of data points and definitions will be compiled and included in a study manual for 
reference. The data will be entered electronically. The data entry screens will resemble the paper study 
forms approved by the Steering Committee (see Appendices 6 and 7). Where possible, the study 
database will be designed to ensure that each given variable can only be entered in a certain format, 
thereby limiting the number of errors in data entry.  A certain percentage of cases will be entered in 
duplicate to ensure accuracy. A small percentage of cases (10%) will also be pulled and compared to the 
source documents to independently verify the accuracy of the data. We will regularly run range and 
logic checks to previously-entered data to locate and fix any errors or discrepancies in the data set. We 
will work closely with staff at the participating Base Hospitals and our local EMS Study Champions to 
locate promptly identify and locate missing data. Queries about particular cases and situations will be 
flagged for review by the Research Coordinator. If the Research Coordinator is unable to determine the 
appropriate course of action, the flagged issue will be brought to the attention of the Principal 
Investigator who will review the issue and advise. Any resulting changes to data definitions will be noted 
and dated in the study manual. 
The study database will be designed and located on servers housed at the Ottawa Hospital Research 
Institute. All electronic study documents will be saved on network folders with limited access. The 
network folders are backed up nightly by the Ottawa Hospital Research Network Information 
Technology team. Paper files will be stored in locked cabinets in locked offices.  
5.4 Statistical Methods 
Analyses will be conducted at the level of individual patient data using generalized linear mixed effects 
regression with a random effect to account for clustering by EMS service, and fixed effects for treatment 
and time interval to account for the stepped wedge design. The primary and co-primary outcomes will 
be analyzed using binomial distribution with identity link and the effect of intervention will be expressed 
as absolute differences with 97.5% confidence intervals. Secondary outcomes will be similarly analyzed 
using binomial distribution and identity or logit link for dichotomous variables, normal distribution and 
identity link after log-transformation or gamma distribution and log-link for continuous variables with a 
skewed distribution, or Poisson or negative binomial distribution with log link for count variables. The 
effect of the intervention on each secondary outcome will be described using absolute difference, 
Relative Risk or Odds Ratio with 95% confidence interval. Subgroup analyses (described below) will be 
conducted by including interactions with time interval and treatment in the regression model.  
 
 
Our health economist will perform a cost-effectiveness analysis from the perspective of the Ministry of 
Health and Long-Term Care. Trial data will be used to populate the relative costs and outcomes of the 
use of the CCR by paramedics with usual care (100% immobilization). Resource use will be collected 
during the trial and obtained from ICES, while unit costs will be obtained from appropriate Canadian 

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sources, such as Schedule of Benefits for Physician Services. Total cost for each patient includes costs of 
the intervention and costs of health services, including the follow-up period of 30-days post ED 
discharge. Cost of intervention covers cost of training and operation. Costs of operating paramedic 
services include personnel cost (e.g. salaries and employee benefits), service cost (e.g. fuel, 
maintenance), medical supplies (e.g. an on-board liquid oxygen system, medications, and single-use 
patient care supplies). Costs of healthcare services will be obtained from ICES and will be estimated by 
multiplying the unit costs by the volume of healthcare used. We will use mixed-effects regression 
analyses to estimate the difference in expected healthcare costs and outcomes between the 
intervention and control groups. The incremental cost-effectiveness ratio will be estimated by dividing a 
difference in cost by a difference in the number of immobilizations. The 95% confidence interval will be 
calculated using a non-parametric bootstrapping method. Results from the bootstrapping exercise will 
also be used to depict a cost-effectiveness acceptability curve (CEAC), which links the probability of a 
treatment being cost-effective to a range of potential threshold values (λ) that the health system may be 
willing to pay for an additional unit of effect (17). A CEAC is a graphical representation of the probability 
that the CCR may be cost effective given alternate dollar values placed on an outcome. This will allow 
estimation of the probability that the CCR can be considered cost-effective given the available data. In 
addition, sensitivity analysis will be undertaken to examine the effect of conducting a complete case-
only analysis and of varying the cost of the intervention.  
 
We will also conduct a budget impact analysis to estimate the financial consequences of implementing 
the CCR by paramedics in Ontario. All analyses will be conducted using STATA version 13.0 and Microsoft 
Excel and Visual Basic for Applications. 
 
 
Pre-Specified Sub-Group Analyses will be conducted to examine the differential effects (possible 
inequity) of the intervention on the following groups, defined by:  
a) sex,  
b) language barrier present vs. not (collected by paramedics on data collection form), 
c) long transport times (longer vs. shorter than 15 min), 
d) age (adult ≥16 vs. children <16),  
e) socioeconomic status and education level (ICES data), and 
f) type of backboard used (full board, open-back scoop, or trunk and neck KED devices). 
 
Section 6. Methods: Monitoring 
6.1 Data Monitoring  
An external, independent Data Safety Monitoring Board (DSMB) will be established to provide a review 
of study safety while the study is ongoing. The composition and membership is being confirmed and we 
hope to include: a paramedic researcher, an emergency physician, a nurse familiar with the application 
of the CCR, a paramedic representative, a statistician and a pediatric emergency physician.  
We have developed Terms of Reference for the DSMB, using the guidance provided by OHRI, entitled 
Data and Safety Monitoring Guidelines for Clinical Trials, as well as the Terms of Reference used for our 
previous single-centre evaluation of the CCR. The Terms of Reference will be reviewed by the Study 
Steering Committee, before being sent for review and approval to the OHRI’s Research Administrative 
Committee. The most up-to-date version of the Terms of Reference has been appended to the study 
protocol (see Appendix 8. Data Safety Monitoring Board Terms of Reference).  

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All members of the DSMB will be required to complete and sign a Confidentiality Agreement, which will 
be kept on file by the study team. The DSMB members will familiarize themselves with the Study 
Protocol, as well as the Terms of Reference. The content and information available for review will 
depend on the availability of outcomes provided by ICES. At a minimum, the DSMB members will be 
provided with a report including information on accrual, application of the CCR by paramedics, protocol 
deviations, mechanism of injury and other data points collected from the paramedic documentation.  If 
available for interim analyses, information provided by ICES on imaging and c-spine injuries will be 
included in the report for review. Due to the short intervention, this information may only be available 
in a final report.  
The meeting frequency has not yet been finalized, but we anticipate the DSMB will meet very shortly 
after data collection begins, followed by another meeting approximately six months later. The DSMB 
may also meet to review the final report. Following each meeting, the DSMB will complete a report to 
be submitted to the Principal Investigator. The report will be presented to the Steering Committee and 
will also be sent to the REB, as well as OHRI’s Research Administration Committee. We will respond to 
any concerns raised by the DSMB and provide additional information requested. Any corresponding 
changes to the protocol will be documented in Table 2.   
6.2 Data Monitoring – Interim Analyses 
The intervention period for this multi-centre study is fairly short - only 12 months long. Because of this, 
there are no interim analyses planned. 
The number of c-spine injuries in eligible patients will be monitored as outcome information is available. 
We plan to obtain preliminary information on a small subset of study outcomes for safety assurance 
purposes before the first cluster of centres begin actively using the CCR. We will send the required 
information to ICES based on the first two months of enrollment following training (see Figure 2).  
Analysts at ICES will link our data at that time with the information available from the Ontario Health 
Insurance Plan (OHIP) database, as well as the Canadian Institute for Health – Discharge Abstract 
Database (CIHI-DAD). This will give us information on which cases had c-spine imaging performed, and of 
those, whether any c-spine injuries were identified. We will then review these cases to ensure that the 
CCR was applied appropriately and that no injuries were missed by either the paramedics, or the CCR 
itself.   
The only situation that would trigger an immediate review to consider stopping the trial would be a 
situation where a spinal cord injury was sustained by an enrolled patient and believed to be a direct 
consequence of having transported a patient without immobilization resulting from the use of the CCR. 
In this case, we would notify the DSMB to review the available information and discuss their review and 
recommendations with the Steering Committee. 
We would not consider a missed significant injury sufficient to warrant stopping the study as long as 
there was no consequence to the patient’s safety and health  i.e. not resulting in a spinal cord injury that 
was not already present before transport to the hospital. Any missed significant injury will be reported 
to both the DSMB and Research Ethics Board in a timely manner. 
6.3 Harms 
Adverse events will be classified according to the following definitions: 

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1. Protocol Deviations – this category will include cases where the CCR was applied to the wrong 
patient population, or situations where the rule was applied inaccurately in the opinion of study 
staff. These will be included in DSMB reports for review at scheduled meetings.  
2. Adverse Events – This category will include transport of patients without immobilization later 
determined to have an important cervical spine injury. This may include cases where the rule 
was applied incorrectly by the treating paramedic, or cases missed by the CCR. These cases will 
be reported to the DSMB and the REB for review and consideration.  
3. Serious Adverse Events – This will include patients transported without immobilization who are 
later determined to have suffered a spinal cord injury with neurological deficit. If such a case 
was to ever occur, the study would immediately be stopped pending DSMB and REB ruling on 
whether the study can resume or not. Note: such a serious adverse event has never been 
observed in more than 36,000 patients evaluated with the CCR in various research studies this 
far.  
6.4 Auditing 
We plan to conduct regular site visits with all participating sites. The initial visit will be primarily to go 
over training material with local study staff, go over study requirements, and ensure local study staff 
have all the necessary study documentation. The intervention is twelve months in length. We will 
conduct one subsequent visit to each site during the invention phase to ensure that study 
documentation is accurate and up to date, and that all study material is accurate and up to date and 
that local study procedures are being conducted as per the study protocol. If concerns are noted, we will 
work individually with each site to address the concern and rectify the situation. 
Section 7. Ethics and Dissemination 
7.1 Research Ethics Approval 
The study protocol and all study-related documents (EMS CCR, study data collection) will be submitted 
to the Ottawa Health Sciences Network Research Ethics Board (OHSN-REB) for review and approval. The 
OHSN REB has recently become a board of record for Clinical Trials Ontario. As a result, and because this 
is a multi-centre study, the study protocol will be submitted to the OHSN-REB through Clinical Trials 
Ontario. All participating sites that have existing agreements in place with Clinical Trials Ontario will be 
included in the initial REB Submission.  We will identify a local site investigator and help coordinate REB 
submission, review and approval for those sites that do not have agreements with Clinical Trials Ontario.  
7.2 Protocol Amendments 
Any changes to the protocol including to the study objectives, design, patient population, sample size, or 
procedures will be first reviewed and approved by the Steering Committee and noted in this document. 
The amended protocol will then be sent through Clinical Trials Ontario to the OHSN-REB. Once 
approved, all sites included on the Clinical Trials Ontario application will receive notification of the 
amendment. We will submit amendments to the additional REBs who are not part of Clinical Trials 
Ontario. 
7.3 Consent  
We will be seeking a waiver of informed consent from the OHSN-REB. This was the case in the previous 
multi-centre prehospital validation of the CCR, as well as the single-centre prehospital implementation 
study.  The study protocol has been reviewed by the Medical Advisory Committee for the Ontario Base 

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Hospitals Group (MAC – OBHG). The MAC provides advice to the Emergency Health Services Branch 
(EHSB) of the Ontario Ministry of Health and Long-Term Care. Paramedics employed by EMS Services 
participating in the study will be allowed via a Medical Directive to use the CCR to evaluate eligible 
patients instead of the usual immobilization protocols. The Medical Directive will be drafted by the 
MAC-OBHG and authorized by the EHSB for the duration of the study.  
7.4 Confidentiality 
Paramedics will evaluate eligible patients using the CCR. They will complete an electronic form that will 
capture information on the elements of the CCR, as well as pain, patient comfort, and paramedic 
comfort with using the CCR. The electronic form will not include any information that can identify a 
patient. Upon receipt of the electronic form, study staff will assign a unique study number. We will also 
receive the corresponding paramedic documentation electronically that will allow us to capture the 
remainder of the pre-hospital data required. The paramedic documentation will also be transmitted 
electronically, stripped of patient identifiers. 
In order to link the pre-hospital information with the data housed at ICES, we will need to maintain a list 
of eligible enrolled patients, including first name, last name, date of birth, sex, postal code, health card 
number (where available). This list will be generated and maintained by staff at each Base Hospital, or 
EMS Service if Base Hospital staff are unable to access this information. The information will be stored in 
a password-protected, encrypted spreadsheet. When this information is required by ICES for linkage 
purposes, it will be transmitted securely according to their protocols. The linked information that we 
receive back from ICES will be stripped of personal identifiers before we receive it. All paper study files 
will be stored in locked filing cabinets in a locked office. All electronic files will be stored on limited-
access network folders which are backed up regularly. Any information shared with DSMB Members or 
other study committees will not include any identifiable information. 
7.5 Declaration of Interests 
All study members with affiliations to the Ottawa Hospital Research Institute are required to disclose 
information on competing interests at least once per year. We will require study members to report 
annually on any real or potential conflicts of interest. This information will be compiled and made 
available to the entire study team. 
7.6 Access to Data 
All personal health information will be kept confidential, unless release is required by law. 
Representatives of government regulators such as Health Canada, representatives of the Ottawa Health 
Sciences Network Research Ethics Board, as well as the Ottawa Hospital Research Institute, may review 
the records under the supervision of Dr. Vaillancourt’s staff for audit purposes. 
Any study information that is shared with participating sites will not have any identifying information. 
Each study subject will be assigned an independent study number. The link between patient name and 
independent study number will only be accessible by Dr. Vaillancourt and/or his staff and will be stored 
separately and securely from the study files. 
7.7 Dissemination 
There will be multiple opportunities to promote and disseminate various aspects of the study. These 
activities will be coordinated by the Publications Committee (see section  

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1.8.2 Publications Committee). We will also work closely with the funding body, OSSU, to capitalize on 
opportunities to disseminate information related to the study, including but not limited to methodology, 
results, patient engagement, future directions. 
Suggestions  for study papers, abstracts and presentations will be brought forward to the Publications 
Committee. A lead will be identified and will work with the Publications Committee to develop, edit and 
finalize the material. Authorship for all study-related papers will follow the International Committee of 
Medical Journal Editors Recommendations for the Conduct, Reporting, Editing, and Publication of 
Scholarly Work in Medical Journals (18). 
Section 8. References 
1. 
Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, et al. SPIRIT 2013 
statement: defining standard protocol items for clinical trials. Annals of internal medicine. 
2013;158(3):200-7. Epub 2013/01/09. 
2. 
Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation 
and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586. Epub 2013/01/11. 
3. 
Abram S, Bulstrode C. Routine spinal immobilization in trauma patients: what are the 
advantages and disadvantages? Surgeon Journal of the Royal Colleges of Surgeons of Edinburgh & 
Ireland. 2010;8(4):218-22. 
4. 
Sundstrom T, Asbjornsen H, Habiba S, Sunde GA, Wester K. Prehospital use of cervical collars in 
trauma patients: a critical review. Journal of neurotrauma. 2014;31(6):531-40. Epub 2013/08/22. 
5. 
Singletary EM, Zideman DA, De Buck ED, Chang WT, Jensen JL, Swain JM, et al. Part 9: First Aid: 
2015 International Consensus on First Aid Science With Treatment Recommendations. Circulation. 
2015;132(16 Suppl 1):S269-311. Epub 2015/10/17. 
6. 
National Association of EMS Physicians and American College of Surgeons Committee on 
Trauma: EMS SPINAL PRECAUTIONS AND THE USE OF THE LONG BACKBOARD. Prehosp Emerg Care. 
2013;Early On Line:doi: 10.3109/10903127.2013.773115. 
7. 
Stiell IG, Wells GA, Vandemheen K, Clement C, Lesiuk H, De Maio VJ, et al. The Canadian Cervical 
Spine Radiography Rule for alert and stable trauma patients. Jama. 2001;286(15):1841-8. 
8. 
Stiell IG, Clement C, McKnight RD, Brison R, Schull MJ, Rowe BH, et al. The Canadian C-spine Rule 
versus the NEXUS low-risk criteria in patients with trauma. The New England journal of medicine. 
2003;349:2510-8. 
9. 
Stiell IG, Clement CM, Grimshaw J, Brison RJ, Rowe BHS, Schull MJ, et al. Implementation of the 
Canadian C-Spine Rule: prospective 12 centre cluster randomised trial. BMJ. 2009;339 (b4146 
doi:10.1136/bmj.b4146):1-7. 
10. 
Stiell IG, Clement C, O’Connor A, Davies B, Leclair C, Sheehan P, et al. Multicentre prospective 
validation of use of the Canadian C-Spine Rule by triage nurses in the emergency department. CMAJ : 
Canadian Medical Association journal = journal de l'Association medicale canadienne. 
2010;182(11):1173-9. 

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11. 
Vaillancourt C, Stiell IG, Maloney J, Anton AR, Bradford P, Cain E, et al. The Prehospital 
Validation of the Canadian C-Spine Rule by Paramedics. Annals of emergency medicine. 2009;54(5):663-
71. 
12. 
Viccellio P, Simon H, Pressman BD, Shah MN, Mower WR, Hoffman JR. A prospective multicenter 
study of cervical spine injury in children. Pediatrics. 2001;108(2):E20. Epub 2001/08/03. 
13. 
Stiell IG, Clement C, McKnight RD, Wells GA, Brison R, Schull MJ, et al. Comparative Validation of 
the Canadian C-Spine Rule and the NEXUS Low-Risk Criteria in Alert and Stable Trauma Patients. The 
New England journal of medicine. 2003;349:2510-8. 
14. 
Leonard JC, Kuppermann N, Olsen C, Babcock-Cimpello L, Brown K, Mahajan P, et al. Factors 
associated with cervical spine injury in children after blunt trauma. Annals of emergency medicine. 
2011;58(2):145-55. Epub 2010/11/03. 
15. 
Burns EC, Yanchar NL. Using cervical spine clearance guidelines in a pediatric population: a 
survey of physician practices and opinions. Cjem. 2011;13(1):1-6. Epub 2011/02/18. 
16. 
de Hoop E, Teerenstra S, van Gaal BG, Moerbeek M, Borm GF. The "best balance" allocation led 
to optimal balance in cluster-controlled trials. Journal of clinical epidemiology. 2012;65(2):132-7. Epub 
2011/08/16. 
17. 
Drummond MF, Stoddart GL. Methods for the economic evaluation of health care programmes. 
Oxford: University Press; 2005. 
18. 
International Committee of Medical Journal Editors (ICMJE): Uniform Requirements for 
Manuscripts Submitted to Biomedical Journals: writing and editing for biomedical publication. 
Haematologica. 2004;89(3):264. Epub 2004/03/17. 
 
 
 
 

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Section 9. Appendices 
Appendix 1. C-Spine Study Team Membership, Roles and Affiliations 
Principal Investigators 
Name 
Institution 
Dr. Christian Vaillancourt 
Ottawa Hospital Research Institute 
Dr. Ian Stiell 
Ottawa Hospital Research Institute 
Co-Investigators 
Name 
Institution 
Dr. Dean Fergusson 
Ottawa Hospital Research Institute 
Dr. Monica Taljaard 
Ottawa Hospital Research Institute 
Dr. Kednapa Thavorn 
Ottawa Hospital Research Institute 
Dr. Jamie Brehaut 
Ottawa Hospital Research Institute 
Dr. Ian Graham 
Ottawa Hospital Research Institute 
Dr. Lisa Calder 
Ottawa Hospital Research Institute 
Dr. Tim Ramsay 
Ottawa Hospital Research Institute 
Dr. Peter Tugwell 
Ottawa Hospital Research Institute 
Dr. Amy Plint 
Children’s Hospital of Eastern Ontario 
Dr. Sheldon Cheskes 
Sunnybrook Centre for Prehospital 
Medicine 
Team Members 
Name 
Role 
Institution 
Ms. Manya Charette 
Study Coordinator 
Ottawa Hospital Research Institute 
Ms. Lucy Turner 
Methods Centre 
Coordinator 
Ottawa Hospital Research Institute 
Mr. Brent McLeod 
Paramedic Representative 
Hamilton Paramedic Service 
Mr. Peter Kelly 
Paramedic Representative 
Ottawa Paramedic Service 
Mrs. Elizabeth Hall 
Patient Representative 
 
Dr. Refik Saskin 
Collaborator 
Institute for Clinical Evaluative Sciences 
Dr. Martin Osmond 
Collaborator 
Ontario Child Health SUPPORT Unit  
Mrs. Lisa Nesbitt 
Pediatric Coordinator 
Children’s Hospital of Eastern Ontario 
Dr. Colin Macarthur 
Collaborator 
Ontario Child Health SUPPORT Unit 
Dr. Sharon Straus 
Collaborator 
Provincial KTE Network 
Dr. Paula Rochon 
Collaborator 
Women’s Xchange 
Dr. Denis Prud’homme 
Collaborator 
Group de travail sur les communautés 
francophones de l’Ontario 
Dr. Simone Dahrouge 
Collaborator 
Bruyère Research Institute 
Mrs. Susan Marlin 
Collaborator 
Clinical Trials Ontario 
Ms. Penny Price 
Ontario Base Hospitals 
Group Representative 
Regional Paramedic Program for Eastern 
Ontario 
Dr. Justin Maloney 
Ontario Base Hospitals 
Group Representative 
Regional Paramedic Program for Eastern 
Ontario 
Mrs. Julie Sinclair 
Ontario Base Hospitals 
Group Representative 
Regional Paramedic Program for Eastern 
Ontario 
Participating Base Hospital Programs 
Regional Paramedic Program for Eastern Ontario 
Central East Prehospital Care Program 

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Sunnybrook Centre for Prehospital Medicine 
Southwestern Ontario Regional Base Hospital Program 
Centre for Paramedic Education and Research 
Centre for Prehospital Care, Health Sciences North 
Northwest Region Base Hospital Program 
Participating Emergency Medical Services 
Ottawa Paramedic Service 
Frontenac Paramedic Service 
Peterborough County/City Paramedics 
Durham Region EMS 
York Region EMS 
County of Simcoe Paramedic Services 
Hastings-Quinte Paramedic Service 
Hamilton Paramedic Service 
Niagara EMS 
Middlesex-London EMS 
Essex-Windsor EMS 
Greater Sudbuy EMS 
Superior North EMS 
 
 
 

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Appendix 2. Steering Committee Terms of Reference

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Appendix 3. Publications Committee Terms of Reference 
To be appended once developed and finalized 
 
 

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Appendix 4. Paramedic Committee Terms of Reference
 

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Appendix 5. Patient Committee Terms of Reference 
To be appended once developed and finalized. 

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Appendix 6. Paramedic Data Collection Form 
 

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Appendix 7. Study Data Collection Form 
 
 

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Appendix 8. Data Safety Monitoring Board Terms of Reference
 

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Version 2 – May 2016 
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