Global Neurotrauma Outcomes Study: Spine
Conditions: Spine Injury, Trauma
Sponsor: University of Cambridge

Published: June 12 2021 
 
 
 
An international, multi-centre, prospective, observational study on traumatic spine injury 
 
 
Study Protocol 
 
Funded by National Institute for Health Research (NIHR) Global Health Research Group on 
Neurotrauma (16/137/105) 
 
Supported by  
 
 
Website  
www.globalspinetrauma.com 
Email   
info@globalspinetrauma.com  
Twitter  
@GNOS_Spine  
Global Neurotrauma Outcomes Study: Spine  
GNOS Spine 

Published: June 12 2021 
1 
 
Contents 
Overview of study  
 
 
 
 
 
 
 
 
2 
Background  
 
 
 
 
 
 
 
 
 
4 
Objectives  
 
 
 
 
 
 
 
 
 
5 
Study Flowchart 
 
 
 
 
 
 
 
 
 
6 
Methods 
 
 
 
 
 
 
 
 
 
 
7 
Data Capture and Validation  
 
 
 
 
 
 
 
10 
Statistical Analysis  
 
 
 
 
 
 
 
 
11 
Limitations  
 
 
 
 
 
 
 
 
 
12 
Approval 
 
 
 
 
 
 
 
 
 
 
13 
Roles, responsibilities, and publication  
 
 
 
 
 
14 
Support and Funding  
 
 
 
 
 
 
 
 
15 
Appendix A – Data Fields  
 
 
 
 
 
 
 
16 
Appendix B – Registration Form  
 
 
 
 
 
 
22 
References  
 
 
 
 
 
 
 
 
 
23 

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Overview of Study 
Background 
Traumatic spinal injury (TSI) accounts for a significant proportion of disability and death worldwide, with the 
majority of this burden affecting individuals in low- to middle- income countries. Crucially, to date, the 
current disease profile of TSI has not been characterised globally. In addition, the global approach to the 
care of patients following TSI is inconsistent with considerable geographical differences in process of care 
reported, and limited data available on the impact of these variations on outcomes following TSI. A better 
understanding of case-mix and processes of care is urgently needed to underpin efforts to identify ways of 
improving outcome relevant to different socioeconomic settings globally. 
Objectives 
The primary objective of this study is to characterise the case-mix, processes of care and variations in non-
operative and operative management strategies, including emergency, ward, ICU care, in patients presenting 
with traumatic spinal injury (TSI) between centres across low and high Human Development Index (HDI) 
countries. The secondary aims are to summarise current local resources and management pathways for TSI 
through validation of provider profiling data, describe differences in indications for nonoperative and 
operative management, and short-term outcomes following TSI. This study aims to identify gaps in processes 
of care to identify targets for future interventions to improve TSI care across high and low-resource settings.  
Methods 
A multi-centre, international, prospective, observational study. Any unit assessing patients with TSI 
worldwide will be eligible to participate. Each participating unit will form a study team responsible for 
gaining local approval, identifying patients for inclusion and conducting data collection. Data will be 
collected via a secure online platform in an anonymised form. Processes of care will be characterised by a 
detailed provider profiling exercise. A registry describing the case-mix and care of all adults presenting with 
radiologically confirmed TSI will be collected, in a given consecutive 30-day period during the study period 
starting in 2021.  
Results 
The dataset, developed through an iterative feedback process involving clinicians from low and high Human 
Development Index (HDI) countries, includes patient demographics, details of injury mechanism, local injury 
management and, if applicable, timing and nature of surgery, post-operative care and immediate post-
operative complications. Outcome measures include Frankel grade at 6 weeks post-admission (or at 
discharge or death, whichever event occurs first), early mortality, peri-operative complications, adverse 
events of special interest, functional status and mobility. Descriptive analyses of case-mix and the variations 

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in processes of care will be conducted. Available resources, use of guidelines and variations in processes of 
care will be characterised using both provider profiling responses and patient-level data collected. Areas 
where known best practice is deficient or unavailable will be identified as potential targets for future 
implementation studies. 
Conclusions 
GNOS Spine aims to provide a global snapshot of the case-mix, management, processes of care and short-
term outcomes of patients presenting with TSI. In addition, we aim to identify areas for further study, and 
establish a platform and clinical network to facilitate this future research in global neurotrauma and spinal 
surgery.  

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Background 
Traumatic spinal injury (TSI) is an umbrella term for injuries to the spinal cord, nerve roots, osseous 
structures, and disco-ligamentous components of the spinal column1. Traumatic spinal cord injury (SCI) is a 
subset of TSI which is most commonly reported in literature. TSI represents a significant global disease 
burden, recently reported to be 1.6 times higher in low- to middle-income countries (LMICs) than high-
income countries (HICs)2. Furthermore, ongoing indirect costs of severe disability secondary to TSI are a 
recognised socioeconomic burden, which may disproportionately affect LMICs3,4. 
Management of traumatic spinal injury (TSI)  
Delays in the initiation of comprehensive management of TSI have been shown to add to the complexity of 
management, result in a higher incidence of complications, longer hospitalisation, added costs and poor 
outcomes5. The Lancet Commission on Global Surgery estimates that 5 billion people worldwide lack access 
to safe, affordable, accessible surgical care and this disparity extends to neurosurgical interventions6. 
Challenges to delivering emergency management of TSI in LMICs are often compounded by inadequate pre-
hospital care, lack of infrastructure and trained manpower7.  
Neurosurgical research in low- to middle-income countries (LMICs)  
Whilst the epidemiology of TSI has been described in a number of LMICs8–11, there is limited literature 
describing current practice for the management of TSI in resource-limited settings. Additionally, a 2011 
bibliometric review of all neurosurgical publications over 13 years found that in almost 70% of all published 
work the first author originated from one of only 5 high or upper-middle income countries12. The limited 
resources that clinicians work within in LMICs presents a challenge to adhere to latest practice guidelines 
that are developed in high-income countries (HICs)3,13,14. The discrepancy between management and 
available resources urges a need for up-to-date, context-specific clinical data collected directly from these 
countries to allow a better understanding of current practice, and future TSI guidelines to be tailored to the 
specific capabilities of the country. Variances in processes of care have even been identified between 
centres in HDI settings and are likely to be substantial at all stages of TSI care, including pre-hospital, 
emergency department, ward-based, operative and ICU phases. Characterisation of these variances may 
offer important opportunities to intervene across both high and low-resource settings.  
Conclusion 
We propose to conduct an international, multi-centre, prospective, observational study of outcomes 
following admissions for TSI. We believe this project will provide valuable insight into current practice to 
identify areas for future studies and establish a platform and clinical network to facilitate this future 
research in global neurotrauma and spinal surgery. 

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1. Objectives  
 
1.1 Primary Objective  
• 
Characterise case-mix, processes of care and variations in nonoperative and operative management 
strategies, including emergency, ward, surgical and ICU care, in patients presenting with traumatic 
spinal injury (TSI) between centres across low and high Human Development Index (HDI) countries 
 
1.2 Secondary Objectives 
• 
Summarise the current resources and management pathways for patients presenting with suspected 
traumatic spinal injury worldwide, through validation of provider profiling data 
• 
Describe differences in current (i) indications for conservative management vs surgery, and (ii) short-
term outcomes (early mortality, functional, neurological, adverse events) following TSI worldwide. 
• 
Identify gaps in implementation of current evidence-based best practice and explore possible 
reasons in specific settings. 
• 
Identify targets for future global health, process of care or clinical interventions to improve 
outcomes across different settings. 
• 
Obtain point-estimates of, and gain insights into local variations in the epidemiology of TSI. 
• 
Define patient profiles which predict efficacy of specific interventions and pathways of care. 
• 
Identify possible performance indicators to characterise TSI care across settings in preparation for a 
future consensus study. 
 
 

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2. Overview – Study Flowchart  
 
 
 

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3. Methods 
 
3.1 Inclusion Criteria  
 
3.1.1 
Centre inclusion Criteria  
Any primary, secondary or tertiary institution worldwide managing patients with TSI is eligible to participate. 
In many institutions, management for TSI may be provided by spinal surgeons – however, centres in which 
management for TSI is provided by general surgeons, trauma surgeons, general medical doctors or even 
non-physician clinicians are also eligible to participate.  
3.1.2 
Patient inclusion and exclusion criteria  
 
3.1.2.1 Inclusion Criteria  
All adult patients presenting to the participating institution with a first presentation of TSI confirmed 
radiographically, during the selected 30-day inclusion period are eligible for inclusion in the core study. 
3.1.2.2  Exclusion Criteria 
• 
Elective (planned) or semi-elective (patient initially discharged after emergency with planned 
intervention at a future date) admissions 
• 
Patients who have previously had an admission for TSI rendering them eligible for inclusion in this 
study (regardless of whether they were included on the previous admission or not)  
 
3.2 Provider Profiling  
Before beginning patient-level data collection, each institution lead will be asked to fill out a provider 
profiling questionnaire on the local caseload, catchment populations, management frameworks and 
resources available at pre-hospital, emergency department, ward, surgical and ICU phases of TSI care.   
3.3 Data Set 
A data set will be collected on all adult patients admitted after TSI within the 30-day inclusion period. This 
will be split into five sections: (i) initial injury and admission data, (ii) imaging data, (iii) injury management, 
(iv) operative data (if applicable) and (v) outcome data. The dataset was developed and refined through 
iterative consultation with clinicians caring for TSI in low and high HDI countries.  
 
 
 

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3.4 Duration of Study 
Local study teams may pick any 30-day period between the 6-month study period to conduct the study. 
Teams must follow patients for up to 6-weeks post-admission or until they are discharged or die (whichever 
event occurs first). For example, if a team selects 1/6/2021 as their start date, they must include all patients 
who meet the inclusion criteria between 1/6/2021 and 30/6/2021. Moreover, if a patient is admitted during 
the inclusion period on 30/6/2021 they should be followed up until the 11/8/2021 or until discharge or 
death (whichever event occurs first).  
3.5 Study measures 
The following categories of routine clinical data will be collected prospectively for all patients included in the 
study. The full data set is included in Appendix A.  
Initial injury and admission data 
• 
Baseline demographics e.g. age, gender 
• 
Type and mechanism of injury 
• 
Pre-hospital timeline, transfers and transportation  
• 
Clinical presentation on arrival to hospital e.g. GCS, Kampala Trauma Score, Frankel grade  
• 
Initial injury details  
• 
Admission details  
Imaging data 
• 
Imaging modalities utilised for radiological characterisation of injury 
• 
Injury classification e.g. AO Spine classification  
Injury management data 
• 
Intended injury management 
• 
Injury management during transfer e.g. immobilisation 
• 
Specialised therapies received e.g. physiotherapy, speech and language therapy  
Operative management (where applicable)  
Where included patients underwent operative management, these details will be collected prospectively. 
However, operative management is not a prerequisite for inclusion in the study.  
• 
Details of the operating team  
• 
Duration, location and type of operation  

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• 
Intra-operative course and complications  
• 
Funding 
Outcome Data 
Outcomes will be measured up to 6-weeks or until death/discharge (whichever event occurs first).  This 
follow-up period was selected after consultation with experienced clinicians from high and low HDI settings 
to balance the aim of capturing significant short-term outcome events with practicalities of robust data 
collection across centres. This is supported by literature suggesting that over half of patients are typically 
lost to follow-up, with significantly increased barriers to follow-up in LMICs, and that early outcomes 
assessed within shorter time frames, particularly in these settings, remain significant and useful14,15. A range 
of outcomes after traumatic spinal injury will be assessed including:  
• 
Frankel grade at 6-weeks post-admission (or at discharge, whichever event occurs first). This has 
been demonstrated as a feasible measure to collect in both high and low resource settings4, 12. 
• 
6-week mortality  
• 
Length of stay (LOS) 
o Hospital 
o Intensive Care Unit  
• 
Perioperative complications (where applicable)  
o Return to operating theatre during follow-up period  
o Surgical site infection (SSI) 
o Adverse events of special interest e.g. pressure ulcer, pneumonia, deep venous thrombus 
• 
Functional status at 6-weeks or discharge 
o Independence with activities of daily living 
o Mobility 
 
 

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4. Data Capture and Validation  
4.1 Data Capture 
Collected data will be stored exclusively on a secure web-based system within the Outcome Registry 
Intervention and Operation Network (ORION) platform: https://orion.net/login. This will enable secure data 
collection, validation and storage in a standard format (SQL) which is compliant with National Health Service 
security standards (including the Information Governance Toolkit). All patient data will be transmitted and 
held anonymously. A pilot will be conducted using the platform to assess feasibility prior to rolling out the 
full study.  
4.2 Data Validation 
A number of steps have been taken to ensure validation of all data entered.  
I. 
The dataset, web-based case report forms, and curation process has been designed according to 
DAQCORD principles16. 
II. 
Web-based forms in the ORION platform contain fixed options at the point of data entry to maximise 
the likelihood of accurate and complete data capture at the point of collection. 
III. 
A local data validator independent to the local study team will be appointed at every participating 
institution. They will have access to a separate platform on Orion to ensure blinding to the rest of 
the data collected at their institution. They will be asked to complete a two-phase validation process, 
with a specific ORION validation user guide available to guide them through the process.  
a. Prospective Case Acquisition: During the selected 4-week inclusion period, the local data 
validator will be asked to independently identify and collect all patient cases suitable for 
inclusion in the study. For validation, they will be required to prospectively collect these 
cases, recording the admission date, age at admission and AO injury type. This will 
subsequently be correlated with the data collected by their local team by the central study 
team.  
b. Retrospective Operative Data: At 10 weeks from the start of the inclusion period (6-weeks 
following the end of the inclusion period), the local data validator will be asked to 
independently access operating theatre logs over the preceding 10 weeks. They will be 
required to document all the patients who have had an operation for TSI during this period 
and input the date and type of operation into the validation system where this corresponds 
to a patient admitted during the inclusion period. This will be used by the central study team 
to validate this specific cohort of their institution’s cases.  
 

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5. Statistical Analysis 
Anonymised data will be analysed by the central study team. Fundamentally the main analysis will consist of 
a quantitative description of case-mix and the variations in processes of care. Identification and description 
of areas where known best practice is lacking or unavailable will be performed. This will enable identification 
of potential targets for future implementation studies. 
In addition, early outcomes will be assessed to identify case-mix and process factors that may form a 
substrate for intervention. Participating centres will be stratified based on their country into groups based 
on their Human Development Index (HDI).  The Human Development Index is calculated for each country 
based on its life expectancy at birth, years of schooling and gross national income (GNI) per capita17.   
Specifically, after data validation and curation, the primary analysis will comprise of (1) statistical descriptive 
analysis of patient-level registry variables, (2) characterisation of processes of care using statistical 
descriptions of both provider profiling data and patient-level process variables followed by a description of 
typical process groupings. This will follow and extend methodologies that have previously been applied 
successfully to traumatic brain injury18 . Case-mix and process analysis will be stratified in a nested way by 
site, country, and association with human development index (HDI).  
Analysis for the secondary objectives will consist of a quantitative statistical summary of non-operative and 
operative management. Intra- and inter-site variances will be compared and associations with HDI and 
process of care factors sought. 
Whilst only short-term outcomes can be obtained in this pragmatic point-study, outcomes analysis will be 
attempted for early mortality, functional status as assessed using the 5-point Frankel Grade, neurology, 
adverse events and trajectory from admission to 6 weeks post-injury (or discharge or death, whichever 
occurs first). These will be analysed by HDI group in an appropriate nested model accounting for random 
effects of site and country.  Either ordinal models (for statistical power) or dichotomised models will be used 
depending on the statistical properties of the data and suitability of model assumptions. Mixed effects 
models will be used to assess the relationship between HDI and deterioration in functional status at 6 weeks 
while controlling for confounding variables.   
Associations between patient factors and processes of care will be sought with recognised indicators of 
evidence-based good practice to identify patient profiles associated with efficacious treatment trajectories. 
Using methodology previously successfully applied to TBI, process of care variables from both the registry 
and provider profiling will be collated with estimates of variability to inform a future Delphi consensus 
process aimed at defining process of care performance indicators that are feasible, measurable, and globally 
relevant19,20.  

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Provider profiling summary statistics will be compared with current evidence-based best practice to identify 
gaps and associations with process of care, case-mix, site and HDI will be explored using standard statistical 
approaches. Variability in guideline availability and any association with TSI care will be assessed by 
comparing provider profiling and registry data using methodology conducted previously for TBI21. 
The data, along with catchment area data from provider profiling will be used to obtain point estimates with 
confidence intervals to provide a high-level description of the epidemiology of TSI across the sites studied 
using routinely available population data. A similar methodology that has been applied to the study of 
chronic subdural haemorrhage will be utilised22. 
 A p-value of less than 0.05 will be considered statistically significant, correction for multiple comparisons 
will not be undertaken. A median odds ratio approach will be used to compare variations in outcomes 
between sites correcting for explanatory features discovered in the descriptive part of the analysis. 
 
6. Limitations 
 
This pragmatic, prospective, observational study has been designed with the aim of obtaining estimates of 
the current global case-mix, management and processes of care for patients who present with TSI at a single 
point in time. Long-term follow-up is therefore not appropriate or feasible across all settings. This protocol 
has not been designed to investigate or provide:  
• 
Worldwide epidemiological data of all TSI  
• 
Indications for or efficacy of specific management for patients with TSI 
• 
Long-term outcomes following TSI  
 
 

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7. Approval 
 
GNOS Spine will not collect any patient identifiable data, with all data entered directly into an anonymised 
form on our secure, online platform. The aim of GNOS Spine is to measure current practice worldwide, with 
no intended changes to standard management of TSI to be introduced using the findings of this study.  
The United Kingdom National Health Service Health Research Authority tool classifies this study as service 
evaluation, rather than original research, and hence, it does not require formal approval by a Research Ethics 
Committee with the United Kingdom. This has been confirmed by the South East Scotland Research Ethics 
Service.  
Local teams should follow local protocol and guidance to obtain approval from either their service 
evaluation, clinical audit, research department or head of department, prior to commencing any data 
collection for this study. Where local institutions require approval from their Research Ethics Committee, we 
would advise seeking an expedited review or ethical waiver if deemed appropriate locally, in view of only 
anonymised routine clinical data being collected. Written confirmation will be requested from each 
institution before local study teams are able to access the online, data-collection platform. 
If classified locally as research, local study teams should follow local protocol, which may involve consenting 
all patients involved to participate in this study. Example participant information leaflets and participant 
consent forms can be found on the study website (www.globalspinetrauma.com) or requested via email 
(info@globalspinetrauma.com). These are available in English, and so should be translated where required. 
 
 

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8. Roles, responsibilities, and publication  
 
8.1 Roles and Responsibilities 
A team of investigators from the United Kingdom, Asia, Africa, Australia and America are responsible for 
running this study on behalf of the NIHR Global Health Research Group on Neurotrauma. At each 
participating unit, there will be a local study team who will conduct local data collection and validation. Local 
teams may consist of a mix of fully trained surgeons, physicians, trainees, and medical students.  
Local collaborators will gain access to their own data upon completion of the study, to compare their 
practice to international practice. Members of the local study team may request access to a subset of the 
data to answer a defined research question through post-hoc analyses.  
 
8.2 Publication 
All main multicentre publications that result from the GNOS Spine Study utilising data from substantially all 
participating centres will include in the authorship designation, “on behalf of the Global Neurotrauma 
Outcomes Study Spine Collaborators”. The international committee of medical journal editors (ICMJE) 
guidelines for authorship will determine the authors who will be fully named on the by-line of publications 
resulting from this study along with the principal and chief investigators as below.   
Every member of the local study team and independent validators at each institution will be listed as 
PubMed citable collaborator status authors on all publications resulting from this study, along with other 
individuals who contribute substantially to the study under the following headings.  
Co-Chief Investigators (Rikin Trivedi, Peter Hutchinson)  
Co-Principal Investigators (Saniya Mediratta, Jibin Francis)  
Protocol Development Group (G Balamurali, Karol Budahoski, Ari Ercole, Alexis Joannides, Tariq Khan, Radek 
Kindl, Colum Nolan, Abenezer Tirsit, Sara Woodrow)  
Honorary Advisory Panel (TBC)  
Writing Group (TBC)  
Dissemination Group (TBC)  
 
 

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9. Support and Funding 
This study has the support of the World Federation of Neurological Societies (WFNS), European Association 
of Neurosurgical Societies (EANS) and Society of British Neurological Surgeons (SBNS). Funding for the 
administrative costs of this study are being provided by the National Institute of Health Research (NIHR) 
Global Health Research Group on Neurotrauma. 
 
 

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10. Appendix A – Data Fields 
10.1 
Initial Injury & Admission data  
ORION Unique Patient Identifier 
 
Gender 
Male, Female  
Date of Birth 
dd/mm/yyyy 
Date/Time of Injury 
dd/mm/yyyy  HH:MM 
Type of Injury 
● 
Blunt 
o 
Low energy 
o 
High energy 
● 
Penetrating 
o 
Low energy 
o 
High energy 
Mechanism of Injury 
Road Traffic Collision (RTC) 
● 
RTC Pedestrian  
● 
RTC Cyclist 
● 
RTC Motorcyclist 
● 
RTC Motorcyclist (passenger)  
● 
RTC Car (driver) 
● 
RTC Car (passenger) 
● 
RTC other vehicle (driver) 
● 
RTC other vehicle (passenger) 
 
Fall 
● 
Fall standing height  
● 
Fall from height  
Assault 
● 
Assault – no weapon  
● 
Assault – blunt instrument 
● 
Assault – sharp instrument 
● 
Assault – firearm  
 
Other 
● 
Self-harm  
● 
Other violence 
● 
Animal attack 
● 
Explosion 
● 
Industrial accident (outside 
categories listed above) 
● 
Sport/recreational activity 
Date/Time of admission to hospital 
dd/mm/yyyy  HH:MM 
Was the patient directly transferred 
from the site of the accident to the 
current institution?  
● 
Yes 
● 
No 
Mode of transport to primary institution  
● 
Air ambulance (helicopter) 
● 
Land ambulance (paramedic staffed) 
● 
Land ambulance (not paramedic staffed) 
● 
Public Transport 
● 
Police 
● 
Private vehicle 
● 
By foot  
● 
Other (specify _________________________) 
Method of transport to the current 
institution 
● 
Air ambulance (helicopter) 
● 
Land ambulance (paramedic staffed) 
● 
Land ambulance (not paramedic staffed) 
● 
Police 
● 
Private vehicle 
● 
By foot  
● 
Other (specify _________________________) 
GCS on arrival to your institution (if 
intubated on arrival, lease state pre-
intubation GCS) 
● 
Eye Response 
o 
Open spontaneously - 4 
o 
Open to verbal command - 3 
o 
Open to pain - 2 
o 
No eye opening - 1 
● 
Verbal Response 
o 
Oriented - 5 
o 
Confused - 4  
o 
Inappropriate words - 3 
o 
Incomprehensible sounds - 2 
o 
No verbal response - 1 
o 
Intubated - T 

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● 
Motor Response 
o 
Obeys commands - 6 
o 
Localising pain - 5 
o 
Withdrawal from pain - 4  
o 
Flexion to pain - 3 
o 
Extension to pain - 2 
o 
No motor response - 1 
Kampala Trauma Score  
● 
Age 
o 
5-55 
o 
<5 or >55 
● 
SBP (mmHg) 
o 
>89 
o 
50-89 
o 
1-49 
o 
Undetectable 
● 
Respiratory rate (/min) 
o 
≤9 
o 
10-29 
o 
≥30 
● 
Neurological status 
o 
Alert 
o 
Responds to verbal stimuli 
o 
Responds to painful stimuli 
o 
Unresponsive 
● 
Serious injuries 
o 
None 
o 
1 
o 
2 or more 
Frankel Grade at initial assessment 
● 
A: Complete motor and sensory loss 
● 
B: Complete motor loss, incomplete sensory loss 
● 
C: Incomplete motor loss without practical use 
● 
D: Incomplete motor loss, able to ambulate with or without walking 
aids 
● 
E: Free of neurological symptoms 
Major intracranial injury (defined as 
requiring hospital admission in its own) 
● 
Yes 
● 
No 
Site of PRIMARY spinal cord injury 
● 
Occipital condyle to S1:  
● 
Unknown 
Primary vertebral fracture Level 
● 
Occipital condyle to S1:  
● 
Unknown 
Deformity 
● 
Yes 
● 
No 
Any other injury (can select multiple) 
● 
Chest 
● 
Abdomen 
● 
Pelvis 
● 
Long bones 
Admission location  
• 
General wards 
• 
HDU 
• 
ITU 
Admitting Team 
● 
Orthopaedics 
● 
Neurosurgery 
● 
General Surgery 
● 
Medicine 
● 
Emergency Department 
 

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10.2 
Imaging Data 
Date/Time of first imaging  
dd/mm/yyyy  HH:MM 
Most advanced type of imaging 
performed 
● 
Plain film radiograph  
● 
Non-contrast CT Scan 
● 
Contrast CT Scan 
● 
MRI Scan 
Anatomical area of spine included on 
imaging (Can select multiple) 
 
● 
Cervical 
● 
Thoracic 
● 
Lumbar 
● 
Sacral 
Level of fracture  
● 
Upper cervical  
● 
Subaxial  
● 
Thoracolumbar 
● 
Sacral 
● 
No injury 
AO Classification of Injury  
 
Subluxation/Translation 
● 
Yes 
● 
No 
Traumatic herniated nucleus pulposis 
(not required if only plain radiograph 
available)  
● 
Yes 
● 
No 
 
If Yes:  
● 
Please specify level:  
● 
Cord compression: Yes/No 
Haematoma (not required if only plain 
radiograph available) 
● 
Yes 
● 
No 
 
10.3 
Injury Management 
What was the intended injury 
management?  
● 
No intervention 
● 
Non-operative 
● 
Operative 
Was there immobilisation during 
transfer? 
● 
Nothing 
● 
Collar 
● 
Trauma board 
● 
Bed 
Did the patient have surgical bedrest? 
● 
Nothing 
● 
Bedrest, no logroll 
● 
Bedrest + logroll 
● 
Collar only 
Traction?  
● 
Yes 
● 
No 
Did the patient receive any specialist 
therapy as an inpatient 
Yes 
No 
 
If Yes, what type of therapy was provided? 
 - Speech and Language Therapy 
 - Tracheostomy care 
 - Physiotherapy  
 - Occupational therapy  
 - Alternative therapy – Ayurveda etc 
 - Other (specify _________________________) 
Was spinal surgery performed?  
● 
Yes, performed at this institution 
● 
Yes, transferred to a different institution for surgery 
● 
No 

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10.4 
Operative Data (If “Yes, performed at this institution” to ‘Was spinal surgery performed?’) 
Grade of most senior surgeon present in 
the operating theatre 
● 
Fully qualified spinal surgeon 
● 
Other qualified surgeon 
● 
Surgical trainee 
● 
Medical doctor 
Type of anaesthesia 
● 
General 
● 
Local 
● 
None 
Grade of most senior anaesthesia 
provider present in the operating 
theatre 
● 
Fully qualified anaesthetist with medical qualification  
● 
Anaesthetist in training with medical qualification  
● 
Not medically qualified anaesthesia provider 
● 
Anaesthetic administered by the surgeon  
Date of Operation 
dd/mm/yyyy   
Duration of operation  
● 
Less than 1 hour 
● 
1-5 hours  
● 
5-10 hours   
● 
Over 10 hours 
Were pre-incision prophylactic 
antibiotics given?  
● 
Yes  
● 
No 
Class of surgical wound 
● 
I Clean 
● 
II Clean-contaminated 
● 
III Contaminated 
● 
IV Dirty-infected 
Location of surgery 
● 
Cranio-cervical 
● 
Cervical 
● 
Thoracic 
● 
Lumbar 
● 
Sacral 
What was the main procedure 
undertaken?  
*If >1 procedure undertaken, refer to 
the main one 
 
** Flow-Chart on ORION Platform ** 
● 
Open 
a. Approach: Anterior/Posterior/360 
b. Minimally invasive surgery? Yes/No 
c. 
Open Reduction? Yes/No 
d. Direct decompression? Yes/No 
e. In situ fusion? Yes/no 
f. 
Fusion? Yes/No 
▪ 
Type of instrumentation  
● 
None 
● 
OC 
● 
C1/2 
● 
Lateral mass 
● 
Pedicle  
● 
Anterior plating  
● 
Bone graft 
● 
Interbody fusion  
● 
Lateral plating  
o 
Fluoroscopy used: Yes/No 
● 
Closed 
o 
Gardener Wells vs Halo 
o 
Mechanism of Maintenance: Collar vs Halo vs Bedrest  
Funding (Select all who contributed) 
● 
Patient 
● 
Family 
● 
Government 
● 
Insurer 
● 
Hospital 
● 
NGO 

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● 
Other (specify _________________________) 
Did the patient experience a 
hypotensive episode (systolic 
BP<90mmHg for >5 minutes) during the 
surgical procedure?  
● 
Yes  
● 
No 
Did the patient experience a hypoxic 
episode (SpO2< 90% for > 5 minutes) 
during the surgical procedure? 
● 
Yes 
● 
No 
Optional further comments regarding 
the procedure 
Free text 
Intraoperative complications (please 
select all that occurred)  
● 
None 
● 
Incorrect level of surgery 
● 
Misplacement of metalwork 
● 
Incidental durotomy  
● 
Death 
● 
Other (specify _________________________) 
 
10.5 
Outcome Data 
Death within the 6-week follow-up 
period?  
● 
Yes 
● 
No 
 
If Yes: 
• 
Date of death: dd/mm/yyyy 
• 
In ICU at time of death? Yes/No 
Discharged within the 6-week follow-up 
period?  
• 
Yes 
• 
No 
 
If Yes: 
• 
Date of discharge: dd/mm/yyyy 
• 
Destination of discharge:  
o 
Transfer to another hospital 
o 
Transfer to a rehabilitation unit  
o 
Usual place of residence/Home 
o 
Absconded 
o 
Other (specify _________________________) 
Was the patient admitted to intensive 
care at any point during the 6-week 
follow up period?  
● 
Yes 
● 
No 
 
If Yes:  
• 
Date of admission to ICU: dd/mm/yyyy 
• 
Was the patient discharged from ICU during the 6-week follow 
up period? Yes/No 
 
If Yes:  
• 
Date of discharge from ICU: dd/mm/yyyy 
Was the patient intubated during 
admission?  
● 
Yes 
● 
No 
Did the patient require a tracheostomy?   ● 
Yes 
● 
No 
Was the patient requiring ventilatory 
support at time of death/the end of the 
6-week follow up period (whichever 
event occurs first)?  
● 
Yes 
● 
No 
Did any adverse events of special 
interest occur in the 6-week follow-up 
period? (Select all that apply) 
● 
None 
● 
Pressure Ulcer 
● 
Pneumonia 
● 
Pulmonary embolism 
● 
Deep venous thrombosis 
● 
Decubitus Ulcer 

Published: June 12 2021 
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● 
Urinary tract infection 
● 
Symptomatic haematoma 
Did any surgical site infections occur in 
the 6-week follow-up period? 
● 
Yes  
● 
No 
 
If Yes: 
● 
Required antibiotics only  
● 
Required debridement 
● 
Required removal of metalwork  
Did the patient return to the operating 
theatre for spinal surgery during the 
current admission?  
● 
Yes - planned 
● 
Yes - unplanned 
● 
No 
 
If Yes: Was the re-operation at: 
● 
Same level 
● 
Different level 
Did the patient survive to the end of the 
follow up period (6 weeks post-
admission or until they were discharged 
from hospital, whichever came first)? 
Yes 
No 
 
Was the patient still an inpatient at the end of 6 weeks post-admission?  
 - Yes 
 - No  
Frankel Grade at the end of the 6-week 
follow up period or at time of 
death/discharge (whichever event 
occurs first)? 
● 
A: Complete motor and sensory loss 
● 
B: Complete motor loss, incomplete sensory loss 
● 
C: Incomplete motor loss without practical use 
● 
D: Incomplete motor loss, able to ambulate with or without walking 
aids 
● 
E: Free of neurological symptoms 
How independent is the patient in the 
following activities of daily living at the 
end of the follow up period or at time of 
discharge? 
 
Unaided 
With Aid 
Completely 
Dependent 
Feeding 
 
 
 
Grooming 
 
 
 
Bathing 
 
 
 
Dressing – upper body 
 
 
 
Dressing – lower body  
 
 
 
Toileting 
 
 
 
Swallowing 
 
 
 
Bladder management 
 
 
 
Bowel management 
 
 
 
Transfers 
 
 
 
Climbing stairs 
 
 
 
What is the patient using to mobilise at 
the end of the follow up period or at 
time of discharge (whichever event 
occurs first)? 
● 
Mobilising independently 
● 
Use of one walking stick / crutch  
● 
Use of two walking sticks / crutches 
● 
Use of a frame  
● 
Wheelchair  
● 
Not mobilising (bed-bound) 
 
 
 
 
 

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11. Appendix B – Registration Form  
To register your institution to participate in the GNOS Spine study, please complete the online registration 
form, which can also be found on the website www.globalspinetrauma.com. 
 
Please note that the information provided in this registration form will not affect your eligibility to 
participate in this study.  
Name of Institution 
 
Address of Institution 
 
Members of the local study team 
Local Study Lead (Mandatory)  
Full name: 
Email:  
Contact number:  
Do you own a smartphone? Yes/No 
 
Additional local team members (Optional – up to 2)  
Full name: 
Email:  
 
Full name: 
Email:  
 
Local data validator (Mandatory) 
Full name: 
Email: 
Does this institution maintain a logbook of all 
admissions (electronic or paper-based)?  
Yes 
No 
Does this institution maintain a logbook of all 
operations (electronic or paper-based)?  
Yes 
No 
Does this institution maintain a logbook of all 
radiological imaging (electronic or paper-based)?  
Yes 
No 
 
 
 

Published: June 12 2021 
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