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DEFINITIONS
Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12621001050842
Ethics application status
Approved
Date submitted
11/05/2021
Date registered
10/08/2021
Date last updated
22/03/2022
Date data sharing statement initially provided
10/08/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Study Of Neck Injuries In Children (SONIC)
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Scientific title
Study Of Neck Injuries In Children (SONIC):
A prospective observational study to validate existing international clinical decision rules for children presenting to the emergency department with suspected cervical spine injuries
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Secondary ID [1]
304123
0
Nil
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Universal Trial Number (UTN)
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Trial acronym
SONIC - Study of neck injuries in children
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
cervical spine injury
321903
0
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Condition category
Condition code
Emergency medicine
319540
319540
0
0
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Other emergency care
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Injuries and Accidents
320038
320038
0
0
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Other injuries and accidents
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Details of clinical history, examination and management (including imaging and any surgical interventions) will be recorded for all patients presenting to the Emergency department (ED) with a possible cervical spine injury (CSI). The primary outcome variable of interest is the presence or absence of CSI.
Data will be used to validate existing clinical decision rules (CDRs) for use in possible CSI. The CDRs to be validated will be
1. National Emergency X-radiography Utilization Study (NEXUS) Low risk Criteria (Hoffman et al 2001 NEJM; Viccellio et al. 2001 Pediatrics)
2. Canadian C-Spine Rule (CCR) (Stiell 2001 JAMA)
3. Pediatric Emergency Care Applied Research Network (PECARN) risk criteria -these risk criteria are evolving, we will use the latest criteria as published or provided by the PECARN investigators (Leonard et al 2011 Ann Emerg Med; Leonard et al 2019 Pediatrics).
The predictor variables of the clinical decision rules will be collected at the time of ED presentation.
Data will be obtained from:
1. Information provided by the initial treating clinician in ED
2. Review of the patient medical records after 21 days
3. Follow up phone call to the Guardian/participants who do not receive cervical spine imaging for their injury presentation 21-60 days post ED presentation with appropriate consent.
This study is an observational study and participants will receive routine clinical care. Information will be obtained during routine clinical assessments.
Eligible participants will be enrolled across a 4 year period.
Data analysis for primary and secondary outcomes will be performed once all data have been collected with no plan for an interim analysis.
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Intervention code [1]
320459
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Diagnosis / Prognosis
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Comparator / control treatment
This study is an independent assessment in our setting of the performance accuracy (sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV)) of three existing clinical decision rules (CDRs)(NEXUS, Canadian C-spine, PECARN) for the assessment of possible cervical spine injury. There is no control group.
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Control group
Active
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Outcomes
Primary outcome [1]
327400
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Sensitivity (as a measure of performance accuracy) in identifying the study defined CSI of (a) the Paediatric Emergency Care Applied Research Network (PECARN) risk criteria (b) the two adult-derived CDRs (National Emergency X-Radiography Utilization Study Low Risk Criteria (NEXUS) and Canadian C spine Rule (CCR)) and (c) current CSI management practice
Sensitivity will be determined by the accuracy of (a), (b),(c) in detecting study defined CSI. There is no gold standard.
Study defined CSI is defined as vertebral fracture, ligamentous injury, intraspinal haemorrhage or spinal cord injury (on MRI; or Spinal cord injury without radiological association) of the cervical region of the spine (occiput to 7th vertebra including ligamentous structures attaching 7th vertebra to 1st thoracic vertebra). The presence of CSI will be determined by review of the study site cervical spine imaging reports and if applicable, spine surgeon consultation notes and phone follow up.
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Assessment method [1]
327400
0
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Timepoint [1]
327400
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At the conclusion of the study
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Primary outcome [2]
328027
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Specificity (as a measure of performance accuracy) in identifying the study defined CSI of (a) the Paediatric Emergency Care Applied Research Network (PECARN) risk criteria (b) the two adult-derived CDRs (National Emergency X-Radiography Utilization Study Low Risk Criteria (NEXUS) and Canadian C spine Rule (CCR)) and (c) current CSI management practice.
Specificity will be determined by the accuracy of (a), (b),(c) in identifying the absence of study defined CSI.
Study defined CSI is defined as vertebral fracture, ligamentous injury, intraspinal haemorrhage or spinal cord injury (on MRI; or Spinal cord injury without radiological association) of the cervical region of the spine (occiput to 7th vertebra including ligamentous structures attaching 7th vertebra to 1st thoracic vertebra).
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Assessment method [2]
328027
0
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Timepoint [2]
328027
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At the conclusion of the study
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Primary outcome [3]
328028
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Negative predictive value (NPV) (as a measure of performance accuracy) in identifying the study defined CSI of (a) the Paediatric Emergency Care Applied Research Network (PECARN) risk criteria (b) the two adult-derived CDRs (National Emergency X-Radiography Utilization Study Low Risk Criteria (NEXUS) and Canadian C spine Rule (CCR)) and (c) current CSI management practice.
Study defined CSI is defined as vertebral fracture, ligamentous injury, intraspinal haemorrhage or spinal cord injury (on MRI; or Spinal cord injury without radiological association) of the cervical region of the spine (occiput to 7th vertebra including ligamentous structures attaching 7th vertebra to 1st thoracic vertebra).
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Assessment method [3]
328028
0
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Timepoint [3]
328028
0
At the conclusion of the study
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Secondary outcome [1]
394960
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Positive predictive value (PPV) (as a measure of performance accuracy) in identifying the study defined CSI of (a) the Paediatric Emergency Care Applied Research Network (PECARN) risk criteria (b) the two adult-derived CDRs (National Emergency X-Radiography Utilization Study Low Risk Criteria (NEXUS) and Canadian C spine Rule (CCR)) and (c) current CSI management practice.
This is a further primary outcome.
Study defined CSI is defined as vertebral fracture, ligamentous injury, intraspinal haemorrhage or spinal cord injury (on MRI; or Spinal cord injury without radiological association) of the cervical region of the spine (occiput to 7th vertebra including ligamentous structures attaching 7th vertebra to 1st thoracic vertebra).
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Assessment method [1]
394960
0
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Timepoint [1]
394960
0
At the conclusion of study
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Secondary outcome [2]
394961
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Sensitivity (as a measure of performance accuracy) in identifying clinically important CSI of a) the PECARN risk criteria (b) the two adult-derived CDRs (NEXUS and CCR) (c) current CSI management practice
Sensitivity will be determined by the accuracy of (a), (b),(c) in detecting clinically important CSI. There is no gold standard.
Clinically important CSI is defined as (i) death where CSI could be a contributing factor, (ii) the need for surgical intervention for CSI, (iii) any CSI-related neurological abnormality lasting > 7 days or (iv) imaging confirmed CSI treated with cervical spine immobilisation lasting >7 days.
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Assessment method [2]
394961
0
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Timepoint [2]
394961
0
At the conclusion of study
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Secondary outcome [3]
394962
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Specificity (as a measure of performance accuracy) in identifying clinically important CSI of a) the PECARN risk criteria (b) the two adult-derived CDRs (NEXUS and CCR) (c) current CSI management practice
Specificity will be determined by the accuracy of (a), (b),(c) in identifying the absence of clinically important CSI.
Clinically important CSI is defined as (i) death where CSI could be a contributing factor, (ii) the need for surgical intervention for CSI, (iii) any CSI-related neurological abnormality lasting > 7 days or (iv) imaging confirmed CSI treated with cervical spine immobilisation lasting >7 days.
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Assessment method [3]
394962
0
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Timepoint [3]
394962
0
At the conclusion of study
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Secondary outcome [4]
394963
0
NPV (as a measure of performance accuracy) in identifying clinically important CSI of a) the PECARN risk criteria (b) the two adult-derived CDRs (NEXUS and CCR) (c) current CSI management practice
Clinically important CSI is defined as (i) death where CSI could be a contributing factor, (ii) the need for surgical intervention for CSI, (iii) any CSI-related neurological abnormality lasting > 7 days or (iv) imaging confirmed CSI treated with cervical spine immobilisation lasting >7 days.
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Assessment method [4]
394963
0
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Timepoint [4]
394963
0
At the conclusion of study
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Secondary outcome [5]
394964
0
PPV (as a measure of performance accuracy) in identifying clinically important CSI of a) the PECARN risk criteria (b) the two adult-derived CDRs (NEXUS and CCR) (c) current CSI management practice
Clinically important CSI is defined as (i) death where CSI could be a contributing factor, (ii) the need for surgical intervention for CSI, (iii) any CSI-related neurological abnormality lasting > 7 days or (iv) imaging confirmed CSI treated with cervical spine immobilisation lasting >7 days.
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Assessment method [5]
394964
0
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Timepoint [5]
394964
0
At the conclusion of study
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Secondary outcome [6]
394965
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Sensitivity (as a measure of performance accuracy) in identifying CSI as defined by existing CDRs or risk criteria of a) the PECARN risk criteria (b) the two adult-derived CDRs (NEXUS and CCR) (c) current CSI management practice
Sensitivity will be determined by the accuracy of (a), (b),(c) in detecting CSI as defined by existing CDRs or risk criteria.
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Assessment method [6]
394965
0
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Timepoint [6]
394965
0
At the conclusion of study
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Secondary outcome [7]
394966
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Specificity (as a measure of performance accuracy) in identifying CSI as defined by existing CDRs or risk criteria of a) the PECARN risk criteria (b) the two adult-derived CDRs (NEXUS and CCR) (c) current CSI management practice
Specificity will be determined by the accuracy of (a), (b),(c) in identifying the absence of CSI as defined by existing CDRs or risk criteria.
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Assessment method [7]
394966
0
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Timepoint [7]
394966
0
At the conclusion of study
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Secondary outcome [8]
394967
0
NPV (as a measure of performance accuracy) in identifying CSI as defined by existing CDRs or risk criteria of a) the PECARN risk criteria (b) the two adult-derived CDRs (NEXUS and CCR) (c) current CSI management practice
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Assessment method [8]
394967
0
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Timepoint [8]
394967
0
At the conclusion of study
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Secondary outcome [9]
394968
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PPV (as a measure of performance accuracy) in identifying CSI as defined by existing CDRs or risk criteria of a) the PECARN risk criteria (b) the two adult-derived CDRs (NEXUS and CCR) (c) current CSI management practice.
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Assessment method [9]
394968
0
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Timepoint [9]
394968
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At the conclusion of study
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Secondary outcome [10]
397598
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Rate of study defined CSI.
Study defined CSI is defined as vertebral fracture, ligamentous injury, intraspinal haemorrhage or spinal cord injury (on MRI; or Spinal cord injury without radiological association) of the cervical region of the spine (occiput to 7th vertebra including ligamentous structures attaching 7th vertebra to 1st thoracic vertebra).
The presence of study defined CSI will be determined for each enrolled participant following medical record review including cervical spine imaging reports, and if applicable spinal surgeon consultation notes and participant follow up.
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Assessment method [10]
397598
0
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Timepoint [10]
397598
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At the conclusion of the study
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Secondary outcome [11]
397599
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Rate of Imaging-confirmed CSI
Imaging confirmed CSI is defined as formal radiology report of any trauma related radiological cervical spine abnormality on plain radiography (XR), Computed Tomography Scan (CT) or Magnetic resonance imaging (MRI). This includes vertebral fracture, facet joint subluxation or dislocation, ligamentous injury, disc injury, intra spinal haemorrhage (including subdural and extradural haemorrhage in the spinal canal)and spinal cord injury of the cervical region of the spine (occiput to 7th vertebra including ligamentous structures attaching 7th vertebra to 1st thoracic vertebra, and C7-T1 disc).
The presence of imaging-confirmed CSI will be determined from medical record review for each participant.
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Assessment method [11]
397599
0
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Timepoint [11]
397599
0
At the conclusion of the study
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Secondary outcome [12]
397600
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Rate of clinically important CSI
Clinically important CSI is defined as (i) death where CSI could be a contributing factor, (ii) the need for surgical intervention for CSI, (iii) any CSI-related neurological abnormality lasting > 7 days or (iv) imaging confirmed CSI treated with cervical spine immobilisation lasting >7 days.
The presence of study defined CSI will be determined for each enrolled participant following medical record review including cervical spine imaging reports, and if applicable spinal surgeon consultation notes and participant follow up.
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Assessment method [12]
397600
0
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Timepoint [12]
397600
0
At the conclusion of the study
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Secondary outcome [13]
397601
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Rate of CSI -related neurological abnormality.
The presence of study defined CSI will be determined for each enrolled participant following medical record review, and if applicable, spinal surgeon consultation notes.
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Assessment method [13]
397601
0
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Timepoint [13]
397601
0
At the conclusion of the study
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Secondary outcome [14]
397602
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Rate of surgical intervention of the cervical spine (as determined by clinical record review)
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Assessment method [14]
397602
0
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Timepoint [14]
397602
0
At the conclusion of the study
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Secondary outcome [15]
397603
0
Determination of missed injury rate, if any, with x-ray (XR)
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Assessment method [15]
397603
0
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Timepoint [15]
397603
0
At the conclusion of the study
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Secondary outcome [16]
397604
0
Determination of missed injury rate, if any, with computed tomography (CT)
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Assessment method [16]
397604
0
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Timepoint [16]
397604
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At the conclusion of the study
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Secondary outcome [17]
397605
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Determination of missed injury rate, if any, with magnetic resonance imaging (MRI).
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Assessment method [17]
397605
0
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Timepoint [17]
397605
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At the conclusion of the study
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Secondary outcome [18]
397606
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Methods of cervical spine immobilisation used
Methods of immobilisation will be determined by information provided by the initial treating clinician, and if applicable medical record review, for each participant.
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Assessment method [18]
397606
0
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Timepoint [18]
397606
0
At the conclusion of the study
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Secondary outcome [19]
397607
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Determination of duration of cervical spine immobilisation.
Duration will be determined by information provided by the initial treating clinician, and if applicable medical record review, for each participant.
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Assessment method [19]
397607
0
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Timepoint [19]
397607
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At the conclusion of the study
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Secondary outcome [20]
397608
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Frequency of Adverse events associated with cervical spine imaging
The presence of adverse events will be determined by medical record review of each participant.
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Assessment method [20]
397608
0
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Timepoint [20]
397608
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At the conclusion of the study
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Secondary outcome [21]
397609
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Inter-observer reliability of clinical decision rules (CDRs) - kappa coefficient
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Assessment method [21]
397609
0
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Timepoint [21]
397609
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At the conclusion of the study
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Secondary outcome [22]
397610
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Cost effectiveness of implementing each CDR; health care costs of different imaging sequences.
Health care costs will be calculated from SONIC study data obtained from the medical record, hospital cost estimates of care provided (e.g. imaging costs, ED presentation) and estimates from the published literature of longer term outcomes (e.g. quality of life/utility values of participants with serious injury; epidemiological studies of risk of cancer resulting from imaging radiation exposure).
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Assessment method [22]
397610
0
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Timepoint [22]
397610
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At the conclusion of the study
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Eligibility
Key inclusion criteria
Children aged less than 16 years with possible cervical spine injury (CSI) after known or suspected blunt trauma
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Minimum age
0
Years
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Maximum age
15
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients who received cervical spine imaging at a centre not participating in this study prior to transfer with definitive external radiology reporting available at the time of arrival at the study ED will be excluded from accuracy analysis.
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Study design
Purpose
Screening
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
Data analysis for primary and secondary outcomes will be performed once all data have been collected with no plan for an interim analysis.
The entire data set will be used to externally assess accuracy in identifying CSI using PECARN risk criteria in children or the adult- focussed CDRs with exact binomial 95% CIs. When applying each CDR, items will be scored as present, absent or unknown. Sensitivity, specificity, NPV and PPV of each of the CDRs will be calculated.
Accuracy of each rule will also be calculated using the exact inclusion, exclusion, predictor and outcome variables, and definitions as set out in the original publications.
An exploratory analysis of the data will be conducted to determine whether a new paediatric SONIC CDR can be derived and validated to improve the accuracy of CSI detection and/or improve risk stratification of children who do and do not require imaging.
Inter-observer reliability of CDR variables will be assessed on approximately five percent of patients at 2 sites.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
30/08/2021
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Actual
7/09/2021
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Date of last participant enrolment
Anticipated
31/12/2024
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Actual
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Date of last data collection
Anticipated
31/12/2025
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Actual
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Sample size
Target
30000
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Accrual to date
631
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,WA,VIC
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Recruitment hospital [1]
19269
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The Royal Childrens Hospital - Parkville
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Recruitment hospital [2]
19270
0
Queensland Children's Hospital - South Brisbane
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Recruitment hospital [3]
19271
0
Logan Hospital - Meadowbrook
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Recruitment hospital [4]
19272
0
Womens and Childrens Hospital - North Adelaide
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Recruitment hospital [5]
19273
0
The Children's Hospital at Westmead - Westmead
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Recruitment hospital [6]
19274
0
Perth Children's Hospital - Nedlands
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Recruitment hospital [7]
19275
0
Monash Children’s Hospital - Clayton
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Recruitment hospital [8]
19276
0
Sydney Children's Hospital - Randwick
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Recruitment hospital [9]
19277
0
Gold Coast University Hospital - Southport
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Recruitment hospital [10]
19278
0
Sunshine Coast University Hospital - Birtinya
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Recruitment hospital [11]
19279
0
Royal Darwin Hospital - Tiwi
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Recruitment postcode(s) [1]
33850
0
3052 - Parkville
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Recruitment postcode(s) [2]
33851
0
4101 - South Brisbane
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Recruitment postcode(s) [3]
33852
0
4131 - Meadowbrook
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Recruitment postcode(s) [4]
33853
0
5006 - North Adelaide
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Recruitment postcode(s) [5]
33854
0
2145 - Westmead
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Recruitment postcode(s) [6]
33855
0
6009 - Nedlands
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Recruitment postcode(s) [7]
33856
0
3168 - Clayton
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Recruitment postcode(s) [8]
33857
0
2031 - Randwick
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Recruitment postcode(s) [9]
33858
0
4215 - Southport
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Recruitment postcode(s) [10]
33859
0
4575 - Birtinya
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Recruitment postcode(s) [11]
33860
0
0810 - Tiwi
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Recruitment outside Australia
Country [1]
23671
0
New Zealand
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State/province [1]
23671
0
Auckland
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Funding & Sponsors
Funding source category [1]
308501
0
Government body
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Name [1]
308501
0
Australian Federal Government Department of Health
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Address [1]
308501
0
Department of Health
GPO Box 9848
Canberra ACT 2601
Australia
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Country [1]
308501
0
Australia
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Funding source category [2]
308505
0
Charities/Societies/Foundations
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Name [2]
308505
0
Emergency Medicine Foundation
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Address [2]
308505
0
Suite 1B, Terraces,
19 Lang Parade,
Milton Qld 4064
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Country [2]
308505
0
Australia
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Funding source category [3]
308506
0
Government body
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Name [3]
308506
0
WA Department of Health
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Address [3]
308506
0
Research Development Unit
Department of Health
PO Box 8172
Perth Business Centre
PERTH WA 6849
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Country [3]
308506
0
Australia
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Primary sponsor type
Other Collaborative groups
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Name
Murdoch Children's Research Institute
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Address
Royal Children's Hospital
Flemington Road,
Parkville Victoria 3052
Australia
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Country
Australia
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Secondary sponsor category [1]
309357
0
None
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Name [1]
309357
0
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Address [1]
309357
0
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Country [1]
309357
0
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Other collaborator category [1]
281767
0
Hospital
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Name [1]
281767
0
Cabrini Hospital
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Address [1]
281767
0
181-183 Wattletree Rd,
Malvern VIC 3144 Australia
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Country [1]
281767
0
Australia
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Other collaborator category [2]
281768
0
University
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Name [2]
281768
0
Queensland University of Technology
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Address [2]
281768
0
Level 4/88 Musk Avenue
Kelvin Grove QLD 4059 Australia
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Country [2]
281768
0
Australia
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Other collaborator category [3]
281769
0
University
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Name [3]
281769
0
Monash University
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Address [3]
281769
0
Wellington Rd,
Clayton VIC 3800
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Country [3]
281769
0
Australia
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Other collaborator category [4]
281770
0
Other Collaborative groups
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Name [4]
281770
0
Research Institute at Nationwide Children's Hospital
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Address [4]
281770
0
700 Children's Dr, Columbus,
OH 43205, United States
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Country [4]
281770
0
United States of America
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Other collaborator category [5]
281771
0
University
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Name [5]
281771
0
University of California
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Address [5]
281771
0
1 Shields Ave,
Davis, CA 95616, USA
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Country [5]
281771
0
United States of America
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
308462
0
The Royal Children’s Hospital Melbourne Human Research Ethics Committee
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Ethics committee address [1]
308462
0
Research Ethics and Governance The Royal Children’s Hospital Melbourne 55 Flemington Road Parkville 3052 VIC Australia
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Ethics committee country [1]
308462
0
Australia
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Date submitted for ethics approval [1]
308462
0
07/12/2020
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Approval date [1]
308462
0
09/04/2021
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Ethics approval number [1]
308462
0
69436
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Summary
Brief summary
This study aims to externally validate existing international adult and paediatric clinical decision rules (CDRs) designed to guide emergency clinician imaging decisions in a large cohort of Australian and New Zealand children presenting with suspected cervical spine injury. It aims to assess (i) their accuracy in detecting cervical spine injury (CSI) (ii) their ability to accurately identify children who do not need cervical spine imaging and (iii) their cost-effectiveness. An exploratory analysis of the data will also be conducted to determine whether a new paediatric CDR can be derived and validated to improve accurate detection of CSI and/or risk stratification of children with suspected CSI into those who do and do not require imaging. This study is expected to identify the most child appropriate CDR. The epidemiology and outcomes of CSI in this cohort of children will also be described.
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Trial website
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Trial related presentations / publications
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Public notes
New Zealand sites (2): Starship Children's Hospital, Auckland Kidz First Hospital, Auckland
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Contacts
Principal investigator
Name
110770
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Prof Franz Babl
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Address
110770
0
Emergency Department
Royal Children's Hospital
Flemington Road
Parkville, Victoria, 3052
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Country
110770
0
Australia
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Phone
110770
0
+61 399366748
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Fax
110770
0
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Email
110770
0
[email protected]
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Contact person for public queries
Name
110771
0
Sharon O'Brien
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Address
110771
0
C/- Emergency Department
Hospital Avenue
Nedlands Western Australia 6009
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Country
110771
0
Australia
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Phone
110771
0
+61 8 6456 4989
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Fax
110771
0
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Email
110771
0
[email protected]
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Contact person for scientific queries
Name
110772
0
Natalie Phillips
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Address
110772
0
Emergency Department
Queensland Children's Hospital
501 Stanley Street,
South Brisbane QLD 4101
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Country
110772
0
Australia
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Phone
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+61 7 3068 4500
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
The study team and sponsor will endeavour to make the published de-identified participant data available for use within the broader scientific community.
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When will data be available (start and end dates)?
12 months after study completion and publication of the primary papers.
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Available to whom?
Recognised clinical researchers
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Available for what types of analyses?
Metanalysis
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How or where can data be obtained?
Individuals or organisations seeking access to the de-identified data arising from the SONIC study can contact the study team, via Dr Natalie Phillips (
[email protected]
) or Professor Franz Babl (
[email protected]
). The request will be reviewed, taking into consideration scientific merit of the proposed use of the data, and legal, regulatory and ethical issues.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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