Is a Two-Film Skull X-ray Series as Sensitive as a Four-Film Series in the Diagnosis of Skull Fractures in Paediatric Patients (4vs2)

Is a Two-Film Skull X-ray Series as Sensitive as a Four-Film Series in the Diagnosis of Skull Fractures in Paediatric Patients With Minor Head Trauma?

Minor head injuries are a common presenting complaint in the pediatric emergency department. Skull x-rays are a useful tool in the evaluation of paediatric patients with a history of minor head trauma. However, there exists ongoing controversy regarding the ideal number of views that should be obtained in a skull series. This study aims to determine if there is a significant difference in the diagnostic accuracy of skull x-rays in the diagnosis of fracture in paediatric minor head trauma patients when a 2-film series as opposed to a 4-film series is provided to participating pediatric emergency physicians.

Study Overview

• Status: Completed
• Conditions: Head Trauma
• Intervention / Treatment: Other: 4-views series; Other: 2-views serie

Detailed Description

Minor head injuries are a common presenting complaint in the pediatric emergency department. Skull x-rays are a useful tool in the evaluation of paediatric patients with a history of minor head trauma. However, there exists ongoing controversy regarding the ideal number of views that should be obtained in a skull series. This study aims to determine if there is a significant difference in the diagnostic accuracy of skull x-rays in the diagnosis of fracture in paediatric minor head trauma patients when a 2-film series as opposed to a 4-film series is provided to participating pediatric emergency physicians.

This will be a prospective, crossover experimental study evaluating the equivalency in sensitivity and specificity of a 2-film series versus a 4-film series in the diagnosis of skull fracture associated with minor head injuries in children.

The study will involve 10 pediatric emergency physicians who will evaluate two modules of 100 series of radiography.

In order to do so, he or she will be given two work modules. Each module will contain the randomized and anonymous x-rays of the same 50 cases and 50 controls mounted on power point slides. Among the 50 cases, the evaluation sequence will be randomized such that 25 cases will be evaluated with the 2-film series in the first module and the 4-film series in the second module while the other 25 cases will evaluated in the reverse order. The same procedure will be used for randomizing the evaluation sequence of the 50 controls.

The primary outcomes will be the overall sensitivity and specificity of pediatric emergency medicine physicians for the detection of skull fractures using two evaluation methods: one in which they are presented with a skull series that has 2 views and another in which they are presented with a standard 4-view series.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3T1C5
      • Sainte-Justine Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children who had a radiography for head trauma

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 4 views radiograph serie; The 4-film series will include the following views: anterior-posterior; one lateral; Waters, and Townes views.	Other: 4-views series; The 4-film series will include the following views: anterior-posterior; one lateral; Waters, and Townes views.
Active Comparator: 2-view radiography serie; The 2-film series will include the following views: anterior-posterior and one lateral.	Other: 2-views serie; The 2-film series will include the following views: anterior-posterior and one lateral.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description
Sensitivity	The sensitivity is a simple proportion and will be measured by dividing the number of cases that were classified as positive for fracture by the total number of cases.
Specificity	The specificity will be measured by dividing the number of x-rays of controls in which x-rays were read as negative by the total number of x-rays of controls.

Secondary Outcome Measures

Outcome Measure	Measure Description
Individual sensitivity	The sensitivity of individual participants in the detection of skull fracture will be calculated.
Individual specificity	The specificity of individual participants in the detection of skull fracture will be calculated.

Collaborators and Investigators

• Sponsor: St. Justine's Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: October 5, 2011
• First Submitted That Met QC Criteria: October 5, 2011
• First Posted (Estimate): October 7, 2011

Study Record Updates

• Last Update Posted (Estimate): March 19, 2013
• Last Update Submitted That Met QC Criteria: March 18, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Children; Head trauma; Radiography
• Additional Relevant MeSH Terms: Nervous System Diseases; Fractures, Bone; Trauma, Nervous System; Wounds and Injuries; Craniocerebral Trauma; Skull Fractures
• Other Study ID Numbers: 4vs2