Creating a Diagnostic Decision Rule for Shoulder Injury: CASH-trial

Study Overview
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Brief Summary
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What combination of ≤ 6 clinical variables will give the highest specificity for indicating significant shoulder injuries (fractures or dislocations) with a set sensitivity of ≥ 97%? Although shoulder trauma is a common injury, there is no clinical decision rule to determine the necessity for radiography for these traumas. With this trial the investigators aim to develop such a rule to reduce the amount of radiographs without missing any significant injuries. The primary objective is to compose a set of clinical diagnostic criteria predictive of shoulder fractures or dislocations that would reduce the amount of radiographs without missing any significant injuries. A second objective is to determine if the clinical decision rule is applicable for triage use.

Detailed Description
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The CASH (Clavicle-AC-Joint-Sub-capital-Humerus) trial is designed as a cross sectional interobserver study. It will randomize between first examiner of the patient to determine applicability for triage use and use a list of 19 criteria to determine a clinical decision rule for significant shoulder injuries. Method/intervention After admittance to the ED, all consecutive shoulder injury patients will be assessed for eligibility in the study. After informed consent is given, the patient will be randomized for first observer (ED physician or triage nurse) to be examined, which means they will be assessed in duplo. The patient will be examined by means of a score form, which contains 19 different diagnostic criteria. The criteria are grouped: anamnesis, inspection, palpation and pain/range of motion(ROM). After completing the list, patients will get a full set of shoulder x-rays: shoulder AP- and axial-view, and clavicle AP and 30' cranio-caudal view. The trial participation for the patient will be completed at this point and final diagnosis and treatment are provided by the ED physician according to his/her own findings and interpretation of the radiographs. For the study, the radiographs will be reassessed by one consultant radiologist specialized in skeletal trauma.

Official Title
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Creating a Diagnostic Decision Rule for Shoulder Injury: CASH-trial

Conditions
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Trauma

Intervention / Treatment
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* Other: Standard diagnostic item list


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged18-65 years Trauma <48h Exclusion Criteria: Any prior ipsilateral shoulder surgery. Any diseases of the bones potentially influencing fracturability (osteogenesis imperfecta, osteoporosis, achondroplasia, M. Kahler, chronic (> 1yr) prednisone use > 5mg) Any shoulder injury as part of a multi-trauma or high energy trauma (HET) with distractible injuries Any condition that will influence the perception of pain (e.g. alcohol intoxication, psychiatric problems, mental retardation)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MD as first examiner<br>Patients will be examined according to a standardized physical examination item list | Other: Standard diagnostic item list<br>* All consecutive patients are assessed by both examiners, according to a standardized physical examination item list.<br>|
| Other: Triage nurse as first examiner<br>Patients will be examined according to a standardized physical examination item list | Other: Standard diagnostic item list<br>* All consecutive patients are assessed by both examiners, according to a standardized physical examination item list.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy (sensitivity and specificity) of the clinical variables assessed with the score form. |  | An average of 12 to 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interobserver agreement for each clinical variable between both observers determined with the Cohen's kappa coefficient |  | An average of 12 to 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trauma of the shoulder