Development and validation of the paediatric elbow trauma (PET) rules as a decision rule for radiography in traumatic elbow injuries: a study protocol.

BACKGROUND

Traumatic elbow injuries in children occur frequently and are among the most common traumatic injuries seen in the emergency department (ED) and in general practice. The use of a validated decision rule to enhance selective radiography in paediatric patients with possible elbow fractures may reduce unnecessary exposure to radiation in children.

METHOD AND ANALYSIS: This study is designed as a multicentre prospective cohort study. An expert panel of orthopaedic elbow surgeons, paediatric orthopaedic surgeons and trauma surgeons will initially determine clinical parameters that provide a possible predictive value for elbow fractures. Four hundred children between the ages of 2 and 17 years visiting the ED with pain following elbow trauma will then be included. The clinical parameters will be collected via patient history and physical examination. Elbow radiographs will be obtained in all patients to identify fractures. The data will be processed in a multivariable logistic regression analysis to determine which clinical parameters predict the presence of an elbow fracture. Only the clinical parameters that predict a fracture will be used to formulate the new decision rule: the paediatric elbow trauma (PET) rules. Internal validation of the prediction model will take place after inclusion is complete and by means of a bootstrap analysis on the acquired data. A calculation will be made to determine how many radiographs can potentially be reduced by applying the PET rules and a cost analysis will be performed.

ETHICS AND DISSEMINATION: The study will be conducted according to the principles of the Declaration of Helsinki and in accordance with the Medical Research Involving Human Subjects Act. The Medical Research Ethics Committees United stated on 16 May 2022 that The Medical Research Involving Human Act (WMO) does not apply to this study and an official approval by the committee is not required, reference number; project W22.086.