Clinical Decision Rule for Excluding Shoulder Fractures

Development and External Validation of a Clinical Decision Rule for Excluding Shoulder Fractures: A Prospective Multicentre Diagnostic Accuracy and Cost-Effectiveness Study (SFER Study)

Many patients with shoulder injuries undergo X-rays even when fractures are unlikely, leading to unnecessary costs and delays in care. This study aims to develop a simple and reliable clinical tool to help healthcare providers determine when imaging is not required. By evaluating this tool in a large number of patients, we aim to improve patient care, reduce waiting times, and optimize the use of healthcare resources.

Abstract Shoulder trauma is a common presentation in orthopedic and emergency settings and frequently leads to routine radiographic imaging despite a relatively low prevalence of fractures. This practice contributes to increased healthcare costs, unnecessary radiation exposure, and inefficiencies in patient flow. Currently, no validated clinical decision rule exists to safely exclude shoulder fractures. We will conduct a prospective, multicentre diagnostic accuracy study in a high-volume orthopedic setting, enrolling approximately 1200 adult patients presenting with acute shoulder trauma. The study will include derivation and external validation cohorts. All participants will undergo standardized clinical assessment using the SFER clinical decision rule, followed by radiographic imaging as the reference standard. The primary outcome is sensitivity for fracture detection, with secondary outcomes including specificity, negative predictive value, reduction in imaging rates, missed fracture rate, inter-rater reliability, and cost-effectiveness. We hypothesize that the SFER rule will achieve sensitivity ≥95% with a missed fracture rate <1%, enabling safe reduction of unnecessary imaging and improving clinical efficiency.

Inclusion Criteria:

• Adult patients aged 18 years or older presenting with acute shoulder trauma within 7 days of injury will be eligible for inclusion

Exclusion Criteria:

- Patients with polytrauma, previous shoulder surgery, open fractures, or inability to cooperate with clinical assessment will be excluded.