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Informed Consent in Orthopaedic Surgery: When a Signature Does Not Mean Understanding: A Prospective Study of 750
Filippo Raggini1, Alberto Vassallo2
1Department of Orthopaedics and Traumatology, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Journal of Evaluation in Clinical Practice
|July 19, 2026
Summary
Most orthopaedic surgery patients lack understanding of informed consent, especially trauma patients. This highlights systemic issues in consent processes, necessitating improved communication strategies for better patient comprehension.
Area of Science:
- Orthopaedic Surgery
- Patient Safety
- Medical Ethics
Background:
- Informed consent is crucial in medicine, but patient understanding of surgical details, particularly in orthopaedics, is often uncertain.
- Older and vulnerable populations may face additional challenges in comprehending complex medical information.
- Orthopaedic surgery settings, especially trauma cases, present unique communication barriers due to urgency and stress.
Purpose of the Study:
- To evaluate real-time patient understanding of informed consent immediately before orthopaedic surgery.
- To compare comprehension levels between patients undergoing elective versus trauma-related orthopaedic procedures.
Main Methods:
- A prospective observational study was conducted with 750 adult orthopaedic patients at a tertiary hospital.
- Patients completed a four-item tool assessing understanding of procedure, risks, benefits, and alternatives.
- Comprehension was categorized as absent, partial, or adequate, with exclusions for cognitive impairment or language barriers.
Main Results:
- A significant majority of patients (65.1%) had absent comprehension, and 25.1% had partial comprehension.
- Trauma patients exhibited lower comprehension than elective patients (28.3% vs. 39.1%).
- Adequate comprehension was low across both groups (9.9% overall), with older age and lower education linked to poorer understanding.
Conclusions:
- Most patients undergoing orthopaedic surgery lack meaningful understanding of their consent information.
- Current consent processes appear to have systemic limitations, affecting both elective and trauma pathways.
- Reforming consent into a dynamic verification process with simplified language and teach-back methods is recommended.