Assessing the Clinical Usefulness and Transparency of Adult Spinal Deformity Randomized Controlled Trials: A...

Area of Science:

• Spine surgery
• Orthopedics
• Clinical trials

Background:

• Adult spinal deformity (ASD) surgery is common, carrying significant risks and costs.
• Randomized controlled trials (RCTs) are crucial for surgical decision-making, but their real-world applicability in ASD is uncertain.

Purpose of the Study:

• To evaluate the clinical usefulness of RCTs in adult spinal deformity (ASD) using the van't Hooft framework.
• To assess trends in usefulness and identify factors influencing it over time.

Main Methods:

• Systematic review of ASD RCTs published between 2001 and 2025.
• Assessment of clinical usefulness using the 13-item van't Hooft framework (clinical utility and transparency).
• Regression analysis to determine associations between usefulness scores and trial characteristics (funding, registration, etc.).

Main Results:

• Twenty-six ASD RCTs were analyzed; most addressed relevant clinical problems.
• Limited pragmatism (23.1%) and absence of value-for-money analyses were noted.
• Transparency improved over time (driven by preregistration), but clinical utility did not significantly change. Self-funded trials had lower usefulness.

Conclusions:

• ASD RCTs often lack real-world applicability and complete transparency.
• Despite reporting improvements, core clinical utility has not advanced.
• Clinicians must interpret ASD RCT evidence considering patient complexity and practice variations.