Assessing the Clinical Usefulness and Transparency of Adult Spinal Deformity Randomized Controlled Trials: A Systematic Review Using the Van't Hooft Framework.

Abstract

Systematic review and regression analysis of randomized controlled trials. To assess the clinical usefulness of randomized controlled trials (RCTs) in adult spinal deformity (ASD) using the van't Hooft framework. ASD surgery is increasingly performed and associated with substantial clinical risk and economic burden. Although RCTs are essential for guiding surgical decision-making, the extent to which ASD RCTs provide clinically useful, real-world evidence remains unclear. RCTs evaluating ASD interventions published between 2001 and 2025 were systematically identified through PubMed, Cochrane, and Embase. Clinical usefulness was assessed using the 13-item van't Hooft framework, encompassing clinical utility and transparency domains. Descriptive analyses summarized trial characteristics and usefulness criteria. Internal consistency was evaluated using Cronbach's alpha. Linear and multivariable ordinary least squares regression analyses examined associations between usefulness scores and trial characteristics, including funding, trial registration, journal category, and publication year. Twenty-six ASD RCTs met inclusion criteria. All addressed a relevant clinical problem, and 96.2% appropriately contextualized findings within existing literature. Pragmatism was limited, with only 23.1% fully meeting pragmatism criteria, and value-for-money analyses were largely absent. Transparency varied widely: 38.5% of trials were preregistered, 7.7% provided a publicly available protocol, and none shared raw data. Overall usefulness scores increased over time (β=0.24, P=0.032), driven primarily by improvements in transparency (β=0.18, P=0.031), while clinical utility showed no meaningful temporal change. Self-funded trials demonstrated significantly lower transparency and usefulness. Despite methodological rigor, many ASD RCTs exhibit limited real-world applicability and incomplete transparency Improvements in reporting over time have not translated into gains in core clinical utility. Clinicians should therefore interpret current randomized evidence in the context of patient complexity and practice variation, recognizing that many trials establish procedural efficacy under controlled conditions rather than effectiveness across heterogeneous ASD populations.