Study characteristics.

Despite advances in deep learning and transformer architectures, prior reviews have focused narrowly on traditional clinical decision support systems (CDSS) or single medical domains, leaving significant gaps in understanding contemporary AI-driven predictive tools. This systematic review and meta-analysis evaluated the predictive performance of artificial intelligence-based CDSS (AI-CDSS) across multiple medical specialties. Following PRISMA guidelines, PubMed and Cochrane Library were searched through December 2024 for studies evaluating predictive AI-CDSS using real-world clinical data. Two reviewers independently screened 3,296 records (κ = 0.833), with study quality assessed via QUADAS-2 and performance measures pooled using random-effects meta-analysis. Fifty studies spanning 17 medical specialties were included. Meta-analysis demonstrated moderate discriminatory ability (pooled AUC: 0.652, 95% CI: 0.562–0.743), high specificity (0.819, 95% CI: 0.793–0.844), moderate accuracy (0.765, 95% CI: 0.734–0.796), and variable sensitivity (0.660, 95% CI: 0.535–0.785), with substantial heterogeneity across all measures (I² ≥ 98.9%). Only 24% of studies involved prospective deployment, and 64% reported exclusively technical metrics without clinical workflow data. Predictive AI-CDSS demonstrate moderate-to-good diagnostic performance with strong specificity; however, the predominance of retrospective study designs and limited implementation reporting reveal critical gaps between technical validation and real-world clinical utility. To address these shortcomings, we propose the ROADMAP framework, structured around seven domains: Representative development, Outcomes-focused evaluation, Assessment for deployment, Data harmonization, Monitoring for bias, Allocation via economic evaluations, and Priorities for standardized reporting and prospective validation. This framework provides a practical roadmap for bridging the gap between algorithmic performance and meaningful clinical integration.