ArticleFrontiers in oncology2026
Implementation of an FMEA-guided quality-improvement workflow is associated with improved setup accuracy in lung stereotactic body radiotherapy.
Article in Frontiers in oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Lung stereotactic body radiotherapy (SBRT) requires highly reproducible workflow execution because of steep dose gradients, respiratory motion, and narrow treatment margins. This study evaluated the workflow effectiveness and process-safety impact of an FMEA-guided quality-improvement workflow for lung SBRT. Methods: This single-center historical-control study included 128 patients treated with lung SBRT. Sixty-three patients treated under conventional quality-control procedures served as the control group, and 65 patients managed after implementation of an FMEA-guided quality-improvement workflow served as the FMEA-guided group. The workflow included risk identification, targeted corrective measures, respiratory coaching, dual verification, immobilization optimization, and enhanced equipment quality control. RPN changes were analyzed using the Wilcoxon signed-rank test. CBCT-derived setup deviations were assessed using patient-level median absolute couch correction values and fraction-level linear mixed-effects models. Workflow-related adverse events were compared using Fisher's exact test. Results: Eleven high-risk failure modes were identified. The overall median residual RPN was lower than the initial RPN [39.0 (IQR, 26.0-46.5) vs 177.5 (IQR, 165.0-209.0); Conclusion: Implementation of an FMEA-guided quality-improvement workflow was associated with reduced residual RPN scores and smaller CBCT-derived setup deviations in lung SBRT. Workflow-related adverse events decreased numerically but did not reach statistical significance. These findings support the value of proactive, closed-loop workflow risk management, while further prospective multicenter validation is warranted.
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