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1061 Optimizing immune toxicity documentation to enhance guideline adherence in oncology care: a lean six sigma approach

jitc · 2025-11-04 · canonical JSON source

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Background Accurate documentation of immune-related adverse events (irAEs) is essential for high-quality immunotherapy toxicity management Timely and standardized grading supports clinical decision-making, improves communication, reduces complications, and facilitates adherence to evidence-based guidelines. 1–3 However, in fast-paced oncology settings, such as urgent care centers, consistently capturing irAE severity and context can be challenging.1 2 Inconsistent documentation remains a widespread challenge, compromising patient safety and increasing healthcare costs.3 At Johns Hopkins Hospital (JHH), a quality improvement initiative was launched to strengthen irAE documentation practices within the Oncology Evaluation and Treatment Center (OETC), with the goal of enhancing guideline-concordant care and improving patient outcomes.Methods A Lean Six Sigma DMAIC (Define, Measure, Analyze, Improve, Control) approach was used to address gaps in irAE grade documentation in the OETC. From July 1, 2022, to September 30, 2023, a retrospective review of 2,398 electronic health records (EHR) flagged for immune checkpoint inhibitor (ICI) use was conducted, identifying 737 patients actively receiving ICI therapy and 67 active irAE encounters. Root cause analysis, including a waste walk, highlighted several system-level contributors, including time constraints, environmental pressures in the urgent care, identified knowledge gaps in irAE complexity, environmental pressures in the urgent care setting, and complexity of navigating nuanced toxicity guidelines in real time. A SMART aim was developed to increase irAE grade documentation to 50% of eligible encounters by December 2025. Quarterly EHR audits were established to track progress.Results Baseline analysis showed that only 5.9% of irAE encounters included grade documentation, with 36.9% exhibiting guideline non-adherence and 13.7% readmissions rate post-discharge from OETC.Conclusions Documentation of irAE severity in urgent oncology settings is a known challenge and can undermine guideline adherence and patient outcomes. To improve consistency and reduce variability, we implemented a multi-pronged approach: (1) smart phrases tailored to streamline EHR charting for irAEs to simplify and expedite documentation; (2) Agile MD algorithmic guidelines for management based on clearly outlined grading; and (3) launched e-consultation capability in the OETC to provide expert support and ensure guideline adherence. These efforts, guided by DMAIC principles, are aimed at enhancing documentation and standardizing care delivery. Sustained through quarterly audits, this initiative offers a scalable framework for improving immune toxicity management across oncology practice settings.References Brahmer JR, Abu-Sbeih H, Ascierto PA, et al. Society for immunotherapy of cancer (SITC) clinical practice guideline on immune checkpoint inhibitor-related adverse events. J Immunother Cancer. 2021;9(6):e002435. doi: 10.1136/jitc-2021-002435.Postow MA, Sidlow R, Hellmann MD. Immune-related adverse events associated with immune checkpoint blockade. N Engl J Med. 2018;378(2):158–68. doi: 10.1056/NEJMra1703481.Thompson JA, Schneider BJ, Brahmer J, et al. Management of immunotherapy-related toxicities, version 1.2019, NCCN clinical practice guidelines in oncology. J Natl Compr Canc Netw. 2019;17(3):255–89. doi: 10.6004/jnccn.2019.0013.