By combining incident learning and process failure-mode-and-effects-analysis (FMEA) in a structure-process-outcome framework we have created a risk profile for our radiation medicine practice and implemented evidence-based risk-mitigation initiatives focused on patient safety. Based on reactive reviews of incidents reported in our departmental incident-reporting system and proactive FMEA, high safety-risk procedures in our paperless radiation medicine process and latent risk factors were identified. Six initiatives aimed at the mitigation of associated severity, likelihood-of-occurrence, and detectability risks were implemented. These were the standardization of care pathways and toxicity grading, pre-treatment-planning peer review, a policy to thwart delay-rushed processes, an electronic whiteboard to enhance coordination, and the use of six sigma metrics to monitor operational efficiencies. The effectiveness of these initiatives over a 3-years period was assessed using process and outcome specific metrics within the framework of the department structure. There has been a 47% increase in incident-reporting, with no increase in adverse events. Care pathways have been used with greater than 97% clinical compliance rate. The implementation of peer review prior to treatment-planning and use of the whiteboard have provided opportunities for proactive detection and correction of errors. There has been a twofold drop in the occurrence of high-risk procedural delays. Patient treatment start delays are routinely enforced on cases that would have historically been rushed. Z-scores for high-risk procedures have steadily improved from 1.78 to 2.35. The initiatives resulted in sustained reductions of failure-mode risks as measured by a set of evidence-based metrics over a 3-years period. These augment or incorporate many of the published recommendations for patient safety in radiation medicine by translating them to clinical practice.
582 Background: After preoperative chemo-radiation, clinical response and tumor pathologic downstaging showed a close correlation with improved outcomes. We report our initial experience in dose escalation using dose-painted intensity-modulated radiation therapy (DP-IMRT) in patients with locally advanced rectal cancer. Methods: Fifteen patients with locally advanced rectal cancer (T3-4,N0-1) were prospectively identified. Tumors were staged using the cTNM classification by PET/CT, EUS & MRI. All received preoperative 5-FU and DP-IMRT. Doses were prescribed as follows:56 Gy/2.0 Gy fractions (fxn) to the planning target volume (PTV) and 47.6Gy/1.7Gyfxn to elective nodal PTV. Surgery was performed 6-8 weeks after chemo-radiation. The surgical procedure was tailored to tumor downstaging. The choice of sphincter-preserving surgery was based on the distance between the lower tumor pole and the anorectal ring “ after” chemoradiation. All were reevaluated for tumor response, preoperatively by imaging studies (ycTNM) and by pathological staging (ypTN) following surgery. Acute and late toxicities were monitored by the treating physician. Results: All patients completed therapy. Tumors were in the lower 1/3 in 3 patients, middle 1/3 in 7, and upper 1/3 in 5. With preoperative endorectal US, PET/CT and MRI, the clinical staging of the tumors was: 13 (T3N0) and 2 (T4N0). Acute toxicity was limited to a moderate proctitis (RTOG acute toxicity scoring system, G1 ) in all patients, with two patients with tumors extending into the anal canal having G 3 dermatitis. Complete clinical response was obtained in 10 of 15 patients.All 15 underwent surgery; 6 had pathological pT0N0, 4 had residual micro foci of carcinoma (pT1N0), and 5 had residual disease limited to the muscularis propria (pT2N0). No difference in perioperative complications was seen. Conclusions: Preoperative dose-escalation using dose-painted radiation therapy (DP-IMRT) seems to be safe. Moderate local acute toxicity was seen with very low-lying tumors. This modality provides a high rate of tumor downsizing especially for patients with lesions in the lower 2/3 of the rectum with a possible potential for an increased ability to perform sphincter-preserving surgery.
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