Failure mode and effect analysis for linear accelerator-based paraspinal stereotactic body radiotherapy.

INTRODUCTION: Paraspinal stereotactic body radiotherapy (SBRT) involves risks of severe complications. We evaluated the safety of the paraspinal SBRT program in a large academic hospital by applying failure modes and effects analysis. METHODS: The analysis was conducted by a multidisciplinary committee (two therapists, one dosimetrist, four physicists, and two radiation oncologists). The paraspinal SBRT workflow was segmented into four phases (simulation, treatment planning, delivery, and machine quality assurance (QA)). Each phase was further divided into a sequence of sub-processes. Potential failure modes (PFM) were identified from each subprocess and scored in terms of the frequency of occurrence, severity and detectability, and a risk priority number (RPN). High-risk PFMs were identified based on RPN and were studied for root causes using fault tree analysis. RESULTS: Our paraspinal SBRT process was characterized by eight simulations, 11 treatment planning, nine delivery, and two machine QA sub-processes. There were 18, 29, 19, and eight PFMs identified from simulation, planning, treatment, and machine QA, respectively. The median RPN of the PFMs was 62.9 for simulation, 68.3 for planning, 52.9 for delivery, and 22.0 for machine QA. The three PFMs with the highest RPN were: previous radiotherapy outside the institution is not accurately evaluated (RPN: 293.3), incorrect registration between diagnostic magnetic resonance imaging and simulation computed tomography causing incorrect contours (273.0), and undetected patient movement before ExacTrac baseline (217.8). Remedies to the high RPN failures were implemented, including staff education, standardized magnetic resonance imaging acquisition parameters, and an image fusion process, and additional QA on beam steering. CONCLUSIONS: A paraspinal SBRT workflow in a large clinic was evaluated using a multidisciplinary and systematic risk analysis, which led to feasible solutions to key root causes. Treatment planning was a major source of PFMs that systematically affect the safety and quality of treatments. Accurate evaluation of external treatment records remains a challenge.

Patient Safety and Satisfaction With Fully Remote Management of Radiation Oncology Care.

Importance: Patients of Memorial Sloan Kettering Cancer Center in New York, New York, are now offered a choice of either in-person or remote telehealth visits for radiation oncology care. However, safety and satisfaction among patients receiving treatment with fully remote physician management is unclear. Objective: To analyze patient safety and satisfaction, financial implications, and environmental consequences associated with fully remote management among a cohort of patients treated with radiotherapy. Design, Setting, and Participants: This single-institution retrospective cohort study was performed at Memorial Sloan Kettering Cancer Center, with patients treated with radiation who opted for fully remote management between October 1, 2020, and October 31, 2022. Data on patient safety events were prospectively collected with an in-house quality improvement reporting system. Patient satisfaction surveys were distributed electronically before, during, and after treatment. Patient transportation costs and environmental consequences were estimated based on differences in travel distance. Data analysis was performed from March 14 through September 19, 2023. Exposure: Radiotherapy with fully remote physician management. Main Outcomes and Measures: Satisfaction rates among patients opting for fully remote management were analyzed via surveys administered electronically after visits with clinicians. Patient safety events, defined as staff-reported actual events and near misses that had the potential to affect patient care, were reviewed. Rates and types of safety events were analyzed and compared with patients treated by onsite clinicians. Distances between patient home zip codes and treatment site locations were compared with estimated cost savings and decreased emissions. Results: This study included 2817 patients who received radiation oncology care with fully remote physician management. The median age of patients was 65 (range, 9-99) years, and more than half were men (1467 [52.1%]). Of the 764 safety events reported, 763 (99.9%) did not reach patients or caused no harm to patients. Nearly all survey respondents (451 [97.6%]) rated patient satisfaction as good to very good across all domains. For treatment with fully remote physician management, out-of-pocket cost savings totaled $612 912.71 ($466.45 per patient) and decreased carbon dioxide emissions by 174 metric tons. Conclusions and Relevance: In this study, radiation oncology care provided by fully remote clinicians was safe and feasible, with no serious patient events. High patient satisfaction, substantial cost savings, and decreased environmental consequences were observed. These findings support the continuation of a fully remote management option for select patients in the post-COVID-19 era.

Replacing 30 Gy in 10 fractions with stereotactic body radiation therapy for bone metastases: A large multi-site single institution experience 2016-2018.

BACKGROUND: Bone metastases cause significant morbidity in patients with cancer, and radiation therapy (RT) is an effective treatment approach. Indications for more complex ablative techniques are emerging. We sought to evaluate RT trends at a large multi-site tertiary cancer center. METHODS: Patients who received RT for bone metastases at a single institution (including regional outpatient clinics) from 2016 to 2018 were identified. Patients were grouped by RT regimen: single-fraction conventional RT (8 Gy × 1), 30 Gy in 10 fractions, SBRT, and "other". Multinomial logistic regression was performed to assess trends in regimens over time. Binary logistic regression was performed to evaluate factors associated with receipt of SBRT. RESULTS: Between 2016 and 2018, 5,952 RT episodes were received by 2,969 patients with bone metastases. Overall, 76% of episodes were ≤ 5 fractions. The median number of fractions planned for SBRT and non-SBRT episodes was 3 (IQR 3-3) and 5 (IQR 5-10), respectively. Use of SBRT increased from 2016 to 2018 (39% to 53%, p < 0.01) while use of 30 Gy in 10 fractions decreased (26% to 12%, p < 0.01), and 8 Gy × 1 was stable (5.3% to 6.9%, p = 0.28). SBRT was associated with higher performance status (p < 0.01) and non-radiosensitive histology (p < 0.01). Use of SBRT increased in the regional network (19% to 48%, p < 0.01) and at the main center (52% to 59%, p = 0.02), but did not increase within 30 days of death. More patients treated with 8 Gy × 1 than SBRT died within 30 days of treatment (24% vs 3.8%, respectively, p < 0.01). CONCLUSIONS: SBRT is replacing 30 Gy in 10 fractions for bone metastases, especially among patients with high performance status and non-radiosensitive histologies. Better prognostic algorithms could further improve patient-centered treatment selection at the end of life.

The impact of new technologies on radiation oncology events and trends in the past decade: an institutional experience.

PURPOSE: To review the type and frequency of patient events from external-beam radiotherapy over a time period sufficiently long to encompass significant technology changes. METHODS AND MATERIALS: Ten years of quality assurance records from January 2001 through December 2010 were retrospectively reviewed to determine the frequency of events affecting patient treatment from four radiation oncology process steps: simulation, treatment planning, data entry/transfer, and treatment delivery. Patient events were obtained from manual records and, from May 2007 onward, from an institution-wide database and reporting system. Events were classified according to process step of origination and segregated according to the most frequently observed event types. Events from the institution-wide database were evaluated to determine time trends. RESULTS: The overall event rate was 0.93% per course of treatment, with a downward trend over time led by a decrease in treatment delivery events. The frequency of certain event types, particularly in planning and treatment delivery, changed significantly over the course of the study, reflecting technologic and process changes. Treatments involving some form of manual intervention carried an event risk four times higher than those relying heavily on computer-aided design and delivery. CONCLUSIONS: Although the overall event rate was low, areas for improvement were identified, including manual calculations and data entry, late-day treatments, and staff overreliance on computer systems. Reducing the incidence of pretreatment events is of particular importance because these were more likely to occur several times before detection and were associated with larger dosimetric impact. Further improvements in quality assurance systems and reporting are imperative, given the advent of electronic charting, increasing reliance on computer systems, and the potentially severe consequences that can arise from mistakes involving complex intensity-modulated or image-guided treatments.