Quantifying risk using FMEA: An alternate approach to AAPM TG-100 for scoring failures and evaluating clinical workflow.

PURPOSE: Renovation of the brachytherapy program at a leading cancer center utilized methods of the AAPM TG-100 report to objectively evaluate current clinical brachytherapy workflows and develop techniques for minimizing the risk of failures, increasing efficiency, and consequently providing opportunities for improved treatment quality. The TG-100 report guides evaluation of clinical workflows with recommendations for identifying potential failure modes (FM) and scoring them from the perspective of their occurrence frequency O, failure severity S, and inability to detect them D. The current study assessed the impact of differing methods to determine the risk priority number (RPN) beyond simple multiplication. METHODS AND MATERIALS: The clinical workflow for a complex brachytherapy procedure was evaluated by a team of 15 staff members, who identified discrete FM using alternate scoring scales than those presented in the TG-100 report. These scales were expanded over all clinically relevant possibilities with care to emphasize mitigation of natural bias for scoring near the median range as well as to enhance the overall scoring-system sensitivity. Based on staff member perceptions, a more realistic measure of risk was determined using weighted functions of their scores. RESULTS: This new method expanded the range of RPN possibilities by a factor of 86, improving evaluation and recognition of safe and efficient clinical workflows. Mean RPN values for each FM decreased by 44% when changing from the old to the new clinical workflow, as evaluated using the TG-100 method. This decreased by 66% when evaluated with the new method. As a measure of the total risk associated with an entire clinical workflow, the integral of RPN values increased by 15% and decreased by 31% with the TG-100 and new methods, respectively. CONCLUSIONS: This appears to be the first application of an alternate approach to the TG-100 method for evaluating the risk of clinical workflows. It exemplifies the risk analysis techniques necessary to rapidly evaluate simple clinical workflows appropriately.

Novel and programmatic improvements to the workflow associated with the AccuBoost breast brachytherapy procedure.

PURPOSE: While the noninvasive breast brachytherapy (NIBB) treatment procedure, known as AccuBoost, for breast cancer patients is well established, the treatment quality can be improved by the efficiency of the workflow delivery. A formalized approach evaluated the current workflow through failure modes and effects analysis and generated insight for developing new procedural workflow techniques to improve the clinical treatment process. METHODS AND MATERIALS: AccuBoost treatments were observed for several months while gathering details on the multidisciplinary workflow. A list of possible failure modes for each procedure step was generated and organized by timing within the treatment process. A team of medical professionals highlighted procedural steps that unnecessarily increased treatment time, as well as introduced quality deficiencies involving applicator setup, treatment planning, and quality control checks preceding brachytherapy delivery. Procedural improvements and their impact on the clinical workflow are discussed. RESULTS: The revised clinical workflow included the following key procedural enhancements. Prepatient arrival: Improvement of prearrival preparation requires advance completion of dose calculation documentation with patient-specific setup data. Patient arrival pretreatment: Physicists carry out dwell time calculations and check the plan, while the therapist concurrently performs several checks of the ensuing hardware configuration. TREATMENT: An electronic method to export the associated HDR brachytherapy paperwork to the electronic medical record system with electronic signatures and captured approvals was generated. Posttreatment: The therapist confirms the applicators were appropriately positioned, and treatment was delivered as expected. CONCLUSIONS: The procedural improvements reduced the overall treatment time, improved consistency across users, and eased performance of this special procedure for all participants.

Electronic intracavitary brachytherapy quality management based on risk analysis: The report of AAPM TG 182.

PURPOSE: The purpose of this study was to provide guidance on quality management for electronic brachytherapy. MATERIALS AND METHODS: The task group used the risk-assessment approach of Task Group 100 of the American Association of Physicists in Medicine. Because the quality management program for a device is intimately tied to the procedure in which it is used, the task group first designed quality interventions for intracavitary brachytherapy for both commercial electronic brachytherapy units in the setting of accelerated partial-breast irradiation. To demonstrate the methodology to extend an existing risk analysis for a different application, the task group modified the analysis for the case of post-hysterectomy, vaginal cuff irradiation for one of the devices. RESULTS: The analysis illustrated how the TG-100 methodology can lead to interventions to reduce risks and improve quality for each unit and procedure addressed. CONCLUSION: This report provides a model to guide facilities establishing a quality management program for electronic brachytherapy.

Interface dosimetry for electronic brachytherapy intracavitary breast balloon applicators.

In this study, we evaluate the attenuation of the dose due to barium-impregnation in the region between the surface of an electronic brachytherapy (EBT) balloon applicator for accelerated partial breast irradiation (APBI) and the prescription point at 1 cm depth in tissue. To perform the study, depth dose curves were calculated using a general purpose multi-particle transport code (FLUKA) for a range of balloon wall thicknesses with and without barium impregnation. Numerical data were verified with experimental readings using a parallel plate extrapolation ionization chamber for different wall thicknesses. Depth dose curves computed using both numerical and experimental methods show a 6.0% attenuation of the dose at the 1.0 cm prescription line due to the impregnation of barium in the balloon material, which agrees well with the manufacturer's specification. By applying this single attenuation factor, dose calculations throughout the entire planned volume are uniformly affected. However, at the balloon surface, attenuation on the order of 18.0% is observed. The AAPM TG-43 source data currently incorporated in commercially-available treatment planning systems do not account for the variable dose distributions attributable to balloon wall attenuation. Our results show that variable attenuation factors that may have clinical significance should be applied in order to determine near-surface dose distributions when using barium impregnated balloons for intracavitary breast brachytherapy. Dose distributions at distances greater than 1 cm from the surface of the balloon appear to be accurately represented without further modification.

Modeling study for optimization of skin dose for partial breast irradiation using Xoft Axxent electronic brachytherapy applicator.

PURPOSE: Balloon brachytherapy with the MammoSite system (Hologic Inc., Bedford, MA) is a widely used approach for accelerated partial breast irradiation. Inherent to this approach, high skin doses can occur if the balloon to skin distance is small. This has been associated with late skin toxicity, particularly telangiectasia. The Xoft Axxent electronic brachytherapy balloon applicator (Xoft, Fremont, CA) is a novel device for accelerated partial breast irradiation. It is unique in that it uses an electronic 50-kV source. This source has a pronounced anisotropy with constriction of isodose distribution at the proximal end of the catheter. This anisotropy can be considered as an advantage to optimize skin dose when the cavity to skin distance is small. In this study, we simulated various balloon-insertion orientations to optimized skin surface dose. METHODS: Breast phantoms were constructed of tissue-equivalent material. Xoft Axxent balloon catheters were inserted at a distance of 6mm from the surface. The catheter was placed at three different catheter to surface orientations: (1) perpendicular to the surface, (2) oblique to the surface (45 degrees), and (3) parallel to the surface. Three-dimensional treatment planning was then performed using Nucletron's Plato planning system (Nucletron, Columbia, MD). Multiple dwell positions were used, and the dose was optimized to the target volume. The target volume was defined as volume from the balloon surface to 1-cm distance from the balloon surface or to the phantom surface (if less then 1cm from the balloon surface). Target volume coverage was compared between plans using dose-volume histograms. Surface doses were compared using isodose line distribution and surface point doses. Plato planned surface doses were then verified by direct measurement using Landauer Dot InLight dosimeters (Landauer, Glenwood, IL). RESULTS: Excellent target coverage was obtained for all three catheter orientations with a D(95) of > or =95%. Surface dose was lowest for the perpendicular orientation with a calculated dose of 99%. The parallel orientation had the highest surface dose of 164%. The oblique orientation showed intermediate results with a surface dose of 117%. Measured surface doses were reproducible and correlated well with calculated values. CONCLUSION: Optimized Xoft Axxent balloon catheter orientation using source anisotropy and multiple dwell positions can be used to minimize excessive skin dose and yet maintain optimal tumor cavity coverage when the cavity to skin distance is small. This has the potential to decrease skin late effects and improve cosmetic outcome. Further clinical study is warranted.

Application of holographic display in radiotherapy treatment planning II: a multi-institutional study.

We hypothesized that use of a true 3D display providing easy visualization of patient anatomy and dose distribution would lead to the production of better quality radiation therapy treatment plans. We report on a randomized prospective multi-institutional study to evaluate a novel 3D display for treatment planning.The Perspecta Spatial 3D System produces 360 degrees holograms by projecting crosssectional images on a diffuser screen rotating at 900 rpm. Specially-developed software allows bi-directional transfer of image and dose data between Perspecta and the Pinnacle planning system.Thirty-three patients previously treated at three institutions were included in this IRB-approved study. Patient data were de-identified, randomized, and assigned to different planners. A physician at each institution reviewed the cases and established planning objectives. Two treatment plans were then produced for each patient, one based on the Pinnacle system alone and another in conjunction with Perspecta. Plan quality was then evaluated by the same physicians who established the planning objectives. All plans were viewable on both Perspecta and Pinnacle for review. Reviewing physicians were blinded to the planning device used. Data from a 13-patient pilot study were also included in the analysis.Perspecta plans were considered better in 28 patients (61%), Pinnacle in 14 patients (30%), and both were equivalent in 4 patients. The use of non-coplanar beams was more common with Perspecta plans (82% vs. 27%). The mean target dose differed by less than 2% between rival plans. Perspecta plans were somewhat more likely to have the hot spot located inside the target (43% vs. 33%). Conversely, 30% of the Pinnacle plans had the hot spot outside the target compared with 18% for Perspecta plans. About 57% of normal organs received less dose from Perspecta plans. No statistically significant association was found between plan preference and planning institution or planner.The study found that use of the holographic display leads to radiotherapy plans preferred in a majority of cases over those developed with 2D displays. These data indicate that continued development of this technology for clinical implementation is warranted.

Dose-modeling study to compare external beam techniques from protocol NSABP B-39/RTOG 0413 for patients with highly unfavorable cardiac anatomy.

PURPOSE: The aim of this study was to select patients with heart anatomy that is specifically unfavorable for tangential irradiation in whole-breast radiotherapy (WBRT), to be used as an experimental cohort to compare cardiac dosimetric and radiobiological parameters of three-dimensional conformal external beam accelerated partial breast irradiation (3D-CRT APBI) to WBRT with techniques as defined by the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-39/Radiation Therapy Oncology Group (RTOG) 0413 clinical trial. METHODS AND MATERIALS: A dosimetric modeling study that compared WBRT and 3D-CRT APBI was performed on CT planning data from 8 patients with left-sided breast cancer. Highly unfavorable cardiac anatomy was defined by the measured contact of the myocardium with the anterior chest wall in the axial and para-sagittal planes. Treatment plans of WBRT and 3D-CRT APBI were generated for each patient in accordance with NSABP B-39/RTOG 0413 protocol. Dose-volume relationships of the heart, including the V5min (minimum dose delivered to 5% of the cardiac volume), biological effective dose (BED) of the V5min, and normal tissue complication probability (NTCP) were analyzed and compared. RESULTS: Despite expected anatomic variation, significantly large differences were found favoring 3D-CRT APBI in cumulative dose-volume histograms (p < 0.01), dose to the entire heart (mean difference 3.85 Gy, p < 0.01), NTCP (median difference, 1.00 Gy; p < 0.01), V5min (mean difference, 24.53 Gy; p < 0.01), and proportional reduction in radiobiological effect on the V5min (85%, p < 0.01). CONCLUSIONS: Use of 3D-CRT APBI can demonstrate improved sparing of the heart in select patients with highly unfavorable cardiac anatomy for WBRT, and may result in reduced risk of cardiac morbidity and mortality.

Combined computed tomography-guided radiofrequency ablation and brachytherapy in a child with multiple recurrences of Wilms' tumor.

BACKGROUND: Treatment of relapsed Wilms' tumor remains a challenge. We describe a case of an 11-year-old girl with multiply relapsed Wilms' tumor in whom combined percutaneous computed tomography (CT)-guided radiofrequency ablation and brachytherapy directed at a retroperitoneal tumor mass resulted in pain palliation and local tumor control. OBSERVATIONS: Over the course of few weeks, her requirement for narcotic pain medications dramatically decreased. A contrast-enhanced CT scan obtained at 8 months after the procedure showed no evidence for local tumor recurrence. However, she subsequently developed myelodysplasia with evolution into leukemia, presumably secondary to chemotherapy, and died 9.5 months after the procedure. CONCLUSION: Combined CT-guided radiofrequency ablation and brachytherapy is a promising new minimally invasive palliative treatment of recurrent Wilms' tumor.

Percutaneous radiofrequency ablation of pulmonary malignancies: combined treatment with brachytherapy.

OBJECTIVE: The purpose of this article is to report the clinical experience and technical feasibility of percutaneous radiofrequency ablation in conjunction with brachytherapy, a novel approach in the treatment of lung neoplasms. Data from three patients with lung malignancies illustrate the expanding therapeutic indications of this minimally invasive intervention. CONCLUSION: Percutaneous radiofrequency ablation in conjunction with brachytherapy is a promising minimally invasive combination modality. It may be a treatment option for patients with primary, recurrent, or metastatic malignancies of the lung that are not amenable to surgery or further external beam radiation therapy.