A statistical approach to IMRT patient-specific QA.

PURPOSE: The intensity modulated radiation therapy (IMRT) patient-specific quality assurance (QA) (referred to as QA in this paper for simplicity) process is a time and resource intensive effort in every clinic. The use of a global QA tolerance criterion for all treatment sites may be too tight for some complex sites increasing false negatives and rejections of QA measurements which typically results in wasted efforts, treatment delays, and decreased efficiency. At the same time, other sites requiring a less complex plan might have a high false positive leading to approvals of QA measurements that actually need to be rejected. This work is an effort to adopt statistical tools to1. develop a tool to identify statistical variations in the process, monitor trends, detect outliers, and proactively identify drifts in the overall QA results;2. analyze the results of the QA process, identify similarities and differences between treatment plans of different treatment sites, and evaluate the possibility of site-specific tolerance levels for QA approval tolerances. METHODS: The analysis was performed for QA measurements made using two ion chamber points. A custom software tool was developed for data processing and analysis. This tool facilitated QA data collection, retrieval, visualization, real-time feedback, and advanced statistical analysis of the data. Statistical techniques based on analysis of variance were used to evaluate the need for site-specific tolerances and statistical process control was used to study statistical variations in the process. RESULTS: A retrospective analysis of the QA process variability was performed in order to identify site-specific tolerances for the QA measurements and to reduce false positive and false negative QA results. From the data, it can be seen that the treatment sites are significantly different and need site-specific tolerance levels for QA approval. The in-house developed tool was used to further monitor the QA process using individual (I), standard deviations (S), and exponentially weighted moving averages charts for process variability studies. CONCLUSIONS: The authors have studied the analysis of variance on ion chamber measurements made for IMRT treatment plans on different sites, identified similarities and differences between different sites, and thereby evaluated the need for site-specific tolerances for QA acceptance policy. The authors have proposed a way to calculate the appropriate tolerances for different treatment sites and illustrated the clinical usage. Variability at each step of the process increases the uncertainty in the process. The authors have explained the different approaches taken to reduce the variability at each step of the entire process. This process can be used for the benefit during∕as part of an IMRT commissioning process in any clinic. The authors have also developed a tool to automate the process of data collection, analysis, and monitoring the process quality via standard deviations and EWMA charts.

Technical note: electronic chart checks in a paperless radiation therapy clinic.

PURPOSE: EcCk, which stands for Electronic Chart ChecK, is a computer software and database system. It was developed to improve quality and efficiency of patient chart checking in radiation oncology departments. The core concept is to automatically collect and analyze patient treatment data, and to report discrepancies and potential concerns. METHODS: EcCk consists of several different computer technologies, including relational database, DICOM, dynamic HTML, and image processing. Implemented in MATLAB and C#, EcCk processes patient data in DICOM, PDF, Microsoft Word, database, and Pinnacle native formats. Generated reports are stored on the storage server and indexed in the database. A standalone report-browser program is implemented to allow users to view reports on any computer in the department. Checks are performed according to predefined logical rules, and results are presented through color-coded reports in which discrepancies are summarized and highlighted. Users examine the reports and take appropriate actions. The core design is intended to automate human task and to improve the reliability of the performed tasks. The software is not intended to replace human audits but rather to aid as a decision support tool. RESULTS: The software was successfully implemented in the clinical environment and has demonstrated the feasibility of automation of this common task with modern clinical tools. The software integrates multiple disconnected systems and successfully supports analysis of data in diverse formats. CONCLUSIONS: While the human is the ultimate expert, EcCk has a significant potential to improve quality and efficiency of patient treatment record audits, and to allow verification of tasks that are not easily performed by humans. EcCk can potentially relieve human experts from simple and repetitive tasks, and allow them to work on other important tasks, and in the end to improve the quality and safety of radiation therapy treatments.

VA-Radiation Oncology Quality Surveillance Program.

PURPOSE: We sought to develop a quality surveillance program for approximately 15,000 US veterans treated at the 40 radiation oncology facilities at the Veterans Affairs (VA) hospitals each year. METHODS AND MATERIALS: State-of-the-art technologies were used with the goal to improve clinical outcomes while providing the best possible care to veterans. To measure quality of care and service rendered to veterans, the Veterans Health Administration established the VA Radiation Oncology Quality Surveillance program. The program carries forward the American College of Radiology Quality Research in Radiation Oncology project methodology of assessing the wide variation in practice pattern and quality of care in radiation therapy by developing clinical quality measures (QM) used as quality indices. These QM data provide feedback to physicians by identifying areas for improvement in the process of care and identifying the adoption of evidence-based recommendations for radiation therapy. RESULTS: Disease-site expert panels organized by the American Society for Radiation Oncology (ASTRO) defined quality measures and established scoring criteria for prostate cancer (intermediate and high risk), non-small cell lung cancer (IIIA/B stage), and small cell lung cancer (limited stage) case presentations. Data elements for 1567 patients from the 40 VA radiation oncology practices were abstracted from the electronic medical records and treatment management and planning systems. Overall, the 1567 assessed cases passed 82.4% of all QM. Pass rates for QM for the 773 lung and 794 prostate cases were 78.0% and 87.2%, respectively. Marked variations, however, were noted in the pass rates for QM when tumor site, clinical pathway, or performing centers were separately examined. CONCLUSIONS: The peer-review protected VA-Radiation Oncology Surveillance program based on clinical quality measures allows providers to compare their clinical practice to peers and to make meaningful adjustments in their personal patterns of care unobtrusively.

Calibration procedures for seeds preloaded in cartridges.

Radioactive seeds preloaded in sterilized cartridges or needles are commonly obtainable from manufacturers. Under the US regulations for control of radioactive materials, seed users are required to account for all seeds and independently verify their air kerma strength (SK). As a result, the viability of inspection schemes that rely on measurement of aggregate seeds is of interest. In this paper we consider the conditions (if any) under which cartridge inspection can satisfy regulatory requirements and still provide practical benefit (i.e., time savings) against the regular single-seed assay. The standards for comparison are the recommendations of AAPM TG40, AAPM TG56, and ACR's "Standard for the Performance of Manually Loaded Brachytherapy Sources." The practical benefit is judged in comparison to the effort required to apply the 10% assay recommendation of TG40 to seeds in cartridges. Two specific cartridge inspection schemes are considered: (a) measuring the SK of each cartridge in a batch; (b) measuring a single cartridge sampled at random from the batch. Unlike the 10% assay, which is defined (imperfectly, in our view) without reference to the prevalence of in-calibration seeds, the estimation of the relative merits of cartridge inspection methods must necessarily include such information and, as such, is manufacturer specific. In this paper results are provided for Oncura model 6711 125I seeds in shielded and unshielded Mick cartridges. We show that the only practically useful cartridge inspection scheme is the batch scheme applied to unshielded cartridges. The false positive rates associated with the other schemes are such that we expect to open a cartridge (and perform the 10% assay) at least 80% of the time. While anything less than 100% of the time is theoretically an improvement, this neglects the additional effort required to assay the cartridges.

Eliminating inconsistencies in simulation and treatment planning orders in radiation therapy.

PURPOSE: To identify deficiencies with simulation and treatment planning orders and to develop corrective measures to improve safety and quality. METHODS AND MATERIALS: At Washington University, the DMAIIC formalism is used for process management, whereby the process is understood as comprising Define, Measure, Analyze, Improve, Implement, and Control activities. Two complementary tools were used to provide quantitative assessments: failure modes and effects analysis and reported event data. The events were classified by the user according to severity. The event rates (ie, number of events divided by the number of opportunities to generate an event) related to simulation and treatment plan orders were determined. RESULTS: We analyzed event data from the period 2008-2009 to design an intelligent SIMulation and treatment PLanning Electronic (SIMPLE) order system. Before implementation of SIMPLE, event rates of 0.16 (420 of 2558) for a group of physicians that were subsequently used as a pilot group and 0.13 (787 of 6023) for all physicians were obtained. An interdisciplinary group evaluated and decided to replace the Microsoft Word-based form with a Web-based order system. This order system has mandatory fields and context-sensitive logic, an ability to create templates, and enables an automated process for communication of orders through an enterprise management system. After the implementation of the SIMPLE order, the event rate decreased to 0.09 (96 of 1001) for the pilot group and to 0.06 (145 of 2140) for all physicians (P<.0001). The average time to complete the SIMPLE form was 3 minutes, as compared with 7 minutes for the Word-based form. The number of severe events decreased from 10.7% (45 of 420) and 12.1% (96 of 787) to 6.2% (6 of 96) and 10.3% (15 of 145) for the pilot group and all physicians, respectively. CONCLUSIONS: There was a dramatic reduction in the total and the number of potentially severe events through use of the SIMPLE system. In addition, the order process has become more efficient and reliable.

Regarding the focal treatment of prostate cancer: inference of the Gleason grade from magnetic resonance spectroscopic imaging.

PURPOSE: To quantify, as a function of average magnetic resonance spectroscopy (MRS) score and tumor volume, the probability that a cancer-suspected lesion has an elevated Gleason grade. METHODS AND MATERIALS: The data consist of MRS imaging ratios R stratified by patient, lesion (contiguous abnormal voxels), voxels, biopsy and pathologic Gleason grade, and lesion volume. The data were analyzed using a logistic model. RESULTS: For both low and high Gleason score biopsy lesions, the probability of pathologic Gleason score >/=4+3 increases with lesion volume. At low values of R a lesion volume of at least 15-20 voxels is needed to reach a probability of success of 80%; the biopsy result helps reduce the prediction uncertainty. At larger MRS ratios (R > 6) the biopsy result becomes essentially uninformative once the lesion volume is >12 voxels. With the exception of low values of R, for lesions with low Gleason score at biopsy, the MRS ratios serve primarily as a selection tool for assessing lesion volumes. CONCLUSIONS: In patients with biopsy Gleason score >/=4+3, high MRS imaging tumor volume and (creatine + choline)/citrate ratio may justify the initiation of voxel-specific dose escalation. This is an example of biologically motivated focal treatment for which intensity-modulated radiotherapy and especially brachytherapy are ideally suited.