Quality Assurance of Dose-Escalated Radiation Therapy in a Randomized Trial for Locally Advanced Oesophageal cancer.

PURPOSE: The ongoing phase 2/3 PRODIGE 26/CONCORDE trial compares chemoradiation therapy with and without dose escalation in patients with locally advanced or unresectable esophageal cancer. The results of a benchmark case procedure are reported here to evaluate the protocol compliance of participating centers as part of quality assurance for radiation therapy. METHODS AND MATERIALS: Volume delineation, target coverage, and dose constraints to the organs at risk (OARs) were assessed on treatment plans of a common benchmark case performed by each participating center. The centers were classified in 3 categories: per protocol, minor acceptable deviation (MiD), or major unacceptable deviation (MaD). A plan was rejected if ≥4 MiDs or 1 MaD were found. RESULTS: Thirty-5 centers submitted 43 plans. Among them, 14 (32.6%) were per protocol, 19 (44.2%) presented at least 1 MiD, 2 (4.6%) presented at least 1 MaD, and 8 (18.6%) presented both MiD and MaD. Overall, 11 (25.6%) plans were rejected. Only 1 plan was rejected because gross tumor volume was not correctly delineated. The OAR delineation was respected in all cases. Dose constraints to the OARs were respected in the majority of cases except for the heart, where one-third of the plans presented a deviation. As for the target volume, 3 plans (5.8%) had a major underdosage and 1 plan (1.9%) had a major overdosage. Overall, 58% of all treatments were planned with intensity modulated radiation therapy, whereas 42% were planned with 3-dimensional chemoradiation therapy. Significantly more plans in the intensity modulated radiation therapy group were accepted compared with the 3-dimensional chemoradiation therapy group (P = .03). CONCLUSION: The high frequency of protocol deviations underlines the importance of a quality assurance program in clinical trials. Further work should assess the impact of quality assurance for radiation therapy on patient outcomes.

Systematic Review of Synthetic Computed Tomography Generation Methodologies for Use in Magnetic Resonance Imaging-Only Radiation Therapy.

Magnetic resonance imaging (MRI) offers superior soft-tissue contrast as compared with computed tomography (CT), which is conventionally used for radiation therapy treatment planning (RTP) and patient positioning verification, resulting in improved target definition. The 2 modalities are co-registered for RTP; however, this introduces a systematic error. Implementing an MRI-only radiation therapy workflow would be advantageous because this error would be eliminated, the patient pathway simplified, and patient dose reduced. Unlike CT, in MRI there is no direct relationship between signal intensity and electron density; however, various methodologies for MRI-only RTP have been reported. A systematic review of these methods was undertaken. The PRISMA guidelines were followed. Embase and Medline databases were searched (1996 to March, 2017) for studies that generated synthetic CT scans (sCT)s for MRI-only radiation therapy. Sixty-one articles met the inclusion criteria. This review showed that MRI-only RTP techniques could be grouped into 3 categories: (1) bulk density override; (2) atlas-based; and (3) voxel-based techniques, which all produce an sCT scan from MR images. Bulk density override techniques either used a single homogeneous or multiple tissue override. The former produced large dosimetric errors (>2%) in some cases and the latter frequently required manual bone contouring. Atlas-based techniques used both single and multiple atlases and included methods incorporating pattern recognition techniques. Clinically acceptable sCTs were reported, but atypical anatomy led to erroneous results in some cases. Voxel-based techniques included methods using routine and specialized MRI sequences, namely ultra-short echo time imaging. High-quality sCTs were produced; however, use of multiple sequences led to long scanning times increasing the chances of patient movement. Using nonroutine sequences would currently be problematic in most radiation therapy centers. Atlas-based and voxel-based techniques were found to be the most clinically useful methods, with some studies reporting dosimetric differences of <1% between planning on the sCT and CT and <1-mm deviations when using sCTs for positional verification.

Quality assurance of radiotherapy in the ongoing EORTC 22042-26042 trial for atypical and malignant meningioma: results from the dummy runs and prospective individual case Reviews.

BACKGROUND: The ongoing EORTC 22042-26042 trial evaluates the efficacy of high-dose radiotherapy (RT) in atypical/malignant meningioma. The results of the Dummy Run (DR) and prospective Individual Case Review (ICR) were analyzed in this Quality Assurance (QA) study. MATERIAL/METHODS: Institutions were requested to submit a protocol compliant treatment plan for the DR and ICR, respectively. DR-plans (n=12) and ICR-plans (n=50) were uploaded to the Image-Guided Therapy QA Center of Advanced Technology Consortium server (http://atc.wustl.edu/) and were assessed prospectively. RESULTS: Major deviations were observed in 25% (n=3) of DR-plans while no minor deviations were observed. Major and minor deviations were observed in 22% (n=11) and 10% (n=5) of the ICR-plans, respectively. Eighteen% of ICRs could not be analyzed prospectively, as a result of corrupted or late data submission. CTV to PTV margins were respected in all cases. Deviations were negatively associated with the number of submitted cases per institution (p=0.0013), with a cutoff of 5 patients per institutions. No association (p=0.12) was observed between DR and ICR results, suggesting that DR's results did not predict for an improved QA process in accrued brain tumor patients. CONCLUSIONS: A substantial number of protocol deviations were observed in this prospective QA study. The number of cases accrued per institution was a significant determinant for protocol deviation. These data suggest that successful DR is not a guarantee for protocol compliance for accrued patients. Prospective ICRs should be performed to prevent protocol deviations.

Impact of quality assurance rounds in a Canadian radiation therapy department.

PURPOSE: Quality assurance (QA) programs aim to identify inconsistencies that may compromise patient care. Radiation treatment planning is a well-documented source of variation in radiation oncology, leading many organizations to recommend the implementation of QA rounds in which radiation therapy plans are peer reviewed. This study evaluates the outcome of QA rounds that have been conducted by a radiation therapy department since 2004. METHODS AND MATERIALS: Prospectively documented records of QA rounds, from 2004 to 2010, were obtained. During rounds, randomly selected radiation therapy plans were peer reviewed and assigned a grade of A (adequate), B (minor suggestions of change to a plan for a future patient), or C (significant change required before the next fraction). The proportion of plans that received each recommendation was calculated, and the relationship between recommendations for each plan, tumor site, and mean years of experience of the radiation oncologist (RO) were explored. Chart reviews were performed for each plan that received a C. RESULTS: During the study period, 1247 plans were evaluated; 6% received a B and 1% received a C. The mean RO years of experience were lower for plans graded C versus those graded A (P=.02). The tumor sites with the highest proportion of plans graded B or C were gastrointestinal (14%), lung (13%), and lymphoma (8%). The most common reasons for plans to receive a grade of C were inadequate target volume coverage (36%), suboptimal dose or fractionation (27%), errors in patient setup (27%), and overtreatment of normal tissue (9%). CONCLUSIONS: This study demonstrated that QA rounds are feasible and an important element of a radiation therapy department's QA program. Through peer review, plans that deviate from a department's expected standard can be identified and corrected. Additional benefits include identifying patterns of practice that may contribute to inconsistencies in treatment planning and the continuing education of staff members who attend.

To code, or not to code?

In summary, it is also important to remember the hidden rules: 1) Just because there is a code in the manual, it doesn't mean it can be billed to insurance, or that once billed, it will be reimbursed. 2) Just because a code was paid once, doesn't mean it will ever be paid again--or that you get to keep the money! 3) The healthcare provider is responsible for knowing all the rules, but then it is impossible to know all the rules! And not knowing all the rules can lead to fines, penalties or worse! New codes are added annually (quarterly for OPPS), definitions of existing codes are changed, and it is the responsibility of healthcare providers to keep abreast of all coding updates and changes. In addition, the federal regulations are constantly updated and changed, making compliant billing a moving target. All healthcare entities should focus on complete documentation, the adherence to authoritative coding guidance and the provision of detailed explanations and specialty education to the payor, as necessary.