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This updated report on stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT) is part of a series of consensus-based white papers previously published addressing patient safety. Since the first white papers were published, SRS and SBRT technology and procedures have progressed significantly such that these procedures are now more commonly used. The complexity and submillimeter accuracy, and delivery of a higher dose per fraction requires an emphasis on best practices for technical, dosimetric, and quality assurance. Therefore, quality and patient safety considerations for these techniques remain an important area of focus. The American Society for Radiation Oncology convened a task force to assess the original SRS/SBRT white paper and update content where appropriate. Recommendations were created using a consensus-building methodology and task force members indicated their level of agreement based on a 5-point Likert scale, from "strongly agree" to "strongly disagree." A prespecified threshold of ≥75% of raters who select "strongly agree" or "agree" indicated consensus. This white paper builds on the previous version and uses of other guidance documents to broadly address SRS and SBRT delivery, primarily focusing on processes related to quality and safety. SRS and SBRT require a team-based approach, staffed by appropriately trained and credentialed specialists as well as significant personnel resources, specialized technology, and implementation time. A thorough feasibility analysis of resources is required to achieve the clinical and technical goals and thoroughly discussed with all personnel before undertaking new disease sites. A comprehensive quality assurance program must be developed, using established treatment guidelines, to ensure SRS and SBRT are performed in a safe and effective manner. Patient safety in SRS/SBRT is everyone's responsibility and professional organizations, regulators, vendors, and end-users must demonstrate a clear commitment to working together to ensure the highest levels of safety. [ABSTRACT FROM AUTHOR]

In recent years, the American Society for Radiation Oncology (ASTRO) has received requests for a standard list of data elements from other societies, database architects, Electronic Health Record vendors and, most recently, the pharmaceutical industry. These requests point to a growing interest in capturing radiation oncology data within registries and for quality measurement, interoperability initiatives, and research. Identifying a short and consistent list will lead to improved care coordination, a reduction in data entry by practice staff, and a more complete view of the holistic approach required for cancer treatment. The task force formulated recommendations based on analysis from radiation specific data elements currently in use in registries, accreditation programs, incident learning systems, and electronic health records. The draft manuscript was peer reviewed by 8 reviewers and ASTRO legal counsel and was revised accordingly and posted on the ASTRO website for public comment in April 2019 for 2 weeks. The final document was approved by the ASTRO Board of Directors in June 2019. [ABSTRACT FROM AUTHOR]

This review will discuss the (perhaps biased) way in which smart oncologists think, biases they can identify, and potential strategies to minimize the impact of bias. It is critical to understand cognitive bias as a significant risk (recognized by the Joint Commission) associated with patient safety, and cognitive bias has been implicated in major radiotherapy incidents. The way in which we think are reviewed, covering both System 1 and system 2 processes of thinking, as well as behavioral economics concepts (prospect theory, expected utility theory). Predisposing factors to cognitive error are explained, with exploration of the groupings of person factors, patient factors, and system factors which can influence the quality of our decision-making. Other factors found to influence decision making are also discussed (rudeness, repeated decision making, hunger, personal attitudes). The review goes on to discuss cognitive bias in the clinic and in workplace interactions (including recruitment), with practical examples provided of each bias. Finally, the review covers strategies to combat cognitive bias, including summarize aloud, crowd wisdom, prospective hindsight, and joint evaluation. More definitive ways to mitigate bias are desirable. [ABSTRACT FROM AUTHOR]

Optical surface imaging is a nonradiographic, noninvasive technology for continuous localization of patients during radiation therapy. Surface-guided radiation therapy (SGRT) has been applied to many treatment sites including breast, intracranial, head and neck, and extremities. SGRT enables a reduction of initial setup variability, provides verification of immobilization continuously during treatment including at noncoplanar linac gantry angles, and provides dynamic surface information for use in gated and breath-hold treatment techniques, all of which can permit reductions in the margins required to account for target localization uncertainty. Ancillary benefits from surface imaging include the ability to use immobilization techniques that confer greater comfort to patients, a reduction in imaging dose through reduced radiographic localization requirements, and improvements to the speed, efficiency, and safety of clinical workflows. This review will describe the objectives of SGRT, review the commercially available surface imaging systems, and provide an overview of SGRT applications by treatment site. Limitations and future applications of surfacing imaging systems are also discussed. [ABSTRACT FROM AUTHOR]

An evolving paradigm in global outreach in radiation oncology has been the implementation of a more region-specific, needs-based approach to help close the gap in radiation services to low- and middle-income countries through the use of innovative tools in information and communication technology. This report highlights 4 information and communication technology tools in action today: (1) the NCCN Framework for Resource Stratification of NCCN guidelines, (2) ASTRO e-Contouring, (3) i.treatsafely.org, and (4) ChartRounds.com. We also render special consideration to matters related to global outreach that we believe require distinct attention to help us meet the goals established by the 2011 United Nations׳ Declaration on noncommunicable diseases: (1) trainee advancement toward careers in global health, (2) ethical challenges of international outreach, (3) critical importance of political advocacy, and (4) collaboration with Industry. [ABSTRACT FROM AUTHOR]

Abstract: This report is part of a series of white papers commissioned for the American Society for Radiation Oncology (ASTRO) Board of Directors as part of ASTRO's Target Safely Campaign, focusing on the role of peer review as an important component of a broad safety/quality assurance (QA) program. Peer review is one of the most effective means for assuring the quality of qualitative, and potentially controversial, patient-specific decisions in radiation oncology. This report summarizes many of the areas throughout radiation therapy that may benefit from the application of peer review. Each radiation oncology facility should evaluate the issues raised and develop improved ways to apply the concept of peer review to its individual process and workflow. This might consist of a daily multidisciplinary (eg, physicians, dosimetrists, physicists, therapists) meeting to review patients being considered for, or undergoing planning for, radiation therapy (eg, intention to treat and target delineation), as well as meetings to review patients already under treatment (eg, adequacy of image guidance). This report is intended to clarify and broaden the understanding of radiation oncology professionals regarding the meaning, roles, benefits, and targets for peer review as a routine quality assurance tool. It is hoped that this work will be a catalyst for further investigation, development, and study of the efficacy of peer review techniques and how these efforts can help improve the safety and quality of our treatments. [Copyright &y& Elsevier]

Abstract: Proton beam therapy (PBT) is a novel method for treating malignant disease with radiotherapy. The purpose of this work was to evaluate the state of the science of PBT and arrive at a recommendation for the use of PBT. The emerging technology committee of the American Society of Radiation Oncology (ASTRO) routinely evaluates new modalities in radiotherapy and assesses the published evidence to determine recommendations for the society as a whole. In 2007, a Proton Task Force was assembled to evaluate the state of the art of PBT. This report reflects evidence collected up to November 2009. Data was reviewed for PBT in central nervous system tumors, gastrointestinal malignancies, lung, head and neck, prostate, and pediatric tumors. Current data do not provide sufficient evidence to recommend PBT in lung cancer, head and neck cancer, GI malignancies, and pediatric non-CNS malignancies. In hepatocellular carcinoma and prostate cancer and there is evidence for the efficacy of PBT but no suggestion that it is superior to photon based approaches. In pediatric CNS malignancies PBT appears superior to photon approaches but more data is needed. In large ocular melanomas and chordomas, we believe that there is evidence for a benefit of PBT over photon approaches. PBT is an important new technology in radiotherapy. Current evidence provides a limited indication for PBT. More robust prospective clinical trials are needed to determine the appropriate clinical setting for PBT. [Copyright &y& Elsevier]

Abstract: Rotational RapidArc (RA) and static intensity-modulated radiosurgery (IMRS) have been used for brain radiosurgery. This study compares the 2 techniques from beam delivery parameters and dosimetry aspects for multiple brain metastases. Twelve patients with 2–12 brain lesions treated with IMRS were replanned using RA. For each patient, an optimal 2-arc RA plan from several trials was chosen for comparison with IMRS. Homogeneity, conformity, and gradient indexes have been calculated. The mean dose to normal brain and maximal dose to other critical organs were evaluated. It was found that monitor unit (MU) reduction by RA is more pronounced for cases with larger number of brain lesions. The MU-ratio of RA and IMRS is reduced from 104% to 39% when lesions increase from 2 to 12. The dose homogeneities are comparable in both techniques and the conformity and gradient indexes and critical organ doses are higher in RA. Treatment time is greatly reduced by RA in intracranial radiosurgery, because RA uses fewer MUs, fewer beams, and fewer couch angles. [Copyright &y& Elsevier]

There has been growing emphasis on quality measures and process analysis techniques that may be implemented in the daily practice of radiation oncology to improve the overall quality of patient care. In this work, quality measures are a form of monitoring that should be actionable and specific to guide process improvement efforts. They are most effective when used to determine the level of execution proficiency against a standard. Control charts are an effective way to separate a change in the process from process noise such that the user can focus on issues that are more likely to improve quality. The field of radiotherapy would benefit from a common dashboard of quality measures for the different processes in radiation oncology clinics, and some suggestions are provided. The dashboard would be used to provide continuous feedback on a clinic''s capability to maintain or exceed standards. [Copyright &y& Elsevier]

Abstract: Purpose: To evaluate the initial clinical experience with a frameless and maskless technique for stereotactic radiosurgery using minimal patient immobilization and real-time patient motion monitoring during treatment. We focus on the evaluation of the patient treatment process. Methods and Materials: The study considered the first 23 patients treated with this technique. Head positioning was achieved with a patient-specific head mold made out of expandable foam that conforms to the patient''s head. The face of the patient is left open for maximal comfort and so that motion of a region of interest consisting of the forehead, nose, eyes, and temporal bones can be monitored during treatment using a video surface imaging system (VisionRT Inc, London, UK). Initial setup of the patient was performed with the surface imaging system using the surface of the patient obtained from the treatment planning computed tomographic (CT) scan. The initial setup was confirmed and finalized with cone-beam CT (CBCT) prior to treatment. The shifts for final setup based on the CBCT and the duration of all the steps in the treatment process were recorded. Patients were monitored during treatment with surface imaging, and a beam hold-off was initiated when the patient''s motion exceeded a prespecified tolerance. Results: The average total setup time including surface imaging and CBCT was 26 minutes, while the portion corresponding to surface imaging was 14 minutes. The average treatment time from when the patient was placed on the treatment table until the last treatment beam was 40 minutes. Eight (35%) patients needed repositioning during the treatment. The average shifts identified from CBCT after initial setup with surface imaging were 1.85 mm in the anterior-posterior direction, and less than 1.0 mm in the lateral and superior-inferior directions. The longest treatment times (including beam hold-offs) happened for patients who fell asleep on the treatment table and were moving involuntarily. Conclusions: The frameless and maskless treatment using minimal immobilization and surface imaging has proven to be reasonably fast for routine clinical use. We observed that patient compliance is important. An additional degree of semi-rigid immobilization would be helpful for patients who fall asleep and involuntarily move during the procedure. [Copyright &y& Elsevier]

Abstract: Background and purpose: In this study, we investigated IMRT QA using Statistical Process Control for the purpose of comparing the processes of patient-specific measurements and the corresponding independent computer calculations. Materials and methods: Point dose data from the treatment planning system (TPS), independent computer calculations, and physical measurements for prostate and head and neck cases were studied. Control charts were used to analyze the IMRT QA processes from several institutions in the academic and community setting. Control charts are a method to describe the performance of a process. The width of the control chart limits (or action limits) describes the process’ ability to meet clinical specifications of ±5%. In all, 24 process comparisons were made (12 measurement QA and 12 independent computer calculation QA). Results: For head and neck IMRT QA, the average process ability for the measurement QA was ±6.9% compared to ±7.2% for the independent computer calculation QA. For prostate IMRT QA, the average process ability was 4.4% for both measurement QA and independent computer calculation QA. It was found that 11 of the 24 processes were in control. At none of the institutions were the processes of measurements and independent computer calculations both in control and performing within clinical specifications. Conclusion: There is room to improve the processes of IMRT QA measurements and independent computer calculations. In situations where the improvement of the processes is such that each is in control and well within clinical specifications, it may be appropriate to suspend patient-specific IMRT QA measurements for every patient in the place of independent computer calculations. [Copyright &y& Elsevier]

Abstract: Kilovoltage imaging systems on linear accelerators are used for patient localization in many clinics. The purpose of this work is to assess on-board imaging (OBI) detection of systematic setup errors and in particular, the dosimetric consequences of undetected head roll in head-and-neck intensity modulated radiation therapy (IMRT) plans when using these systems. The system used in this study was the Trilogy linear accelerator and associated software (Varian Medical Systems, Palo Alto, CA). Accuracy of OBI localization was evaluated using an anthropomorphic head phantom. The head phantom is rigidly attached to a specially designed positioning device with 5° of freedom, 3 translational and 2 rotational in the axial and coronal planes. Simulated setup errors were 3° and 5° rotations in the axial plane and displacements of 5 mm in the left-right, anterior-posterior, and superior-inferior directions. The coordinates set by the positioning device were compared with the coordinates obtained as measured by using the image matching tools of paired 2-dimensional (2D) orthogonal image matching, and 3D cone-beam computed tomography (CT) volume matching. In addition, 6 physician-approved IMRT plans of nasopharynx and tonsil carcinoma were recalculated to evaluate the impact of undetected 3° and 5° head roll. Application of cone-beam CT (CBCT) for patient localization was superior to 2D matching techniques for detecting rotational setup errors. The use of CBCT allowed the determination of translational errors to within 0.5 mm, whereas kV planar was within 1 to 2 mm. Head roll in the axial plane was not easily detected with orthogonal image sets. Compared to the IMRT plans with no head roll, dose-volume histogram analysis demonstrated an average increase in the maximal spinal cord dose of 3.1% and 6.4% for 3° and 5° angles of rotation, respectively. Dose to the contralateral parotid was unchanged with 3° roll and increased by 2.7% with 5° roll. The results of this study show that volumetric setup verification using CBCT can improve bony anatomy setup detection to millimeter accuracy, and is a reliable method to detect head roll. However, the magnitude of possible dose errors due to undetected head roll suggests that CBCT does not need to be performed on a daily basis but rather weekly or bi-weekly to ensure fidelity of the head position with the immobilization system. [Copyright &y& Elsevier]

Purpose: To study the impact on nodal coverage and dose to fixed organs at risk when using daily fiducial localization of the prostate to deliver intensity-modulated radiotherapy (IMRT). Methods and Materials: Five patients with prostate cancer in whom prostate and pelvic nodes were irradiated with IMRT were studied. Dose was prescribed such that 95% of the prostate planning target volume (PTV) and 90% of the nodal PTV were covered. Random and systematic prostate displacements in the anterior–posterior, superior–inferior, and left–right directions were simulated to shift the original isocenter of the IMRT plan. The composite dose during the course of treatment was calculated. Results: Compared with a static setup, simulating random shifts reduced dose by less than 1.5% for nodal hotspot (i.e., dose to 1 cm3), by less than 1% for the 90% nodal PTV coverage, and by less than 0.5% for the nodal mean dose. Bowel and femoral head hotspots were reduced by less than 1.5% and 2%, respectively. A 10-mm systematic offset reduced nodal coverage by up to 10%. Conclusion: The use of prostate fiducials for daily localization during IMRT treatment results in negligible changes in dose coverage of pelvic nodes or normal tissue sparing in the absence of a significant systematic offset. This offers a simple and practical solution to the problem of image-guided radiotherapy for prostate cancer when including pelvic nodes. [Copyright &y& Elsevier]

Abstract: A hypofractionation treatment protocol for prostate cancer was initiated in our department in December 2003. The treatment regimen consists of a total dose of 36.25 Gy delivered at 7.25 Gy per fraction over 10 days. We discuss the rationale for such a prostate hypofractionation protocol and the need for frequent prostate imaging during treatment. The CyberKnife (Accuray Inc., Sunnyvale, CA), a linear accelerator mounted on a robotic arm, is currently being used as the radiation delivery device for this protocol, due to its incorporation of near real-time kV imaging of the prostate via 3 gold fiducial seeds. Recently introduced conventional linac kV imaging with intensity modulated planning and delivery may add a new option for these hypofractionated treatments. The purpose of this work is to investigate the use of intensity modulated radiotherapy (IMRT) and the Varian Trilogy Accelerator with on-board kV imaging (Varian Medical Systems Inc., Palo Alto, CA) for treatment of our hypofractionated prostate patients. The dose-volume histograms and dose statistics of 2 patients previously treated on the CyberKnife were compared to 7-field IMRT plans. A process of acquiring images to observe intrafraction prostate motion was achieved in an average time of about 1 minute and 40 seconds, and IMRT beam delivery takes about 40 seconds per field. A complete 7-field IMRT plan can therefore be imaged and delivered in 10 to 17 minutes. The Varian Trilogy Accelerator with on-board imaging and IMRT is well suited for image-guided hypofractionated prostate treatments. During this study, we have also uncovered opportunities for improvement of the on-board imaging hardware/software implementation that would further enhance performance in this regard. [Copyright &y& Elsevier]

: PurposeThe objectives of this work are: (1) to determine typical dose to the lens during step-and-shoot intensity modulated radiotherapy (IMRT) treatments of the head and neck, and (2) to report on the dose calculation accuracy of a commercial inverse planning system in predicting lens dose.: Methods and materialsThe Corvus inverse treatment planning system (Nomos, Cranberry Township, PA) was used to plan IMRT treatments for patients with head-and-neck cancers in our clinic. Patients were treated on Varian C-series linacs (Varian, Palo Alto, CA) with 4-MV or 6-MV X-rays. A Rando phantom (Alderson Laboratories, Stamford, CT) was specially modified to accommodate 1 × 1 × 1 mm3 thermoluminescent dosimeters at the position of the lens. The IMRT treatment plans were then delivered to the modified Rando phantom. The thermoluminescent dosimeter measurements were converted to dose and taken as an estimate of the lens dose. A total of 20 cases were used in this study (15 cases with 4 MV and 5 cases with 6 MV).: ResultsExpressed as a percentage of the prescription dose, the mean dose to the left and right lens for all 4-MV cases was 9.1% (range, 2.0% to 61.3%). For the 6-MV cases, the mean dose to the left and right lens was 12.8% (range, 3.6% to 41.3%). For both the 4-MV and 6-MV cases, the case of maximum dose occurred when the IMRT treatment target included volumes superior to the level of the lens. The field size and number of monitor units did not correlate with the measured lens dose. The only factor of significance affecting lens dose was the inferior-to-superior distance of the target to the lens. For target–lens distance ≥6 mm, the maximum measured lens doses were 5.9% and 9.0% relative to the prescribed dose for the 4-MV and 6-MV beams, respectively. These data are similar to those observed in conventional head-and-neck treatments. For all cases, the difference between the dose measured and that predicted by Corvus was less than 2% and 4% of the dose prescribed to the gross tumor volume for the 4-MV and 6-MV cases, respectively.: ConclusionIn IMRT, factors such as leaf leakage and number of monitor units play a secondary role and are not more significant than what is observed in conventional head-and-neck treatment when the lens is shielded by the collimator jaws. The target–lens distance is the parameter that affects the lens dose most strongly. For cases where the tumor is at or above the level of the lens, the lens dose can amount to an appreciable fraction of the prescription dose. To keep the lens dose to a minimum, noncoplanar beams that enter or exit into the lens should not be used. [Copyright &y& Elsevier]

Cone beam computed tomography (CBCT)-based online adaptive radiation therapy (ART) is especially beneficial for patients with large interfractional anatomic changes. However, treatment planning and review decisions need to be made at the treatment console in real-time and may be delegated to clinical staff whose conventional scope of practice does not include making such decisions. Therefore, implementation can create new safety risks and inefficiencies. The objective of this work is to systematically analyze the safety and efficiency implications of human decision-making during the treatment session for CBCT-based online ART. The analysis was performed by applying the Systems-Theoretical Process Analysis technique and its extension for human decision-making. Four centers of different CBCT-based online ART practice models comprised the analysis team. The general radiation therapy control structure was refined to model the interactions between routine treatment delivery staff and in-person or remote support staff. The treatment delivery staff perform 6 key control actions. Eighteen undesirable states of those control actions were identified as affecting safety and/or efficiency. In turn, 97 hazardous clinical scenarios were identified, with the control action "prepare and position patient" having the least number of scenarios and "delineate/edit influencer and target structures" having the most. Five of these are specific to either in-person or remote support during the treatment session, and 12 arise from staff support in general. An optimally safe and efficient online ART program should require little to no support staff at the treatment console to reduce staff coordination. Uptraining of the staff already at the treatment console is needed to achieve this goal. Beyond the essential knowledge and skills such as contour editing and the selection of an optimal plan, uptraining should also target the specific cognitive biases identified in this work and the cognitive strategies to overcome these biases. Additionally, technological and organizational changes are necessary. [ABSTRACT FROM AUTHOR]

Abstract: Purpose: To analyze the implementation of a passive radiofrequency identification (RFID) clinical system and to evaluate the clinical workflow on 2 linear accelerators using the RFID technology. Methods and Materials: The clinical area of a typical radiation therapy center was equipped with RFID readers and antennae, which included linear accelerator (linac) treatment vaults. Both were dual energy linacs (6 and 15 MV). One linac was an iX with RapidArc (Varian Medical Systems, Inc, Palo Alto, CA) and the other was a TrueBeam (Varian Medical Systems, Inc, Palo Alto, CA). Patients were given an RFID transponder card on their first day of treatment. Location timestamps were collected when the patients entered and exited the linac vaults. Each fraction was categorized by treatment machine, treatment site (brain, head and neck, prostate, and other), and treatment type (static field intensity modulated radiation therapy [IMRT], RapidArc, and 3-dimensional [3D]). The Mann-Whitney nonparametric test was used to determine statistical significance between median times in the linac vault. Results: A total of 4302 fractions from 144 patients were analyzed over a 10-month period. With minimal staff training, an approximately 70% read reliability was achieved. The median treatment time for all treatment fractions on the TrueBeam linac was 11.0 minutes (n = 1425) while the median time was 11.9 minutes (n = 1576) on the iX linac (P < .0001). Median times for the RapidArc cases was 10.9 minutes (n = 610) and 12.0 minutes (n = 1729) for IMRT cases (P < .0001). Median values for 3D delivery versus modulated delivery (RapidArc and IMRT) were 9.8 minutes (n = 315) and 11.7 minutes (n = 2339), P < .0001. Conclusions: Automatic remote reading of passive transponder cards is not without its challenges. However, with little or no clinical introduction, we experienced a read reliability that warrants further development. Our initial use of the system indicates that continual collection and analysis of workflow data may allow clinics to improve efficiency and safety. [Copyright &y& Elsevier]

The purpose of this work was to highlight the importance of controlling process variability for successful quality assurance (QA). We describe the method of statistical process control for characterizing and controlling a process. Traditionally, QA has been performed by comparing some important measurement (e.g., linear accelerator output) against a corresponding specification. Although useful in determining the fitness of a particular measurement, this approach does not provide information about the underlying process behavior over time. A modern view of QA is to consider the time-ordered behavior of a process. Every process displays characteristic behaviors that are independent of the specifications imposed on it. The goal of modern QA is, not only to ensure that a process is on-target, but that it is also operating with minimal variation. This is accomplished by way of a data-driven approach using process behavior charts. The development of process behavior charts, historically known as control charts, and process behavior (action) limits are described. The effect these concepts have on quality management is also discussed. [Copyright &y& Elsevier]

The CyberKnife is a complex, emerging technology that is a significant departure from current stereotactic radiosurgery and external beam radiotherapy technologies. In its clinical application and quality assurance (QA) approach, the CyberKnife is currently situated somewhere in between stereotactic radiosurgery and radiotherapy. The clinical QA for this image-guided treatment delivery system typically follows the vendor''s guidance, mainly because of the current lack of vendor-independent QA recommendations. The problem has been exacerbated because very little published data are available for QA for the CyberKnife system, especially for QA of the interaction between individual system components. The tools and techniques for QA of the CyberKnife are under development and will continue to improve with longer clinical experience of the users. The technology itself continues to evolve, forcing continuous changes and adaptation of QA. To aid in the process of developing comprehensive guidance on CyberKnife QA, a database of errors based on users reporting incidents and corrective actions would be desirable. The goal of this work was to discuss the status of QA guidelines in the clinical implementation of the CyberKnife system. This investigation was done from the perspective of an active clinical and research site using the CyberKnife. [Copyright &y& Elsevier]

Our purpose was to investigate the effect of physicist-patient consults on patient anxiety and patient satisfaction with a randomized prospective phase III clinical trial. Sixty-six patients were randomly assigned to the physics direct patient care (PDPC) arm or the control arm of the trial. Patients assigned to the PDPC arm received 2 physicist-patient consults to educate them on the technical aspects of their radiation therapy, while patients assigned to the control arm received the standard of care (ie, standard radiation therapy workflow without any additional physicist-patient consults). Questionnaires were administered to all patients at 4 time points (after enrollment, after the simulation, after the first treatment, and after the last treatment) to assess anxiety and satisfaction. The decrease in anxiety for the PDPC arm, compared with the control arm, was statistically significant at the first treatment (P =.027) time point. The increase in technical satisfaction for the PDPC arm, compared with the control arm, was statistically significant at the simulation (P =.005), first treatment (P <.001), and last treatment (P =.002) time points. The increase in overall satisfaction for the PDPC arm, compared with the control arm, was statistically significant at the first treatment (P =.014) and last treatment (P =.001) time points. Physicist-patient consults improved the patient experience by decreasing anxiety and increasing satisfaction. Future work is needed to modify current radiation oncology workflows and medical physics responsibilities to allow all patients to benefit from this advancement in patient care. [ABSTRACT FROM AUTHOR]

Abstract: The concept of peer review for radiation therapists and medical dosimetrists has been studied very little in radiation oncology practice. The purpose of this manuscript is to analyze the concept of peer review in the clinical setting for both radiation therapists and medical dosimetrists. The literature reviewed both the percentages and causes of radiation therapy deviations. The results indicate that peer review can be both implemented and evaluated into both the radiation therapist and medical dosimetrist clinical practice patterns. [Copyright &y& Elsevier]

Purpose: To evaluate the efficacy of a training program designed to teach medical physicists how to communicate with patients effectively in the clinical environment.Methods and Materials: The training program was offered 3 times between 2016 and 2019. Participants were asked to rank their level of confidence in 5 categories relevant to patient communication on a 5-point Likert scale at 3 separate time points over the course of the training program. Participants were also asked to provide written responses to 5 common questions from patients at 2 separate time points, and these responses were numerically scored using the Constant Comparative Method. Competency in patient communication was assessed during simulated patient consults using a 9-element clinical competency assessment form. Changes in participants' stated level of confidence over the course of the training program and differences between faculty and residents were analyzed using the Student t test, and participants' scored responses to common questions were analyzed using analysis of variance.Results: Fifteen medical physicists participated in the training program: 6 resident physicists (4 first year and 2 second year) and 9 faculty physicists. Mean participant-stated level of confidence increased significantly across all categories (P < .05) between the first and second training intervention and between the second and third training intervention. There was no significant difference in mean participant-stated level of confidence between faculty and resident medical physicists. We observed statistically significant improvements in scored responses to common patient questions between the 2 assessment time points (P < .05). Of the 15 participants, 14 met competency assessment goals during simulated patient consults.Conclusions: The patient communication skills training program increases medical physicists' level of confidence across 5 patient communication categories and improves their responses to common questions from patients. In addition, the program can discern differences in communication competency between physicists. [ABSTRACT FROM AUTHOR]

While peer review is critical for quality and safety in radiotherapy, there are neither formal guidelines nor format examples for brachytherapy (BT) peer review. We report on a gynecologic BT peer-review method implemented at a high-volume academic center. We analyzed discussions at bimonthly gynecologic BT peer-review rounds between July and December 2018. Rounds consisted of 2–5 attending physicians with gynecologic BT expertise, 1–2 BT physicists, and trainees. Peer-review targets included clinical case review, contours, implant technique, dose/fractionation, and target/organ-at-risk (OAR) dosimetry. The projected/final target and OAR dosimetry were analyzed. 55 separate implants from 44 patients were reviewed. Implants were mostly reviewed after the first BT fraction (n = 16, 29%) or at another time point during BT (n = 20, 36%). One (2%) implant was presented prospectively. The applicator type and BT technique were reviewed for all implants. Dose/fractionation was evaluated for 46 implants (84%); contours were discussed for 21 (38%). Target and OAR dosimetry were reviewed for 54 (98%) and 28 implants (51%), respectively. Six cases (11%) underwent minor changes to the applicator type to improve target and/or OAR dosimetry. One case (2%) had a major change recommended to the dose/fractionation. Gynecologic BT peer review may enhance BT quality by allowing for implant optimization and formal review of challenging cases, ultimately improving medical decision-making and team communication. Peer review should be implemented in centers offering gynecologic BT. [ABSTRACT FROM AUTHOR]

Purpose: To investigate a new clinical role for medical physicists in direct patient care with a prospective phase 2 clinical trial.Materials and Methods: Medical physicists participated in the Physics Direct Patient Care (PDPC) protocol, establishing independent professional relationships with radiation oncology patients. After attending a dedicated patient communication training program, medical physicists routinely met with patients for 2 physicist-patient consults to explain the treatment planning and delivery process, review the patient's treatment plan, and answer all technical questions. The first physicist-patient consult took place immediately before the computed tomography simulation, and the second took place immediately before the first treatment. Questionnaires were administered to each patient on the PDPC protocol at 3 time points to assess both anxiety and satisfaction. The first questionnaire was given shortly after the first physicist-patient consult, the second questionnaire was given shortly after the second physicist-patient consult, and the third questionnaire was given after the last treatment appointment, with no associated physicist-patient consult.Results: The mean patient anxiety score was considered to be low at all questionnaire time points. There was a statistically significant decrease (P < .0001) in anxiety from the simulation time point to the first treatment time point. The mean patient technical satisfaction score was considered to be high at all measurement time points. There was a statistically significant increase (P = .0012) in technical satisfaction from the simulation time point to the first treatment time point. There was a statistically significant decrease (P < .023) in technical satisfaction from the first treatment time point to the last treatment time point.Conclusions: Establishing a new clinical role for medical physicists and investigating its effects on patient anxiety and satisfaction have created the foundation for future studies. Based on the results of this trial, the PDPC protocol will be expanded to a larger group of medical physicists, radiation oncologists, and patient disease sites and investigated with a randomized phase 3 clinical trial. [ABSTRACT FROM AUTHOR]

Purpose: To analyze all recalls involving radiation oncology devices (RODs) from the US Food and Drug Administration (FDA)'s recall database, comparing these with non-radiation oncology device recalls to identify discipline-specific trends that may inform improvements in device safety.Methods and Materials: Recall data on RODs from 2002 to 2015 were sorted into 4 product categories (external beam, brachytherapy, planning systems, and simulation systems). Outcomes included determined cause of recall, recall class (severity), quantity in commerce, time until recall termination (date FDA determines recall is complete), and time since 510(k) approval. Descriptive statistics were performed with linear regression of time-series data. Results for RODs were compared with those for other devices by Pearson χ2 test for categorical data and 2-sample Kolmogorov-Smirnov test for distributions.Results: There were 502 ROD recalls and 9534 other class II device recalls during 2002 to 2015. Most recalls were for external beam devices (66.7%) and planning systems (22.9%), and recall events peaked in 2011. Radiation oncology devices differed significantly from other devices in all recall outcomes (P≤.04). Recall cause was commonly software related (49% vs 10% for other devices). Recall severity was more often moderate among RODs (97.6% vs 87.2%) instead of severe (0.2% vs 4.4%; P<.001). Time from 510(k) market approval to recall was shorter among RODs (P<.001) and progressively shortened over time. Radiation oncology devices had fewer recalled devices in commerce than other devices (P<.001).Conclusions: Compared with other class II devices, RODs experience recalls sooner after market approval and are trending sooner still. Most of these recalls were moderate in severity, and software issues are prevalent. Comprehensive analysis of recall data can identify areas for device improvement, such as better system design among RODs. [ABSTRACT FROM AUTHOR]

Purpose: Radiation oncology relies on rapidly evolving technology and highly complex processes. The US Food and Drug Administration collects reports of adverse events related to medical devices. We sought to characterize all events involving radiation oncology devices (RODs) from the US Food and Drug Administration's postmarket surveillance Manufacturer and User Facility Device Experience (MAUDE) database, comparing these with non-radiation oncology devices.Methods and Materials: MAUDE data on RODs from 1991 to 2015 were sorted into 4 product categories (external beam, brachytherapy, planning systems, and simulation systems) and 5 device problem categories (software, mechanical, electrical, user error, and dose delivery impact). Outcomes included whether the device was evaluated by the manufacturer, adverse event type, remedial action, problem code, device age, and time since 510(k) approval. Descriptive statistics were performed with linear regression of time-series data. Results for RODs were compared with those for other devices by the Pearson χ2 test for categorical data and 2-sample Kolmogorov-Smirnov test for distributions.Results: There were 4234 ROD and 4,985,698 other device adverse event reports. Adverse event reports increased over time, and events involving RODs peaked in 2011. Most ROD reports involved external beam therapy (50.8%), followed by brachytherapy (24.9%) and treatment planning systems (21.6%). The top problem types were software (30.4%), mechanical (20.9%), and user error (20.4%). RODs differed significantly from other devices in each outcome (P<.001). RODs were more likely to be evaluated by the manufacturer after an event (46.9% vs 33.0%) but less likely to be recalled (10.5% vs 37.9%) (P<.001). Device age and time since 510(k) approval were shorter among RODs (P<.001).Conclusions: Compared with other devices, RODs may experience adverse events sooner after manufacture and market approval. Close postmarket surveillance, improved software design, and manufacturer-user training may help mitigate these events. [ABSTRACT FROM AUTHOR]

Purpose: The radiobiology of prostate cancer favors a hypofractionated dose regimen. We report results of a prospective Phase II clinical trial of stereotactic body radiotherapy (SBRT) for localized prostate cancer. Methods and Materials: Forty-one low-risk prostate cancer patients with 6 months'' minimum follow-up received 36.25 Gy in five fractions of 7.25 Gy with image-guided SBRT alone using the CyberKnife. The early (<3 months) and late (>6 months) urinary and rectal toxicities were assessed using validated quality of life questionnaires (International Prostate Symptom Score, Expanded Prostate Cancer Index Composite) and the Radiation Therapy Oncology Group (RTOG) toxicity criteria. Patterns of prostate-specific antigen (PSA) response are analyzed. Results: The median follow-up was 33 months. There were no RTOG Grade 4 acute or late rectal/urinary complications. There were 2 patients with RTOG Grade 3 late urinary toxicity and none with RTOG Grade 3 rectal complications. A reduced rate of severe rectal toxicities was observed with every-other-day vs. 5 consecutive days treatment regimen (0% vs. 38%, p = 0.0035). A benign PSA bounce (median, 0.4 ng/mL) was observed in 12 patients (29%) occurring at 18 months (median) after treatment. At last follow-up, no patient has had a PSA failure regardless of biochemical failure definition. Of 32 patients with 12 months minimum follow-up, 25 patients (78%) achieved a PSA nadir ≤0.4 ng/mL. A PSA decline to progressively lower nadirs up to 3 years after treatment was observed. Conclusions: The early and late toxicity profile and PSA response for prostate SBRT are highly encouraging. Continued accrual and follow-up will be necessary to confirm durable biochemical control rates and low toxicity profiles. [Copyright &y& Elsevier]

Abstract: Purpose: To present the clinical implementation of a new HDR device for partial breast irradiation, the Strut-Adjusted Volume Implant (SAVI), at the University of California, San Diego. Methods and materials: The SAVI device has multiple peripheral struts that can be differentially loaded with the HDR source. Planning criteria used for evaluation of the treatment plans included the following dose volume histogram (DVH) criteria: V90 >90%, V150 <50cc and V200 <20cc. Results: SAVI has been used on 20 patients to date at UC San Diego. In each case, the dose was modulated according to patient-specific anatomy to cover the tumor bed, while sparing normal tissues. The dosimetric data show that we can achieve greater than 90% coverage with respect to V90 (median of 95.3%) and also keep a low V150 and V200 dose at 24.5 and 11.2cc, respectively. Complete treatment can be done within a 30-min time slot, which includes implant verification, setup, and irradiation time as well as wound dressing. Conclusion: SAVI has been implemented at UC San Diego for accelerated partial breast irradiation with excellent tumor bed conformance and minimal normal tissue exposure. Patient positioning is the key to identifying any inter-fraction device motion. Device asymmetry or tissue conformance has been shown to resolve itself 24h after the device implantation. The device can be implemented into an existing HDR program with minimal effort. [Copyright &y& Elsevier]

Abstract: Objectives: To report our experience using Image-Guided Radiation Therapy (IGRT) in patients undergoing post-prostatectomy irradiation. Methods: Twenty-six patients were treated with radiotherapy following radical prostatectomy using Intensity Modulated Radiation Therapy (IMRT). Prostate bed localization was done using image guidance to align surgical clips relative to the reference isocenter on the planning digitally reconstructed radiographs. Assuming surgical clips to be surrogate for prostate bed, daily shifts in their position were calculated after aligning with the bony anatomy. Shifts were recorded in three dimensions. The acute toxicity was measured during and after completion of treatment. Results: The average (standard deviation) prostate bed motion in anterior–posterior, superior–inferior and left–right directions were: 2.7mm (2.1), 2.4mm (2.1) and 1.0mm (1.7), respectively. The majority of patients experienced only grade 1 symptoms, two patients had grade 2 symptoms and none had grade 3 or higher acute toxicity. Conclusions: Daily IGRT is recommended for accurate target localization during radiation delivery to improve efficacy of treatment and enhance therapeutic ratio. Larger studies with longer follow-up are necessary to make definitive recommendations regarding magnitude of margin reduction around clinical target volume. [Copyright &y& Elsevier]

Purpose: To evaluate indirect magnetic resonance lymphangiography (MR-LAG) using interstitial injection of conventional gadolinium contrast (gadoteridol and gadopentetate dimeglumine) for delineating the primary lymphatic drainage of head-and-neck sites. Methods and Materials: We performed head-and-neck MR-LAG in 5 healthy volunteers, with injection of dermal and mucosal sites. We evaluated the safety of the procedure, the patterns of enhancement categorized by injection site and nodal level, the time course of enhancement, the optimal concentration and volume of contrast, and the optimal imaging sequence. Results: The worst side effects of interstitial contrast injection were brief, mild pain and swelling at the injected sites that were self-limited. MR-LAG resulted in consistent visualization of the primary lymphatic drainage pattern specific to each injected site, which was reproducible on repeated examinations. The best enhancement was obtained with injection of small volumes (0.3-0.5 mL) of either agent diluted, imaging within 5-15 min of injection, and a three-dimensional fast spoiled gradient echo sequence with magnetization transfer. Conclusions: We found head-and-neck MR-LAG to be a safe, convenient imaging method that provides functional information about the lymphatic drainage of injected sites. Applied to head-and-neck cancer, it has the potential to identify sites at highest risk of occult metastatic spread for radiotherapy or surgical planning, and possibly to visualize micrometastases. [ABSTRACT FROM AUTHOR]