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Purpose: To assess the temporal and spatial accuracy of the GateCT™ system (VisionRT, London, UK), a recently released respiratory tracking system for 4DCT, under both ideal and nonideal respiratory conditions. Methods: Three experiments were performed by benchmarking and comparing its results with the ground-truth input data and those generated by the widely used Varian RPM™ system (Real-time Position Management, Varian, Palo Alto, CA). The first experiment used 10 sinusoidal breathing patterns (constant amplitude and frequency using sin6ωt), 10 'consistent' patient breathing patterns, and 10 'sporadic' patient breathing patterns. Motion was simulated with the quasar™ Programmable Respiratory Motion Platform (MODUS, London, Canada) as the surrogate. The GateCT™ and RPM™ systems were used to track the breathing patterns. The data from both systems were then analyzed in the Fourier domain, to evaluate temporal/phase accuracy, using the Pearson's correlation coefficient (PCC). The analysis correlated the ground-truth input data against the GateCT™ and RPM™ tracking results, respectively. The second experiment used 10 ideal sinusoidal breathing patterns, five of period 2.0 s, and five of period 5.0 s, with varying abdominal amplitudes found in clinical cases (peak-to-peak range: 1.67-10 mm) to test the sensitivity of the system to reconstruct various range of motion. And, the third experiment used 12 consecutive clinical patients to track the abdominal motion simultaneously by the GateCT™ and RPM™ systems. The baseline of the tracking results from both the two systems was analyzed via the mean-position-estimate (MPE) calculations. All experiments were tracked for at least 120 s. Results: In the first experiment, the average PCC values (±SD) of all thirty breathing patterns were 0.9995 ± 0.00035 and 0.9994 ± 0.00041 for the GateCT™ and the RPM™ system, respectively. These nearly identical results demonstrated similar temporal/phase tracking accuracy for the two systems. The results in the second experiment, however, revealed a pattern for the GateCT™ system in which the uncertainty of its mean-position tracking increased as the amplitude of the breathing pattern decreased. For example, a non-negligible baseline drift of up to 29.3% with respect to the peak-to-peak amplitude of 1.67-mm was observed. On the contrary, the RPM™ system displayed a more consistent recording of amplitudes over time with the greatest drift being <7.7%. The third experiment confirmed these findings in the clinical setting. Consistent decrease in PCC values due to the increase in artificial amplitude drifts, as the breathing amplitude decreased, was found. The lowest PCC value was 0.7239 for a patient with 1.57-mm peak-to-peak amplitude. Conclusions: The GateCT™ system revealed its consistency in temporal/phase tracking but had limitations in accurately tracking the absolute abdominal positions, thus suggesting its appropriateness for phase-sorting of 4DCT rather than amplitude-sorting. In contrast, the RPM™ system demonstrated stable respiratory signal tracking in all ranges and accurately both in phase and amplitude, and is a robust system to use for both phase-sorting and amplitude-sorting techniques. The impact of the observed mean-position drift in the GateCT™ system on the resulting 4DCT image quality, in amplitude-sorting, needs further investigation. [ABSTRACT FROM AUTHOR]

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]

Purpose: All forms of past and current high-dose-rate brachytherapy utilize immobile applicators during treatment delivery. The only moving part is the source itself. This paradigm misses an important degree of freedom that, if explored, can in some instances produce previously unachievable dose conformality; that is, the dynamic motion of the applicator itself during treatment delivery. Monte Carlo and treatment planning simulations were used to illustrate the potential benefits of moving applicators for rectal cancer applications in particular. This concept is termed dynamic modulated brachytherapy (DMBT). Methods: The DMBT system uses a high-density, 18.0 g/cm3, 45 mm long tungsten alloy shield, cylindrical in shape, with a small window on one side to encapsulate a 192Ir source, to create collimation that results in a highly directional beam profile. This shield can be dynamically translated and rotated, using an attached robotic arm, during treatment to create a volumetric modulated arc therapy-type delivery, but from inside the rectal cavity. Monte Carlo simulations and planning optimization algorithms were developed inhouse to evaluate the effectiveness of this new approach using 36 clinical treatment plans comprised of 13 patients each treated using the intracavitary mold applicator (ICMA, Nucletron, The Netherlands) to quantify the potential clinical benefit. The prescription dose was 10 Gy/fx and the group had an average clinical target volume of 9.0 ± 3.5 cm3. Ideal phantom geometries were used to evaluate the impact of various shield dimensions and designs on the resulting plan quality. Results: Simulations of ideal phantom geometries found that shields as small as 10 mm in diameter can produce high quality plans. For the clinical patient cases, compared to the ICMA, for equal prescription tumor coverage, the DMBT plans provided >30% decrease in D5 (high dose volume) resulting in a ∼40% decrease in dose heterogeneity index. In addition, mean dose and D98 showed a reduction (typically 40%-60%) on all critical structures evaluated. However, for a 10 Gy prescribed dose there was an increase in total treatment time on average from 7.6 to 20.8 min for a source with an air-kerma strength of 40.25 kU (10 Ci). Conclusions: Dosimetric properties of a novel DMBT system have been described and evaluated. Comparison with the ICMA commercial applicator has shown it to be a prospective step forward in high-dose-rate brachytherapy 192Ir technology. Dynamic motion of an applicator during treatment, for any applicator and site in general, can provide additional degrees of freedom that, if properly considered, can potentially increase the plan quality significantly. [ABSTRACT FROM AUTHOR]

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]

The clinical use of surface imaging has increased dramatically, with demonstrated utility for initial patient positioning, real‐time motion monitoring, and beam gating in a variety of anatomical sites. The Therapy Physics Subcommittee and the Imaging for Treatment Verification Working Group of the American Association of Physicists in Medicine commissioned Task Group 302 to review the current clinical uses of surface imaging and emerging clinical applications. The specific charge of this task group was to provide technical guidelines for clinical indications of use for general positioning, breast deep‐inspiration breath hold treatment, and frameless stereotactic radiosurgery. Additionally, the task group was charged with providing commissioning and on‐going quality assurance (QA) requirements for surface‐guided radiation therapy (SGRT) as part of a comprehensive QA program including risk assessment. Workflow considerations for other anatomic sites and for computed tomography simulation, including motion management, are also discussed. Finally, developing clinical applications, such as stereotactic body radiotherapy (SBRT) or proton radiotherapy, are presented. The recommendations made in this report, which are summarized at the end of the report, are applicable to all video‐based SGRT systems available at the time of writing. [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]

Incident reporting and learning systems provide an opportunity to identify systemic vulnerabilities that contribute to incidents and potentially degrade quality. The narrative of an incident is intended to provide a clear, easy to understand description of an incident. Unclear, incomplete or poorly organized narratives compromise the ability to learn from them. This report provides guidance for drafting effective narratives, with particular attention to the use of narratives in incident reporting and learning systems (IRLS). Examples are given that compare effective and less than effective narratives. This report is mostly directed to organizations that maintain IRLS, but also may be helpful for individuals who desire to write a useful narrative for entry into such a system. Recommendations include the following: (1) Systems should allow a one- or two-sentence, free-text synopsis of an incident without guessing at causes; (2) Information included should form a sequence of events with chronology; and (3) Reporting and learning systems should consider using the headings suggested to guide the reporter through the narrative: (a) incident occurrences and actions by role; (b) prior circumstances and actions; (c) method by which the incident was identified; (d) equipment related details if relevant; (e) recovery actions by role; (f) relevant time span between responses; (g) and how individuals affected during or immediately after incident. When possible and appropriate, supplementary information including relevant data elements should be included using numerical scales or drop-down choices outside of the narrative. Information that should not be included in the narrative includes: (a) patient health information (PHI); (b) conjecture or blame; (c) jargon abbreviations or details without specifying their significance; (d) causal analysis., (© 2024 American Association of Physicists in Medicine.)

Systems-theoretic process analysis (STPA) is a prospective safety assessment tool increasingly applied in healthcare. A problem hampering STPA proliferation is the difficulty of modeling systems for analysis by creating control structures. In this work, a method is proposed to use existing process maps-commonly available in healthcare-when creating a control structure. The proposed method entails (1) extract information from the process map, (2) determine the modeling boundary of the control structure, (3) transfer the extracted information to the control structure, (4) add additional information to complete the control structure. Two case studies were conducted: (1) ambulance patient offloading in the emergency department and (2) ischemic stroke care with intravenous thrombolysis. The amount of process map-derived information in the control structures was quantified. On average, 68% of the information in the final control structures was derived from the process map. Additional control actions and feedback were added from nonprocess map sources for management and frontline controllers. Despite the differences between process maps and control structures, much of the information in a process map can be used when creating a control structure. The method enables the creation of a control structure from a process map to be done in a structured fashion., (© 2023 Society for Risk Analysis.)

Purpose This study aimed to perform a longitudinal analysis of linear accelerator (linac) technical faults reported with a cloud-based Machine Log system in use in a busy academic clinic and derive operational insights related to linac reliability, clinical utilization, and performance. Methods We queried the Machine Log system for the following parameters: linac type, number of reported technical faults, types of fault, number of faults where the linac was disabled, and estimated clinical downtime. The number of fractions treated and monitor units (MU) delivered were obtained from the record and verify system as metrics of linac utilization and to normalize the number of reported linac faults, facilitating inter-comparison. Two Varian TrueBeam C-arm linacs (Varian Medical Systems, Palo Alto, CA), one Varian 21iX C-arm linac (Varian Medical Systems, Palo Alto, CA), and one newly installed Varian Halcyon ring gantry linac (Varian Medical Systems, Palo Alto, CA) were evaluated. The linacs were studied over a 30-month period from September 2017 to March 2020.  Results Over 30 months, comprising 677 clinical days, 1234 faults were reported from all linacs, including 153 "linac down" events requiring rescheduling or cancellation of treatments. The TrueBeam linacs reported nearly twice as many imaging, multileaf collimator (MLC), and beam generation faults per fraction, and MU as the Halcyon. Halcyon experienced fewer beam generation/steering, accessory, and cooling-related faults than the other linacs but reported more computer and networking issues. Although it employs a relatively new MLC design compared to the C-arm linacs and delivers primarily intensity-modulated treatments, Halcyon reported fewer MLC faults than the other linacs. The 21iX linac had the fewest software-related faults but was subject to the most cooling-related faults, which we attributed to extensive use of this linac for treatment techniques with extended beam-on times. Conclusions A longitudinal analysis of a cloud-based Machine Log system yielded operational insights into the utilization, performance, and technical reliability of the linacs in use at our institution. Several trends in linac sub-system reliability were identified and could be attributed to either age, design, clinical use, or operational demands. The results of this analysis will be used as a basis for designing linac quality assurance schedules that reflect actual linac usage and observed sub-system reliability. Such a practice may contribute to a clinic workflow subject to fewer disruptions from linac faults, ultimately improving efficiency and patient safety., Competing Interests: The authors have declared financial relationships, which are detailed in the next section., (Copyright © 2021, Hoisak et al.)

Purpose: To provide insight into the types of questions asked to medical physicists by patients during one-on-one physicist-patient consults at one institution., Materials and Methods: Medical physicists trained in patient communication techniques met with patients to provide an overview of the treatment planning and delivery processes, discuss the patient's treatment plan, and answer any technical questions. From August 2016 to December 2019, 152 physicist-patient consults were conducted. In the initial months of the study (August 2016-December 2017), following each physicist-patient consult, all patient questions were documented by the physicists. For the remaining time period (January 2018-December 2019), any newly encountered questions were periodically added to the list. The questions were compiled into a comprehensive list and organized into categories., Results: There were a total of 88 unique patient questions. These questions fit into four topical categories. Fifty-four questions (61.4%) were in the "Treatment Planning and Delivery Questions" category, 15 questions (17.1%) were in the "General Radiation Questions or Concerns" category, 13 questions (14.8%) were in the "Safety and Quality Assurance Questions" category, and 6 questions (6.8%) were in the "Medical Questions" category. Overall, patients were primarily concerned about how radiation works, the treatment planning and delivery processes, and what is being done to keep them safe throughout their treatment., Conclusion: Physicist-patient consults provided an opportunity to address the technical aspects of radiation therapy with patients in greater detail. The fact that patient questions could be conveniently grouped into only four topical categories indicates that it may be straightforward for other medical physicists to prepare for effectively addressing technical questions during physicist-patient consults., (© 2020 The Authors. Journal of Applied Clinical Medical Physics published by Wiley Periodicals, Inc. on behalf of American Association of Physicists in Medicine.)

Purpose/objectives: Three-dimensional (3D) printing is recognized as an effective clinical and educational tool in procedurally intensive specialties. However, it has a nascent role in radiation oncology. The goal of this investigation is to clarify the extent to which 3D printing applications are currently being used in radiation oncology through a systematic review of the literature., Materials/methods: A search protocol was defined according to preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines. Included articles were evaluated using parameters of interest including: year and country of publication, experimental design, sample size for clinical studies, radiation oncology topic, reported outcomes, and implementation barriers or safety concerns., Results: One hundred and three publications from 2012 to 2019 met inclusion criteria. The most commonly described 3D printing applications included quality assurance phantoms (26%), brachytherapy applicators (20%), bolus (17%), preclinical animal irradiation (10%), compensators (7%), and immobilization devices (5%). Most studies were preclinical feasibility studies (63%), with few clinical investigations such as case reports or series (13%) or cohort studies (11%). The most common applications evaluated within clinical settings included brachytherapy applicators (44%) and bolus (28%). Sample sizes for clinical investigations were small (median 10, range 1-42). A minority of articles described basic or translational research (11%) and workflow or cost evaluation studies (3%). The number of articles increased over time (P < 0.0001). While outcomes were heterogeneous, most studies reported successful implementation of accurate and cost-effective 3D printing methods., Conclusions: Three-dimensional printing is rapidly growing in radiation oncology and has been implemented effectively in a diverse array of applications. Although the number of 3D printing publications has steadily risen, the majority of current reports are preclinical in nature and the few clinical studies that do exist report on small sample sizes. Further dissemination of ongoing investigations describing the clinical application of developed 3D printing technologies in larger cohorts is warranted., (© 2020 The Authors. Journal of Applied Clinical Medical Physics published by Wiley Periodicals, Inc. on behalf of American Association of Physicists in Medicine.)

Purpose: To assess the performance of routine cone-beam computed tomography (CBCT) quality assurance (QA) at predicting and diagnosing clinically recognizable linac CBCT image quality issues., Methods: Monthly automated linac CBCT image quality QA data were acquired on eight Varian linacs (Varian Medical Systems, Palo Alto, CA) using the CATPHAN 500 series phantom (The Phantom Laboratory, Inc., Greenwich, NY) and Total QA software (Image Owl, Inc., Greenwich, NY) over 34 months between July 2014 and May 2017. For each linac, the following image quality metrics were acquired: geometric distortion, spatial resolution, Hounsfield Unit (HU) constancy, uniformity, and noise. Quality control (QC) limits were determined by American Association of Physicists in Medicine (AAPM) expert consensus documents Task Group (TG-142 and TG-179) and the manufacturer acceptance testing procedure. Clinically recognizable CBCT issues were extracted from the in-house incident learning system (ILS) and service reports. The sensitivity and specificity of CATPHAN QA at predicting clinically recognizable image quality issues was investigated. Sensitivity was defined as the percentage of clinically recognizable CBCT image quality issues that followed a failing CATPHAN QA. Quality assurance results are categorized as failing if one or more image quality metrics are outside the QC limits. The specificity of CATPHAN QA was defined as one minus the fraction of failing CATPHAN QA results that did not have a clinically recognizable CBCT image quality issue in the subsequent month. Receiver operating characteristic (ROC) curves were generated for each image quality metric by plotting the true positive rate (TPR) against the false-positive rate (FPR)., Results: Over the study period, 18 image quality issues were discovered by clinicians while using CBCT to set up the patient and five were reported prior to x-ray tube repair. The incidents ranged from ring artifacts to uniformity problems. The sensitivity of the TG-142/179 limits was 17% (four of the prior monthly QC tests detected a clinically recognizable image quality issue). The area under the curve (AUC) calculated for each image quality metric ROC curve was: 0.85 for uniformity, 0.66 for spatial resolution, 0.51 for geometric distortion, 0.56 for noise, 0.73 for HU constancy, and 0.59 for contrast resolution., Conclusion: Automated monthly QA is not a good predictor of CBCT image quality issues. Of the available metrics, uniformity has the best predictive performance, but still has a high FPR and low sensitivity. The poor performance of CATPHAN QA as a predictor of image quality problems is partially due to its reliance on region-of-interest (ROI) based algorithms and a lack of a global algorithm such as correlation. The manner in which image quality issues occur (trending toward failure or random) is still not known and should be studied further. CBCT image quality QA should be adapted based on how CBCT is used clinically., (© 2019 American Association of Physicists in Medicine.)