Monitoring Variations in the Use of Automated Contouring Software.

PURPOSE: Our purpose was to identify variations in the clinical use of automatically generated contours that could be attributed to software error, off-label use, or automation bias. METHODS AND MATERIALS: For 500 head and neck patients who were contoured by an in-house automated contouring system, Dice similarity coefficient and added path length were calculated between the contours generated by the automated system and the final contours after editing for clinical use. Statistical process control was used and control charts were generated with control limits at 3 standard deviations. Contours that exceeded the thresholds were investigated to determine the cause. Moving mean control plots were then generated to identify dosimetrists who were editing less over time, which could be indicative of automation bias. RESULTS: Major contouring edits were flagged for: 1.0% brain, 3.1% brain stem, 3.5% left cochlea, 2.9% right cochlea, 4.8% esophagus, 4.1% left eye, 4.0% right eye, 2.2% left lens, 4.9% right lens, 2.5% mandible, 11% left optic nerve, 6.1% right optic nerve, 3.8% left parotid, 5.9% right parotid, and 3.0% of spinal cord contours. Identified causes of editing included unexpected patient positioning, deviation from standard clinical practice, and disagreement between dosimetrist preference and automated contouring style. A statistically significant (P < .05) difference was identified between the contour editing practice of dosimetrists, with 1 dosimetrist editing more across all organs at risk. Eighteen percent (27/150) of moving mean control plots created for 5 dosimetrists indicated the amount of contour editing was decreasing over time, possibly corresponding to automation bias. CONCLUSIONS: The developed system was used to detect statistically significant edits caused by software error, unexpected clinical use, and automation bias. The increased ability to detect systematic errors that occur when editing automatically generated contours will improve the safety of the automatic treatment planning workflow.

A real-time contouring feedback tool for consensus-based contour training.

Purpose: Variability in contouring structures of interest for radiotherapy continues to be challenging. Although training can reduce such variability, having radiation oncologists provide feedback can be impractical. We developed a contour training tool to provide real-time feedback to trainees, thereby reducing variability in contouring. Methods: We developed a novel metric termed localized signed square distance (LSSD) to provide feedback to the trainee on how their contour compares with a reference contour, which is generated real-time by combining trainee contour and multiple expert radiation oncologist contours. Nine trainees performed contour training by using six randomly assigned training cases that included one test case of the heart and left ventricle (LV). The test case was repeated 30 days later to assess retention. The distribution of LSSD maps of the initial contour for the training cases was combined and compared with the distribution of LSSD maps of the final contours for all training cases. The difference in standard deviations from the initial to final LSSD maps, ΔLSSD, was computed both on a per-case basis and for the entire group. Results: For every training case, statistically significant ΔLSSD were observed for both the heart and LV. When all initial and final LSSD maps were aggregated for the training cases, before training, the mean LSSD ([range], standard deviation) was -0.8 mm ([-37.9, 34.9], 4.2) and 0.3 mm ([-25.1, 32.7], 4.8) for heart and LV, respectively. These were reduced to -0.1 mm ([-16.2, 7.3], 0.8) and 0.1 mm ([-6.6, 8.3], 0.7) for the final LSSD maps during the contour training sessions. For the retention case, the initial and final LSSD maps of the retention case were aggregated and were -1.5 mm ([-22.9, 19.9], 3.4) and -0.2 mm ([-4.5, 1.5], 0.7) for the heart and 1.8 mm ([-16.7, 34.5], 5.1) and 0.2 mm ([-3.9, 1.6],0.7) for the LV. Conclusions: A tool that uses real-time contouring feedback was developed and successfully used for contour training of nine trainees. In all cases, the utility was able to guide the trainee and ultimately reduce the variability of the trainee's contouring.

Addressing the Global Expertise Gap in Radiation Oncology: The Radiation Planning Assistant.

PURPOSE: Automation, including the use of artificial intelligence, has been identified as a possible opportunity to help reduce the gap in access and quality for radiotherapy and other aspects of cancer care. The Radiation Planning Assistant (RPA) project was conceived in 2015 (and funded in 2016) to use automated contouring and treatment planning algorithms to support the efforts of oncologists in low- and middle-income countries, allowing them to scale their efforts and treat more patients safely and efficiently (to increase access). DESIGN: In this review, we discuss the development of the RPA, with a particular focus on clinical acceptability and safety/risk across jurisdictions as these are important indicators for the successful future deployment of the RPA to increase radiotherapy availability and ameliorate global disparities in access to radiation oncology. RESULTS: RPA tools will be offered through a webpage, where users can upload computed tomography data sets and download automatically generated contours and treatment plans. All interfaces have been designed to maximize ease of use and minimize risk. The current version of the RPA includes automated contouring and planning for head and neck cancer, cervical cancer, breast cancer, and metastases to the brain. CONCLUSION: The RPA has been designed to bring high-quality treatment planning to more patients across the world, and it may encourage greater investment in treatment devices and other aspects of cancer treatment.

Hazard testing to reduce risk in the development of automated planning tools.

PURPOSE: Hazard scenarios were created to assess and reduce the risk of planning errors in automated planning processes. This was accomplished through iterative testing and improvement of examined user interfaces. METHODS: Automated planning requires three user inputs: a computed tomography (CT), a prescription document, known as the service request, and contours. We investigated the ability of users to catch errors that were intentionally introduced into each of these three stages, according to an FMEA analysis. Five radiation therapists each reviewed 15 patient CTs, containing three errors: inappropriate field of view, incorrect superior border, and incorrect identification of isocenter. Four radiation oncology residents reviewed 10 service requests, containing two errors: incorrect prescription and treatment site. Four physicists reviewed 10 contour sets, containing two errors: missing contour slices and inaccurate target contour. Reviewers underwent video training prior to reviewing and providing feedback for various mock plans. RESULTS: Initially, 75% of hazard scenarios were detected in the service request approval. The visual display of prescription information was then updated to improve the detectability of errors based on user feedback. The change was then validated with five new radiation oncology residents who detected 100% of errors present. 83% of the hazard scenarios were detected in the CT approval portion of the workflow. For the contour approval portion of the workflow none of the errors were detected by physicists, indicating this step will not be used for quality assurance of contours. To mitigate the risk from errors that could occur at this step, radiation oncologists must perform a thorough review of contour quality prior to final plan approval. CONCLUSIONS: Hazard testing was used to pinpoint the weaknesses of an automated planning tool and as a result, subsequent improvements were made. This study identified that not all workflow steps should be used for quality assurance and demonstrated the importance of performing hazard testing to identify points of risk in automated planning tools.

Automated Contouring and Planning in Radiation Therapy: What Is 'Clinically Acceptable'?

Developers and users of artificial-intelligence-based tools for automatic contouring and treatment planning in radiotherapy are expected to assess clinical acceptability of these tools. However, what is 'clinical acceptability'? Quantitative and qualitative approaches have been used to assess this ill-defined concept, all of which have advantages and disadvantages or limitations. The approach chosen may depend on the goal of the study as well as on available resources. In this paper, we discuss various aspects of 'clinical acceptability' and how they can move us toward a standard for defining clinical acceptability of new autocontouring and planning tools.

Statistical process control to monitor use of a web-based autoplanning tool.

PURPOSE: To investigate the use of statistical process control (SPC) for quality assurance of an integrated web-based autoplanning tool, Radiation Planning Assistant (RPA). METHODS: Automatically generated plans were downloaded and imported into two treatment planning systems (TPSs), RayStation and Eclipse, in which they were recalculated using fixed monitor units. The recalculated plans were then uploaded back to the RPA, and the mean dose differences for each contour between the original RPA and the TPSs plans were calculated. SPC was used to characterize the RPA plans in terms of two comparisons: RayStation TPS versus RPA and Eclipse TPS versus RPA for three anatomical sites, and variations in the machine parameters dosimetric leaf gap (DLG) and multileaf collimator transmission factor (MLC-TF) for two algorithms (Analytical Anisotropic Algorithm [AAA]) and Acuros in the Eclipse TPS. Overall, SPC was used to monitor the process of the RPA, while clinics would still perform their routine patient-specific QA. RESULTS: For RayStation, the average mean percent dose differences across all contours were 0.65% ± 1.05%, -2.09% ± 0.56%, and 0.28% ± 0.98% and average control limit ranges were 1.89% ± 1.32%, 2.16% ± 1.31%, and 2.65% ± 1.89% for the head and neck, cervix, and chest wall, respectively. In contrast, Eclipse's average mean percent dose differences across all contours were -0.62% ± 0.34%, 0.32% ± 0.23%, and -0.91% ± 0.98%, while average control limit ranges were 1.09% ± 0.77%, 3.69% ± 2.67%, 2.73% ± 1.86%, respectively. Averaging all contours and removing outliers, a 0% dose difference corresponded with a DLG value of 0.202 ± 0.019 cm and MLC-TF value of 0.020 ± 0.001 for Acuros and a DLG value of 0.135 ± 0.031 cm and MLC-TF value of 0.015 ± 0.001 for AAA. CONCLUSIONS: Differences in mean dose and control limits between RPA and two separately commissioned TPSs were determined. With varying control limits and means, SPC provides a flexible and useful process quality assurance tool for monitoring a complex automated system such as the RPA.

Development and validation of a checklist for use with automatically generated radiotherapy plans.

PURPOSE: To develop a checklist that improves the rate of error detection during the plan review of automatically generated radiotherapy plans. METHODS: A custom checklist was developed using guidance from American Association of Physicists in Medicine task groups 275 and 315 and the results of a failure modes and effects analysis of the Radiation Planning Assistant (RPA), an automated contouring and treatment planning tool. The preliminary checklist contained 90 review items for each automatically generated plan. In the first study, eight physicists were recruited from our institution who were familiar with the RPA. Each physicist reviewed 10 artificial intelligence-generated resident treatment plans from the RPA for safety and plan quality, five of which contained errors. Physicists performed plan checks, recorded errors, and rated each plan's clinical acceptability. Following a 2-week break, physicists reviewed 10 additional plans with a similar distribution of errors using our customized checklist. Participants then provided feedback on the usability of the checklist and it was modified accordingly. In a second study, this process was repeated with 14 senior medical physics residents who were randomly assigned to checklist or no checklist for their reviews. Each reviewed 10 plans, five of which contained errors, and completed the corresponding survey. RESULTS: In the first study, the checklist significantly improved the rate of error detection from 3.4 ± 1.1 to 4.4 ± 0.74 errors per participant without and with the checklist, respectively (p = 0.02). Error detection increased by 20% when the custom checklist was utilized. In the second study, 2.9 ± 0.84 and 3.5 ± 0.84 errors per participant were detected without and with the revised checklist, respectively (p = 0.08). Despite the lack of statistical significance for this cohort, error detection increased by 18% when the checklist was utilized. CONCLUSION: Our results indicate that the use of a customized checklist when reviewing automated treatment plans will result in improved patient safety.

Using Failure Mode and Effects Analysis to Evaluate Risk in the Clinical Adoption of Automated Contouring and Treatment Planning Tools.

PURPOSE: In this study, we applied the failure mode and effects analysis (FMEA) approach to an automated radiation therapy contouring and treatment planning tool to assess, and subsequently limit, the risk of deploying automated tools. METHODS AND MATERIALS: Using an FMEA, we quantified the risks associated with the Radiation Planning Assistant (RPA), an automated contouring and treatment planning tool currently under development. A multidisciplinary team identified and scored each failure mode, using a combination of RPA plan data and experience for guidance. A 1-to-10 scale for severity, occurrence, and detectability of potential errors was used, following American Association of Physicists in Medicine Task Group 100 recommendations. High-risk failure modes were further explored to determine how the workflow could be improved to reduce the associated risk. RESULTS: Of 290 possible failure modes, we identified 126 errors that were unique to the RPA workflow, with a mean risk priority number (RPN) of 56.3 and a maximum RPN of 486. The top 10 failure modes were caused by automation bias, operator error, and software error. Twenty-one failure modes were above the action threshold of RPN = 125, leading to corrective actions. The workflow was modified to simplify the user interface and better training resources were developed, which highlight the importance of thorough review of the output of automated systems. After the changes, we rescored the high-risk errors, resulting in a final mean and maximum RPN of 33.7 and 288, respectively. CONCLUSIONS: We identified 126 errors specific to the automated workflow, most of which were caused by automation bias or operator error, which emphasized the need to simplify the user interface and ensure adequate user training. As a result of changes made to the software and the enhancement of training resources, the RPNs subsequently decreased, showing that FMEA is an effective way to assess and reduce risk associated with the deployment of automated planning tools.