Real-time analysis and display of quantitative measures to track and improve clinical workflow.

PURPOSE: Radiotherapy treatment planning is a complex process with multiple, dependent steps involving an interdisciplinary patient care team. Effective communication and real-time tracking of resources and care path activities are key for clinical efficiency and patient safety. MATERIALS AND METHODS: We designed and implemented a secure, interactive web-based dashboard for patient care path, clinical workflow, and resource utilization management. The dashboard enables visualization of resource utilization and tracks progress in a patient's care path from the time of acquisition of the planning CT to the time of treatment in real-time. It integrates with the departmental electronic medical records (EMR) system without the creation and maintenance of a separate database or duplication of work by clinical staff. Performance measures of workflow were calculated. RESULTS: The dashboard implements a standardized clinical workflow and dynamically consolidates real-time information queried from multiple tables in the EMR database over the following views: (1) CT Sims summarizes patient appointment information on the CT simulator and patient load; (2) Linac Sims summarizes patient appointment times, setup history, and notes, and patient load; (3) Task Status lists the clinical tasks associated with a treatment plan, their due date, status and ownership, and patient appointment details; (4) Documents provides the status of all documents in the patients' charts; and (5) Diagnoses and Interventions summarizes prescription information, imaging instructions and whether the plan was approved for treatment. Real-time assessment and quantification of progress and delays in a patient's treatment start were achieved. CONCLUSIONS: This study indicates it is feasible to develop and implement a dashboard, tailored to the needs of an interdisciplinary team, which derives and integrates information from the EMR database for real-time analysis and display of resource utilization and clinical workflow in radiation oncology. The framework developed facilitates informed, data-driven decisions on clinical workflow management as we seek to optimize clinical efficiency and patient safety.

AAPM Task Group 198 Report: An implementation guide for TG 142 quality assurance of medical accelerators.

The charges on this task group (TG) were as follows: (a) provide specific procedural guidelines for performing the tests recommended in TG 142; (b) provide estimate of the range of time, appropriate personnel, and qualifications necessary to complete the tests in TG 142; and (c) provide sample daily, weekly, monthly, or annual quality assurance (QA) forms. Many of the guidelines in this report are drawn from the literature and are included in the references. When literature was not available, specific test methods reflect the experiences of the TG members (e.g., a test method for door interlock is self-evident with no literature necessary). In other cases, the technology is so new that no literature for test methods was available. Given broad clinical adaptation of volumetric modulated arc therapy (VMAT), which is not a specific topic of TG 142, several tests and criteria specific to VMAT were added.

Quantifying risk using FMEA: An alternate approach to AAPM TG-100 for scoring failures and evaluating clinical workflow.

PURPOSE: Renovation of the brachytherapy program at a leading cancer center utilized methods of the AAPM TG-100 report to objectively evaluate current clinical brachytherapy workflows and develop techniques for minimizing the risk of failures, increasing efficiency, and consequently providing opportunities for improved treatment quality. The TG-100 report guides evaluation of clinical workflows with recommendations for identifying potential failure modes (FM) and scoring them from the perspective of their occurrence frequency O, failure severity S, and inability to detect them D. The current study assessed the impact of differing methods to determine the risk priority number (RPN) beyond simple multiplication. METHODS AND MATERIALS: The clinical workflow for a complex brachytherapy procedure was evaluated by a team of 15 staff members, who identified discrete FM using alternate scoring scales than those presented in the TG-100 report. These scales were expanded over all clinically relevant possibilities with care to emphasize mitigation of natural bias for scoring near the median range as well as to enhance the overall scoring-system sensitivity. Based on staff member perceptions, a more realistic measure of risk was determined using weighted functions of their scores. RESULTS: This new method expanded the range of RPN possibilities by a factor of 86, improving evaluation and recognition of safe and efficient clinical workflows. Mean RPN values for each FM decreased by 44% when changing from the old to the new clinical workflow, as evaluated using the TG-100 method. This decreased by 66% when evaluated with the new method. As a measure of the total risk associated with an entire clinical workflow, the integral of RPN values increased by 15% and decreased by 31% with the TG-100 and new methods, respectively. CONCLUSIONS: This appears to be the first application of an alternate approach to the TG-100 method for evaluating the risk of clinical workflows. It exemplifies the risk analysis techniques necessary to rapidly evaluate simple clinical workflows appropriately.

Performance of clinicopathologic models in men with high risk localized prostate cancer: impact of a 22-gene genomic classifier.

BACKGROUND: Prostate cancer exhibits biological and clinical heterogeneity even within established clinico-pathologic risk groups. The Decipher genomic classifier (GC) is a validated method to further risk-stratify disease in patients with prostate cancer, but its performance solely within National Comprehensive Cancer Network (NCCN) high-risk disease has not been undertaken to date. METHODS: A multi-institutional retrospective study of 405 men with high-risk prostate cancer who underwent primary treatment with radical prostatectomy (RP) or radiation therapy (RT) with androgen-deprivation therapy (ADT) at 11 centers from 1995 to 2005 was performed. Cox proportional hazards models were used to determine the hazard ratios (HR) for the development of metastatic disease based on clinico-pathologic variables, risk groups, and GC score. The area under the receiver operating characteristic curve (AUC) was determined for regression models without and with the GC score. RESULTS: Over a median follow-up of 82 months, 104 patients (26%) developed metastatic disease. On univariable analysis, increasing GC score was significantly associated with metastatic disease ([HR]: 1.34 per 0.1 unit increase, 95% confidence interval [CI]: 1.19-1.50, p < 0.001), while age, serum PSA, biopsy GG, and clinical T-stage were not (all p > 0.05). On multivariable analysis, GC score (HR: 1.33 per 0.1 unit increase, 95% CI: 1.19-1.48, p < 0.001) and GC high-risk (vs low-risk, HR: 2.95, 95% CI: 1.79-4.87, p < 0.001) were significantly associated with metastasis. The addition of GC score to regression models based on NCCN risk group improved model AUC from 0.46 to 0.67, and CAPRA from 0.59 to 0.71. CONCLUSIONS: Among men with high-risk prostate cancer, conventional clinico-pathologic data had poor discrimination to risk stratify development of metastatic disease. GC score was a significant and independent predictor of metastasis and may help identify men best suited for treatment intensification/de-escalation.

Validation of a Monte Carlo model for multi leaf collimator based electron delivery.

PURPOSE: To develop and validate a Monte Carlo model of the Varian TrueBeam to study electron collimation using the existing photon multi-leaf collimators (pMLC), instead of conventional electron applicators and apertures. MATERIALS AND METHODS: A complete Monte Carlo model of the Varian TrueBeam was developed using Tool for particle simulation (TOPAS) (version 3.1.p3). Vendor-supplied information was used to model the treatment head components and the source parameters. A phase space plane was setup above the collimating jaws and captured particles were reused until a statistical uncertainty of 1% was achieved in the central axis. Electron energies 6, 9, 12, 16, and 20 MeV with a jaw-defined field of 20 × 20 cm2 at iso-center, pMLC-defined fields of 6.8 × 6.8 cm2 and 11.4 × 11.4 cm2 at 80 cm source-to-surface distance (SSD) and an applicator-defined field of 10 × 10 cm2 at iso-center were evaluated. All the measurements except the applicator-defined fields were measured using an ionization chamber in a water tank using 80 cm SSD. The dose difference, distance-to-agreement and gamma index were used to evaluate the agreement between the Monte Carlo calculations and measurements. Contributions of electron scattering off pMLC leaves and inter-leaf leakage on dose profiles were evaluated and compared with Monte Carlo calculations. Electron transport through a heterogeneous phantom was simulated and the resulting dose distributions were compared with film measurements. The validated Monte Carlo model was used to simulate several clinically motivated cases to demonstrate the benefit of pMLC-based electron delivery compared to applicator-based electron delivery. RESULTS: Calculated and measured percentage depth-dose (PDD) curves agree within 2% after normalization. The agreement between normalized percentage depth dose curves were evaluated using one-dimensional gamma analysis with a local tolerance of 2%/1 mm and the %points passing gamma criteria was 100% for all energies. For jaw-defined fields, calculated profiles agree with measurements with pass rates of >97% for 2%/2 mm gamma criteria. Calculated FWHM and penumbra width agree with measurements within 0.4 cm. For fields with tertiary collimation using an pMLC or applicator, the average gamma pass rate of compared profiles was 98% with 2%/2 mm gamma criteria. The profiles measured to evaluate the pMLC leaf scattering agreed with Monte Carlo calculations with an average gamma pass rate of 96.5% with 3%/2 mm gamma criteria. Measured dose profiles below the heterogenous phantom agreed well with calculated profiles and matched within 2.5% for most points. The calculated clinically applicable cases using TOPAS MC and Eclipse TPS for single enface electron beam, electron-photon mixed beam and a matched electron-electron beam exhibited a reasonable agreement in PDDs, profiles and dose volume histograms. CONCLUSION: We present a validation of a Monte Carlo model of Varian TrueBeam for pMLC-based electron delivery. Monte Carlo calculations agreed with measurements satisfying gamma criterion of 1%/1 mm for depth dose curves and 2%/1 mm for dose profiles. The simulation of clinically applicable cases demonstrated the clinical utility of pMLC-based electrons and the use of MC simulations for development of advanced radiation therapy techniques.

Novel and programmatic improvements to the workflow associated with the AccuBoost breast brachytherapy procedure.

PURPOSE: While the noninvasive breast brachytherapy (NIBB) treatment procedure, known as AccuBoost, for breast cancer patients is well established, the treatment quality can be improved by the efficiency of the workflow delivery. A formalized approach evaluated the current workflow through failure modes and effects analysis and generated insight for developing new procedural workflow techniques to improve the clinical treatment process. METHODS AND MATERIALS: AccuBoost treatments were observed for several months while gathering details on the multidisciplinary workflow. A list of possible failure modes for each procedure step was generated and organized by timing within the treatment process. A team of medical professionals highlighted procedural steps that unnecessarily increased treatment time, as well as introduced quality deficiencies involving applicator setup, treatment planning, and quality control checks preceding brachytherapy delivery. Procedural improvements and their impact on the clinical workflow are discussed. RESULTS: The revised clinical workflow included the following key procedural enhancements. Prepatient arrival: Improvement of prearrival preparation requires advance completion of dose calculation documentation with patient-specific setup data. Patient arrival pretreatment: Physicists carry out dwell time calculations and check the plan, while the therapist concurrently performs several checks of the ensuing hardware configuration. TREATMENT: An electronic method to export the associated HDR brachytherapy paperwork to the electronic medical record system with electronic signatures and captured approvals was generated. Posttreatment: The therapist confirms the applicators were appropriately positioned, and treatment was delivered as expected. CONCLUSIONS: The procedural improvements reduced the overall treatment time, improved consistency across users, and eased performance of this special procedure for all participants.

NRG Oncology medical physicists' manpower survey quantifying support demands for multi-institutional clinical trials.

PURPOSE: A survey was created by NRG to assess a medical physicists' percent full time equivalent (FTE) contribution to multi-institutional clinical trials. A 2012 American Society for Radiation Oncology report, "Safety Is No Accident," quantified medical physics staffing contributions in FTE factors for clinical departments. No quantification of FTE effort associated with clinical trials was included. METHODS: To address this lack of information, the NRG Medical Physics Subcommittee decided to obtain manpower data from the medical physics community to quantify the amount of time medical physicists spent supporting clinical trials. A survey, consisting of 16 questions, was designed to obtain information regarding physicists' time spent supporting clinical trials. The survey was distributed to medical physicists at 1996 radiation therapy institutions included on the membership rosters of the 5 National Clinical Trials Network clinical trial groups. RESULTS: Of the 451 institutions who responded, 50% (226) reported currently participating in radiation therapy trials. On average, the designated physicist at each institution spent 2.4 hours (standard deviation [SD], 5.5) per week supervising or interacting with clinical trial staff. On average, 1.2 hours (SD, 3.1), 1.8 hours (SD, 3.9), and 0.6 hours (SD, 1.1) per week were spent on trial patient simulations, treatment plan reviews, and maintaining a Digital Imaging and Communications in Medicine server, respectively. For all trial credentialing activities, physicists spent an average of 32 hours (SD, 57.2) yearly. Reading protocols and supporting dosimetrists, clinicians, and therapists took an average of 2.1 hours (SD, 3.4) per week. Physicists also attended clinical trial meetings, on average, 1.2 hours (SD, 1.9) per month. CONCLUSION: On average, physicist spent a nontrivial total of 9 hours per week (0.21 FTE) supporting an average of 10 active clinical trials. This time commitment indicates the complexity of radiation therapy clinical trials and should be taken into account when staffing radiation therapy institutions.

Accuracy evaluation of a six-degree-of-freedom couch using cone beam CT and IsoCal phantom with an in-house algorithm.

PURPOSE: The accuracy of a six degree of freedom (6DoF) couch was evaluated using a novel method. METHODS: Cone beam CT (CBCT) images of a 3D phantom (IsoCal) were acquired with different, known combinations of couch pitch and roll angles. Pitch and roll angles between the maximum allowable values of 357 and 3 degrees were tested in one degree increments. A total of 49 combinations were tested at 0 degrees of yaw (couch rotation angle). The 3D positions of 16 tungsten carbide ball bearings (BBs), each 4 mm in diameter and arranged in a known geometry within the IsoCal phantom, were determined in the 49 image sets with in-house software. The BB positions at different rotation angles were determined using a rotation matrix from the original BB positions at zero pitch and roll angles. A linear least squares fit method estimated the rotation angles and differences between detected and nominal rotation angles were calculated. This study was conducted for the case with and without extra weight on the couch. Couch walk shifts for the system were investigated using eight combinations of rotation, roll and pitch. RESULTS: A total of 49 CBCT images with voxel sizes 0.5 × 0.5 × 1.0 mm3 were taken for the case without extra weight on the couch. The 16 BBs were determined to evaluate the isocenter translation and rotation differences between the calculated and nominal couch values. Among all 49 calculations, the maximum rotation angle differences were 0.10 degrees for pitch, 0.15 degrees for roll and 0.09 degrees for yaw. The corresponding mean and standard deviation values were 0.028 ± 0.032, -0.043 ± 0.058, and -0.009 ± 0.033 degrees. The maximum translation differences were 0.3 mm in the left-right direction, 0.5 mm in the anterior-posterior direction and 0.4 mm in the superior-inferior direction. The mean values and corresponding standard deviations were 0.07 ± 0.12, -0.05 ± 0.25, and -0.12±0.14 mm for the planes described above. With an 80 kg phantom on the couch, the maximum translation shift was 0.69 mm. The couch walk translation shifts were less than 0.1 mm and rotation shifts were less than 0.1 degree. CONCLUSIONS: Errors of a new 6DoF couch were tested using CBCT images of a 3D phantom. The rotation errors were less than 0.3 degree and the translation errors were less than or equal to 0.8 mm in each direction. This level of accuracy is warranted for clinical radiotherapy utilization including stereotactic radiosurgery.

Commissioning and initial experience with the first clinical gantry-mounted proton therapy system.

The purpose of this study is to describe the comprehensive commissioning process and initial clinical experience of the Mevion S250 proton therapy system, a gantry-mounted, single-room proton therapy platform clinically implemented in the S. Lee Kling Proton Therapy Center at Barnes-Jewish Hospital in St. Louis, MO, USA. The Mevion S250 system integrates a compact synchrocyclotron with a C-inner gantry, an image guidance system and a 6D robotic couch into a beam delivery platform. We present our commissioning process and initial clinical experience, including i) CT calibration; ii) beam data acquisition and machine characteristics; iii) dosimetric commissioning of the treatment planning system; iv) validation through the Imaging and Radiation Oncology Core credentialing process, including irradiations on the spine, prostate, brain, and lung phantoms; v) evaluation of localization accuracy of the image guidance system; and vi) initial clinical experience. Clinically, the system operates well and has provided an excellent platform for the treatment of diseases with protons.

Measured Neutron Spectra and Dose Equivalents From a Mevion Single-Room, Passively Scattered Proton System Used for Craniospinal Irradiation.

PURPOSE: To measure, in the setting of typical passively scattered proton craniospinal irradiation (CSI) treatment, the secondary neutron spectra, and use these spectra to calculate dose equivalents for both internal and external neutrons delivered via a Mevion single-room compact proton system. METHODS AND MATERIALS: Secondary neutron spectra were measured using extended-range Bonner spheres for whole brain, upper spine, and lower spine proton fields. The detector used can discriminate neutrons over the entire range of the energy spectrum encountered in proton therapy. To separately assess internally and externally generated neutrons, each of the fields was delivered with and without a phantom. Average neutron energy, total neutron fluence, and ambient dose equivalent [H* (10)] were calculated for each spectrum. Neutron dose equivalents as a function of depth were estimated by applying published neutron depth-dose data to in-air H* (10) values. RESULTS: For CSI fields, neutron spectra were similar, with a high-energy direct neutron peak, an evaporation peak, a thermal peak, and an intermediate continuum between the evaporation and thermal peaks. Neutrons in the evaporation peak made the largest contribution to dose equivalent. Internal neutrons had a very low to negligible contribution to dose equivalent compared with external neutrons, largely attributed to the measurement location being far outside the primary proton beam. Average energies ranged from 8.6 to 14.5 MeV, whereas fluences ranged from 6.91 × 10(6) to 1.04 × 10(7) n/cm(2)/Gy, and H* (10) ranged from 2.27 to 3.92 mSv/Gy. CONCLUSIONS: For CSI treatments delivered with a Mevion single-gantry proton therapy system, we found measured neutron dose was consistent with dose equivalents reported for CSI with other proton beamlines.

The impact of CT scan energy on range calculation in proton therapy planning.

The purpose of this study was to investigate the impact of tube potential (kVp) on the CT number (HU) to proton stopping power ratio (PSPR) conversion. The range and dosimetric change introduced by a mismatch in kVp used for the CT scan and the HU to PSPR table, based on a specific kVp, used to calculate dose are analyzed. Three HU to PSPR curves, corresponding to three kVp settings on the CT scanner, were created. A treatment plan was created for a single beam in a water phantom passing through a wedge-shaped bone heterogeneity. The dose was recalculated by changing only the HU to PSPR table used in the dose calculation. The change in the position of the distal 90% isodose line was recorded as a function of heterogeneity thickness along the beam path. The dosimetric impact of a mismatch in kVp between the CT and the HU to PSPR table was investigated by repeating this procedure for five clinical plans comparing DVH data and dose difference distributions. The HU to PSPR tables diverge for CT numbers greater than 200 HU. In the phantom plan, the divergence of the tables resulted in a difference in range of 1.6 mm per cm of bone in the beam path, for the HU used. For the clinical plans, the dosimetric effect of a kVp mismatch depends on the amount of bone in the beam path and the proximity of OARs to the distal range of the planned beams. A mismatch in kVp between the CT and the HU to PSPR table can introduce inaccuracy in the proton beam range. For dense bone, the measured range difference was approximately 1.6 mm per cm of bone along the beam path. However, the clinical cases analyzed showed a range change of 1 mm or less. Caution is merited when such a mismatch may occur.