Interventions to Promote Safety Culture in Cancer Care: A Systematic Review.

OBJECTIVES: There is limited guidance on how to effectively promote safety culture in health care settings. We performed a systematic review to identify interventions to promote safety culture, specifically in oncology settings. METHODS: Medical Subject Headings and text words for "safety culture" and "cancer care" were combined to conduct structured searches of MEDLINE, EMBASE, CDSR, CINAHL, Cochrane CENTRAL, PsycINFO, Scopus, and Web of Science for peer-reviewed articles published from 1999 to 2021. To be included, articles had to evaluate a safety culture intervention in an oncology setting using a randomized or nonrandomized, pre-post (controlled or uncontrolled), interrupted time series, or repeated-measures study design. The review followed PRISMA guidelines; quality of included citations was assessed using the ROBINS-I risk of bias tool. RESULTS: Eighteen articles meeting the inclusion criteria were retained, reporting on interventions in radiation (14 of 18), medical (3 of 18), or general oncology (1 of 18) settings. Articles most commonly addressed incident learning systems (7 of 18), lean initiatives (4 of 18), or quality improvement programs (3 of 18). Although 72% of studies reported improvement in safety culture, there was substantial heterogeneity in the evaluation approach; rates of reporting of adverse events (9 of 18) or Agency for Healthcare Research and Quality Safety Culture survey results (9 of 18) were the most commonly used metrics. Most of the studies had moderate (28%) or severe (67%) risk of bias. CONCLUSIONS: Despite a growing evidence base describing interventions to promote safety culture in cancer care, definitive recommendations were difficult to make because of heterogeneity in study designs and outcomes. Implementation of incident learning systems seems to hold most promise.

A Clinical Consensus Approach to Developing a New Funding Model for Radiation Services in Ontario.

In 2021, Ontario Health (Cancer Care Ontario) introduced a quality-based procedure model for the funding of radiation treatment (RT) in Ontario. This model ties reimbursement to patient care activities, ensuring equity and transparency in funding. Over 200 RT interprofessionals (oncologists, therapists and physicists) participated on 22 expert panels to establish or identify 288 evidence-based RT protocols and 672 quality expectations (QEs) to optimally deliver RT, which eventually led to the micro-costing of all protocols. Iterative review is required to ensure updated techniques and identify evolving standards of care, thereby providing the highest quality of RT care to Ontarians.

Liver SBRT dose accumulation to assess the impact of anatomic variations on normal tissue doses and toxicity in patients treated with concurrent sorafenib.

BACKGROUND AND PURPOSE: Unexpected liver volume reductions occurred during trials of liver SBRT and concurrent sorafenib. The aims were to accumulate liver SBRT doses to assess the impact of these anatomic variations on normal tissue dose parameters and toxicity. MATERIALS AND METHODS: Thirty-two patients with hepatocellular carcinoma (HCC) or metastases treated on trials of liver SBRT (30-57 Gy, 6 fractions) and concurrent sorafenib were analyzed. SBRT doses were accumulated using biomechanical deformable registration of daily cone-beam CT. Dose deviations (accumulated-planned) for normal tissues were compared for patients with liver volume reductions > 100 cc versus stable volumes, and accumulated doses were reported for three patients with grade 3-5 luminal gastrointestinal toxicities. RESULTS: Patients with reduced (N = 12) liver volumes had larger mean deviations of 0.4-1.3 Gy in normal tissues, versus -0.2-0.4 Gy for stable cases (N = 20), P > 0.05. Deviations > 5% of the prescribed dose occurred in both groups. Two HCC patients with toxicities to small and large bowel had liver volume reductions and deviations to the maximum dose of 4% (accumulated 36.9 Gy) and 3% (accumulated 33.4 Gy) to these organs respectively. Another HCC patient with a toxicity of unknown location plus tumor rupture, had stable liver volumes and deviations to luminal organs of -6% to 4.5% (accumulated < 30.5 Gy). CONCLUSION: Liver volume reductions during SBRT and concurrent sorafenib were associated with larger increases in accumulated dose to normal tissues versus stable liver volumes. These dosimetric changes may have further contributed to toxicities in HCC patients who have higher baseline risks.

3'-Deoxy-3'-(18F) Fluorothymidine Positron Emission Tomography/Computed Tomography in Non-small Cell Lung Cancer Treated With Stereotactic Body Radiation Therapy: A Pilot Study.

Purpose: The primary objective was to compare 3'-deoxy-3'-(18F) fluorothymidine (FLT) positron emission tomography (PET)/computed tomography (CT) uptake in 3 cohorts of stereotactic body radiation therapy (SBRT) patients: (1) pre-SBRT, (2) stable post-SBRT lung fibrosis, and (3) suspicious or proven local recurrence post-SBRT. The secondary objectives were to optimize FLT-PET imaging by comparing FLT uptake in respiratory-gated (4-dimensional) versus nongated (3-dimensional) FLT-PET scans. Methods: Patients with early-stage non-small cell lung cancer planned or treated with SBRT at the institution with radiographic findings of fibrosis or recurrence were eligible for the study. All patients underwent imaging with FLT-PET/CT before SBRT in cohort 1 and at fibrosis or recurrence in cohort 2 and 3, respectively. The planned sample size was 20 patients in each cohort, with 60 patients total. FLT-PET standardized uptake value (SUV) variables including SUVmax, SUVmean, SUVpeak, SUV50, and SUV95 were compared among the 3 cohorts using the Kruskal-Wallis test. The correlation of respiratory-gated and nongated FLT-PET SUV variables was performed using the Spearman correlation coefficient. Results: Forty-one patients were recruited for the study (20 in cohort 1, 16 in cohort 2, and 5 in cohort 3) between 2015 and 2019. The majority received a diagnosis of stage I lung cancer (86%), and the most common prescription was 48 Gy in 4 fractions (59%). Respiratory-gated FLT-PET was performed in 35 patients. The FLT SUV variables were well correlated between respiratory-gated and nongated scans (r = 0.8-1.0). The SUVpeak, SUVmean, and SUVmax were significantly lower in the fibrosis cohort compared with the recurrence and pretreatment cohorts. The SUV50 and SUV95 values in the recurrence cohort were statistically similar to the pretreatment cohort. Conclusions: FLT-PET/CT may be helpful in differentiating SBRT-related fibrosis from recurrence. Nongated FLT-PET/CT with reporting of SUVmax and SUV95 values is recommended.

Time-course assessment of 3D-image distortion on the 1.5 T Marlin/Elekta Unity MR-LINAC.

PURPOSE: The efficacy of MR-guided radiotherapy on a MR-LINAC (MR-L) is dependent on the geometric accuracy of its MR images over clinically relevant Fields-of-View (FOVs). Our objectives were to: evaluate gradient non-linearity (GNL) on the Elekta Unity MR-L across time via 76 weekly measurements of 3D-distortion over concentrically larger diameter spherical volumes (DSVs); quantify distortion measurement error; and assess the temporal stability of spatial distortion using statistical process control (SPC). METHODS: MR-image distortion was assessed using a large-FOV 3D-phantom containing 1932 markers embedded in seven parallel plates, spaced 25 mm × 25 mm in- and 55 mm through-plane. Automatically analyzed T1 images yielded distortions in 200, 300, 400 and 500 mm concentric DSVs. Distortion measurement error was evaluated using median absolute difference analysis of imaging repeatability tests. RESULTS: Over the measurement period absolute time-averaged distortion varied between: dr = 0.30 - 0.49 mm, 0.53 - 0.80 mm, 1.0 - 1.4 mm and 2.28 - 2.37 mm, for DSVs 200, 300, 400 and 500 mm at the 98th percentile level. Repeatability tests showed that imaging/repositioning introduces negligible error: mean ≤ 0.02 mm (max ≤ 0.3 mm). SPC analysis showed image distortion was stable across all DSVs; however, noticeable changes in GNL were observed following servicing at the one-year mark. CONCLUSIONS: Image distortion on the MR-L is in the sub-millimeter range for DSVs ≤ 300 mm and stable across time, with SPC analysis indicating all measurements remain within control for each DSV.

Multispecialty Enterprise Imaging Workgroup Consensus on Interactive Multimedia Reporting Current State and Road to the Future: HIMSS-SIIM Collaborative White Paper.

Diagnostic and evidential static image, video clip, and sound multimedia are captured during routine clinical care in cardiology, dermatology, ophthalmology, pathology, physiatry, radiation oncology, radiology, endoscopic procedural specialties, and other medical disciplines. Providers typically describe the multimedia findings in contemporaneous electronic health record clinical notes or associate a textual interpretative report. Visual communication aids commonly used to connect, synthesize, and supplement multimedia and descriptive text outside medicine remain technically challenging to integrate into patient care. Such beneficial interactive elements may include hyperlinks between text, multimedia elements, alphanumeric and geometric annotations, tables, graphs, timelines, diagrams, anatomic maps, and hyperlinks to external educational references that patients or provider consumers may find valuable. This HIMSS-SIIM Enterprise Imaging Community workgroup white paper outlines the current and desired clinical future state of interactive multimedia reporting (IMR). The workgroup adopted a consensus definition of IMR as "interactive medical documentation that combines clinical images, videos, sound, imaging metadata, and/or image annotations with text, typographic emphases, tables, graphs, event timelines, anatomic maps, hyperlinks, and/or educational resources to optimize communication between medical professionals, and between medical professionals and their patients." This white paper also serves as a precursor for future efforts toward solving technical issues impeding routine interactive multimedia report creation and ingestion into electronic health records.

Survey of patient-specific quality assurance practice for IMRT and VMAT.

A first-time survey across 15 cancer centers in Ontario, Canada, on the current practice of patient-specific quality assurance (PSQA) for intensity modulated radiation therapy (IMRT) and volumetric modulated arc therapy (VMAT) delivery was conducted. The objectives were to assess the current state of PSQA practice, identify areas for potential improvement, and facilitate the continued improvement in standardization, consistency, efficacy, and efficiency of PSQA regionally. The survey asked 40 questions related to PSQA practice for IMRT/VMAT delivery. The questions addressed PSQA policy and procedure, delivery log evaluation, instrumentation, measurement setup and methodology, data analysis and interpretation, documentation, process, failure modes, and feedback. The focus of this survey was on PSQA activities related to routine IMRT/VMAT treatments on conventional linacs, including stereotactic body radiation therapy but excluding stereotactic radiosurgery. The participating centers were instructed to submit answers that reflected the collective view or opinion of their department and represented the most typical process practiced. The results of the survey provided a snapshot of the current state of PSQA practice in Ontario and demonstrated considerable variations in the practice. A large majority (80%) of centers performed PSQA measurements on all VMAT plans. Most employed pseudo-3D array detectors with a true composite (TC) geometry. No standard approach was found for stopping or reducing frequency of measurements. The sole use of delivery log evaluation was not widely implemented, though most centers expressed interest in adopting this technology. All used the Gamma evaluation method for analyzing PSQA measurements; however, no universal approach was reported on how Gamma evaluation and pass determination criteria were determined. All or some PSQA results were reviewed regularly in two-thirds of the centers. Planning related issues were considered the most frequent source for PSQA failures (40%), whereas the most frequent course of action for a failed PSQA was to review the result and decide whether to proceed to treatment.

Non-small cell lung cancer stage migration as a function of wait times from diagnostic imaging: A pooled analysis from five international centres.

INTRODUCTION: Patients with non-small cell lung cancer (NSCLC) can experience rapid disease progression between initial staging FDG-PET scans and commencement of curative-intent radiotherapy (RT). Previous studies that estimated stage migration rates by comparing staging PET/CT and treatment-planning PET/CT images were limited by small sample sizes. METHODS: This multicenter, international study combined prospective data from five institutions for PET-staged patients with NSCLC who were intended to receive curative-intent RT. TNM status was compared for staging and RT planning scans and the probability of TNM status and overall stage migration was analyzed as a function of the interval between PET/CT scans. The impacts of N classification, overall stage, and pathology were also studied. RESULTS: Pooled data from 181 patients were analyzed. The median interval between PET/CT scans was 42 days (range, 2-208). Upstaging occurred in 32 % of patients. The overall rate of stage migration was higher for patients presenting with initial stage IIIB/IIIC disease (p = 0.006) and patients with N2-3 nodal disease (p = 0.019). Upstaging to M1 disease was significantly associated with initial stage IIIB/IIIC disease (HR = 15.2) and adenocarcinoma (HR = 10) histology. CONCLUSION: Longer intervals between imaging and treatment in patients with NSCLC were associated with high rates disease progression with consequent risks of geographic miss in RT planning and futile treatment in patients with M1 disease. Patients with more extensive initial nodal involvement and those with adenocarcinoma had the highest rates of stage migration. Dedicated RT planning PET/CT imaging is recommended, especially if >3 weeks have elapsed after initial staging.

Introducing operator characteristic curves to define appropriate frequency of quality control tests: A case study involving whole breast radiotherapy image guidance.

BACKGROUND AND PURPOSE: Sampling theory and operator characteristic curves are methods that can determine an optimal schedule for quality control tests. We apply this method to positional data for whole breast radiotherapy since several surveys report inconsistent image guidance practice for this technique. MATERIALS AND METHODS: Positional errors were defined, for 55 consecutive breast cancer patients, by comparing the central lung distance measured on portal images with that obtained from the corresponding digitally reconstructed radiograph. From the distribution of positional errors, the probability of a setup error >5 mm in the direction of the mediastinum was established. Using operator characteristic curves, we compared the effectiveness of various image-guidance schedules in dealing with such errors. We also calculated the dosimetric impact of undetected errors. RESULTS: Setup errors >5 mm towards the mediastinum for this cohort were unlikely, at 2.7%. Imaging half of the fractions protects most patients against three or more undetected errors. Undetected, such an error increases, on average, the maximum dose to 10 cm3 of the heart by 50 cGy, the mean heart dose by 4 cGy, and the left lung V20Gy by 0.2%; therefore, the clinical impact is minute. Given that detected positional errors outside of tolerance are corrected, their residual likelihood decreases with the ratio of fractions being imaged. CONCLUSIONS: For most tangential breast radiotherapy patients, setup errors >5 mm towards the mediastinum are unlikely, and their dosimetric impact is remote. Imaging half of the fractions of a course of whole breast radiotherapy prevents these errors to occur more than twice.

Rationale and Protocol for a Canadian Multicenter Phase II Randomized Trial Assessing Selective Metabolically Adaptive Radiation Dose Escalation in Locally Advanced Non-small-cell Lung Cancer (NCT02788461).

We explain the rationale for metabolically adaptive radiation dose escalation in stage III non-small-cell lung cancer and describe the design of a Canadian phase II randomized trial investigating this approach. In the trial, patients are randomized to either conventional chemoradiation treatment (60 Gy in 30 fractions) or metabolically adaptive chemoradiation, where fluorodeoxyglucose-avid tumor sub-volumes receive an integrated boost dose to a maximum of 85 Gy in 30 fractions. The trial sample size is 78 patients, and the target population is patients with newly diagnosed, inoperable stage III non-small-cell lung cancer treated with radical intent chemoradiation. The primary objective of the trial is to determine if dose escalation to metabolically active sub-volumes will reduce 2-year local-regional failure rate from 42.3% to 22.3%, when compared with standard treatment. The secondary objectives are to determine the effect of dose escalation on overall survival, progression-free survival, quality of life, and rate of grade 3 to 5 toxicities.

COMP report: CPQR technical quality control guidelines for accelerator-integrated cone-beam systems for verification imaging.

The Canadian Organization of Medical Physicists, in close partnership with the Canadian Partnership for Quality Radiotherapy has developed a series of Technical Quality Control (TQC) guidelines for radiation treatment equipment. These guidelines outline the performance objectives that equipment should meet in order to ensure an acceptable level of radiation treatment quality. The TQC guidelines have been rigorously reviewed and field tested in a variety of Canadian radiation treatment facilities. The development process enables rapid review and update to keep the guidelines current with changes in technology. This article presents the quality control guideline accelerator-integrated cone-beam systems for verification imaging that has resulted from this process.

COMP report: CPQR technical quality control guidelines for radiation treatment centers.

The Canadian Organization of Medical Physicists (COMP), in close partnership with the Canadian Partnership for Quality Radiotherapy (CPQR) has developed a series of Technical Quality Control (TQC) guidelines for radiation treatment equipment. These guidelines outline the performance objectives that equipment should meet in order to ensure an acceptable level of radiation treatment quality. The TQC guidelines have been rigorously reviewed and field tested in a variety of Canadian radiation treatment facilities. The development process enables rapid review and update to keep the guidelines current with changes in technology. This announcement provides an introduction to the guidelines, describing their scope and how they should be interpreted. Details of recommended tests can be found in separate, equipment specific TQC guidelines published in the JACMP (COMP Reports), or the website of the Canadian Partnership for Quality Radiotherapy (www.cpqr.ca).

Serial 4DCT/4DPET imaging to predict and monitor response for locally-advanced non-small cell lung cancer chemo-radiotherapy.

BACKGROUND AND PURPOSE: A FDG-PET/CT image feature with optimal prognostic potential for locally-advanced non-small cell lung cancer (LA-NSCLC) patients has yet to be identified, and neither has the optimal time for FDG-PET/CT response assessment; furthermore, nodal features have been largely ignored in the literature. We propose to identify image features or imaging time point with maximal prognostic power. MATERIALS AND METHODS: Consecutive consenting patients with LA-NSCLC receiving curative intent CRT were enrolled. 4DPET/4DCT scans were acquired 0, 2, 4, and 7 weeks during IMRT treatment. Eleven image features and their rates of change were recorded for each time point and tested for each of the possible outcome 2 years post CRT using the Kaplan-Meier method. RESULTS: 32 consecutive patients were recruited, 27 completing all scans. Restricting analysis to 4DPET/4DCT features and rates of change with p < 0.005, several volume-based features and their rates of change reached significance. Image features involving nodal disease were the only ones associated with overall survival. CONCLUSIONS: Several 4DPET/CT features and rates of change can reach significant association (p < 0.005) with outcomes, including overall survival, at many time points. The optimal time for adaptive CRT is therefore not constrained uniquely on imaging.

Brachytherapy patient safety events in an academic radiation medicine program.

PURPOSE: To describe the incidence and type of brachytherapy patient safety events over 10 years in an academic brachytherapy program. METHODS AND MATERIALS: Brachytherapy patient safety events reported between January 2007 and August 2016 were retrieved from the incident reporting system and reclassified using the recently developed National System for Incident Reporting in Radiation Treatment taxonomy. A multi-incident analysis was conducted to identify common themes and key learning points. RESULTS: During the study period, 3095 patients received 4967 brachytherapy fractions. An additional 179 patients had MR-guided prostate biopsies without treatment as part of an interventional research program. A total of 94 brachytherapy- or biopsy-related safety events (incidents, near misses, or programmatic hazards) were identified, corresponding to a rate of 2.8% of brachytherapy patients, 1.7% of brachytherapy fractions, and 3.4% of patients undergoing MR-guided prostate biopsy. Fifty-one (54%) events were classified as actual incidents, 29 (31%) as near misses, and 14 (15%) as programmatic hazards. Two events were associated with moderate acute medical harm or dosimetric severity, and two were associated with high dosimetric severity. Multi-incident analysis identified five high-risk activities or clinical scenarios as follows: (1) uncommon, low-volume or newly implemented brachytherapy procedures, (2) real-time MR-guided brachytherapy or biopsy procedures, (3) use of in-house devices or software, (4) manual data entry, and (5) patient scheduling and handoffs. CONCLUSIONS: Brachytherapy is a safe treatment and associated with a low rate of patient safety events. Effective incident management is a key element of continuous quality improvement and patient safety in brachytherapy.

Voxel-by-voxel correlation between radiologically radiation induced lung injury and dose after image-guided, intensity modulated radiotherapy for lung tumors.

PURPOSE: To correlate radiation dose to the risk of severe radiologically-evident radiation-induced lung injury (RRLI) using voxel-by-voxel analysis of the follow-up computed tomography (CT) of patients treated for lung cancer with hypofractionated helical Tomotherapy. METHODS AND MATERIALS: The follow-up CT scans from 32 lung cancer patients treated with various regimens (5, 8, and 25 fractions) were registered to pre-treatment CT using deformable image registration (DIR). The change in density was calculated for each voxel within the combined lungs minus the planning target volume (PTV). Parameters of a Probit formula were derived by fitting the occurrences of changes of density in voxels greater than 0.361gcm-3 to the radiation dose. The model's predictive capability was assessed using the area under receiver operating characteristic curve (AUC), the Kolmogorov-Smirnov test for goodness-of-fit, and the permutation test (Ptest). RESULTS: The best-fit parameters for prediction of RRLI 6months post RT were D50 of 73.0 (95% CI 59.2.4-85.3.7)Gy, and m of 0.41 (0.39-0.46) for hypofractionated (5 and 8 fractions) and D50 of 96.8 (76.9-123.9)Gy, and m of 0.36 (0.34-0.39) for 25 fractions RT. According to the goodness-of-fit test the null hypothesis of modeled and observed occurrence of RRLI coming from the same distribution could not be rejected. The AUC was 0.581 (0.575-0.583) for fractionated and 0.579 (0.577-0.581) for hypofractionated patients. The predictive models had AUC>upper 95% band of the Ptest. CONCLUSIONS: The correlation of voxel-by-voxel density increase with dose can be used as a support tool for differential diagnosis of tumor from benign changes in the follow-up of lung IMRT patients.

Hazards and incidents: Detection and learning in radiation medicine, a comparison of 2 educational interventions.

PURPOSE: Interprofessional, educational live simulations were compared with group discussion-based exercises in terms of their ability to improve radiation medicine trainees' ability to detect hazards and incidents and understand behaviors that may prevent them. METHODS AND MATERIALS: Trainees and recent graduates of radiation therapy, medical physics, and radiation oncology programs were recruited and randomized to either a simulation-based or group discussion-based training intervention. Participants engaged in hazard and incident detection, analysis, and a discussion of potential preventive measures and the concept of the "highly reliable team." A video examination tool modeled on actual incidents, using 5-minute videos created by faculty, students, and volunteers, was created to test hazard and incident recognition ability before and after training. Hazard and incident detection sensitivity and specificity analyses were conducted, and a survey of the participants' and facilitators' perceptions was conducted. RESULTS: Twenty-seven participants were assigned to the simulation (n = 15) or discussion group (n = 12). Hazard and incident-detection sensitivity ranged from 0.04 to 0.56 before and 0.04 to 0.35 after training for the discussion and simulation groups, respectively. The pre- and posttraining difference in sensitivity between groups was 0.03 (P = .75) for the minimum and 0.33 (P = .034) for the maximum reaction time. Participant perceptions of the training's educational value in a variety of domains ranged from a mean score of 6.58 to 8.17 and 7 to 8.07 for the discussion and simulation groups, respectively. Differences were not statistically significant. Twenty-six of the 27 participants indicated that they would recommend this event to a colleague. CONCLUSIONS: Participants' ability to detect hazards and incidents as portrayed in 5-minute videos in this study was low both before and after training, and simulation-based training was not superior to discussion-based training. However, levels of satisfaction and perceptions of the training's educational value were high, especially with simulation-based training.

Production, review, and impact of technical quality control guidelines in a national context.

A close partnership between the Canadian Partnership for Quality Radiotherapy (CPQR) and the Canadian Organization of Medical Physicist's (COMP) Quality Assurance and Radiation Safety Advisory Committee (QARSAC) has resulted in the development of a suite of Technical Quality Control (TQC) guidelines for radiation treatment equipment; they outline specific performance objectives and criteria that equipment should meet in order to assure an acceptable level of radiation treatment quality. The adopted framework for the development and maintenance of the TQCs ensures the guidelines incorporate input from the medical physics com-munity during development, measures the workload required to perform the QC tests outlined in each TQC, and remain relevant (i.e., "living documents") through subsequent planned reviews and updates. The framework includes consolidation of existing guidelines and/or literature by expert reviewers, structured stages of public review, external field-testing, and ratification by COMP. This TQC develop-ment framework is a cross-country initiative that allows for rapid development of robust, community-driven living guideline documents that are owned by the com-munity and reviewed to keep relevant in a rapidly evolving technical environment. Community engagement and uptake survey data shows 70% of Canadian centers are part of this process and that the data in the guideline documents reflect, and are influencing, the way Canadian radiation treatment centers run their technical quality control programs. For a medium-sized center comprising six linear accelerators and a comprehensive brachytherapy program, we evaluate the physics workload to 1.5 full-time equivalent physicists per year to complete all QC tests listed in this suite.