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To determine the rate of patient safety events by severity at a large academic institution. The rate can be used to compare to other radiation therapy institutions and other industries. A voluntary incident reporting system was used to collect patient safety events over a six-year period (CY2016-2021), representing a rather mature state of the quality and safety improvement program that began around 2009. Events were defined broadly as any condition, defect, event, situation, or miscommunication that could have or did reach the patient, with or without harm. Each event was analyzed by a multidisciplinary committee using a severity score and categorized on a scale of 1-6, comparable to that of the Agency of Healthcare Research and Quality (AHRQ) harm scale. A total of 2,583 events were scored in this six-year period. See Table 1, below. Rates of events with severity 1-2 declined over time by around 40% over six years. In contrast, the rate of events with severity 3-6, with or without harm, has stayed constant and may reflect complex technological changes, variabilities in treatment planning approaches and issues with coordination of care. Further research is needed to understand why the rate of events with severity 1-2 has decreased, while that of severity 3-6 has stayed constant and how this compares to other radiation therapy centers and other industries. [ABSTRACT FROM AUTHOR]

Active galaxies hosting two accreting and merging supermassive black holes (SMBHs)--dual active galactic nuclei (AGNs)--are predicted by many current and popular models of black-hole-galaxy co-evolution. We present here the results of a program that has identified a set of probable dual AGN candidates based on near-infrared laser guide star adaptive optics imaging with the Keck II telescope. These candidates are selected from a complete sample of radio-quiet quasi-stellar objects (QSOs) drawn from the Sloan Digital Sky Survey (SDSS), which show double-peaked narrow AGN emission lines. Of the 12 AGNs imaged, we find 6 with double galaxy structure, of which four are in galaxy mergers. We measure the ionization of the two velocity components in the narrow AGN lines to test the hypothesis that both velocity components come from an active nucleus. The combination of a well-defined parent sample and high-quality imaging allows us to place constraints on the fraction of SDSS QSOs that host dual accreting black holes separated on kiloparsec scales: ~0.3%-0.65%. We derive from this fraction the time spent in a QSO phase during a typical merger and find a value that is much lower than estimates that arise from QSO space densities and galaxy merger statistics. We discuss possible reasons for this difference. Finally, we compare the SMBH mass distributions of single and dual AGNs and find little difference between the two within the limited statistics of our program, hinting that most SMBH growth happens in the later stages of a merger process. [ABSTRACT FROM AUTHOR]

The Tower of Hanoi (ToH) task was given to 238 children aged from 7 to 15 years, and 20 adults. Individual variation within an age band was substantial. ToH score did not correlate significantly with Verbal IQ, nor with ability to inhibit a prepotent response. We readministered the ToH to 45 children after 30 to 40 days. The test-retest correlation of .5 is low in relation to accepted psychometric standards, though at least as high as reliability of the related Tower of London (ToL) in adults. The reasons for low reliability remain unclear; task novelty did not seem to be involved, as children did not improve on retest. We conclude that it is not safe to use this test to index integrity or maturation of underlying neurological systems in children. We compared our results with three published studies using the ToL with children, and found similar levels of performance on problems involving the same number of moves. Another study using automated ToL obtained much poorer scores, suggesting that computerised presentation may impair children's performance. [ABSTRACT FROM AUTHOR]

Purpose/objective(s): The majority of errors during radiation therapy (RT) treatment planning and associated quality assurance (QA) processes are ascribed to 'human error'. Most centers typically use in-house QA checklists but without formal human factors engineering evaluations. We herein comprehensively evaluate the perceived usability of a dosimetry-QA checklist and associated cognitive workload, performance, and patient safety in real clinical settings at an academic medical center.Materials/methods: Four dosimetrists (female = 2, male = 2) performed pre-treatment QA tasks on 76 different RT plans with varying degrees of difficulty (low (35), medium (35), and hard (6) based on subjective rating by physicists) in the clinic. For each plan, the perceived usability and workload were assessed using a variety of validated tools (see results). We compare these scores with the recommended standards in human-computer interaction and human factors and ergonomics. Performance was measured using the time taken to complete the QA tasks on 46 different RT plans. Patient safety was measured as the number of errors leading to patient harm.Results: See Table 1. The perceived usability of the dosimetry-QA checklist meets only 1 out of 6 standards assessed. The workload assessments are within the recommended standards. The average time taken to complete pre-treatment QA tasks is 37.25 minutes. No errors leading to patient harm were reported.Conclusion: Our institutional dosimetry-QA checklist has suboptimal usability, but the associated workload is acceptable. QA checklists should be evaluated for usability and redesigned to reduce the risk of human errors, which are likely, at least in part, to result from the use of sub optimally designed tools. Future studies evaluating the association between usability and workload of QA checklists with patient safety indicators may be helpful. [ABSTRACT FROM AUTHOR]

Incident learning is key to developing and maintaining quality and safety in healthcare. We aimed to characterize acute and sustained changes in incident submissions, point of incident origin/detection, severity and associated contributing factors during the COVID-19 pandemic. Hypothesis: The frequency and pattern of incident origin/detection were changed by altered workflows in response to COVID-19. Events from our experienced incident learning system were analyzed between three 12-month intervals: pre-COVID (March 1, 2019 – February 29, 2020), early-COVID (March 1, 2020 – February 28, 2021), and late-COVID (March 1, 2021 – February 28, 2022). In addition to review by the department quality and safety committee, at least two physicians reviewed all incidents. Using descriptive statistics and chi-square test as applicable, we compared the reporting rates, incident severity, contributing factors, points of origin/ detection according to time the pre-specified time intervals prior to and during COVID. See Table. During COVID the number of reported incidents, particularly incidents reaching the patient, markedly declined. The number of incidents per patient increased with early-COVID altered workflows. This suggests that existing quality and safety checks were effective during early-COVID. The point of incident origin was similar across time periods. During early-COVID, the point of incident detection shifted to earlier points in the care pathway (e.g., pre-RT chart checks vs chart checks during RT), p<0.001. During late-COVID, as clinical workflows adapted, the point of detection shifted to later in the care pathway consistent with pre-COVID patterns. During COVID, workload was implicated in fewer incidents (in the setting of reduced treatment volumes), while communication and hand-offs were more frequently cited as contributing factors (in the setting of remote work). Our data supports the utility of consistent standards, minimizing inter-provider variations and maintaining robust quality and safety checks to optimize communication and safe patient care in radiation oncology. [ABSTRACT FROM AUTHOR]

Culture is a key factor in maintaining high-quality care. We have instituted a series of mutually-reinforcing initiatives aimed to improve operations, and patient and staff safety. We herein review the impact of these initiatives on our Patient Safety Culture over 14 years. We hypothesize that these initiatives can lead to sustained improvements in Culture. In ≈ 2009, our department, with help of dedicated quality improvement coaches from our internal Division of Healthcare Engineering (with knowledge of Lean-Six Sigma and High Reliability methods and tools), instituted (and largely sustained) initiatives aimed to improve our operations, and to improve patient/staff safety; including: (a) daily multidisciplinary team huddles, (b) daily pre-planning /treatment peer review, (c) a robust Incident Learning System, (d) weekly meetings to review reported incidents, (e) monthly department-wide meetings to review the highlights from the weekly incident review meetings, (f) celebration/recognitions for staff participation and (g) leader Gemba walks. Culture was quantitatively assessed via the AHRQ (Agency for Healthcare Research and Quality) Patient Safety Culture Survey (with 51 questions) which was sent to the department every two years (2021 was skipped due to Covid). Changes in the summary survey results over time were assessed using 2-tailed chi-square. Within 2-4 years of starting of our initiatives, there was an increase in the number of survey respondents, and an increase in the % of favorable responses (vs. pre-initiative data from 2009), for most comparisons (see Table with representative data). The % favorable responses plateaued in ≈ 2013-2015, and there was a non-significant decline in % favorable responses in later years (vs. the high scores in 2015). A series of mutually reinforcing initiatives aimed to improve operations, and to improve patient/staff safety, can lead to improvements in Patient Safety Culture; and these improvements can be largely sustained over time. Some of the modest non-significant decline in later years may reflect staff changes, fatigue, increasing practice complexity, financial pressures, and/or Covid-related issues (in the 2022 survey). This speaks to the importance of maintaining quality/safety initiatives through transitions in leadership, staff and external stressors. [ABSTRACT FROM AUTHOR]

Purpose/objective(s): Incident learning is key to developing and maintaining quality and safety in healthcare. This work aims to quantify how submissions to our incident learning system and contributing factors for events have changed in the time of COVID.Materials/methods: Events from our incident learning system were analyzed for the 11 months pre-COVID (March 1, 2019 - January 31, 2020) and compared to 11 months during COVID (March 1, 2020 - January 31, 2021). Descriptive statistics were used to evaluate and compare the reporting rate, incident severity, contributing factors, and where in patient pathway the incident originated and was caught.Results: See Table.Conclusion: During COVID the number of reported incidents, particularly incidents reaching the patient, markedly declined. This is perhaps related to a decline in the number of treatments delivered during COVID and the presence of new COVID-related workflows. The site of origin of the incidents was similar pre- vs. during-COVID. However, the locations where incidents were caught (detected) shifted to more near-'end of the line' safeguards (e.g., pre-RT Physics and RTT chart checks & write-up), suggesting a potential degradation of safeguards present earlier in the process (e.g., pre-RT peer review, Dosimetry pre-RT check). Communication, hand-offs, and cross-coverage were more likely to be contributing factors during COVID which is most likely attributable to people working virtually/remotely during the pandemic. This emphasizes the need to reduce inter-provider variations, and consistent standards for communication and treatment. [ABSTRACT FROM AUTHOR]

Purpose: Pretreatment quality assurance (QA) of treatment plans often requires a high cognitive workload and considerable time expenditure. This study explores the use of machine learning to classify pretreatment chart check QA for a given radiation plan as difficult or less difficult, thereby alerting the physicists to increase scrutiny on difficult plans., Methods and Materials: Pretreatment QA data were collected for 973 cases between July 2018 and October 2020. The outcome variable, a degree of difficulty, was collected as a subjective rating by physicists who performed the pretreatment chart checks. Potential features were identified based on clinical relevance, contribution to plan complexity, and QA metrics. Five machine learning models were developed: support vector machine, random forest classifier, adaboost classifier, decision tree classifier, and neural network. These were incorporated into a voting classifier, where at least 2 algorithms needed to predict a case as difficult for it to be classified as such. Sensitivity analyses were conducted to evaluate feature importance., Results: The voting classifier achieved an overall accuracy of 77.4% on the test set, with 76.5% accuracy on difficult cases and 78.4% accuracy on less difficult cases. Sensitivity analysis showed features associated with plan complexity (number of fractions, dose per monitor unit, number of planning structures, and number of image sets) and clinical relevance (patient age) were sensitive across at least 3 algorithms., Conclusions: This approach can be used to equitably allocate plans to physicists rather than randomly allocate them, potentially improving pretreatment chart check effectiveness by reducing errors propagating downstream., (© 2023 The Authors.)

Objectives: Stereotactic body radiation therapy (SBRT) can improve therapeutic ratios and patient convenience, but delivering higher doses per fraction increases the potential for patient harm. Incident learning systems (ILSs) are being increasingly adopted in radiation oncology to analyze reported events. This study used an ILS coupled with a Human Factor Analysis and Classification System (HFACS) and barriers management to investigate the origin and detection of SBRT events and to elucidate how safeguards can fail allowing errors to propagate through the treatment process., Methods: Reported SBRT events were reviewed using an in-house ILS at 4 institutions over 2014-2019. Each institution used a customized care path describing their SBRT processes, including designated safeguards to prevent error propagation. Incidents were assigned a severity score based on the American Association of Physicists in Medicine Task Group Report 275. An HFACS system analyzed failing safeguards., Results: One hundred sixty events were analyzed with 106 near misses (66.2%) and 54 incidents (33.8%). Fifty incidents were designated as low severity, with 4 considered medium severity. Incidents most often originated in the treatment planning stage (38.1%) and were caught during the pretreatment review and verification stage (37.5%) and treatment delivery stage (31.2%). An HFACS revealed that safeguard failures were attributed to human error (95.2%), routine violation (4.2%), and exceptional violation (0.5%) and driven by personnel factors 32.1% of the time, and operator condition also 32.1% of the time., Conclusions: Improving communication and documentation, reducing time pressures, distractions, and high workload should guide proposed improvements to safeguards in radiation oncology., Competing Interests: B.S.C. and L.M.M. have a financial relationship (e.g., royalties and equity) with Communify Health, which provides software for incident reporting and analysis. The other authors disclose no conflict of interest., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Purpose/Objectives: Stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT) may be considered "high risk" due to the high doses per fraction. We analyzed CyberKnife™ (CK) SRS and SBRT-related incidents that were prospectively reported to our in-house incident learning system (ILS) in order to identify severity, contributing factors, and common error pathways. Material and Methods: From 2012 to 2019, 221 reported incidents related to the 4,569 CK fractions delivered (5.8%) were prospectively analyzed by our multi-professional Quality and Safety Committee with regard to severity, contributing factors, as well as the location where the incident occurred ( tripped ), where it was discovered ( caught ), and the safety barriers that were traversed (crossed) on the CK process map. Based on the particular step in the process map that incidents tripped , we categorized incidents into general error pathways. Results: There were 205 severity grade 1-2 (did not reach patient or no clinical impact), 11 grade 3 (clinical impact unlikely), 5 grade 4 (altered the intended treatment), and 0 grade 5-6 (life-threatening or death) incidents, with human performance being the most common contributing factor (79% of incidents). Incidents most commonly tripped near the time when the practitioner requested CK simulation (e.g., pre-CK simulation fiducial marker placement) and most commonly caught during the physics pre-treatment checklist. The four general error pathways included pre-authorization, billing, and scheduling issues ( n = 119); plan quality ( n = 30); administration of IV contrast during simulation or pre-medications during treatment ( n = 22); and image guidance ( n = 12). Conclusion: Most CK incidents led to little or no patient harm and most were related to billing and scheduling issues. Suboptimal human performance appeared to be the most common contributing factor to CK incidents. Additional study is warranted to develop and share best practices to reduce incidents to further improve patient safety., (Copyright © 2020 Mullins, Mazur, Dance, McGurk, Schreiber, Marks, Shen, Lawrence and Chera.)

Purpose: Ensuring safety within RT is of paramount importance. To further support and augment patient safety efforts, the purpose of this research was to test and refine a robust methodology for analyzing human errors that defeat individual controls within RT quality assurance (QA) programs., Methods: The method proposed for performing Bowtie Analysis (BTA) was based on training and recommendations from practitioners in the field of Human Factors and Ergonomics practice. Multidisciplinary meetings to iteratively develop BTA focused on incorrect site setup instructions was conducted., Results: From November 2015 to February 2017, we had 12 reported incidents related to site setup notes that could have led to site setup errors. Based on this data, we conducted five BTA analyses related to incorrect site setup instructions. None of the individual controls within our QA program designed to check for potential errors with site setup instructions met the level of robustness to be classified as key safeguards or barriers., Conclusions: The relatively low number of incidents causing patient harm has led us to typically assume that we have sufficient and effective controls in place to prevent serious human errors from leading to severe patient consequences. Based on our BTA, we question how well we truly understand the details of our individual controls. To meet the level of safety achieved by high reliability organizations (HROs), we need to better ensure that our controls are as reliable and robust as we assume., (Published by Elsevier Inc.)

The use of positron emission tomography (PET) in radiation therapy (RT) is rapidly increasing in the areas of staging, segmentation, treatment planning, and response assessment. The most common radiotracer is 18 F-fluorodeoxyglucose ([ 18 F]FDG), a glucose analog with demonstrated efficacy in cancer diagnosis and staging. However, diagnosis and RT planning are different endeavors with unique requirements, and very little literature is available for guiding physicists and clinicians in the utilization of [ 18 F]FDG-PET in RT. The two goals of this report are to educate and provide recommendations. The report provides background and education on current PET imaging systems, PET tracers, intensity quantification, and current utilization in RT (staging, segmentation, image registration, treatment planning, and therapy response assessment). Recommendations are provided on acceptance testing, annual and monthly quality assurance, scanning protocols to ensure consistency between interpatient scans and intrapatient longitudinal scans, reporting of patient and scan parameters in literature, requirements for incorporation of [ 18 F]FDG-PET in treatment planning systems, and image registration. The recommendations provided here are minimum requirements and are not meant to cover all aspects of the use of [ 18 F]FDG-PET for RT., (© 2019 American Association of Physicists in Medicine.)

The purpose of preclinical murine model development is to establish that the pathophysiological outcome of the rodent model of radiation-induced lung injury is sufficiently representative of the anticipated pulmonary response in the human population. This objective is based on concerns that the C57BL/6J strain may not be the most appropriate preclinical model of lethal radiation lung injury in humans. In this study, the authors assessed this issue by evaluating the relationship between morbidity (pulmonary function, histopathologic damage) and mortality among three strains of mice: C57BL/6J, CBA/J, and C57L/J. These different strains display variations in latency and phenotypic expression of radiation-induced lung damage. By comparing the response of each strain to the human pulmonary response, an appropriate animal model(s) of human radiation-induced pulmonary injury was established. Observations in the C57L/J and CBA/J murine models can be extrapolated to the human lung for evaluation of the mechanisms of action of radiation as well as future efficacy testing and approving agents that fall under the "Animal Rule" of the U.S. Food and Drug Administration (FDA) (21 CFR Parts 314 and 601).

Advances in large scale screening of medical countermeasures for radiation-induced normal tissue toxicity are currently hampered by animal irradiation paradigms that are both inefficient and highly variable among institutions. Here, a novel high-throughput small animal irradiation platform is introduced for use in orthovoltage small animal irradiators. Radiochromic film and metal oxide semiconductor field effect transistor detectors were used to examine several parameters, including 2D field uniformity, dose rate consistency, and shielding transmission. The authors posit that this setup will improve efficiency of drug screens by allowing for simultaneous targeted irradiation of multiple animals to improve efficiency within a single institution. Additionally, they suggest that measurement of the described parameters in all centers conducting countermeasure studies will improve the translatability of findings among institutions. The use of tissue equivalent phantoms in performing dosimetry measurements for small animal irradiation experiments was also investigated. Though these phantoms are commonly used in dosimetry, the authors recorded a significant difference in both the entrance and target tissue dose rates between euthanized rats and mice with implanted detectors and the corresponding phantom measurement. This suggests that measurements using these phantoms may not provide accurate dosimetry for in vivo experiments. Based on these measurements, the authors propose that this small animal irradiation platform can increase the capacity of animal studies by allowing for more efficient animal irradiation. They also suggest that researchers fully characterize the parameters of whatever radiation setup is in use in order to facilitate better comparison among institutions.

Background: Patient-centered measures of the inpatient neurorehabilitation experience are needed to assess services., Objective: The objective of this study was to develop a valid and reliable Neurorehabilitation Experience Questionnaire (NREQ) to assess whether neurorehabilitation inpatients experience service elements important to them., Methods: Based on the themes established in prior qualitative research, adopting questions from established inventories and using a literature review, a draft version of the NREQ was generated. Focus groups and interviews were conducted with 9 patients and 26 staff from neurological rehabilitation units to establish face validity. Then, 70 patients were recruited to complete the NREQ to ascertain reliability (internal and test-retest) and concurrent validity., Results: On the basis of the face validity testing, several modifications were made to the draft version of the NREQ. Subsequently, internal reliability (time 1 α = .76, time 2 α = .80), test retest reliability (r = 0.70), and concurrent validity (r = 0.32 and r = 0.56) were established for the revised version. Whereas responses were associated with positive mood (r = 0.30), they appeared not to be influenced by negative mood, age, education, length of stay, sex, functional independence, or whether a participant had been a patient on a unit previously., Conclusions: Preliminary validation of the NREQ suggests promise for use with its target population.

The purpose of this work was to create a computational platform for studying motion in intensity modulated radiotherapy (IMRT). Specifically, the non-uniform rational B-spline (NURB) cardiac and torso (NCAT) phantom was modified for use in a four-dimensional Monte Carlo (4D-MC) simulation system to investigate the effect of respiratory-induced intra-fraction organ motion on IMRT dose distributions as a function of diaphragm motion, lesion size and lung density. Treatment plans for four clinical scenarios were designed: diaphragm peak-to-peak amplitude of 1 cm and 3 cm, and two lesion sizes--2 cm and 4 cm diameter placed in the lower lobe of the right lung. Lung density was changed for each phase using a conservation of mass calculation. Further, a new heterogeneous lung model was implemented and tested. Each lesion had an internal target volume (ITV) subsequently expanded by 15 mm isotropically to give the planning target volume (PTV). The PTV was prescribed to receive 72 Gy in 40 fractions. The MLC leaf sequence defined by the planning system for each patient was exported and used as input into the MC system. MC simulations using the dose planning method (DPM) code together with deformable image registration based on the NCAT deformation field were used to find a composite dose distribution for each phantom. These composite distributions were subsequently analyzed using information from the dose volume histograms (DVH). Lesion motion amplitude has the largest effect on the dose distribution. Tumor size was found to have a smaller effect and can be mitigated by ensuring the planning constraints are optimized for the tumor size. The use of a dynamic or heterogeneous lung density model over a respiratory cycle does not appear to be an important factor with a

The choice of adjuvant hormone treatments in post-menopausal women with breast cancer increasingly includes anastrozole as an alternative to tamoxifen. Clearly there may be overlapping side-effects, but other important differences may have serious implications for health and quality of life. Patients consequently require information regarding the side-effects of recommended treatments and their comparisons. This study evaluates the extent of information provision about the side-effects of adjuvant anastrozole and tamoxifen by respective breast cancer professionals within 16 different breast care teams in the United Kingdom (UK). The study used interviews with individual members of breast cancer multidisciplinary teams (surgeons, oncologists and breast care nurses) from 11 cancer centres and 3 district general hospitals, to examine the information they give to patients relating to the side-effects of tamoxifen and anastrozole. The results show that vasomotor symptoms were the most frequently mentioned side-effect for both treatments. All teams, in large part addressed the adverse effects of both treatments (endometrial cancer and thrombo-embolic events for tamoxifen and anastrozole-associated loss of bone density). There was variation between the different professionals as to how frequently side-effects were mentioned. The greatest discrepancies occurred between the information given by team members and that included in patient information leaflets. In some cases, important information pertaining to side-effects was omitted from leaflets. This study suggests the need to standardise information-provision nationally in the UK and within breast cancer teams regarding the evidence-based side-effects of tamoxifen and anastrozole.

The aim of this study was to determine the treatment preferences (adjuvant goserelin or cyclophosphamide, methotrexate and fluorouracil (CMF) chemotherapy) of healthy premenopausal women should they hypothetically develop oestrogen-receptor (ER) positive early breast cancer. Two hundred pre or peri-menopausal women read two scenarios describing goserelin or chemotherapy. Information included: How and where treatments were administered, side-effects, their likely persistence and impact on fertility. Women stated their unprompted initial and final preferences with reasons for the choices made. Respondents showed an overwhelming preference for goserelin. 156 (78%) women favoured goserelin, 22 (11%) chemotherapy and 22 (11%) remained undecided (P<0.0001). Primary reasons for preferring goserelin for were 105 (71%) avoidance of chemotherapy side-effects, especially hair loss, perceived convenience and less disruption to normal life 54 (36%). The minority who preferred chemotherapy, valued the treatment finishing more quickly. These results together with clinical trial data showing equivalence of goserelin with CMF regimens suggest that premenopausal women with ER-positive tumours should at least be offered the choice of either adjuvant hormone therapy or chemotherapy.