Beatrice Bloom

Pathology concordance levels for meningioma classification and grading in NRG Oncology RTOG Trial 0539

BACKGROUND With advances in the understanding of histopathology on outcome, accurate meningioma grading becomes critical and drives treatment selection. The 2000 and 2007 WHO schema greatly increased the proportion of grade II meningiomas. Although associations with progression-free survival (PFS) and overall survival (OS) have been independently validated, interobserver concordance has not been formally assessed. METHODS Once mature, NRG Oncology RTOG-0539 will report PFS and OS in variably treated low-, intermediate-, and high-risk cohorts. We address concordance of histopathologic assessment between enrolling institutions and central review, performed by a single pathologist (AP), who is also involved in developing current WHO criteria. RESULTS The trial included 170 evaluable patients, 2 of whom had 2 eligible pathology reviews from different surgeries, resulting in 172 cases for analysis. Upon central review, 76 cases were categorized as WHO grade I, 71 as grade II, and 25 as grade III. Concordance for tumor grade was 87.2%. Among patients with WHO grades I, II, and III meningioma, respective concordance rates were 93.0%, 87.8%, and 93.6% (P values < .0001). Moderate to substantial agreement was encountered for individual grading criteria and were highest for brain invasion, ≥20 mitoses/10 high-powered field [HPF], and spontaneous necrosis, and lowest for small cells, sheeting, and ≥4 mitoses/10 HPF. In comparison, published concordance for gliomas in clinical trials have ranged from 8%-74%. CONCLUSION Our data suggest that current meningioma classification and grading are at least as objective and reproducible as for gliomas. Nevertheless, reproducibility remains suboptimal. Further improvements may be anticipated with education and clarification of subjective criteria, although development of biomarkers may be the most promising strategy.

Incident Learning and Failure-Mode-and-Effects-Analysis Guided Safety Initiatives in Radiation Medicine

By combining incident learning and process failure-mode-and-effects-analysis (FMEA) in a structure-process-outcome framework we have created a risk profile for our radiation medicine practice and implemented evidence-based risk-mitigation initiatives focused on patient safety. Based on reactive reviews of incidents reported in our departmental incident-reporting system and proactive FMEA, high safety-risk procedures in our paperless radiation medicine process and latent risk factors were identified. Six initiatives aimed at the mitigation of associated severity, likelihood-of-occurrence, and detectability risks were implemented. These were the standardization of care pathways and toxicity grading, pre-treatment-planning peer review, a policy to thwart delay-rushed processes, an electronic whiteboard to enhance coordination, and the use of six sigma metrics to monitor operational efficiencies. The effectiveness of these initiatives over a 3-years period was assessed using process and outcome specific metrics within the framework of the department structure. There has been a 47% increase in incident-reporting, with no increase in adverse events. Care pathways have been used with greater than 97% clinical compliance rate. The implementation of peer review prior to treatment-planning and use of the whiteboard have provided opportunities for proactive detection and correction of errors. There has been a twofold drop in the occurrence of high-risk procedural delays. Patient treatment start delays are routinely enforced on cases that would have historically been rushed. Z-scores for high-risk procedures have steadily improved from 1.78 to 2.35. The initiatives resulted in sustained reductions of failure-mode risks as measured by a set of evidence-based metrics over a 3-years period. These augment or incorporate many of the published recommendations for patient safety in radiation medicine by translating them to clinical practice.

Prospective contouring rounds: A novel, high-impact tool for optimizing quality assurance

PURPOSE This study was designed to present the results of a novel prospective contouring rounds (CR), in which peer review occurs once the contours and written directive are completed but before initiation of treatment planning. METHODS AND MATERIALS Beginning in 2012, all patients undergoing conventionally fractionated radiation therapy at a high-volume academic center were reviewed in a newly initiated daily, prospective, multidisciplinary CR. Cases were scheduled for presentation 2 days after simulation with the expectation that contours would be complete. The clinical suitability of the clinical plan, prescription, contours, and written directive were evaluated and recorded in a prospective database. Treatment planning did not commence until CR approval. Patient information and the prospective database from the first 6 months since program inception, which represented 581 consecutive treatment plans, were pooled and analyzed retrospectively to determine the impact of the prospective peer review at this stage of care delivery. RESULTS Sixty-four percent of cases were completed on time without correction. The remaining 36% of cases required modification before treatment planning was initiated. Incomplete contours, target-volume modifications, and alterations to the written directive were the most common corrections or reasons for delay. Decreasing rates of incomplete contours, contour modifications, and miscellaneous delays were seen over time as the program became established. The percentage of cases that had no delays or modifications increased continuously as the program matured in the first 6 months, from 59% to 70%. CONCLUSIONS Prospective CR is a meaningful and impactful tool in the quality assurance process. More than one-third of cases required contour, directive, or scheduling modification. The establishment of CR improved quality of care, with the percentage of timely, errorless cases increasing steadily over time. The impact of clinical peer review may be optimized by implementation at this early stage of delivery of care rather than at the time of traditional chart rounds.

Screening for depression in cancer patients receiving radiotherapy: Feasibility and identification of effective tools in the NRG Oncology RTOG 0841 trial

Brief tools are needed to screen oncology outpatients for depressive symptoms.

Our Pledge to Achieve Safety

It has become glaringly apparent that delivering safe radiation therapy is more complex and associated with more risk than was previously understood. The public exegesis of several treatment transgressions has identified both the spectacular natureof andtheunfortunate aspectsofradiation therapy failures (1). Therecognitionofthesefailureshasbeenatransformative event for the field of industrial and systems engineering in radiation oncology. Engineering and manufacturing processes have become the new language for clinical operations and patient care. Much is discussed about the departmental safety culture in which resetting the traditional norms defines and influences operational behaviors. As a result, we would expect that radiation oncology facilities in the United States have had fresh discussions about safety and have very likely reinforced rules, policies, or processes hoping to mitigate risk. But has this resulted in safer radiation therapy? We are still learning about risk mitigation and how best to implement processes without being disruptive to the needed efficiency of a busy clinical practice. Information from event-reporting databases, discussions at national meetings, failure modes and effects analysis, and root cause analysis studies are yielding important information that will establish and advance operational performance for radiation oncology. Nonetheless, we remain in the no man’s land between our aspirations for evidence-based improvements and public expectations for patient safety vs. actual performance outcomes. Our department has reconstructed every aspect of care from the initial consultation to the initiation, continuation, and completion of therapy and developed a quality checklist approach to verify that all aspects of care are addressed and completed (2, 3). We have implemented interlocks (the ‘‘no-fly’’ policy) for treatment initiation when certain items are incomplete and perform root cause analysis rounds weekly for each noncompliant event. We have spent the last 18 months using our multicenter clinic to quantify and process the operations of radiation oncology, in an effort to distill the essence of what is necessary to mitigate risk while maintaining efficient and forwardlooking operations. We decided that the six-sigma approach toward processdriven operations such as radiation therapy provides the most robust tool to improve quality and safety performance. Implementation of this process included education and detailed instructions, along with several safety-first initiatives. The department’s paperless environment allows us to calculate our compliance and efficiency using a monthly Z-score. Yet, several months after the kickoff of this process, wewere disappointed that our Z-scores barely changed. These results appear to indicate that policies and procedures to improve quality may be ineffective for that purpose.

Palliative treatment directives for bone metastases: A quality-directed approach to guiding institutional practice.

188 Background: The efficacy of single fraction (fx) radiation treatment (RT) has proven to have equipoise for palliation of bone metastases when compared to courses of 10 fx or more. Despite these data, there has been a slow adoption of this practice in the US and worldwide. Examination of our multicenter practice from 2004 - 2016 showed that single fx RT utilization has remained at 17% and hypofractionationed (HFX) courses (1 or 5 fx) have remained at 71% since 2009. We hypothesized that evidence-based, treatment-guiding directives could improve HFX utilization in this population. METHODS Institutionally, palliative bone metastasis treatments are routinely tracked by a Quality Assurance committee. In 2/2016, two consensus-driven and evidence-based clinical directives were created within our electronic health system for use with either simple or complicated bone metastasis, irrespective of primary histology. The simple and complex directives had default prescriptions of 8 Gy/1fx or 20 Gy/5fx, respectively. The directives were reviewed with physician staff to improve compliance; directives were allowed to be edited at the physicians discretion if an alternative fx was indicated. The chi-square test was used for analysis. RESULTS From 1/2009-5/2016, there were 1,781 treatment courses of palliative external beam RT. Following implementation in 2/2016, the new clinical directives were used for 96% of cases and were modified in 12 cases (n = 72). Single fx use increased from 17% to 36% among palliative bone metastasis treatments (p ≤ 0.001) and HFX (1 or 5 fx) utilization increased from 71% to 92% compared to other fractionation schemes (10 fx or other) (p = 0.001). CONCLUSIONS The institution-wide adoption of evidence-based, treatment directives proved to be a straightforward and successful intervention which allowed for rapid adoption and increased utilization of the standard of care. Our early data suggests that this may be a useful approach in the setting of reticence to new treatment paradigms. Further examination of evidence based directives is warranted to address issues of overtreatment in palliation and in standardizing oncologic care.

Root-cause and failure-mode analyses with an in-house incident reporting system: Comparison of its structure with ASTRO RO-ILS.

163 Background: In industries with well-established processes for failure analyses, incident reporting systems facilitate analyzing root causes of adverse or near-miss events, and the dissemination of lessons learned. Such a system is now being promoted in radiation medicine as patient safety and care quality come into focus in clinical practice. METHODS An incident reporting system has been in place in our department since 2010 for staff to report actual or near-miss events. A quality management committee was concurrently established to review reported incidents on a weekly basis. A taxonomy of root causes was set up to analyze and categorize root causes of incidents. This taxonomy is compared to that of the 2012 consensus recommendations for incident learning database (Ford et al.) which was the basis of ASTRO RO-ILS currently in prototype phase. RESULTS To date, over 2,000 incidents have been analyzed in our in-house system. The majority of the reported incidents pertain to procedural mis-steps or miss-cues in the process leading up to patient treatment, resulting in delays. Identifying the root causes has helped re-engineer or fine-tune department processes and has resulted in smoother clinical operations (e.g., obtaining third-party imaging prior to making treatment appointments) as well as more safety checks (e.g., pace-maker alerts.) Our taxonomy of root causes is multi-dimensional and quite specific to clinical radiation oncology, e.g., drilling down to specific morbidities. In comparison, the taxonomy of causes in the RO-ILS is more generic and at a higher level (e.g., procedural or technical issues). The RO-ILS has at most second-degree branches compared with our taxonomy of 6-8 degrees in depth. CONCLUSIONS Incident reporting is vital in analyzing and learning from reported events. Process changes in our clinic has been aided by the incident database and a hierarchical taxonomy between 6 to 8 degrees in root causes. The RO-ILS system in prototype is only 2 degrees deep. While the RO-ILS system appears capable of cataloging data from multiple centers, it is not clear that it will be able to understand or affect meaningful process changes given its lack of depth.