Ralph P. Ermoian

Measurable improvement in patient safety culture: A departmental experience with incident learning

PURPOSE Rigorous use of departmental incident learning is integral to improving patient safety and quality of care. The goal of this study was to quantify the impact of a high-volume, departmental incident learning system on patient safety culture. METHODS AND MATERIALS A prospective, voluntary, electronic incident learning system was implemented in February 2012 with the intent of tracking near-miss/no-harm incidents. All incident reports were reviewed weekly by a multiprofessional team with regular department-wide feedback. Patient safety culture was measured at baseline with validated patient safety culture survey questions. A repeat survey was conducted after 1 and 2 years of departmental incident learning. Proportional changes were compared by χ(2) or Fisher exact test, where appropriate. RESULTS Between 2012 and 2014, a total of 1897 error/near-miss incidents were reported, representing an average of 1 near-miss report per patient treated. Reports were filed by a cross section of staff, with the majority of incidents reported by therapists, dosimetrists, and physicists. Survey response rates at baseline and 1 and 2 years were 78%, 80%, and 80%, respectively. Statistically significant and sustained improvements were noted in several safety metrics, including belief that the department was openly discussing ways to improve safety, the sense that reports were being used for safety improvement, and the sense that changes were being evaluated for effectiveness. None of the surveyed dimensions of patient safety culture worsened. Fewer punitive concerns were noted, with statistically significant decreases in the worry of embarrassment in front of colleagues and fear of getting colleagues in trouble. CONCLUSIONS A comprehensive incident learning system can identify many areas for improvement and is associated with significant and sustained improvements in patient safety culture. These data provide valuable guidance as incident learning systems become more widely used in radiation oncology.

Practice patterns of photon and proton pediatric image guided radiation treatment: Results from an International Pediatric Research Consortium

PURPOSE Image guided radiation therapy (IGRT) has become common practice for both photon and proton radiation therapy, but there is little consensus regarding its application in the pediatric population. We evaluated clinical patterns of pediatric IGRT practice through an international pediatrics consortium comprised of institutions using either photon or proton radiation therapy. METHODS AND MATERIALS Seven international institutions with dedicated pediatric expertise completed a 53-item survey evaluating patterns of IGRT use in definitive radiation therapy for patients ≤21 years old. Two institutions use proton therapy for children and all others use IG photon therapy. Descriptive statistics including frequencies of IGRT use and means and standard deviations for planning target volume (PTV) margins by institution and treatment site were calculated. RESULTS Approximately 750 pediatric patients were treated annually across the 7 institutions. IGRT was used in tumors of the central nervous system (98%), abdomen or pelvis (73%), head and neck (100%), lung (83%), and liver (69%). Photon institutions used kV cone beam computed tomography and kV- and MV-based planar imaging for IGRT, and all proton institutions used kV-based planar imaging; 57% of photon institutions used a specialized pediatric protocol for IGRT that delivers lower dose than standard adult protocols. Immobilization techniques varied by treatment site and institution. IGRT was utilized daily in 45% and weekly in 35% of cases. The PTV margin with use of IGRT ranged from 2 cm to 1 cm across treatment sites and institution. CONCLUSIONS Use of IGRT in children was prevalent at all consortium institutions. There was treatment site-specific variability in IGRT use and technique across institutions, although practices varied less at proton facilities. Despite use of IGRT, there was no consensus of optimum PTV margin by treatment site. Given the desire to restrict any additional radiation exposure in children to instances where the exposure is associated with measureable benefit, prospective studies are warranted to optimize IGRT protocols by modality and treatment site.

Targeting safety improvements through identification of incident origination and detection in a near-miss incident learning system.

PURPOSE Radiation treatment planning involves a complex workflow that has multiple potential points of vulnerability. This study utilizes an incident reporting system to identify the origination and detection points of near-miss errors, in order to guide their departmental safety improvement efforts. Previous studies have examined where errors arise, but not where they are detected or applied a near-miss risk index (NMRI) to gauge severity. METHODS From 3/2012 to 3/2014, 1897 incidents were analyzed from a departmental incident learning system. All incidents were prospectively reviewed weekly by a multidisciplinary team and assigned a NMRI score ranging from 0 to 4 reflecting potential harm to the patient (no potential harm to potential critical harm). Incidents were classified by point of incident origination and detection based on a 103-step workflow. The individual steps were divided among nine broad workflow categories (patient assessment, imaging for radiation therapy (RT) planning, treatment planning, pretreatment plan review, treatment delivery, on-treatment quality management, post-treatment completion, equipment/software quality management, and other). The average NMRI scores of incidents originating or detected within each broad workflow area were calculated. Additionally, out of 103 individual process steps, 35 were classified as safety barriers, the process steps whose primary function is to catch errors. The safety barriers which most frequently detected incidents were identified and analyzed. Finally, the distance between event origination and detection was explored by grouping events by the number of broad workflow area events passed through before detection, and average NMRI scores were compared. RESULTS Near-miss incidents most commonly originated within treatment planning (33%). However, the incidents with the highest average NMRI scores originated during imaging for RT planning (NMRI = 2.0, average NMRI of all events = 1.5), specifically during the documentation of patient positioning and localization of the patient. Incidents were most frequently detected during treatment delivery (30%), and incidents identified at this point also had higher severity scores than other workflow areas (NMRI = 1.6). Incidents identified during on-treatment quality management were also more severe (NMRI = 1.7), and the specific process steps of reviewing portal and CBCT images tended to catch highest-severity incidents. On average, safety barriers caught 46% of all incidents, most frequently at physics chart review, therapists chart check, and the review of portal images; however, most of the incidents that pass through a particular safety barrier are not designed to be capable of being captured at that barrier. CONCLUSIONS Incident learning systems can be used to assess the most common points of error origination and detection in radiation oncology. This can help tailor safety improvement efforts and target the highest impact portions of the workflow. The most severe near-miss events tend to originate during simulation, with the most severe near-miss events detected at the time of patient treatment. Safety barriers can be improved to allow earlier detection of near-miss events.

Patterns of Care in Proton Radiation Therapy for Pediatric Central Nervous System Malignancies

PURPOSE Proton beam therapy (PBT) potentially allows for improved sparing of normal tissues, hopefully leading to decreased late side effects in children. Using a national registry, we sought to perform a patterns-of-care analysis for children receiving PBT for primary malignancies of the central nervous system (CNS). METHODS AND MATERIALS Using the National Cancer Data Base, we identified pediatric patients with primary CNS malignancies that were diagnosed between 2004 and 2012. We used a standard t test for comparison of means and χ2 testing to identify differences in demographic and clinical characteristics. Univariate and multivariate logistical regression was applied to identify predictors of PBT use. RESULTS We identified 4637 pediatric patients receiving radiation therapy from 2004 to 2012, including a subset of 267 patients treated with PBT. We found that PBT use increased with time from <1% in 2004 to 15% in 2012. In multivariate logistical regression, we found the following to be predictors of receipt of PBT: private insurance, the highest income bracket, younger age, living in a metropolitan area, and residing >200 miles from a radiation treatment facility (P<.05). CONCLUSIONS We noted the proportion of children receiving PBT to be significantly increasing over time from <1% to 15% from 2004 to 2012. We also observed important disparities in receipt of PBT based on socioeconomic status. Children from higher-income households and with private insurance were more likely to use this expensive technology. As we continue to demonstrate the potential benefits of PBT in children, efforts are needed to expand the accessibility of PBT for children of all socioeconomic backgrounds and regions of the country.

Total Body Irradiation Is Safe and Similarly Effective as Chemotherapy-Only Conditioning in Autologous Stem Cell Transplantation for Mantle Cell Lymphoma

Autologous stem cell transplant (ASCT) consolidation has become a standard approach for patients with mantle cell lymphoma (MCL), yet there is little consensus on the role of total body irradiation (TBI) as part of high-dose transplantation conditioning. We analyzed 75 consecutive patients with MCL who underwent ASCT at our institution between 2001 and 2011 with either TBI-based (n = 43) or carmustine, etoposide, cytarabine, melphalan (BEAM; n = 32) high-dose conditioning. Most patients (97%) had chemosensitive disease and underwent transplantation in first remission (89%). On univariate analysis, TBI conditioning was associated with a trend toward improved PFS (hazard ratio [HR], .53; 95% confidence interval [CI], .28-1.00; P = .052) and similar OS (HR, .59; 95% CI, .26-1.35; P = .21), with a median follow-up of 6.3 years in the TBI group and 6.6 years in the BEAM group. The 5-year PFS was 66% in the TBI group versus 52% in the BEAM group; OS was 82% versus 68%, respectively. However, on multivariate analysis, TBI-based conditioning was not significantly associated with PFS (HR, .57; 95% CI .24-1.34; P = .20), after controlling for age, disease status at ASCT, and receipt of post-transplantation rituximab maintenance. Likewise, early toxicity, nonrelapse mortality, and secondary malignancies were similar in the 2 groups. Our data suggest that both TBI and BEAM-based conditioning regimens remain viable conditioning options for patients with MCL undergoing ASCT.

45 Gy is not sufficient radiotherapy dose for Group III orbital embryonal rhabdomyosarcoma after less than complete response to 12 weeks of ARST0331 chemotherapy: A report from the Soft Tissue Sarcoma Committee of the Children's Oncology Group

Recent Childrens Oncology Group (COG) trials tested the efficacy of reduced therapy in an effort to lessen late effects compared to the Intergroup Rhabdomyosarcoma Study (IRS) IV regimen with associated hematologic and hepatic toxicity, and infertility. Here, we analyze the efficacy of 45 Gray (Gy) local radiotherapy (RT) in patients with Group III orbital embryonal rhabdomyosarcoma (ERMS) enrolled on the COG low‐risk study ARST0331.

Practice patterns of palliative radiation therapy in pediatric oncology patients in an international pediatric research consortium

The practice of palliative radiation therapy (RT) is based on extrapolation from adult literature. We evaluated patterns of pediatric palliative RT to describe regimens used to identify opportunity for future pediatric‐specific clinical trials.

Ocular prostate cancer metastasis treated with external beam radiation.

PURPOSE The purpose of this study was to report a rare case of ocular metastasis from prostate cancer treated successfully with external beam radiation therapy. METHODS Case report and literature review. PATIENT A 60-year-old man with a history of metastatic castration-resistant prostate cancer presented with decreased visual acuity in the right eye. Ophthalmoscopic examination showed a choroidal mass with characteristic surface retinal pigment epithelium spots (leopard spots), consistent with a metastatic tumor. The patient was treated with external beam radiation therapy. He had a dramatic improvement in visual acuity within 4 weeks of completing radiation treatment. Two and half years from radiation treatment to the right eye, he has maintained excellent vision (20/20 with best correction) in spite of systemic disease progression. CONCLUSION Uveal metastasis is a rare cause of unexplained blurred vision in the setting of metastatic adenocarcinoma of prostate. Palliative external beam radiotherapy provides effective and durable relief of symptoms during treatment and is generally a well-tolerated regimen with low risk of long-term morbidity.

An update from the Pediatric Proton Consortium Registry

Background/objectives The Pediatric Proton Consortium Registry (PPCR) was established to expedite proton outcomes research in the pediatric population requiring radiotherapy. Here, we introduce the PPCR as a resource to the oncology community and provide an overview of the data available for further study and collaboration. Design/methods A multi-institutional registry of integrated clinical, dosimetric, radiographic, and patient-reported data for patients undergoing proton radiation therapy was conceived in May 2010. Massachusetts General Hospital began enrollment in July of 2012. Subsequently, 12 other institutions joined the PPCR and activated patient accrual, with the latest joining in 2017. An optional patient-reported quality of life (QoL) survey is currently implemented at six institutions. Baseline health status, symptoms, medications, neurocognitive status, audiogram findings, and neuroendocrine testing are collected. Treatment details of surgery, chemotherapy, and radiation therapy are documented and radiation plans are archived. Follow-up is collected annually. Data were analyzed 25 September, 2017. Results A total of 1,854 patients have consented and enrolled in the PPCR from October 2012 until September 2017. The cohort is 55% male, 70% Caucasian, and comprised of 79% United States residents. Central nervous system (CNS) tumors comprise 61% of the cohort. The most common CNS histologies are as follows: medulloblastoma (n = 276), ependymoma (n = 214), glioma/astrocytoma (n = 195), craniopharyngioma (n = 153), and germ cell tumors (n = 108). The most common non-CNS tumors diagnoses are as follows: rhabdomyosarcoma (n = 191), Ewing sarcoma (n = 105), Hodgkin lymphoma (n = 66), and neuroblastoma (n = 55). The median follow-up is 1.5 years with a range of 0.14 to 4.6 years. Conclusion A large prospective population of children irradiated with proton therapy has reached a critical milestone to facilitate long-awaited clinical outcomes research in the modern era. This is an important resource for investigators both in the consortium and for those who wish to access the data for academic research pursuits.

Children's Oncology Group L991 final study report: Establishing an important benchmark for assessing late effects of trimodality care of pediatric patients treated for high grade gliomas

As advances are made in children’s cancer care, there will be growing numbers of adult survivors of pediatric cancer. In the United States, the number of adult survivors of pediatric cancers is approaching 300,000 (1). According to the National Cancer Institute’s Surveillance Epidemiology and End Result’s Cancer Statistics Review 1975-2008, the 5 year overall survival rate for children with brain tumors has risen from 58.8 % in 1975-1977 to 75% from 2001-2007 (2). With improved survivorship from childhood cancers, researchers have generated an abundance of literature pertaining to quality of life. A PubMed literature search with the terms “childhood cancer survivors quality of life” yields 420 citations. Studies focus on late effects in nearly every organ system, secondary malignancies, fertility, productivity, socioeconomic impact, and numerous other effects.