Multi-Institutional Stereotactic Body Radiation Therapy Incident Learning: Evaluation of Safety Barriers Using a Human Factors Analysis and Classification System.

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.

The impact of pathologic staging of the hilar/mediastinal nodes on outcomes in patients with early-stage NSCLC receiving stereotactic body radiotherapy.

BACKGROUND: The importance of invasive mediastinal nodal staging in early-stage non-small cell lung cancer (NSCLC) in the PET/CT era is dependent on tumor factors that increase risk of nodal metastasis. At our institution, patients undergo biopsy via either CT-guidance (without nodal staging) or navigational bronchoscopy with endobronchial ultrasound transbronchial needle aspiration for nodal staging. This study aims to compare outcomes after stereotactic body radiotherapy (SBRT) stratified by receipt of invasive mediastinal nodal staging. METHODS: In this retrospective study, records of all consecutive patients undergoing SBRT for early-stage NSCLC between 2010 and 2017 were analyzed. The association between time-to event outcomes (recurrence and survival) were evaluated with covariates of interest including tumor size, location, histology, smoking history, prior lung cancer history, radiation dose and receipt of nodal staging. Both univariable and multivariable analyses were used to examine these comparisons. RESULTS: Overall, 158 patients were treated with SBRT. One hundred forty-nine out of one hundred fifty-eight patients (94%) underwent PET/CT staging, and all patients underwent tumor-directed biopsy. Seventy-nine patients underwent navigational bronchoscopy with nodal staging and 79 patients underwent CT-guided biopsy without nodal staging. Receipt of nodal staging was not associated with tumor size (P=0.35), yet was associated with central tumor location (P<0.001). There was no statistically significant association between receipt of nodal staging and time-to-event recurrence or survival outcomes; for example 3-year overall survival (OS) was 65% vs. 67% (P=0.65) and 3-year freedom from nodal failure was 84% vs. 69% (P=0.1) for those with and without nodal staging, respectively. CONCLUSIONS: Similar recurrence and survival outcomes were observed after SBRT regardless of receipt of invasive mediastinal nodal staging. Further prospective evaluation can help identify which patients might derive greatest benefit from invasive staging of the mediastinum in the PET/CT era.

Common Error Pathways in CyberKnife™ Radiation Therapy.

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.

Incorporating Human Factors Analysis and Classification System (HFACS) Into Analysis of Reported Near Misses and Incidents in Radiation Oncology.

PURPOSE: Human factors analysis and classification system (HFACS) is a framework for investigation into causation of human errors. We herein assess whether radiation oncology professionals, with brief training, can conduct HFACS on reported near misses or safety incidents (NMSIs) in a reliable (eg, with a high level of agreement) and practical (eg, timely and with user satisfaction) manner. METHODS AND MATERIALS: We adapted a classical HFACS framework by selecting and modifying main headings, subheadings, and nano-codes that were most likely to apply to radiation oncology settings. The final modified HFACS included 3 main headings, 8 subheadings, and 20 nano-codes. The modified HFACS was first tested in a simulated trial on 8 NMSI and was analyzed by 5 to 10 radiation oncology professionals, with 2 endpoints: (1) agreement among participants at the main-heading, subheading, and nano-code level, and (2) time to complete the analysis. We then performed a prospective trial integrating this approach into a weekly NMSI review meeting, with 10 NMSIs analyzed by 8 to 13 radiation oncology professionals with the same endpoints, while also collecting survey data on participants' satisfaction. RESULTS: In the simulated trial, agreement among participants was 85% on the main headings, 73% on the subheadings, and 70% on the nano-codes. Participants needed, on average, 16.4 minutes (standard deviation, 5.7 minutes) to complete an analysis. In the prospective trial, agreement between participants was 81% on the main headings, 75% on the subheadings, and 74% on the nano-codes. Participants needed, on average, 8.3 minutes (standard deviation, 4.7 minutes) to complete an analysis. The average satisfaction with the proposed HFACS approach was 3.9 (standard deviation 1.0) on a scale from 1 to 5. CONCLUSIONS: This study demonstrates that, after relatively brief training, radiation oncology professionals were able to perform HFACS analysis in a reliable and timely manner and with a relatively high level of satisfaction.

Hyperbaric oxygen therapy for radiation-induced brachial plexopathy, a case report and literature review.

AIM: To report a case of radiation-induced brachial plexopathy (RIBP) with significant radiographic and clinical improvement after a course of hyperbaric oxygen (HBO). BACKGROUND: RIBP is a rare complication after radiotherapy to the neck and axilla. There are no standard treatment options, with empirical use pharmacotherapy being predominately used, which has had mixed results.HBO is efficacious for the treatment of other severe radiation-induced side effects, however, its benefit in RIBP has conflicting reports. CASE PRESENTATION: A 45-year-old male, with a 33 pack-year smoking history, presented with a 6-month history of a progressive left neck mass. The final diagnosis was unknown primary squamous cell carcinoma of the head and neck. He received intensity-modulated radiation therapy (IMRT) with 70 Gy prescribed to the gross tumor volume (PTV HR) and 56 Gy to the oropharynx, nasopharynx, and bilateral lymphatics (PTV SR) in 35 daily fractions with three cycles of concurrent cisplatin at 100 mg/m2.Fifteen months following therapy completion, the patient began to endorse symptoms of left brachial plexopathy. Decadron was prescribed for 2 weeks, trental and vitamin E for 6 months, and HBO. The patient returned for follow-up 2 months after completing 30 dives of HBO at 2.4 atmospheres for 2 hours per session. He reported pain resolution and full range of motion of his left arm. CONCLUSIONS: The best management strategy of RIBP is prevention by reducing total RT doses and close follow-up. However, when RIBP occurs, we recommend treatment with HBO therapy, steroids, trental, and vitamin E as tolerable.

Increased radiation toxicity with germline ATM variant of uncertain clinical significance.

BACKGROUND: While patients with ataxia telangiectasia are known to have increased radiation sensitivity, patients with germline heterozygous ataxia telangiectasia mutated (ATM) mutations can have widely varying functional and clinical effects, which can make management decisions difficult. With an increased prevalence of gene panel-based testing for breast cancer patients, radiation oncologists are increasingly confronted with patients who carry germline ATM variants of uncertain clinical significance. This study describes the clinical courses and outcomes of 5 breast cancer patients with varying germline heterozygous ATM mutations undergoing radiation therapy at our institution in order to provide additional knowledge of the varying clinical effects to aid future decision making. CASE SERIES: We identified 5 patients with breast cancer and varying germline heterozygous ATM mutations treated at the University of North Carolina Hospitals between 2015 and 2017. The median age at breast cancer diagnosis for the patient series was 46. Clinical effects of radiation treatment varied amongst the 5 patients. The one patient with a pathogenic ATM mutation had no increased radiation related toxicity. Of the 4 patients with ATM variants of uncertain significance, one patient had increased radiation sensitivity with Grade 3 dermatitis. All patients have remained recurrence free with a median duration of 18 months. CONCLUSION: Our data illustrates that patients with germline heterozygous ATM mutations can have widely varying clinical effects with radiation therapy. Given the possibility of unpredictable deleterious effects, our study highlights the importance of caution and careful consideration when devising the multi-modality management strategy in these patients.

Human Error Bowtie Analysis to Enhance Patient Safety in Radiation Oncology.

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.

Patient-reported sexual quality of life after different types of radical prostatectomy and radiotherapy: Analysis of a population-based prospective cohort.

BACKGROUND: Although patients with prostate cancer face many treatment options, to the authors' knowledge the comparative effects of different surgical and radiotherapy (RT) options on sexual function are unclear. METHODS: In the current study, a population-based cohort of 835 men with newly diagnosed prostate cancer from 2011 through 2013 was recruited throughout North Carolina in collaboration with the Rapid Case Ascertainment system of the North Carolina Central Cancer Registry. All men were enrolled prior to treatment and followed prospectively using the validated Prostate Cancer Symptom Indices (PCSI) instrument. This analysis compares the sexual dysfunction scores of the PCSI among patients who received external-beam RT (EBRT), EBRT with androgen deprivation therapy (ADT), brachytherapy, nerve-sparing radical prostatectomy (RP), and non-nerve-sparing RP. Propensity scores were used to balance patient characteristics across groups, and multiple imputation was used for missing data. RESULTS: EBRT and brachytherapy resulted in similar PCSI scores through 24 months. Compared with those receiving EBRT, patients treated with EBRT with ADT and RP with or without nerve sparing were found to have worse PCSI scores at all posttreatment time points. Preservation of useful sexual function at 24 months was associated with treatment type, baseline score, and age. Predicted preservation rates were 14.1% to 70.7% for EBRT, 8.4% to 52.3% for EBRT with ADT, 4.7% to 45.3% for nerve-sparing RP, and 4.8% to 34.5% for non-nerve-sparing RP. CONCLUSIONS: The findings of the current study indicate that RT alone results in the best preservation of sexual function, and brachytherapy provides similar outcomes. RT with ADT and nerve-sparing RP yielded similar outcomes, whereas patients treated with non-nerve-sparing RP experienced the worst sexual function. These results help patients to make decisions among the specific types of surgery and RT they face based on each individual's diagnosis.

Safety and Efficacy of Accelerated Hypofractionation and Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma Patients With Varying Degrees of Hepatic Impairment.

PURPOSE: To report the toxicities and outcomes for stereotactic body radiation therapy (SBRT) and accelerated hypofractionated radiation therapy (AHRT) in patients with Child-Pugh (CP) class A, B, or C and albumin-bilirubin (ALBI) score 1, 2, or 3 hepatocellular carcinoma. METHODS AND MATERIALS: We retrospectively reviewed the data from 146 patients with hepatocellular carcinoma who had undergone SBRT (50 Gy in 5 fractions) or AHRT (45 Gy in 18 fractions). The primary endpoint was liver toxicity, defined as an increase in the CP score of ≥2 within 6 months of radiation therapy. The secondary endpoints of ALBI change, overall survival, and local control were also calculated. RESULTS: The median follow-up was 23 months (range 1-59). Most received SBRT (72%), and 28% received AHRT. Of all 146 patients, 45 (31%) had a CP score elevation of ≥2 within 6 months of radiation therapy (RT) (27 patients [28%] with baseline CP-A/B7 and 18 [35%] with baseline CP-B8/B9/C cirrhosis; P = .45). On multivariate analysis, neither baseline CP nor ALBI score was predictive of toxicity. No patient with a decline in liver functionality of CP ≥2 within 6 months of RT returned to baseline at later time points. Eleven grade 4 toxicities were observed. The mean change in the raw ALBI score at ∼6 months was similar for all baseline ALBI groups. Twenty-two patients underwent orthotopic liver transplantation after RT, 13 of whom had baseline CP-B8/B9/C liver functionality. For all patients, the 1- and 2-year treated-lesion local control was greater for SBRT than for AHRT (2-year 94% vs 65%, P < .0001). CONCLUSIONS: The tolerability of SBRT or AHRT as measured by a CP score decline of ≥2 within 6 months of RT was similar across baseline liver functionality groups. Compared with AHRT, SBRT was associated with superior local control. Because the true tolerability of limited-volume RT for patients with CP-B or CP-C cirrhosis is unknown, prospective trials validating its safety and efficacy are warranted.

Evaluation of PET/MRI for Tumor Volume Delineation for Head and Neck Cancer.

INTRODUCTION: Computed tomography (CT), combined positron emitted tomography and CT (PET/CT), and magnetic resonance imaging (MRI) are commonly used in head and neck radiation planning. Hybrid PET/MRI has garnered attention for potential added value in cancer staging and treatment planning. Herein, we compare PET/MRI vs. planning CT for head and neck cancer gross tumor volume (GTV) delineation. MATERIAL AND METHODS: We prospectively enrolled patients with head and neck cancer treated with definitive chemoradiation to 60-70 Gy using IMRT. We performed pretreatment contrast-enhanced planning CT and gadolinium-enhanced PET/MRI. Primary and nodal volumes were delineated on planning CT (GTV-CT) prospectively before treatment and PET/MRI (GTV-PET/MRI) retrospectively after treatment. GTV-PET/MRI was compared to GTV-CT using separate rigid registrations for each tumor volume. The Dice similarity coefficient (DSC) metric evaluating spatial overlap and modified Hausdorff distance (mHD) evaluating mean orthogonal distance difference were calculated. Minimum dose to 95% of GTVs (D95) was compared. RESULTS: Eleven patients were evaluable (10 oropharynx, 1 larynx). Nine patients had evaluable primary tumor GTVs and seven patients had evaluable nodal GTVs. Mean primary GTV-CT and GTV-PET/MRI size were 13.2 and 14.3 cc, with mean intersection 8.7 cc, DSC 0.63, and mHD 1.6 mm. D95 was 65.3 Gy for primary GTV-CT vs. 65.2 Gy for primary GTV-PET/MRI. Mean nodal GTV-CT and GTV-PET/MRI size were 19.0 and 23.0 cc, with mean intersection 14.4 cc, DSC 0.69, and mHD 2.3 mm. D95 was 62.3 Gy for both nodal GTV-CT and GTV-PET/MRI. CONCLUSION: In this series of patients with head and neck (primarily oropharynx) cancer, PET/MRI and CT-GTVs had similar volumes (though there were individual cases with larger differences) with overall small discrepancies in spatial overlap, small mean orthogonal distance differences, and similar radiation doses.

Malignant peripheral nerve sheath tumors of the head and neck: a case series and literature review.

Background. Malignant peripheral nerve sheath tumors (MPNSTs) of the head and neck are rare aggressive neoplasms with a poor prognosis. This study describes the management and outcomes of 3 of our patients with MPNSTs of the head and neck. Methods. We identified 3 patients presenting with MPNST of the head and neck and treated at the University of North Carolina. We compared our results to the literature from 1963 to 2014. Results. Mean follow-up was 31 months. Average age at diagnosis was 44.7 years of age. All patients received wide-local excision and adjuvant radiotherapy. No patients recurred during the series. Recurrence-free survival time for the patients was 45, 37, and 3 months, respectively. Conclusions. Our data series confirms that a combined-modality approach with complete surgical resection and adjuvant radiotherapy leads to improved outcomes in MPNSTs of the head and neck. Nonetheless, due to historically poor outcomes, continued research into newer therapies needs to be explored.

Adult alveolar soft part sarcoma of the head and neck: a report of two cases and literature review.

Background. Alveolar soft part sarcomas (ASPS) of the head and neck are rare, aggressive soft-tissue malignancies. This study describes the clinical course and management of two patients presenting with ASPS in very rare head and neck locations, the larynx and parotid gland. Methods. We identified two patients presenting with ASPS of the head and neck and treated at the University of North Carolina. We compared our results to the literature from 1987 to 2013. Results. Patient ages at diagnosis were 27 and 39 with presenting symptoms of hoarseness and parotid swelling, respectively. Mean follow-up was 87 months. All patients received surgical resection and adjuvant radiotherapy. There were no recurrences or evidence of distant metastatic spread during the series. Disease-free survival time for the patients was 4 months and 168 months, respectively. Conclusions. Our study suggests that a combined-modality approach is important in the treatment of ASPS of the head and neck even in these rare locations. Continued research into new therapies is necessary to improve historically poor outcomes.