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.

Assessment of Risk of Xerostomia After Whole-Brain Radiation Therapy and Association With Parotid Dose.

Importance: Whole-brain radiation therapy (WBRT) delivers a substantial radiation dose to the parotid glands, but the parotid glands are not delineated for avoidance and xerostomia has never been reported as an adverse effect. Minimizing the toxic effects in patients receiving palliative treatments, such as WBRT, is crucial. Objective: To assess whether xerostomia is a toxic effect of WBRT. Design, Setting, and Participants: This observational cohort study enrolled patients from November 2, 2015, to March 20, 2018, at 1 academic center (University of North Carolina Hospitals) and 2 affiliated community hospitals (High Point Regional Hospital and University of North Carolina Rex Hospital). Adult patients (n = 100) receiving WBRT for the treatment or prophylaxis of brain metastases were enrolled. Patients who had substantial baseline xerostomia or did not complete WBRT or at least 1 postbaseline questionnaire were prospectively excluded from analysis and follow-up. Patients received 3-dimensional WBRT using opposed lateral fields covering the skull and the C1 or C2 vertebra. Per standard practice, the parotid glands were not prospectively delineated. Main Outcomes and Measures: Patients completed the University of Michigan Xerostomia Questionnaire and a 4-point bother score at baseline, immediately after WBRT, at 1 month, at 3 months, and at 6 months. The primary end point was the 1-month xerostomia score, with a hypothesized worsening score of 10 points from baseline. Results: Of the 100 patients enrolled, 73 (73%) were eligible for analysis and 55 (55%) were evaluable at 1 month. The 73 patients included 43 women (59%) and 30 men (41%) with a median (range) age of 61 (23-88) years. The median volume of parotid receiving at least 20 Gy (V20Gy) was 47%. The mean xerostomia score was 7 points at baseline and was statistically significantly higher at each assessment period, including 21 points immediately after WBRT (95% CI, 16-26; P < .001), 23 points (95% CI, 16-30; P < .001) at 1 month, 21 points (95% CI, 13-28; P < .001) at 3 months, and 14 points (95% CI, 7-21; P = .03) at 6 months. At 1 month, the xerostomia score increased by 20 points or more in 19 patients (35%). The xerostomia score at 1 month was associated with parotid dose as a continuous variable and was 35 points in patients with parotid V20Gy of 47% or greater, compared with only 9 points in patients with parotid V20Gy less than 47% (P < .001). The proportion of patients who self-reported to be bothered quite a bit or bothered very much by xerostomia at 1 month was 50% in those with parotid V20Gy of 47% or greater, compared with only 4% in those with parotid V20Gy less than 47% (P < .001). At 3 months, this difference was 50% vs 0% (P = .001). Xerostomia was not associated with medication use. Conclusions and Relevance: Clinically significant xerostomia occurred by the end of WBRT, appeared to be persistent, and appeared to be associated with parotid dose. The findings from this study suggest that the parotid glands should be delineated for avoidance to minimize these toxic effects in patients who undergo WBRT and often do not survive long enough for salivary recovery.

The Persistent Problem of Local/Regional Failure After Surgical Intervention for Early-Stage Lung Cancer.

BACKGROUND: The goal of the present study was to estimate the rate of local/regional failure (LRF) after definitive surgical intervention for early-stage non-small cell lung cancer (NSCLC), without postoperative radiotherapy, in the era of contemporary imaging and minimally invasive surgical techniques. METHODS: Medical records of patients with early-stage NSCLC (pathologic T1-4, N0-1) who underwent lobectomy, sleeve lobectomy, bilobectomy, or pneumonectomy, with or without adjuvant chemotherapy, between 2007 and 2015, were retrospectively reviewed. LRF was defined as recurrence at the ipsilateral lung, bronchial stump, mediastinum, chest wall, or supraclavicular region. The Kaplan-Meier method was used to estimate time to LRF, with patients censored at death, and log-rank tests were used for comparisons. A two-sided p value of less than 0.05 was considered significant. RESULTS: Included were 217 patients (median age, 65 years). Preoperative staging with positron emission tomography/computed tomography was performed in 89% of patients, mediastinoscopy was performed in 42%, and video-assisted thoracoscopic surgery was performed in 51%. At a median follow-up of 36 months (range, 1 to 120 months), the 5-year estimated LRF was 26% (95% confidence interval, 20% to 35%). LRF rates were not significantly different in those with and without staging positron emission tomography/computed tomography (hazard ratio, 1.52; p = 0.43) and those with video-assisted thoracoscopic surgery versus open thoracotomy (hazard ratio, 1.00; p = 0.99). CONCLUSIONS: Despite contemporary staging procedures and surgical techniques for early-stage NSCLC, LRF occurs in approximately 1 of 4 patients. The observed rates of LRF are similar to those reported more than a decade ago, suggesting that local/regional control remains a persistent problem. The use of additional local treatments, such as radiotherapy, should be reevaluated to further improve outcomes.

Identifying Factors and Root Causes Associated With Near-Miss or Safety Incidents in Patients Treated With Radiotherapy: A Case-Control Analysis.

PURPOSE: To identify factors associated with a near-miss or safety incident (NMSI) in patients undergoing radiotherapy and identify common root causes of NMSIs and their relationship with incident severity. METHODS: We retrospectively studied NMSIs filed between October 2014 and April 2016. We extracted patient-, treatment-, and disease-specific data from patients with an NMSI (n = 200; incident group) and a similar group of control patients (n = 200) matched in time, without an NMSI. A root cause and incident severity were determined for each NMSI. Univariable and multivariable analyses were performed to determine which specific factors were contributing to NMSIs. Multivariable logistic regression was used to determine root causes of NMSIs and their relationship with incident severity. RESULTS: NMSIs were associated with the following factors: head and neck sites (odds ratio [OR], 5.2; P = .01), image-guided intensity-modulated radiotherapy (OR, 3; P = .009), daily imaging (OR, 7; P < .001), and tumors staged as T2 (OR, 3.3; P = .004). Documentation and scheduling errors were the most common root causes (29%). Communication errors were more likely to affect patients ( P < .001), and technical treatment delivery errors were most associated with a higher severity score ( P = .005). CONCLUSION: Several treatment- and disease-specific factors were found to be associated with an NMSI. Overall, our results suggest that complexity (eg, head and neck, image-guided intensity-modulated radiotherapy, and daily imaging) might be a contributing factor for an NMSI. This promotes an idea of developing a more dedicated and robust quality assurance system for complex cases and highlights the importance of a strong reporting system to support a safety culture.