Department of Human Oncology, University of Wisconsin-Madison, Madison, Wisconsin, USA.
J Appl Clin Med Phys. 2022 Jul;23(7):e13653. doi: 10.1002/acm2.13653. Epub 2022 May 26.
The purpose of this work was to assess how the coronavirus disease 2019 (COVID-19) pandemic impacted our incident learning system data and communicate the impact of a major exogenous event on radiation oncology clinical practice.
Trends in our electronic incident reporting system were analyzed to ascertain the impact of the COVID-19 pandemic, including any direct clinical changes. Incident reports submitted in the 18 months prior to the pandemic (September 14, 2018 to March 13, 2020) and reports submitted during the first 18 months of the pandemic (March 14, 2020 to September 13, 2021) were compared. The incident reports include several data elements that were evaluated for trends between the two time periods, and statistical analysis was performed to compare the proportions of reports.
In the 18 months prior to COVID-19, 192 reports were submitted per 1000 planning tasks (n = 832 total). In the first 18 months of the pandemic, 147 reports per 1000 planning tasks were submitted (n = 601 total), a decrease of 23.4%. Statistical analysis revealed that there were no significant changes among the data elements between the pre- and during COVID-19 time periods. An analysis of the free-text narratives in the reports found that phrases related to pretreatment imaging were common before COVID-19 but not during. Conversely, phrases related to intravenous contrast, consent for computed tomography, and adaptive radiotherapy became common during COVID-19.
The data elements captured by our incident learning system were stable after the onset of the COVID-19 pandemic, with no statistically significant findings after correction for multiple comparisons. A trend toward fewer reports submitted for low-risk issues was observed. The methods used in the work can be generalized to events with a large-scale impact on the clinic or to monitor an incident learning system to drive future improvement activities.
本研究旨在评估 2019 年冠状病毒病（COVID-19）大流行如何影响我们的不良事件报告系统数据，并就重大外源性事件对放射肿瘤临床实践的影响进行交流。
分析电子不良事件报告系统中的趋势，以确定 COVID-19 大流行的影响，包括任何直接的临床变化。将大流行前 18 个月（2018 年 9 月 14 日至 2020 年 3 月 13 日）提交的不良事件报告与大流行期间的前 18 个月（2020 年 3 月 14 日至 2021 年 9 月 13 日）提交的报告进行比较。不良事件报告包含多个数据元素，对两个时间段之间的趋势进行评估，并进行统计学分析以比较报告的比例。
在 COVID-19 之前的 18 个月中，每 1000 次计划任务提交 192 份报告（n=832 份）。在大流行期间的前 18 个月中，每 1000 次计划任务提交 147 份报告（n=601 份），下降了 23.4%。统计分析显示，在 COVID-19 前后两个时间段之间，数据元素之间没有显著变化。对报告中的自由文本叙述进行分析发现，与治疗前成像相关的短语在 COVID-19 之前很常见，但在 COVID-19 期间则不然。相反，与静脉内造影剂、计算机断层扫描同意书和适应性放疗相关的短语在 COVID-19 期间变得常见。
在 COVID-19 大流行开始后，我们的不良事件学习系统捕获的数据元素保持稳定，经过多次比较校正后，没有发现具有统计学意义的发现。观察到提交的低风险问题报告数量呈下降趋势。该研究中使用的方法可以推广到对临床产生重大影响的事件，或用于监测不良事件学习系统以推动未来的改进活动。
