University of Chicago, Chicago, Illinois.
Medical College of Wisconsin, Milwaukee, Wisconsin.
J Patient Saf. 2022 Apr 1;18(3):e672-e679. doi: 10.1097/PTS.0000000000000911.
Adverse event (AE) reporting is crucial for determining safety of trials. Adverse events are captured manually by clinical research associates (CRAs) and research nurses (RNs), and prior studies show underreporting. It is necessary to understand AE reporting training, processes, and institution-level differences to improve AE capture.
A 26-item questionnaire regarding AE reporting training, identification, tracking, and challenges was distributed to all Children's Oncology Group (COG) CRAs and RNs from February 15 to March 11, 2019, regardless of if they report AEs based on limitations of COG rosters. Results were tabulated. Institutions were grouped by self-reported full-time equivalents and compared using χ2 tests.
Of 1315 CRAs and 2703 RNs surveyed, 509 (12.7%) responded. Of those, 369 (64.9%) representing 71.8% of COG institutions report AEs. Only data from respondents who report AEs were collected and analyzed. There was a range in AE training; COG training modules were most common (79.7%). There was wide variability in AE ascertainment; only 51.2% use standardized approaches at their site. There was no standard AE tracking method; larger sites more commonly use spreadsheets (P = 0.002) and smaller sites more commonly use paper (P = 0.028). The greatest AE reporting challenges were differences between protocols (70%) and between AE definitions and documentation (53%). Half of the respondents endorsed 6 of 13 proposed tools for improving reporting including online AE reporting modules (75.3%), tip sheets for interpreting Common Terminology Criteria for Adverse Events definitions (67.5%), and standardized AE tracking forms (66.9%). Only half of the respondents reported that all colleagues at their site followed the same AE reporting practices, and there was no dominant AE tracking approach across the respondents.
There is wide variability in AE reporting training and practices. Numerous challenges exist, including differences between trials, challenges in interpreting AE definitions, and engaging clinicians.
Respondents are eager for additional central resources. These results provide a roadmap for areas of potential improvement.
不良事件（AE）报告对于确定试验安全性至关重要。临床研究助理（CRA）和研究护士（RN）手动采集不良事件，先前的研究表明存在漏报情况。为了提高不良事件的采集，有必要了解不良事件报告培训、流程和机构层面的差异。
2019 年 2 月 15 日至 3 月 11 日，向所有儿童肿瘤学组（COG）的 CRA 和 RN 发放了一份 26 项关于不良事件报告培训、识别、跟踪和挑战的问卷，无论他们是否根据 COG 名册的限制报告不良事件。结果进行了列表总结。根据自我报告的全职等效人员对机构进行分组，并使用 χ2 检验进行比较。
在接受调查的 1315 名 CRA 和 2703 名 RN 中，有 509 名（12.7%）做出了回应。其中，369 名（64.9%）代表 71.8%的 COG 机构报告了 AE。仅收集和分析了报告不良事件的应答者的数据。不良事件培训的范围不同；COG 培训模块最为常见（79.7%）。不良事件的确定存在很大的差异；只有 51.2%的机构在其站点使用标准化方法。没有标准的不良事件跟踪方法；较大的站点更常使用电子表格（P=0.002），而较小的站点更常使用纸质表格（P=0.028）。最大的不良事件报告挑战是方案之间的差异（70%）和不良事件定义和文件之间的差异（53%）。一半的应答者认可了用于改善报告的 13 个工具中的 6 个，包括在线不良事件报告模块（75.3%）、解释不良事件常用术语标准定义的提示表（67.5%）和标准化不良事件跟踪表格（66.9%）。只有一半的应答者报告说，他们所在站点的所有同事都遵循相同的不良事件报告实践，并且在应答者中没有占主导地位的不良事件跟踪方法。
不良事件报告培训和实践存在很大的差异。存在许多挑战，包括试验之间的差异、不良事件定义解释方面的挑战以及临床医生的参与。
应答者渴望获得更多的中央资源。这些结果为潜在的改进领域提供了指导。
