Land Kevin J, Townsend Mary, Goldman Mindy, Whitaker Barbee I, Perez Gabriela E, Wiersum-Osselton Jo C
Blood Systems, Inc., San Antonio, Texas.
UT Health Science Center at San Antonio, Department of Pathology, San Antonio, Texas.
Transfusion. 2018 Nov;58(11):2589-2595. doi: 10.1111/trf.14948. Epub 2018 Oct 8.
In December 2014, a multinational collaboration of hemovigilance experts from the International Society of Blood Transfusion (ISBT), the International Hemovigilance Network, and AABB published harmonized definitions of complications related to blood donation titled "Standard for Surveillance of Complications Related to Blood Donation." Both mandatory and optional terms were included. The definitions are endorsed by the Alliance of Blood Operators and the European Blood Alliance.
The objective of this study was to validate harmonized donor hemovigilance definitions with potential users. In June 2016, 30 real-world cases were sent to potential users around the world along with the definitions, an answer sheet, and instructions on how to complete the validation exercise.
Overall, 54 responses from 25 countries were received, including over 400 comments. The results were presented for feedback at both ISBT and AABB meetings. Case diagnoses were consistent across most responders. Exceptions were rare adverse events, nonstandard presentations, or incomplete information. In general, the application of optional definitions, including severity grading and imputability, had the most variability.
The use of standardized terms in the donor setting serves to increase focus on donor safety, facilitate conversation, foster exchange of information, and frame questions for future research. Overall, the definitions provide adequate coverage of donor reactions; however, some terms require clarification. Severity grading and imputability and other optional terms need clear and objective definitions and instructions on when and how to use them. Additional feedback and final recommendations are summarized in this report.
2014年12月，来自国际输血协会（ISBT）、国际血液警戒网络和美国血库协会（AABB）的血液警戒专家开展了一项跨国合作，发布了与献血相关并发症的统一定义，题为《献血相关并发症监测标准》。其中包括强制性和可选性术语。这些定义得到了血液运营者联盟和欧洲血液联盟的认可。
本研究的目的是与潜在用户一起验证统一的献血者血液警戒定义。2016年6月，30个实际案例被发送给世界各地的潜在用户，同时附上定义、答卷以及关于如何完成验证练习的说明。
总体而言，收到了来自25个国家的54份回复，包括400多条评论。研究结果在ISBT和AABB会议上进行了展示以获取反馈。大多数回复者对病例的诊断是一致的。例外情况是罕见不良事件、非标准表现或信息不完整。一般来说，可选定义的应用，包括严重程度分级和可归责性，具有最大的变异性。
在献血者环境中使用标准化术语有助于增强对献血者安全的关注、促进交流、推动信息交换以及为未来研究提出问题。总体而言，这些定义对献血者反应提供了充分的涵盖；然而，一些术语需要进一步明确。严重程度分级和可归责性以及其他可选术语需要清晰、客观的定义以及关于何时以及如何使用它们的说明。本报告总结了更多反馈和最终建议。
