Khalilzadeh Omid, Baerlocher Mark O, Shyn Paul B, Connolly Bairbre L, Devane A Michael, Morris Christopher S, Cohen Alan M, Midia Mehran, Thornton Raymond H, Gross Kathleen, Caplin Drew M, Aeron Gunjan, Misra Sanjay, Patel Nilesh H, Walker T Gregory, Martinez-Salazar Gloria, Silberzweig James E, Nikolic Boris
Department of Radiology, Icahn School of Medicine at Mount Sinai, New York, New York.
Department of Radiology, Royal Victoria Hospital, Barrie, Ontario, Canada.
J Vasc Interv Radiol. 2017 Oct;28(10):1432-1437.e3. doi: 10.1016/j.jvir.2017.06.019. Epub 2017 Jul 27.
To develop a new adverse event (AE) classification for the interventional radiology (IR) procedures and evaluate its clinical, research, and educational value compared with the existing Society of Interventional Radiology (SIR) classification via an SIR member survey.
A new AE classification was developed by members of the Standards of Practice Committee of the SIR. Subsequently, a survey was created by a group of 18 members from the SIR Standards of Practice Committee and Service Lines. Twelve clinical AE case scenarios were generated that encompassed a broad spectrum of IR procedures and potential AEs. Survey questions were designed to evaluate the following domains: educational and research values, accountability for intraprocedural challenges, consistency of AE reporting, unambiguity, and potential for incorporation into existing quality-assurance framework. For each AE scenario, the survey participants were instructed to answer questions about the proposed and existing SIR classifications. SIR members were invited via online survey links, and 68 members participated among 140 surveyed. Answers on new and existing classifications were evaluated and compared statistically. Overall comparison between the two surveys was performed by generalized linear modeling.
The proposed AE classification received superior evaluations in terms of consistency of reporting (P < .05) and potential for incorporation into existing quality-assurance framework (P < .05). Respondents gave a higher overall rating to the educational and research value of the new compared with the existing classification (P < .05).
This study proposed an AE classification system that outperformed the existing SIR classification in the studied domains.
为介入放射学（IR）程序制定一种新的不良事件（AE）分类方法，并通过介入放射学会（SIR）成员调查，评估其与现有SIR分类方法相比的临床、研究和教育价值。
SIR实践标准委员会成员制定了一种新的AE分类方法。随后，由SIR实践标准委员会和服务部门的18名成员组成的小组创建了一项调查。生成了12个临床AE病例场景，涵盖了广泛的IR程序和潜在AE。调查问题旨在评估以下领域：教育和研究价值、术中挑战的责任认定、AE报告的一致性、明确性以及纳入现有质量保证框架的可能性。对于每个AE场景，调查参与者被要求回答有关提议的和现有的SIR分类的问题。通过在线调查链接邀请SIR成员，140名被调查者中有68名成员参与。对新分类和现有分类的答案进行评估并进行统计学比较。通过广义线性模型对两项调查进行总体比较。
在报告一致性（P <.05）和纳入现有质量保证框架的可能性（P <.05）方面，提议的AE分类获得了更高的评价。与现有分类相比，受访者对新分类的教育和研究价值给予了更高的总体评价（P <.05）。
本研究提出了一种AE分类系统，在研究领域中其表现优于现有的SIR分类。
