Neptune S M, Hopper K D, Matthews Y L
College of Medicine, Penn State University, Hershey 17033.
AJR Am J Roentgenol. 1994 Feb;162(2):451-4. doi: 10.2214/ajr.162.2.8310946.
Opinions differ on the need to obtain informed consent for IV administration of contrast material. If the potential risks are common knowledge among most patients, the need for informed consent is reduced. The purpose of this study was to assess patients' baseline knowledge of the risks associated with use of IV contrast material.
This study included 150 consecutive outpatients who had radiographic studies (CT or excretory urography) requiring use of IV contrast material. Before the procedure, patients were asked to complete a 10-question questionnaire assessing their understanding of the risks associated with the use of contrast material. Questions concerned the nature of their test and the reasons for and risks of contrast material. Analysis was done with Fisher's exact chi 2-test of association and Wilcoxon's two-sample test.
On average, the patients performed significantly better on this questionnaire than if they had randomly picked each answer, indicating that the average patient has acquired some information about IV contrast material. However, the mean score was 51%, demonstrating that the average patient is not knowledgeable about all risks associated with the use of IV contrast material. We found no differences associated with sex or age. Patients with more than a high school level of education and who had previously received contrast material scored better, although they still correctly answered only 56% and 54% of the questions, respectively.
Information about the risks associated with use of IV contrast material cannot be considered common knowledge among the general population of patients.
对于静脉注射造影剂是否需要获得知情同意，存在不同观点。如果大多数患者都普遍了解潜在风险，那么对知情同意的需求就会降低。本研究的目的是评估患者对静脉注射造影剂相关风险的基线知识。
本研究纳入了150例连续的门诊患者，他们进行了需要使用静脉造影剂的影像学检查（CT或排泄性尿路造影）。在检查前，要求患者完成一份包含10个问题的问卷，以评估他们对使用造影剂相关风险的理解。问题涉及检查的性质以及造影剂使用的原因和风险。采用Fisher精确卡方关联检验和Wilcoxon两样本检验进行分析。
总体而言，患者在这份问卷上的表现显著优于随机选择答案的情况，这表明一般患者已经获取了一些关于静脉造影剂的信息。然而，平均得分是51%，这表明一般患者并不了解与使用静脉造影剂相关的所有风险。我们未发现与性别或年龄相关的差异。受过高中以上教育且之前接受过造影剂的患者得分更高，尽管他们分别仅正确回答了56%和54%的问题。
关于静脉注射造影剂相关风险的信息不能被视为患者总体人群中的常识。
