Hopper K D, Lambe H A, Shirk S J
Department of Radiology, Penn State University, Hershey 17033.
Radiology. 1993 Apr;187(1):279-83. doi: 10.1148/radiology.187.1.8451429.
Informed consent forms used before intravenous administration of contrast media by both private practice (Pennsylvania Blue Shield) and academic (Association of University Radiologists) physician groups were analyzed to evaluate for readability and content. Most of the 160 consent forms required at least a high school education to be understood; 10 (6%) required a college education. Consent forms from academic institutions tended to be longer and contain more problems with sentence structure than those from private practice. Consent forms from both groups tended to have a weak, wordy writing style. Although most of the consent forms discussed at least some of the potential adverse reactions from intravenous contrast media, 37 (23%) made no mention of any potential adverse reaction. Indeed, 25 (16%) made no mention of contrast media at all. Only 12 (8%) consent forms included a discussion of nonionic contrast media. The authors provide sample consent forms that cover the common risks of ionic and nonionic contrast media and describe the availability of nonionic contrast media; these forms are understandable by an individual reading at only an eighth-grade level.
对私人执业医师团体（宾夕法尼亚蓝盾）和学术医师团体（大学放射学家协会）在静脉注射造影剂前使用的知情同意书进行了分析，以评估其可读性和内容。160份同意书中的大多数需要至少高中文化程度才能理解；10份（6%）需要大学文化程度。学术机构的同意书往往更长，句子结构问题比私人执业机构的更多。两组的同意书往往写作风格薄弱、冗长。虽然大多数同意书至少讨论了静脉造影剂的一些潜在不良反应，但37份（23%）未提及任何潜在不良反应。实际上，25份（16%）根本未提及造影剂。只有12份（8%）同意书包含了关于非离子型造影剂的讨论。作者提供了涵盖离子型和非离子型造影剂常见风险的样本同意书，并描述了非离子型造影剂的可得性；这些同意书八年级水平的人就能读懂。
