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白内障手术的知情同意:患者对口头、书面和录像信息的理解。

Informed consent for cataract surgery: patient understanding of verbal, written, and videotaped information.

机构信息

Department of Ophthalmology, Veterans Affairs Boston Healthcare System, Boston University School of Medicine, Boston, Massachusetts, USA.

出版信息

J Cataract Refract Surg. 2012 Jan;38(1):80-4. doi: 10.1016/j.jcrs.2011.07.030. Epub 2011 Nov 6.

Abstract

PURPOSE

To determine the effectiveness of verbal, written, and videotaped descriptions of cataract surgery on patients' understanding of the risks, benefits, and treatment alternatives.

SETTING

Veterans Affairs Boston Healthcare System, Boston, Massachusetts, USA.

DESIGN

Randomized prospective study.

METHODS

Patients eligible for cataract surgery were randomized into 1 of 4 arms of the informed consent process as follows: Group 1, conventional verbal information; Group 2, conventional verbal information plus second-grade reading level brochure; Group 3, conventional verbal information plus eighth-grade reading level brochure; Group 4, conventional verbal information plus American Academy of Ophthalmology DVD Understanding Cataract Surgery: Patient Education DVD Featuring an Aid to Informed Consent. After the informed consent process, patients in each group completed a 12-question questionnaire discussing the surgical procedure, its benefits, its foreseeable and unforeseeable risks, and the alternatives to cataract surgery. Scores in each group were calculated as the number of correct responses out of 12 questions.

RESULTS

Patients in Group 2 (mean score 10.8 ± 1.29 [SD]) and Group 4 (mean score 10.56 ± 1.44) scored significantly higher than patients in Group 1 (mean score 7.68 ± 2.80) or Group 3 (mean score 9.08 ± 1.60). Previous cataract surgery and education level had no significant influence on recall of the informed-consent process.

CONCLUSIONS

Concise informed consent information sheets at lower reading grade levels and videotape presentation optimized patient understanding of the risks, benefits, and treatment alternatives to cataract surgery. The cost-benefit of these results is important because better patient understanding has the potential to decrease the risk for indemnity payments awarded because of inadequate informed consent.

摘要

目的

确定口头、书面和录像描述白内障手术对患者理解手术风险、益处和治疗选择的效果。

地点

美国马萨诸塞州波士顿退伍军人事务部医疗保健系统。

设计

随机前瞻性研究。

方法

符合白内障手术条件的患者被随机分为知情同意过程的 4 个组之一,如下所示:组 1,常规口头信息;组 2,常规口头信息加二年级阅读水平手册;组 3,常规口头信息加八年级阅读水平手册;组 4,常规口头信息加美国眼科学会 DVD《理解白内障手术:患者教育 DVD,突出辅助知情同意》。在知情同意过程之后,每组患者完成了一份 12 个问题的问卷,讨论手术过程、其益处、可预见和不可预见的风险以及白内障手术的替代方案。每组的分数计算为 12 个问题中正确回答的数量。

结果

组 2(平均得分 10.8 ± 1.29 [SD])和组 4(平均得分 10.56 ± 1.44)的患者得分明显高于组 1(平均得分 7.68 ± 2.80)或组 3(平均得分 9.08 ± 1.60)的患者。先前的白内障手术和教育水平对回忆知情同意过程没有显著影响。

结论

简洁的低阅读水平知情同意信息表和录像演示优化了患者对白内障手术风险、益处和治疗选择的理解。这些结果的成本效益很重要,因为更好的患者理解有可能降低因知情同意不足而判给的赔偿付款的风险。

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