Modifying a standard industry clinical trial consent form improves patient information retention as part of the informed consent process
Modifying a standard industry clinical trial consent form improves patient information retention as part of the informed consent process
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DOI：
10.1111/j.1553-2712.2001.tb01300.x
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发表时间：
2001-03-01
影响因子：
4.4
通讯作者：
Levitt, MA
中科院分区：
文献类型：
--
作者：
Dresden, GM;Levitt, MA
目的：知情同意是临床研究的必要环节。行业同意书可能很复杂，难以理解。对标准的行业知情同意书（IF）和相同知情同意书（MF）的修改缩短版本进行了比较，以确定哪种版本允许患者在知情同意后即刻保留更多信息。方法：这是一项前瞻性、随机研究，在城市、县教学急诊科（艾德）进行。纳入了100例在艾德就诊的有哮喘病史的患者的便利样本（基于艾德中两名研究助理之一的可用性）。在阅读同意书后，对50名MF和50名IF患者进行了同意后测试，以确定保留了多少信息。确定IF和MF之间测试分数的平均差异。结果：人群的平均年龄（+/-SD）为39.4 +/- 12.1岁（范围18-80岁）; 52%为女性。研究人群的总体评分为9.6（+/-2.0），范围为2-12（最大12）。MF评分为10.6（+/-1.4），IF评分为8.6（+/-2.1）;平均差异= 2.0（95% CI = 1.3 - 2.7，p < 0.0001）。在以下问题上，MF组的正确答案明显多于IF组（MF%，IF%;比例的平均差异及95% CI）：目的（96，70; 26，95% CI = 12 - 40）;随机化（78，44; 34，95% CI = 16 - 52）;研究持续时间（94，70; 24，95% CT = 10至38）;风险（92，74; 18，95% CI = 4 - 32）;获益C94，78; 16，95% CI = 3 - 29）;替代治疗（88，70; 18，95% CI = 2 - 34）;保密性（98，88; 10，95% CI = 0.2 - 20）;和自愿参与（74，54; 20，95% CI = 2 - 38）。不良事件补偿的正确率最低（54，38; 13，95% CI = -6至32）。随后，在进行知情同意后测试后，98%的人写道他们阅读了整个MF，而只有68%的人写道他们阅读了整个IF（比例平均差异为30%，95% CI = 17%至43%）。结论：与行业知情同意书相比，缩短版的知情同意书侧重于食品和药物管理局以及卫生与公众服务部的知情同意指南，允许患者在同意后立即保留更多信息。
Objective: Informed consent is a required part of clinical research. Industry consent forms may be complex and difficult to understand. A comparison was performed between a standard, industry consent form (IF) and a modified, shortened version of the same form (MF) to determine which allows the patient to retain more information in the immediate postconsent period. Methods: This was a prospective, randomized study performed in an urban, county teaching emergency department (ED). A convenience sample (based on the availability of one of two research assistants being present in the ED) of 100 patients with a history of asthma seen in the ED were enrolled. After reading the consent form, 50 MF and 50 IF patients were given a postconsent test to determine how much information was retained. Mean differences in test scores between the IF and MF were determined. Results: The population had a mean age (+/-SD) of 39.4 +/- 12.1 years (range 18-80); 52% were female. The overall score for the study population was 9.6 (+/-2.0), range 2-12 (maximum 12). The MF score was 10.6 (+/-1.4) vs the IF score of 8.6 (+/-2.1); mean difference = 2.0 (95% CI = 1.3 to 2.7, p < 0.0001). The MF group had significantly more correct answers than the IF group with the following questions (MF%, IF%; mean difference in proportions with 95% CIs): purpose (96, 70; 26, 95% CI = 12 to 40); randomization (78, 44; 34, 95% CI = 16 to 52); study duration (94, 70; 24, 95% CT = 10 to 38); risks (92, 74; 18, 95% CI = 4 to 32); benefits C94, 78; 16, 95% CI = 3 to 29); alternative treatments (88, 70; 18, 95% CI = 2 to 34); confidentiality (98, 88; 10, 95% CI = 0.2 to 20); and voluntary participation (74, 54; 20, 95% CI = 2 to 38). Adverse event compensation had the poorest correct rate (54, 38; 13, 95% CI = -6 to 32). Subsequently, after taking the postconsent test, 98% wrote that they read the entire MF, while only 68% wrote that they read the entire IF (mean difference in proportions 30%, 95% CI = 17% to 43%). Conclusions: Compared with an industry consent form, a shortened version, focusing on Food and Drug Administration and Department of Health and Human Services informed consent guidelines, allowed patients to retain more information in the immediate postconsent period.