Dresden G M, Levitt M A
Department of Emergency Medicine, Alameda County Medical Center, Highland Campus, Oakland, CA, USA.
Acad Emerg Med. 2001 Mar;8(3):246-52. doi: 10.1111/j.1553-2712.2001.tb01300.x.
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.
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.
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% CI = 10 to 38); risks (92, 74; 18, 95% CI = 4 to 32); benefits (94, 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%).
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.
知情同意是临床研究的必要组成部分。行业同意书可能复杂且难以理解。对一份标准的行业同意书（IF）和同一表格的修改缩短版（MF）进行了比较，以确定哪一份能让患者在同意后即刻保留更多信息。
这是一项在城市县教学急诊科（ED）进行的前瞻性随机研究。纳入了在急诊科就诊的100例有哮喘病史的患者的便利样本（基于两名研究助理之一在急诊科的可及性）。在阅读同意书后，50名MF组患者和50名IF组患者接受了同意后测试，以确定保留了多少信息。确定了IF组和MF组测试分数的平均差异。
研究人群的平均年龄（±标准差）为39.4±12.1岁（范围18 - 80岁）；52%为女性。研究人群的总体分数为9.6（±2.0），范围2 - 12（满分12）。MF组分数为10.6（±1.4），而IF组分数为8.6（±2.1）；平均差异 = 2.0（95%置信区间 = 1.3至2.7，p < 0.0001）。对于以下问题，MF组的正确答案显著多于IF组（MF%，IF%；比例的平均差异及95%置信区间）：目的（96，70；26，95%置信区间 = 12至40）；随机分组（78，44；34，95%置信区间 = 16至52）；研究持续时间（94，70；24，95%置信区间 = 10至38）；风险（92，74；18，95%置信区间 = 4至32）；益处（94，78；16，95%置信区间 = 3至29）；替代治疗（88，70；18，95%置信区间 = 2至34）；保密（98，88；10，95%置信区间 = 0.2至20）；以及自愿参与（74，54；20，95%置信区间 = 2至38）。不良事件补偿的正确率最低（54，38；13，95%置信区间 = -6至32）。随后，在进行同意后测试后，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（比例的平均差异为30%，95%置信区间 = 17%至43%）。
与行业同意书相比，一份聚焦于美国食品药品监督管理局和美国卫生与公众服务部知情同意指南的缩短版同意书能让患者在同意后即刻保留更多信息。
