一项关于乳腺科目前参与临床试验的女性对“知情同意”看法的调查。

A survey of the opinions on 'informed consent' of women currently involved in clinical trials within a breast unit.

作者信息

Maslin A

出版信息

Eur J Cancer Care (Engl). 1994 Dec;3(4):153-62. doi: 10.1111/j.1365-2354.1994.tb00037.x.

DOI:10.1111/j.1365-2354.1994.tb00037.x

Abstract

Research indicates there is confusion in the minds of patients and the public surrounding the issue of 'informed consent'. This confusion is compounded when patients are asked to participate in a clinical trial. This study aimed to survey, by self-completed postal questionnaires, the experiences and opinions of 100 randomly selected healthy volunteers not in a clinical trial, 100 healthy volunteers in a clinical trial and 100 breast cancer patients in a clinical trial. A 71% response rate was achieved. The results indicate that there are areas in the current procedure which scored highly and some where improvements could be made. Overall, 72% of respondents indicated they were satisfied with the level of support they are currently receiving. The results also show that healthy volunteers in a clinical trial were better informed about the trial than the corresponding cancer patients. They were given more written information (86% versus 60%, P < 0.005), had a better indication of their time commitment (81% versus 62%, P < 0.025), were better informed of possible physical discomforts (61% versus 43%, P < 0.05), were better informed of possible side-effects (75% versus 57%, P < 0.025) and were more aware of their rights to withdraw from the trial (84% versus 46%, P < 0.005). Patients were also asked for their opinions on their requirements for giving informed consent. The overwhelming majority of the women responding to Questionnaire 2 wanted all the information and support outlined. Only two areas scored below 90%: those were concerned with wanting assurance that all information about the patient will be kept confidential (75%) and those wanting information on protection of the patient's privacy (66%). This response appears to be against the general trend. These results clearly show that most patients require access to a wide range of information prior to consenting to treatment or inclusion in a clinical trial.

摘要

研究表明，患者和公众对于“知情同意”问题存在困惑。当要求患者参与临床试验时，这种困惑会更加复杂。本研究旨在通过自行填写邮寄问卷的方式，调查100名随机挑选的未参与临床试验的健康志愿者、100名参与临床试验的健康志愿者以及100名参与临床试验的乳腺癌患者的经历和意见。获得了71%的回复率。结果表明，当前程序中有些方面得分很高，有些方面则有待改进。总体而言，72%的受访者表示对他们目前所获得的支持水平感到满意。结果还显示，参与临床试验的健康志愿者比相应的癌症患者对试验了解得更多。他们收到了更多的书面信息（86%对60%，P<0.005），对所需投入的时间有更清晰的了解（81%对62%，P<0.025），对可能出现的身体不适了解得更好（61%对43%，P<0.05），对可能的副作用了解得更好（75%对57%，P<0.025），并且更清楚自己退出试验的权利（84%对46%，P<0.005）。患者还被问及他们对给予知情同意的要求的看法。对问卷2做出回应的绝大多数女性希望获得所概述的所有信息和支持。只有两个方面的得分低于90%：一是希望确保有关患者的所有信息都将保密（75%），二是希望获得有关保护患者隐私的信息（66%）。这一回应似乎与总体趋势相悖。这些结果清楚地表明，大多数患者在同意接受治疗或参与临床试验之前需要获得广泛的信息。