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参与和了解艾滋病临床试验的原因:一项初步研究。

Reasons for entry into and understanding of HIV/AIDS clinical trials: a preliminary study.

作者信息

Ross M W, Jeffords K, Gold J

机构信息

Center for Health Promotion Research Development, School of Public Health, University of Texas, Houston 77225.

出版信息

AIDS Care. 1994;6(1):77-82. doi: 10.1080/09540129408258027.

Abstract

Thirty-two men who participated in a trial of Zidovudine (> 500 CD4 cells/10(6) L) were surveyed regarding their reasons for participation in clinical trials. The major source of influence to enter the trial was the clinic doctor, and importance for self in participation was rated as the least important reason. Medical science and medical researchers were seen as the major beneficiaries. Being seen to do something about one's illness was also seen as being important and probability of delaying AIDS was rated lowest. Chance of occurrence of risks of treatment were rated as slightly below 50%. Results of Flesch and Fry tests of informed consent documents suggested that they were written in the style of a scientific article, required the readability level of a university graduate and that recall was imperfect. Those who saw more benefits in their trial participation appeared to be most knowledgeable. These data suggest that participation in this clinical trial was based on altruistic, rather than personal reasons and that participants had realistic perceptions of outcomes.

摘要

对32名参与齐多夫定试验(CD4细胞计数>500/10⁶L)的男性就其参与临床试验的原因进行了调查。参与试验的主要影响源是临床医生,而参与对自身的重要性被评为最不重要的原因。医学科学和医学研究人员被视为主要受益者。被视为对自身疾病采取了措施也被视为很重要,而延缓艾滋病的可能性被评为最低。治疗风险发生的几率被评为略低于50%。知情同意文件的弗莱什和弗莱测试结果表明,这些文件是用科学文章的风格撰写的,要求具备大学毕业生的阅读水平,且回忆并不完美。那些在参与试验中看到更多益处的人似乎知识最丰富。这些数据表明,参与该临床试验是基于利他而非个人原因,且参与者对结果有现实的认知。

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