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研究程序的治疗性误解:简单的信息图表是否能提高理解?

Therapeutic Misconception about Research Procedures: Does a Simple Information Chart Improve Understanding?

机构信息

Research assistant at the Winship Cancer Institute of Emory University.

Supervisor and project coordinator at the Winship Cancer Institute of Emory University.

出版信息

Ethics Hum Res. 2022 Mar;44(2):18-25. doi: 10.1002/eahr.500120.

Abstract

In phase I trials, some biospecimens are used both for research and patient care and some for research only. Some research participants have therapeutic misconception, assuming all biospecimens are for patient care. This study's aim was to test if a simple information chart would improve understanding of nontherapeutic research procedures. A two-arm study was conducted. Participants in the control group (C) were asked whether biospecimens were for their care, for research only, or for both. The experimental group (E) was asked the same questions but provided with a study-specific information chart labeling the purpose of each biospecimen. One hundred one patients were interviewed. In both arms, understanding that pretreatment blood draws were for patient care and research was moderate (49% for C and 62% for E). Understanding that posttreatment blood draws were for research only was significantly higher in the experimental arm (16% for C and 44% for E; p = 0.002). Providing a simple information chart may help alleviate this aspect of therapeutic misconception.

摘要

在 I 期临床试验中,一些生物标本既用于研究又用于患者护理,而另一些则仅用于研究。一些研究参与者存在治疗误解,认为所有生物标本都用于患者护理。本研究旨在测试简单的信息图表是否能提高对非治疗性研究程序的理解。进行了一项双臂研究。对照组 (C) 的参与者被问及生物标本是用于他们的护理、仅用于研究还是两者兼而有之。实验组 (E) 被问到相同的问题,但提供了一份特定于研究的信息图表,标记了每个生物标本的用途。对 101 名患者进行了访谈。在两个臂中,理解预处理血液采集既用于患者护理又用于研究的程度适中(C 组为 49%,E 组为 62%)。理解治疗后血液采集仅用于研究在实验组中明显更高(C 组为 16%,E 组为 44%;p=0.002)。提供简单的信息图表可能有助于缓解这方面的治疗误解。

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