Quality of informed consent: Measuring understanding among participants in oncology clinical trials
Quality of informed consent: Measuring understanding among participants in oncology clinical trials
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DOI：
10.1188/05.onf.751-755
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发表时间：
2005-07-01
影响因子：
1.9
通讯作者：
Barrett, R
中科院分区：
文献类型：
--
作者：
Barrett, R
目的/目的：描述新入组的临床试验受试者对其参与的肿瘤临床试验的认识和理解情况。设计：描述性、相关性。地点：新英格兰一家小型社区医院的肿瘤中心。样本：8名同意参加肿瘤临床试验的患者。方法：向17名近期同意参加肿瘤临床试验的潜在参与者发送知情同意质量问卷。主要研究变量：知情同意的基本要素的知识和参与者对他们参加的临床试验的理解。调查结果：知情同意问卷的质量得分表明，参与者对知情同意的基本要素以及他们参加的临床试验有很好的总体理解。然而，一半的样本不了解临床试验治疗不是标准治疗，与标准治疗相比可能涉及额外的风险。结论：本调查的结果为参与者对知情同意过程的理解提供了有价值的反馈。知情同意质量调查问卷可能是监测知情同意过程质量的有用工具，有助于患者了解临床试验和研究过程。对护理的启示：知情同意问卷的质量可以为临床试验参与者对临床试验和研究过程的理解提供有价值的反馈。在整个试验入组过程中，对问卷问题的个人回答可用于帮助个性化患者教育和知情同意的验证。未来的研究工作需要侧重于开发可靠的工具来衡量参与者对知情同意和护理干预的理解，以改善知情同意过程，并增强患者对研究过程的理解。
Purpose/Objectives: To describe newly enrolled clinical trial subjects' knowledge and understanding of the oncology clinical trials in which they were participating.Design: Descriptive, correlational.Setting: The oncology center of a small community hospital in New England.Sample: 8 patients who consented to enroll in oncology clinical trials.Methods: The Quality of Informed Consent questionnaire was sent to 17 potential participants who recently had consented to participate in oncology clinical trials.Main Research Variables: Knowledge of the basic elements of informed consent and participants' understanding of the clinical trials in which they were enrolled.Findings: Scores on the Quality of Informed Consent questionnaire indicated that participants had a good overall understanding of the basic elements of informed consent as well as the clinical trials in which they were enrolled. However, half of the sample failed to understand that clinical trial treatment is not standard treatment and may involve additional risk when compared with standard treatment.Conclusions: The results of this investigation provide valuable feedback regarding participants' understanding of the informed consent process. The Quality of Informed Consent questionnaire may be a useful tool for monitoring the quality of the informed consent process and contributing to patients' understanding of clinical trials and the research process.Implications for Nursing: The Quality of Informed Consent questionnaire may provide valuable feedback regarding clinical trial participants' understanding of clinical trials and the research process. Individual responses to questions on the questionnaire may be used to aid personalized patient education and validation of the informed consent throughout trial enrollment. Future research efforts need to focus on the development of reliable tools to measure participants' understanding of informed consent and nursing interventions that improve the informed consent process as well as enhance patients' understanding of the research process.