为参与者提供临床试验结果:分享负面研究结果
Ann H Partridge1, Julia S Wong, Katherine Knudsen
1Department of Medical and Radiation Oncology, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA. ahpartridge@partners.org
给临床试验参与者提供负面的研究结果是可行的,并且受到好评. 这项乳腺癌试验中的大多数参与者都想知道结果,并报告了对这一过程的积极感受.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 患者沟通 患者沟通
背景情况:
- 患者往往缺乏关于临床试验结果的信息.
- 负面的研究结果很少与参与者分享.
研究的目的:
- 评估与临床试验参与者分享负面研究结果的过程和影响.
- 评估患者的接待和对接受试验结果的感受.
主要方法:
- 为135名参与者提供了II期乳腺癌试验的负面结果.
- 该试验研究了单独切除乳房,用于在位管道癌.
- 收集关于参与者反应和人口因素 (教育水平) 的数据.
主要成果:
- 90%的受访者 (85/94) 选择接受研究结果.
- 获得结果的参与者比非受试者受过更高的教育程度.
- 大多数参与者对收到结果和临床试验表达了积极的情绪.
结论:
- 与参与者分享负面临床试验结果是一种可行的,受到积极欢迎的做法.
- 通知参与者关于试验结果可以提高他们的参与度和对研究的看法.
- 需要进一步研究临床试验中患者与从业人员之间的沟通.
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