Offering participants results of a clinical trial: sharing results of a negative study
Offering participants results of a clinical trial: sharing results of a negative study
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DOI：
10.1016/s0140-6736(05)71085-0
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发表时间：
2005-03-12
期刊：
影响因子：
168.9
通讯作者：
Winer, EP
中科院分区：
文献类型：
--
作者：
Partridge, AH;Wong, JS;Winer, EP
一般来说，患者不被告知他们所参加的试验的结果。我们的目的是评估向临床试验参与者提供阴性研究结果的过程和效果。我们提供了一项II期试验的135名参与者的结果，该试验仅对患有导管原位癌的女性进行乳房切除术，由于早期局部复发率高，因此早期停止。94名回答者中有85人（90%）选择接收结果；这些女性受教育程度更高（85名大学毕业生中有57名[67%]），而那些选择不受教育的女性（9名中有2名[22%]，p=0.006）。总的来说，大多数参与者对提供的结果和临床试验都有积极的感觉。这些分享临床试验结果的初步发现令人鼓舞。
In general, patients are not given information about the results of trials in which they have participated. We aimed to assess the process and effect of providing clinical trial participants with results of a negative study. We offered results to 135 participants in a phase II trial of breast excision alone for women with ductal carcinoma in situ, which was stopped early because of an early high rate of local recurrence. 85 (90%) of 94 respondents chose to receive results; these women were more educated (57 [67%] of 85 college graduates) than those who chose not to (two [22%] of nine, p=0.006). Most participants reported positive feelings about being offered results and about clinical trials in general. These preliminary findings from sharing clinical trial results are encouraging.