Oncology physician and nurse practices and attitudes regarding offering clinical trial results to study participants
Oncology physician and nurse practices and attitudes regarding offering clinical trial results to study participants
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DOI：
10.1093/jnci/djh096
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发表时间：
2004-04-21
期刊：
影响因子：
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通讯作者：
Winer, EP
中科院分区：
文献类型：
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作者：
Partridge, AH;Hackett, N;Winer, EP
尽管最近肿瘤学临床试验的倡导者和研究人员对分享研究结果感兴趣，但这些试验的参与者并不经常被告知结果。我们通过癌症和白血病B组数据库确定了肿瘤科医生和护士，并调查了他们与参与者分享临床试验结果的情况。在1977名合格成员中，796人(40.3%)回复了邮寄调查，其中497人(62.4%)报告说他们向参与者提供试验结果的时间不到五分之一。共有576名(72.4%)的应答者认为大多数患者想知道研究结果，634名(79.7%)的应答者表示愿意在未来向大多数研究参与者提供结果，认为大多数患者想知道试验结果，常规提供结果不会对患者产生负面影响。一些应答者对常规提供试验结果的担忧包括对患者的负面情绪影响，患者难以理解信息，以及提供结果所需的资源。值得关注的是，16.2%(129/796)的应答者认为向研究参与者提供结果的义务会降低他们招募患者参加研究的可能性。未来的研究应该考虑与患者分享试验结果，并评估这一过程及其对患者和临床医生的影响。[《癌症杂志》2004；96：629-32]
Despite recent interest on the part of advocates and researchers of oncology clinical trials in sharing study results, participants in these trials are not routinely informed about the results. We identified oncology physicians and nurses through the Cancer and Leukemia Group B database and surveyed them about sharing clinical trial results with participants. Of 1977 eligible members, 796 (40.3%) responded to the mailed survey, 497 (62.4%) of whom reported that they offer trial results to participants less than one-fifth of the time. A total of 576 (72.4%) of responders believed that most patients want to know the results of studies, and 634 (79.7%) of responders expressed willingness to offer results to most study participants in the future, believing that most patients want to know trial results and that routinely offering results would not have a negative effect on patients. Concerns of some responders about routinely offering trial results included negative emotional effect on patients, patient difficulty understanding the information, and resources required to offer the results. Of concern, 16.2% (129/796) of responders believed an obligation to offer results to study participants would make them less likely to enroll patients on studies. Future studies should consider sharing trial results with patients and evaluating the process and its effect on both patients and clinicians. [J Natl Cancer Inst 2004; 96:629-32]