Okada Hiroko, Okuhara Tsuyoshi, Kiuchi Takahiro
Department of Health Communication, School of Public Health, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
Contemp Clin Trials Commun. 2021 Nov 11;24:100854. doi: 10.1016/j.conctc.2021.100854. eCollection 2021 Dec.
Patients often consent to participate in cancer clinical trials despite misunderstanding the trial content. We developed a tablet-based clinical trial decision aid and tested its use with the usual discussion at the time of clinical trial registration.
Participants were individuals considering participating in a breast cancer clinical trial. The control participated in usual discussions; the intervention group participated in discussion using the decision aid. Pre- and post-discussion, we investigated knowledge, decision-making conflict, and discussion length.
We enrolled 54 patients, 27 in the control group and 27 in the intervention group. Post-discussion clinical trial knowledge was significantly higher in the intervention group than in the control group (p = 0.003). No significant difference was found in decisional conflict, but the intervention group tended to have lower post-discussion conflict than the control group. There was no between-group difference in the length of discussions with physicians and clinical research coordinators.
For women considering participation in cancer clinical trials, a tablet-based decision aid may promote clinical trial understanding without increasing discussion length or patient burden. This pre-learning decision aid incorporating a quiz and bidirectional question prompt lists may improve participants' understanding of clinical trials.
尽管患者对试验内容存在误解，但他们仍经常同意参与癌症临床试验。我们开发了一种基于平板电脑的临床试验决策辅助工具，并在临床试验登记时将其与常规讨论一起使用进行了测试。
参与者为考虑参与乳腺癌临床试验的个体。对照组参与常规讨论；干预组使用决策辅助工具参与讨论。在讨论前后，我们调查了知识、决策冲突和讨论时长。
我们招募了54名患者，对照组27名，干预组27名。讨论后，干预组的临床试验知识显著高于对照组（p = 0.003）。在决策冲突方面未发现显著差异，但干预组讨论后的冲突往往低于对照组。与医生和临床研究协调员的讨论时长在组间没有差异。
对于考虑参与癌症临床试验的女性，基于平板电脑的决策辅助工具可能会促进对临床试验的理解，而不会增加讨论时长或患者负担。这种包含测验和双向问题提示列表的预学习决策辅助工具可能会提高参与者对临床试验的理解。
