Wake Forest University School of Medicine, 475 Vine St, Winston-Salem, NC, 27101, USA.
Duke University School of Medicine, 40 Duke Medicine Cir., Durham, NC, 27710, USA.
BMC Med Ethics. 2023 Feb 19;24(1):12. doi: 10.1186/s12910-023-00890-4.
Although patient advocates have developed templates for standard consent forms, evaluating patient preferences for first in human (FIH) and window of opportunity (Window) trial consent forms is critical due to their unique risks. FIH trials are the initial use of a novel compound in study participants. In contrast, Window trials give an investigational agent over a fixed duration to treatment naïve patients in the time between diagnosis and standard of care (SOC) surgery. Our goal was to determine the patient-preferred presentation of important information in consent forms for these trials.
The study consisted of two phases: (1) analyses of oncology FIH and Window consents; (2) interviews of trial participants. FIH consent forms were analyzed for the location(s) of information stating that the study drug has not been tested in humans (FIH information); Window consents were analyzed for the location(s) of information stating the trial may delay SOC surgery (delay information). Participants were asked about their preferred placement of the information in their own trial's consent form. The location of information in the consent forms was compared to the participants' suggestions for placement.
34 [17 FIH; 17 Window] of 42(81%) cancer patients approached participated. 25 consents [20 FIH; 5 Window] were analyzed. 19/20 FIH consent forms included FIH information, and 4/5 Window consent forms included delay information. 19/20(95%) FIH consent forms contained FIH information in the risks section 12/17(71%) patients preferred the same. Fourteen (82%) patients wanted FIH information in the purpose, but only 5(25%) consents mentioned it there. 9/17(53%) Window patients preferred delay information to be located early in the consent, before the "Risks" section. 3/5(60%) consents did this.
Designing consents that reflect patient preferences more accurately is essential for ethical informed consent; however, a one-size fits all approach will not accurately capture patient preferences. We found that preferences differed for FIH and Window trial consents, though for both, patients preferred key risk information early in the consent. Next steps include determining if FIH and Window consent templates improve understanding.
尽管患者倡导者已经为标准同意书制定了模板，但由于其独特的风险，评估患者对首次人体（FIH）和机会窗（Window）试验同意书的偏好至关重要。FIH 试验是在研究参与者中首次使用新型化合物。相比之下，Window 试验在诊断后和标准治疗（SOC）手术之间的固定时间段内，将研究药物给予未经治疗的患者。我们的目标是确定这些试验中同意书中重要信息的患者首选呈现方式。
该研究由两个阶段组成：（1）肿瘤学 FIH 和 Window 同意书的分析；（2）试验参与者的访谈。分析了 FIH 同意书以确定说明研究药物尚未在人体中进行测试的信息的位置（FIH 信息）；分析了 Window 同意书以确定说明试验可能延迟 SOC 手术的信息的位置（延迟信息）。参与者被要求就他们在自己试验同意书中首选放置信息的位置发表意见。同意书中信息的位置与参与者提出的放置位置进行了比较。
在 42 名癌症患者中，有 34 名（81%）接受了邀请并参与了研究。分析了 25 份同意书[20 份 FIH；5 份 Window]。20 份 FIH 同意书中有 19 份包含 FIH 信息，5 份 Window 同意书中有 4 份包含延迟信息。19/20（95%）份 FIH 同意书中的风险部分包含 FIH 信息，17/20（85%）名患者对此表示认同。14 名（82%）患者希望在目的部分看到 FIH 信息，但只有 5 份（25%）同意书提及了这一点。9/17（53%）名 Window 患者希望将延迟信息放在同意书的早期，放在“风险”部分之前。5 份同意书中有 3 份（60%）这样做了。
设计更准确地反映患者偏好的同意书对于伦理知情同意至关重要；然而，一刀切的方法并不能准确地捕捉患者的偏好。我们发现，FIH 和 Window 试验同意书的偏好不同，但对于两者，患者都希望在同意书中尽早看到关键风险信息。下一步包括确定 FIH 和 Window 同意书模板是否能提高理解程度。
