We performed a quasi-randomized controlled trial and compared the method by which patients were informed either in the patient admission area following patient admission by the same staff member (Group A) or in a separate room by another staff member (Group B). The consent decision was hypothetical in nature. Additionally, we evaluated if there was the need for additional time after the information session and before taking the consent decision. Data were collected during a structured interview based on questionnaires where participants reflected on the information and consent process they went through.
Questionnaire data were obtained from 157 participants in Group A and 106 participants in Group B. Overall, participants in both groups were satisfied with their experienced process and with the way information was provided. They reported that their (hypothetical) consent decision was freely made. Approximately half of the interested participants in Group B did not show up in the separate room, while all interested participants in Group A could be informed about the secondary use of their routine data and left-over samples. No participants, except for one in Group B, wanted to take extra time for their consent decision. The hypothetical consent rate for both routine data and left-over samples was very high in both groups.
The willingness to support medical research by allowing the use of routine data and left-over samples seems to be widespread among patients. Information concerning this secondary data use may be given by trained administrative staff immediately following patient admission. Patients mainly prefer making a consent decision directly after information is provided and discussed. Furthermore, less patients are informed when the process is organized in a separate room.
我们进行了一项准随机对照试验,并比较了在患者入院后由同一工作人员(A组)在患者入院区域或由另一名工作人员在单独房间(B组)通知患者的方法。同意决定本质上是假设的。此外,我们评估了在信息发布会之后和做出同意书决定之前是否需要额外的时间.数据是在基于问卷调查的结构化访谈中收集的,参与者反映了他们所经历的信息和同意过程。
问卷调查数据来自A组157名参与者和B组106名参与者。两组参与者都对他们经验丰富的过程和提供信息的方式感到满意.他们报告说,他们(假设的)同意决定是自由做出的。B组大约一半感兴趣的参与者没有出现在单独的房间里,而A组的所有感兴趣的参与者都可以被告知其常规数据和剩余样本的二次使用。没有参与者,除了B组中的一个,想要花更多的时间来决定他们的同意。两组常规数据和剩余样本的假设同意率都非常高。
通过允许使用常规数据和剩余样本来支持医学研究的意愿在患者中似乎很普遍。患者入院后,经过培训的管理人员可以立即提供有关此次要数据使用的信息。患者主要倾向于在提供和讨论信息后直接做出同意决定。此外,当过程在一个单独的房间组织时,更少的患者被告知。