Nyholm Gaarskjær Anne, Crookshanks Duroux Meg, Hogreffe Rasmus
Molecular Pharmacology, Department of Health Science and Technology (HST), Faculty of Medicine, Aalborg University, Denmark.
Decentralized Clinical Trial Innovation, Medable, USA.
Contemp Clin Trials Commun. 2022 May 27;28:100927. doi: 10.1016/j.conctc.2022.100927. eCollection 2022 Aug.
Teleconsent via video conferencing enables decentralized trials with remote consent and has the additional benefit of allowing a real-time reaction to potential misunderstandings. However, participant acceptance of and satisfaction with teleconsent versus in-person consent processes are unknown.
We conducted a parallel-group pilot study to evaluate participant comprehension and perspectives regarding the convenience, security, and satisfaction with teleconsent compared to in-person consent among Danish citizens for a hypothetical research study.
There were no statistically significant differences in perceptions of security or satisfaction between teleconsent and in-person consent arms. However, participants viewed teleconsent as more convenient than in-person consent, as no transportation was needed and the process was less time-consuming. Recruitment was also faster in the teleconsent arm, and more people dropped out of the in-person arm, citing difficulties with transportation and time.
Decentralized clinical trials have been demonstrated to increase recruitment and enrollment rates, improve trial efficiency, and decrease dropout rates and trial delays. We add to this literature by suggesting that patients perceive teleconsent as similar to in-person consent, suggesting this is a feasible and acceptable substitution for in-person consent in multisite, decentralized trials. Future work should include patient perspectives from a larger, more diverse group of participants.
通过视频会议进行远程同意能够实现具有远程同意功能的去中心化试验，并且还有额外的好处，即能够对潜在的误解做出实时反应。然而，参与者对远程同意与面对面同意流程的接受度和满意度尚不清楚。
我们进行了一项平行组试点研究，以评估丹麦公民对于一项假设性研究的远程同意与面对面同意相比，在便利性、安全性和满意度方面的理解及看法。
远程同意组和面对面同意组在安全性或满意度认知方面没有统计学上的显著差异。然而，参与者认为远程同意比面对面同意更方便，因为无需交通出行且流程耗时更短。远程同意组的招募速度也更快，更多人退出了面对面同意组，理由是交通和时间方面存在困难。
已证明去中心化临床试验能够提高招募和入组率，提升试验效率，并降低退出率和试验延迟。我们在此文献基础上补充指出，患者认为远程同意与面对面同意类似，这表明在多中心、去中心化试验中，远程同意是面对面同意的一种可行且可接受的替代方式。未来的工作应纳入来自更广泛、更多样化参与者群体的患者观点。
