van den Bos Noa, van den Berg Sophie A, Caupain Catalina Mm, Pols Jeannette Aj, van Middelaar Tessa, Chalos Vicky, Dippel Diederik Wj, Roos Yvo Bwem, Kappelhof Manon, Nederkoorn Paul J
Department of Neurology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
Department of Ethics, Law and Humanities, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
Eur Stroke J. 2021 Dec;6(4):395-402. doi: 10.1177/23969873211057421. Epub 2021 Nov 13.
Deferral of consent for participation in a clinical study is a relatively novel procedure, in which informed consent is obtained after randomisation and study treatment. Deferred consent can be used in emergency situations, where small therapeutic time windows limit possibilities for patients to provide informed consent. We aimed to investigate patients' or their proxies' experiences and opinions regarding deferred consent in acute stroke randomised trials.
For this qualitative study, Dutch Collaboration for New Treatments of Acute Stroke (CONTRAST) trial participants were selected. Study participants were either patients or their proxies who provided consent and were selected with theoretical sampling based on patient characteristics. Semi-structured interviews were conducted face-to-face or by telephone. Themes and subthemes were iteratively defined.
Twenty of the 23 interviewed participants (16 patients and 7 proxies) considered deferred consent acceptable. The received study treatment and consent conversation were remembered by 18 participations, although the concept of randomisation and treatment comparison were generally not well understood. Sixteen participants felt capable of overseeing the decision to give deferred consent. Distress in the first days after stroke, lack of understanding and neurological deficits were reasons for feeling incapable of providing consent. Four participants would have preferred a different timing of the consent conversation, of whom two prior to treatment.
Our study found that deferred consent was considered acceptable by most study participants who provided consent for acute stroke randomised trials. Though they felt capable, the recall and comprehension of consent were overall limited.
推迟参与临床研究的同意是一种相对新颖的程序，即在随机分组和开始研究治疗后再获得知情同意。推迟同意可用于紧急情况，此时较短的治疗时间窗限制了患者提供知情同意的可能性。我们旨在调查患者或其代理人对急性中风随机试验中推迟同意的体验和看法。
对于这项定性研究，选取了荷兰急性中风新治疗协作组（CONTRAST）试验的参与者。研究参与者为提供同意的患者或其代理人，并根据患者特征采用理论抽样法进行选择。通过面对面或电话方式进行半结构化访谈。反复定义主题和子主题。
23名接受访谈的参与者中有20名（16名患者和7名代理人）认为推迟同意是可以接受的。18名参与者记得接受的研究治疗和同意谈话，不过随机分组和治疗比较的概念总体上理解得不太好。16名参与者觉得自己有能力监督给予推迟同意的决定。中风后头几天的痛苦、缺乏理解和神经功能缺损是感觉无法提供同意的原因。4名参与者希望同意谈话的时间有所不同，其中2名希望在治疗前进行。
我们的研究发现，大多数为急性中风随机试验提供同意的研究参与者认为推迟同意是可以接受的。尽管他们觉得自己有能力，但对同意的回忆和理解总体上是有限的。
