Hofmeijer J, Amelink G J, den Hertog H M, Algra A, Kappelle L J, van der Worp H B
Department of Neurology, C03.236, University Medical Centre Utrecht, PO Box 85500, 3508 GA Utrecht, The Netherlands.
J Neurol Neurosurg Psychiatry. 2007 Oct;78(10):1124-8. doi: 10.1136/jnnp.2006.110726. Epub 2007 Mar 30.
As non-randomised studies have suggested that surgical decompression may reduce mortality in patients with space occupying hemispheric infarction, randomisation may be considered unethical in controlled trials testing this treatment strategy. We studied differences in recall of information and in appreciation of the informed consent procedure between representatives included in the Hemicraniectomy After Middle cerebral artery infarction with Life-threatening Edema Trial (HAMLET) and representatives of patients participating in the randomised trial of Paracetamol (Acetaminophen) In Stroke (PAIS).
1 year after study inclusion, we contacted 30 consecutive representatives who had given informed consent for participation of their relative in HAMLET, and 30 for PAIS. Recall of trial details and appreciation of the informed consent procedure were investigated using standardised questionnaires and compared between the two groups.
All 30 PAIS representatives and 28 HAMLET representatives were interviewed. Participation of their relative in a clinical trial was remembered by 86% of HAMLET and 40% of PAIS representatives (p<0.001). HAMLET representatives remembered more trial details (effect of the treatment under study (61% vs 3%, p<0.001); randomised treatment allocation (71% vs 0%, p<0.001)). With respect to appreciation of the informed consent procedure, we found no differences between the groups: in each trial, four representatives (14% vs 13%) had considered the question of randomisation unacceptable.
Participation of patients in a randomised controlled trial of surgical decompression for space occupying infarction is generally considered acceptable by their representatives, and recall of trial details is better than in a trial in which less vital issues are at stake.
由于非随机研究表明手术减压可能降低大脑半球占位性梗死患者的死亡率，因此在测试该治疗策略的对照试验中，随机分组可能被认为不符合伦理道德。我们研究了大脑中动脉梗死伴危及生命水肿的去骨瓣减压术试验（HAMLET）的受试者代表与参与对乙酰氨基酚治疗卒中随机试验（PAIS）的患者代表在信息回忆及对知情同意程序理解方面的差异。
在纳入研究1年后，我们联系了30位连续的曾为其亲属参与HAMLET试验签署知情同意书的代表，以及30位PAIS试验的代表。使用标准化问卷调查对试验细节的回忆及对知情同意程序的理解，并在两组之间进行比较。
对所有30位PAIS代表和28位HAMLET代表进行了访谈。86%的HAMLET代表和40%的PAIS代表记得其亲属参与了一项临床试验（p<0.001）。HAMLET代表记得更多的试验细节（所研究治疗的效果（61%对3%，p<0.001）；随机治疗分配（71%对0%，p<0.001））。在对知情同意程序的理解方面，我们发现两组之间没有差异：在每项试验中，四位代表（14%对13%）认为随机分组的问题不可接受。
患者代表普遍认为患者参与针对占位性梗死的手术减压随机对照试验是可以接受的，并且对试验细节的回忆比在涉及不太重要问题的试验中更好。
