Mendyk Anne-Marie, Labreuche Julien, Henon Hilde, Girot Marie, Cordonnier Charlotte, Duhamel Alain, Leys Didier, Bordet Régis
U1171-Department of Neurology, University of Lille, Inserm, Faculty of Medicine, Lille University Hospital, Lille, France.
Clinical Research Federation, University of Lille, Lille University Hospital, Lille, France.
BMC Med Ethics. 2015 Apr 24;16:26. doi: 10.1186/s12910-015-0018-8.
The provision of informed consent is a prerequisite for inclusion of a patient in a clinical research project. In some countries, the legislation on clinical research authorizes a third person to provide informed consent if the patient is unable to do so directly (i.e. surrogate consent). This is the case during acute stroke, when the symptoms may prevent the patient from providing informed consent and thus require a third party to be approached. Identification of factors associated with the medical team's decision to resort to surrogate consent may (i) help the care team during the inclusion process and (ii) enable the patient's family circle to be better informed (and thus feel less guilty) about providing surrogate consent.
Patients included in the BIOSTROKE cohort (initially dedicated to the analysis of factors influencing stroke severity) were divided into two groups: those having provided informed consent directly and those for whom a third party (such as a family member) had provided surrogate consent. We compared the groups in terms of the initial clinical characteristics (age, gender, type of stroke, severity on the National Institutes of Health Stroke Scale (NIHSS), pre-stroke cognitive status according to the Informant Questionnaire on Cognitive Decline in the Elderly, and the stroke's aetiology) and the functional and cognitive impairments (according to the NIHSS, the modified Rankin score (mRS) and the Mini Mental State Examination) on post-stroke days 8 and 90.
Three hundred and ninety five patients were included (mean ± SD age: 67 ± 15 years; 53% males). Surrogate consent had been obtained in 228 cases, and 167 patients had provided consent themselves. The patients included with surrogate consent were likely to be older and more aphasic, with a pre-existing cognitive disorder and more severe stroke (relative to the patients having provided consent). In terms of recovery, the patients included with surrogate consent had a worse functional prognosis (day 90 mRS ≥3: 57.6%, compared with 16.8% in patients having provided consent themselves; p < 0.0001) and a worse cognitive prognosis (day 90 MMS < 24: 15.4% and 4.8%, respectively; p < 0.002). The mortality rate was significantly higher in the surrogate consent group.
We found that in addition to age, aphasia and stroke severity, pre-stroke cognitive status is a factor that should prompt the care team to consider requesting surrogate consent for participation in a clinical study. Given that the unfavourable outcome in patients with surrogate consent is often due to their initial clinical state (rather than inclusion in a trial per se), the issue of the family's feelings of guilt (and how to avoid these feelings) should be further addressed.
获得知情同意是患者纳入临床研究项目的前提条件。在一些国家，临床研究法规规定，如果患者无法直接提供知情同意（即替代同意），可由第三方提供。急性中风时就是这种情况，症状可能使患者无法提供知情同意，因此需要联系第三方。识别与医疗团队决定采用替代同意相关的因素可能（i）在纳入过程中帮助护理团队，（ii）使患者的家人能更好地了解（从而减少因提供替代同意而产生的内疚感）。
纳入BIOSTROKE队列研究（最初致力于分析影响中风严重程度的因素）的患者被分为两组：直接提供知情同意的患者和由第三方（如家庭成员）提供替代同意的患者。我们比较了两组患者的初始临床特征（年龄、性别、中风类型、美国国立卫生研究院卒中量表（NIHSS）评分、根据老年人认知功能下降知情者问卷得出的中风前认知状态以及中风病因）以及中风后第8天和第90天的功能和认知障碍（根据NIHSS、改良Rankin量表（mRS）和简易精神状态检查表）。
共纳入395例患者（平均年龄±标准差：67±15岁；53%为男性）。228例获得了替代同意，167例患者自行提供了同意。获得替代同意的患者年龄可能更大，失语更严重，存在既往认知障碍且中风更严重（相对于自行提供同意的患者）。在恢复方面，获得替代同意的患者功能预后更差（第90天mRS≥3：57.6%，而自行提供同意的患者为16.8%；p<0.0001），认知预后也更差（第90天MMS<24：分别为15.4%和4.8%；p<0.002）。替代同意组的死亡率显著更高。
我们发现，除年龄、失语和中风严重程度外，中风前认知状态也是一个应促使护理团队考虑要求替代同意以参与临床研究的因素。鉴于获得替代同意的患者预后不良往往归因于其初始临床状态（而非本身纳入试验），应进一步探讨患者家属的内疚感问题（以及如何避免这些感受）。
