Abstract
BackgroundThe 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.MethodsPatients 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.ResultsThree 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.ConclusionsWe 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.
Highlights
The provision of informed consent is a prerequisite for inclusion of a patient in a clinical research project
Informed consent to participation in the study was provided by the patient him/herself in 42% (n = 167) of the cases and by a surrogate in 58% (n = 228)
The impact of patient- and stroke-related factors on the provision of informed consent When compared with patients who provided informed consent themselves, patients with surrogate consent were older, less likely to perform regular physical activity, and more likely to be male, smoke and have a history of stroke, coronary artery disease or heart failure
Summary
The provision of informed consent is a prerequisite for inclusion of a patient in a clinical research project. Stroke constitutes the leading cause of adult handicap, the second leading cause of dementia, and the third leading cause of death [1] This impact on public health explains the ongoing development of basic research (using genetics, imaging, biomarkers, etc.) and clinical studies (on stroke prevention, acutephase treatments, long-term outcomes, etc.). Research in this field is very active, as evidenced by the large number of studies registered on the ClinicalTrials.gov website. About 16% of stroke patients have pre-existing cognitive disorders; this context might conceivably hinder the comprehension of study information, there are no literature data on the potential impact of these disorders [8]
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