Ethical Issues of Informed Consent in Acute Stroke

Demarquay, Geneviève; Derex, Laurent; Nighoghossian, Norbert; Adeleine, P.; Philippeau, Frédéric; Honnorat, Jérôme; Trouillas, P

doi:10.1159/000083250

Cited by 46 publications

(31 citation statements)

References 14 publications

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“…Trials investigating acute stroke treatment face special obstacles to recruitment. The condition itself may have an impact on the patient's willingness or ability to participate, and frequently patients are not capable of giving informed consent or answering questions [2,3,4]. This may furthermore have an impact on efforts to investigate time of ictus, medical history or previous intake.…”

Section: Introductionmentioning

confidence: 99%

Impact of Selection Criteria on Recruitment in an Interventional Stroke Trial

Hotter

Jegzentis²,

Steinbrink³

et al. 2013

Cerebrovasc Dis

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Background: Randomized controlled clinical trials are the gold standard for scientific evaluation of clinical diagnostic and treatment concepts. Frequently, recruitment of participants is slower than expected, especially in acute conditions with a short time frame for inclusion. Simple prediction models have been proposed to extrapolate recruitment rates. We hypothesized a significant overestimation of recruitment when ignoring interdependence of selection criteria, leading to an insufficient representation of reality by available models. We proposed that slight modifications to inclusion criteria might augment recruitment without causing selection bias. Methods: We analyzed recruitment in an acute intervention trial of acute ischemic stroke initiated by our facility. Frequencies of selection criteria were recorded and analyzed individually as well as cumulatively. We then amended the trial protocol by moderate modifications to the selection criteria. The main outcome criterion was the rate of recruited over screened patients, with the goal of increasing recruitment fourfold without adding unacceptable selection bias. A previously presented prediction model was applied to our trial and compared with actual recruitment. Data were compared between screening periods at recruitment prior to and after the implementation of the amendments. Results: The impact of typical as well as novel inclusion criteria such as age limits, imaging-based definition of pathology, time between onset and presentation as well as inability to consent were quantified. Age restriction, definition of index event and late arrival after ictus were identified as the most challenging modifiable selection criteria. Amending those criteria increased recruitment by a factor of 4.1. Inability to consent was a significant exclusion criterion gaining impact with the target population. The selection criteria had a cumulative rather than separate recruitment-limiting impact. A previously presented model did not predict recruitment sufficiently. Conclusion: We describe frequencies of selection criteria in a typical cohort of patients suffering from acute cerebrovascular events, and their cumulative impact. These data may help to better understand recruitment limitations and allow designing future trials more effectively. Ability to consent especially is a major contributor to trial exclusion, strongly interfering with the targeted trial population of ischemic stroke. Tentative prescreening phases before site or trial initiation should be considered. No predictive statistical models of recruitment have been established so far.

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Section: Introductionmentioning

confidence: 99%

Impact of Selection Criteria on Recruitment in an Interventional Stroke Trial

Hotter

Jegzentis²,

Steinbrink³

et al. 2013

Cerebrovasc Dis

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show abstract

“…The standard approach to recruitment in a randomized trial of a non-emergency treatment is to require fully informed written consent after giving the patient sufficient time to consider the matter. This is clearly not practicable in the emergency treatment of acute stroke, where patients may have a variety of neurological deficits which either impair effective spoken or written communication and/or writing (e.g., coma, confusion, paralysis, aphasia) [1, 2]. There is substantial variation between countries in the legal and regulatory requirements for consent procedures for trials being conducted in such patients.…”

Section: Introductionmentioning

confidence: 99%

Impact of Stroke Syndrome and Stroke Severity on the Process of Consent in the Third International Stroke Trial

et al. 2006

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Background: Obtaining informed consent for a patient’s participation in a randomized trial of treatment for use in a medical emergency may be achieved in a variety of ways. We sought to assess the process of consent and to evaluate the influence of the patient’s neurological deficit on the method used to obtain consent in the first 300 patients recruited into the Third International Stroke Trial (IST-3). Methods: IST-3 is the first large-scale randomized controlled trial of intravenous thrombolysis in acute ischaemic stroke. The clinician could use one of four procedures to recruit the patient: written consent, witnessed consent, assent, or a waiver of consent. The patient’s neurological deficits were recorded at baseline. We analysed the relationship between the neurological deficits at baseline and the consent procedure. Results: The method of consent used was written consent in 71 subjects (24%), witnessed verbal consent in 30 subjects (10%), assent by a relative in 197 subjects (66%), and waiver of consent in 2 subjects (1%). Patients with severe neurological deficits (as measured either by their stroke syndrome or their lower predicted probability of being alive and independent at 6 months) were more likely to be recruited by assent. Patients able to give written consent had less severe strokes. Conclusions: Patients with non-lacunar hemispheric stroke syndromes or with a more severe neurological deficit were less likely to give written consent. Excluding such patients from acute stroke treatment trials would eliminate many otherwise eligible subjects, who have a poor predicted outcome without treatment and yet might benefit from acute treatments such as thrombolysis. Flexible consent procedures developed for IST-3 have made it feasible to recruit the target population.

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“…Much debate currently surrounds this last requirement [2,3,4,5,6]. The purpose of community consultation is to ensure that the research is respectful of the community in which it is conducted and as such, understanding community perceptions and opinions of the research is paramount [7,8].…”

Section: Introductionmentioning

confidence: 99%

Ischemic Stroke Survivors’ Opinion Regarding Research Utilizing Exception from Informed Consent

Kleindorfer¹,

Lindsell²,

Alwell³

et al. 2011

Cerebrovasc Dis

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Introduction: ‘Exception from informed consent for research’ (EFIC) is a rigorous procedure regulated by the FDA that requires community assent but allows enrollment without patient or family consent. Recently, several acute stroke trials have explored the use of EFIC to improve enrollment. We obtained ischemic stroke survivors’ opinions regarding hypothetical enrollment into a clinical trial at the time of their stroke without personal or proxy consent. Methods: During 2005, 460 ischemic stroke patients (or their proxy) who met case criteria were prospectively interviewed and followed. After 2 years, patients were asked to think back to the time of their stroke and indicate whether they would have wished to be enrolled in an acute stroke research study before individual or proxy consent could be obtained, understanding that consent would be sought as soon as possible thereafter, and they rated how agreeable they would have been to acute stroke research with different levels of invasiveness. Predictors of a positive opinion regarding the hypothetical research were analyzed using logistic regression. Variables included in the model were age, race, sex, education, initial NIHSS, modified Rankin Scale prior to stroke and 30 days after stroke, and proxy versus patient responder. Results: At 2 years after stroke, after excluding patient deaths, missing data or refusals, there were 194 patient/proxy responses included in this analysis. Overall, 72–79% of responses were favorable for chart review or blood draw without consent. The proportions answering agreeably to questions about medications or invasive strategies were smaller (62.9 and 59.8%). Older subjects were less likely to offer an agreeable response regarding use of medications [OR 0.97 per year (95% CI 0.94–0.99)] and invasive procedures [OR 0.97 per year (95% CI 0.94–0.99)]. Nonblacks tended to be more agreeable than blacks to invasive procedures. Men had twice the odds of being agreeable to blood draws than women. Conclusions: We found that the majority of interviewed ischemic stroke patients were agreeable to being enrolled in acute stroke research with exception from informed consent, although the rates of agreement were lower than we expected among a cohort of patients who had already agreed to research. Older subjects, black race, and women were less likely to agree to blood draws or treatment strategies.

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Ethical Issues of Informed Consent in Acute Stroke

Cited by 46 publications

References 14 publications

Impact of Selection Criteria on Recruitment in an Interventional Stroke Trial

Impact of Selection Criteria on Recruitment in an Interventional Stroke Trial

Impact of Stroke Syndrome and Stroke Severity on the Process of Consent in the Third International Stroke Trial

Ischemic Stroke Survivors’ Opinion Regarding Research Utilizing Exception from Informed Consent

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