Advanced consent for acute stroke trials

Shamy, Michel; Dewar, Brian; Niznick, Naomi; Nicholls, Stuart G.; Dowlatshahi, Dar

doi:10.1016/s1474-4422(21)00029-6

Cited by 9 publications

(9 citation statements)

References 6 publications

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“…These data reflect a potential 100–150 candidates annually who could be consented in clinic using advance consent methods for RCTs pertaining to acute ischaemic strokes in the ED . 30 Moreover, an electronic medical record could be used to document decisions about advance consent in such a way that it is obvious on presentation to the ED. Because the study by Cole et al failed to enrol a patient using advance consent, they conclude that the approach is not feasible; we believe it is important to note that they struggled to enrol patients into their study by any means and that this is unlikely owing simply to the use of advance consent.…”

Section: Discussionmentioning

confidence: 99%

Advance consent for participation in randomised controlled trials for emergency conditions: a scoping review

et al. 2023

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ObjectiveAdvance consent is a recognised method of obtaining informed consent for participation in research, whereby a potential participant provides consent for future involvement in a study contingent on qualifying for the study’s inclusion criteria on a later date. The goal of this study is to map the existing literature on the use of advance consent for enrolment in randomised controlled trials (RCTs) for emergency conditions.DesignScoping review designed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses–Extension for Scoping Reviews guidelines.Data sourcesWe searched electronic databases including MEDLINE, Embase, Web of Science and the Cochrane Register of Clinical Trials from inception to 10 February 2020.Eligibility criteriaEligible studies included articles that discussed or employed the use of advance consent for enrolment in RCTs related to emergency conditions. There were no restrictions on the type of eligible study. Data were extracted directly from included papers using a standardised data charting form. We produced a narrative review including article type and authors’ dispositions towards advance consent.ResultsOur search yielded 1039 titles with duplicates removed. Six articles met inclusion criteria. Three articles discussed the theoretical use of research advance directives in emergency conditions; one article evaluated stakeholders’ perceptions of advance consent; and one article described a method for patients to document their preferences for participation in future research. Only one study employed advance consent to enrol participants into a clinical trial for an emergency condition.ConclusionOur review demonstrates that there has been minimal exploration of advance consent for enrolment in RCTs for emergency conditions. Future studies could aim to assess the acceptability of advance consent to participants, along with the feasibility of enrolling research participants using this method of consent.ProtocolThe protocol for this scoping review was published a priori.

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Section: Discussionmentioning

confidence: 99%

Advance consent for participation in randomised controlled trials for emergency conditions: a scoping review

et al. 2023

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“…User‐friendly ARD documentation is essential to support this process, and the ARD form and guidance booklet from this study provide a model that may be adapted for use elsewhere. While this article focuses on dementia, advance planning approaches could address barriers to research participation in other contexts, such as stroke, cancer, and palliative care 56 . Across different jurisdictions, the legal rules vary as to the permissible inclusion in research of people who lack capacity to consent, the status of ARDs, and the role of proxy decision‐makers in research contexts 57 .…”

Section: Discussionmentioning

confidence: 99%

Making an Advance Research Directive: An Interview Study with Adults Aged 55 and Older with Interests in Dementia Research

Ries

Johnston

2023

Ethics & Human Research

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Many people with dementia are interested in taking part in research, including when they no longer have capacity to provide informed consent. Advance research directives (ARD) enable people to document their wishes about research participation prior to becoming decisionally incapacitated. However, there are few available ARD resources. This Australian interview study elicited the views of people aged 55 years and older about the content of an ARD form and guidance booklet and processes to support research planning. Participants (n = 25; 55 to 83 years) had interests in dementia research. All participants described the ARD materials as easy to understand, and all expressed willingness to take part in future research. Nearly half believed that an ARD should be legally enforceable, while others saw it as a nonbinding document to guide decisions about their participation in research. Close family members were preferred as proxy decision‐makers. The ARD form and guidance booklet may be adapted for use elsewhere.

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“…10 This process would be the closest approximation of true informed consent at the time of the stroke but has not yet been assessed in a real-world context for patients eligible for enrollment into acute stroke trials. 21 the World Medical Association's Declaration of Helsinki (1964). 22 There are many different approaches to regulating departures from informed consent.…”

Section: Informed Consent and Its Variationsmentioning

confidence: 99%

“…(10) This process would be the closest approximation of true informed consent at the time of the stroke, but has not yet been assessed in a real world context for patients eligible for enrollment into acute stroke trials. (20)…”

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confidence: 99%

Protocol for Deferral of Consent in Acute Stroke Trials

et al. 2023

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The challenges of conducting hyperacute stroke research and obtaining informed consent have been increasingly recognized within the stroke research community in recent years. Deferral of consent, in which a patient is enrolled in a trial and then provides consent at some point thereafter, is increasingly used to enroll patients into hyperacute stroke trials in Canada and Europe, though it is not permitted in the United States. Deferral of consent offers several potential advantages – quicker door-to-randomization, increased enrolment, decreased selection bias – but these must be balanced against the risk of enrolling patients against their wishes. We seek to minimize the attendant risks of deferral of consent by offering practical guidance regarding how to conduct acute stroke trials using deferral of consent. Building upon existing guidelines and recent experiences with deferral of consent in acute stroke trials, we have developed a protocol for the use of deferral of consent that aims to maximize patient involvement while minimizing ethical and scientific risks.

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Advanced consent for acute stroke trials

Cited by 9 publications

References 6 publications

Advance consent for participation in randomised controlled trials for emergency conditions: a scoping review

Advance consent for participation in randomised controlled trials for emergency conditions: a scoping review

Making an Advance Research Directive: An Interview Study with Adults Aged 55 and Older with Interests in Dementia Research

Protocol for Deferral of Consent in Acute Stroke Trials

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