Deferral of Consent in Acute Stroke Trials

Shamy, Michel; Dewar, Brian; Chevrier, Stephanie; Wang, Chu-Qi; Page, Stacey; Goyal, Mayank; Demchuk, Andrew M.; Hill, Michael D.

doi:10.1161/strokeaha.118.024096

Cited by 27 publications

(51 citation statements)

References 13 publications

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“…Their work also revealed that delayed consent allowed surrogates to express a sense that they could understand trial information better than if it was presented earlier when the context was more stressful, findings applicable to patients themselves faced with potential decision making in critical illness [63]. However, it should be noted that public acceptance of the deferred consent process has not been universally consistent, and further work is justified to understand the patient and legally authorized representative’s perspectives on these issues is warranted [70]. It is possible that there may be disconnect between how respondents felt about deferred consent in theory and how they perceived the process in the real world [70].…”

Section: Discussionmentioning

confidence: 99%

Ethical considerations in conducting surgical research in severe complicated intra-abdominal sepsis

et al. 2019

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Background Severe complicated intra-abdominal sepsis (SCIAS) has high mortality, thought due in part to progressive bio-mediator generation, systemic inflammation, and multiple organ failure. Treatment includes early antibiotics and operative source control. At surgery, open abdomen management with negative-peritoneal-pressure therapy (NPPT) has been hypothesized to mitigate MOF and death, although clinical equipoise for this operative approach exists. The Closed or Open after Laparotomy (COOL) study ( https://clinicaltrials.gov/ct2/show/NCT03163095 ) will prospectively randomize eligible patients intra-operatively to formal abdominal closure or OA with NPTT. We review the ethical basis for conducting research in SCIAS. Main body Research in critically ill incapacitated patients is important to advance care. Conducting research among SCIAS is complicated due to the severity of illness including delirium, need for emergent interventions, diagnostic criteria confirmed only at laparotomy, and obtundation from anaesthesia. In other circumstances involving critically ill patients, clinical experts have worked closely with ethicists to apply principles that balance the rights of patients whilst simultaneously permitting inclusion in research. In Canada, the Tri-Council Policy Statement-2 (TCPS-2) describes six criteria that permit study enrollment and randomization in such situations: (a) serious threat to the prospective participant requires immediate intervention; (b) either no standard efficacious care exists or the research offers realistic possibility of direct benefit; (c) risks are not greater than that involved in standard care or are clearly justified by prospect for direct benefits; (d) prospective participant is unconscious or lacks capacity to understand the complexities of the research; (e) third-party authorization cannot be secured in sufficient time; and (f) no relevant prior directives are known to exist that preclude participation. TCPS-2 criteria are in principle not dissimilar to other (inter)national criteria. The COOL study will use waiver of consent to initiate enrollment and randomization, followed by surrogate or proxy consent, and finally delayed informed consent in subjects that survive and regain capacity. Conclusions A delayed consent mechanism is a practical and ethical solution to challenges in research in SCIAS. The ultimate goal of consent is to balance respect for patient participants and to permit participation in new trials with a reasonable opportunity for improved outcome and minimal risk of harm.

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Section: Discussionmentioning

confidence: 99%

Ethical considerations in conducting surgical research in severe complicated intra-abdominal sepsis

et al. 2019

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“…, However, the first published study to ask acute stroke trial participants about their attitudes towards deferred consent found that respondents were overwhelmingly opposed. 3 What could account for the discrepancy between that response, and those of SPOTLIGHT participants? The literature suggests that the severity of illness The main limitation of the present study is its small sample size, reflecting both the small size of SPOTLIGHT (50 patients), and a low response rate (20%) for this substudy.…”

Section: Discussionmentioning

confidence: 99%

Spotlight on Consent: Lessons from the SPOTLIGHT Trial for Acute Intracerebral Hemorrhage

Fitzpatrick

Shamy²,

Dewar

et al. 2020

Preprint

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Background SPOTLIGHT was a Canadian multicentre, placebo-controlled, randomized trial of emergency treatment with recombinant Factor VIIa for patients with acute intracerebral hemorrhage that enrolled a subset of eligible patients via deferral of consent. We investigated attitudes towards deferral of consent among participants and their legally-authorized representatives (LARs).Methods All participants or LARs approached for enrolment in SPOTLIGHT were invited to complete an 11-item questionnaire within the first 4 days of enrolment, and again at 90 days.Results Eight out of 50 participants in SPOTLIGHT (16%) were enrolled via deferral of consent. Ten LARs for participants (20%) completed the initial survey and 6 completed the 90 day follow-up survey.Ninety percent of respondents agreed with the process of deferral of consent both in principle and specifically for the SPOTLIGHT trial. Participants were more likely to support deferral of consent for low-risk or time-sensitive interventions, or in situations with no alternative treatment options.Conclusions The majority of respondents were supportive of using deferral of consent to enrol participants into SPOTLIGHT and acute stroke trials.

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“…Postponing consent seems tolerated by patients and their relatives in several clinical studies and trials [58][59][60][61][62][63][64][65]. However, a substudy of the ESCAPE trial (the Endovascular Treatment for Small Core and Anterior Circulation Proximal cOcclusion with Emphasis on Minimizing CT to Recanalization Times) showed that the majority of patients or their representatives disagreed with the use of deferred consent [66]. Yet, none of the patients enrolled with deferred consent in this trial withdrew consent later, and patients agreed with the conditions used to justify deferred consent procedures.…”

Section: Deferral Of Consentmentioning

confidence: 99%

Multicenter randomized clinical trial of endovascular treatment for acute ischemic stroke. The effect of periprocedural medication: acetylsalicylic acid, unfractionated heparin, both, or neither (MR CLEAN-MED). Rationale and study design

Chalos

Graaf

Roozenbeek

et al. 2020

Trials

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Background: Despite evidence of a quite large beneficial effect of endovascular treatment (EVT) for ischemic stroke caused by anterior circulation large vessel occlusion, many patients do not recover even after complete recanalization. To some extent, this may be attributable to incomplete microvascular reperfusion, which can possibly be improved by antiplatelet agents and heparin. It is unknown whether periprocedural antithrombotic medication in patients treated with EVT improves functional outcome. The aim of this study is to assess the effect of acetylsalicylic acid (ASA) and unfractionated heparin (UFH), alone, or in combination, given to patients with an ischemic stroke caused by an intracranial large vessel occlusion in the anterior circulation during EVT.

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Deferral of Consent in Acute Stroke Trials

Cited by 27 publications

References 13 publications

Ethical considerations in conducting surgical research in severe complicated intra-abdominal sepsis

Ethical considerations in conducting surgical research in severe complicated intra-abdominal sepsis

Spotlight on Consent: Lessons from the SPOTLIGHT Trial for Acute Intracerebral Hemorrhage

Multicenter randomized clinical trial of endovascular treatment for acute ischemic stroke. The effect of periprocedural medication: acetylsalicylic acid, unfractionated heparin, both, or neither (MR CLEAN-MED). Rationale and study design

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