Who Will Consent to Emergency Treatment Trials for Subarachnoid Hemorrhage?

Giudice, Angela Del; Plaum, Justin; Maloney, Eileen; Kasner, Scott E.; Roux, Peter D. Le; Baren, Jill M.

doi:10.1111/j.1553-2712.2009.00367.x

Cited by 12 publications

(11 citation statements)

References 41 publications

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“…This suggests that the design and potential benefits of the RAR feature were able to attract and recruit more participants to join the research study in an acute stroke trial scenario. Importantly, the participation rate of the standard group was comparable to that of other studies, 2, 3 indicating that the conditions of our hypothetical scenario were likely to be comparable to actual experiences in acute stroke trials.…”

Section: Discussionsupporting

confidence: 69%

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Can Response-Adaptive Randomization Increase Participation in Acute Stroke Trials?

Tehranisa

Meurer

2014

Stroke

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Background and Purpose A response-adaptive randomization (RAR) trial design actively adjusts the ratio of participants assigned to each trial arm, favoring the better performing treatment by using outcome data from participants already in the trial. Compared to a standard clinical trial, a RAR study design has the potential to improve patient participation in acute stroke trials. Methods This cross-sectional randomized survey included adult emergency department patients, age 18 and over, without symptoms of stroke or other critical illness. A standardized protocol was used, and subjects were randomized to either an RAR or standard hypothetical acute stroke trial. After viewing the video describing the hypothetical trial (http://youtu.be/cKIWduCaPZc), reviewing the consent form, and having questions answered, subjects indicated whether they would consent to the trial. A multivariable logistic regression model was fitted to estimate the impact of RAR, while controlling for demographic factors and patient understanding of the design. Results A total of 418 subjects (210 standard 208 RAR) were enrolled. All baseline characteristics were balanced between groups. There was significantly higher participation in the RAR trial (67.3%) versus the standard trial (54.5%), absolute increase: 12.8% (95% CI: 3.7 to 22.2%). The RAR group had a higher odds ratio of agreeing to research (O.R. 1.89, 95% CI [1.2 – 2.9]), while adjusting for patient level factors. Trial designs were generally well understood by the participants. Conclusions The hypothetical RAR trial attracted more research participation than standard randomization. RAR has the potential to increase recruitment and offer benefit to future trial participants.

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Section: Discussionsupporting

confidence: 69%

“…These studies have shown that just over half of participants or their proxies consent to research. 2, 3 Hesitation to join emergency research studies was attributed to the perceived risk of such trials and preexisting negative attitudes toward research. 3 …”

Section: Introductionmentioning

confidence: 99%

Can Response-Adaptive Randomization Increase Participation in Acute Stroke Trials?

Tehranisa

Meurer

2014

Stroke

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“…As there are many personal, medical, sociocultural, emotional, spiritual, and legal factors involved in giving informed consent for a RCT, patients should be able consider their options thoughtfully. When asked about the time allotted to make such a decision for a stroke trial, 30 min was deemed sufficient for only 56% of respondents (Del Giudice et al, 2009). Subjects were more likely to participate if they felt that they had enough time, though many wished they had more time and opportunity to discuss their choice with others.…”

Section: Time Pressurementioning

confidence: 99%

“…However, none of these factors appeared to be significantly associated with the decision to participate in RCTs involving cerebral infarction, ICH, or SAH (Del Giudice et al, 2009; Kasner et al, 2009). This suggests that these factors may not be directly relevant to giving informed consent in these clinical situations.…”

Section: Research Insight and Literacymentioning

confidence: 99%

Informed Consent: The Rate-Limiting Step in Acute Stroke Trials

Rose¹,

Kasner²

2011

Front. Neur.

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Successful implementation of a randomized clinical trial (RCT) for neuro-vascular emergencies such as cerebral infarction, intracerebral hemorrhage, or subarachnoid hemorrhage is extraordinarily challenging. Besides establishing an accurate, hyper-expedited diagnosis among many mimics in a person with acute neurological deficits, informed consent must be obtained from this vulnerable group of patients who may be unable to convey their own wishes, grasp the gravity of their situation, or give a complete history or examination. We review the influences, barriers, and factors investigators encounter when providing established and putative stroke therapies, and focus on informed consent, the most important research protector of human subjects, as the rate-limiting step for enrollment into acute stroke RCTs. The informed consent process has received relatively little attention in the stroke literature, but is especially important for stroke victims with acute cognitive, aural, lingual, motor, or visual impairments. Consent by a surrogate may not accurately reflect the patient’s wishes. Further, confusion about trial methodology, negative opinions of placebo-controlled studies, and therapeutic misconception by patients or surrogates may impede trial enrollment and requires further study. Exception from informed consent offers an opportunity that is rarely if ever utilized for stroke RCTs. Ultimately, advancing the knowledge base and treatment paradigms for acute stroke is essential but autonomy, beneficence (non-malfeasance), and justice must also be carefully interwoven into any well-designed RCT.

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“…Predictors of an agreeable response were identified using multivariable logistic regression. We hypothesized that younger subjects, nonblack race, being female, being better educated, and having poorer functional status or more severe stroke would increase the odds of providing an agreeable response, based on prior research participation studies [13,14]. We also tested whether responses were given by the patient or a proxy was predictive of an agreeable response.…”

Section: Methodsmentioning

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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Who Will Consent to Emergency Treatment Trials for Subarachnoid Hemorrhage?

Cited by 12 publications

References 41 publications

Can Response-Adaptive Randomization Increase Participation in Acute Stroke Trials?

Can Response-Adaptive Randomization Increase Participation in Acute Stroke Trials?

Informed Consent: The Rate-Limiting Step in Acute Stroke Trials

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

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