Racial disparities in refusal of stroke thrombolysis in Chicago

Mendelson, Scott; Aggarwal, Neelum T.; Richards, Christopher T; O’Neill, Kathleen; Holl, Jane L.; Prabhakaran, Shyam

doi:10.1212/wnl.0000000000004905

Cited by 29 publications

(35 citation statements)

References 38 publications

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“…2 Despite this and similar initiatives, substantial proportions of tPA-eligible patients still have delayed treatment 2 while some refuse tPA treatment altogether. 3…”

Section: Introductionmentioning

confidence: 99%

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National Practice Patterns of Obtaining Informed Consent for Stroke Thrombolysis

Mendelson¹,

Courtney

Gordon

et al. 2018

Stroke

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“…2 Despite this and similar initiatives, substantial proportions of tPA-eligible patients still have delayed treatment 2 while some refuse tPA treatment altogether. 3…”

Section: Introductionmentioning

confidence: 99%

“…4, 5 Improvement in the informed consent process has been a suggested target to further reduce delays. 3, 6 However, no standardized approach exists to obtain informed consent for tPA. The objective of this national survey was to determine current practice patterns of informed consent for stroke thrombolysis.…”

Section: Introductionmentioning

confidence: 99%

National Practice Patterns of Obtaining Informed Consent for Stroke Thrombolysis

Mendelson¹,

Courtney

Gordon

et al. 2018

Stroke

Self Cite

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“…This approach could, however, cause selection bias and limit external validity of study results. 10,[19][20][21][22] Several measures of capacity have been proposed to provide more accurate measurement of decisional capacity, but all have substantial limitations. 7, 23 We propose several conditions that could be used to help determine the validity of patient consent before intervention (panel 1).…”

Section: Patient Informed Consent Before Medical Interventionmentioning

confidence: 99%

Informed consent procedures for emergency interventional research in patients with traumatic brain injury and ischaemic stroke

Kompanje

Dijck

Chalos

et al. 2020

The Lancet Neurology

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Health-care professionals and researchers have a legal and ethical responsibility to inform patients before carrying out diagnostic tests or treatment interventions as part of a clinical study. Interventional research in emergency situations can involve patients with some degree of acute cognitive impairment, as is regularly the case in traumatic brain injury and ischaemic stroke. These patients or their proxies are often unable to provide informed consent within narrow therapeutic time windows. International regulations and national laws are criticised for being inconclusive or restrictive in providing solutions. Currently accepted consent alternatives are deferred consent, exception from consent, or waiver of consent. However, these alternatives appear under-utilised despite being ethically permissible, socially acceptable, and regulatorily compliant. We anticipate that, when the requirements for medical urgency are properly balanced with legal and ethical conduct, the increased use of these alternatives has the potential to improve the efficiency and quality of future emergency interventional studies in patients with an inability to provide informed consent.

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“…Efforts to increase the availability of rapid bedside interpretation services, such as with interpreter phones and professional translators, may help correct well-documented, ethnicity-based disparities in thrombolysis. (63,64) Additional barriers in the consent process may also exist for patients who speak foreign languages. Patients with limited English proficiency may have lower health literacy, availability of surrogate decision makers, or knowledge of concepts related to study design, such as randomization and clinical equipoise.…”

Section: Discussionmentioning

confidence: 99%

Ethical Considerations during the Informed Consent Process for Acute Ischemic Stroke in International Clinical Trials

Bellomo

Fokas

Anderson

et al. 2020

Preprint

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Introduction: Obtaining informed consent from acute ischemic stroke patients poses many challenges, especially in the context of a research setting. Specifically, consenting for alternative acute ischemic stroke treatments to the standard of care, Tissue Plasminogen Activator (tPA), can cause delays leading to increased time to reperfusion and worse outcomes. Objectives: We sought to investigate the experiences of researchers in existing active-control trials in acute ischemic stroke comparing investigational therapy to tPA in order to identify the approaches and challenges in obtaining informed consent in this unique patient population. Methods: Out of 401 articles evaluated, 14 trials met inclusion criteria of patients receiving IV tPA vs alternative treatment within 4.5 hours of onset of symptoms for acute ischemic stroke. Trial representatives were emailed by the study team with a request for a copy of their patient consent form, other documents related to informed consent, and to complete a survey concerning aspects of the consent process. Results: Of the 6 trials conducted across 6 continents that completed the survey in its entirety, 2 were ongoing, 4 were published between 2009 and 2016, and the median NIHSS for each published trial was at least an 8. All published trials in the sample stated that informed consent was obtained, but only half reported involvement of a research ethics committee. Although 3 trials performed in Europe or Asia reported directly consenting 75-100% of enrolled patients, the median NIHSS for these trials represented a moderate stroke. Trials with 75-100% of patients directly consented had shorter door to treatment (DTT) times than trials that directly consented less than 50% of enrolled patients. 5 trials allowed consent by proxy, but only 2 of those trials also required patient assent. 4 trials had translators available and translated consent documents, and these trials had longer DTT times. All trials relied on experienced providers or dedicated research coordinators to obtain informed consent; however, only 2 of 6 trials mentioned specific training with regards to informed consent skills. Conclusions: The current informed consent process is not transparent and poses challenges to investigators in the USA directly comparing tPA to an alternative treatment. International differences in the standards of informed consent, such as deferred consent, may have allowed more patients with moderate strokes to provide direct consent after treatment administration without delaying DTT time. While targeted and innovative approaches for informed consent are needed to improve patient outcomes, we must balance protecting the autonomy of individuals whose willing involvement enables such pivotal discoveries. The stroke community must aim for efficiency, transparency, and inclusion of patients of diverse backgrounds in the informed consent process so that therapeutic advances are possible.

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Racial disparities in refusal of stroke thrombolysis in Chicago

Cited by 29 publications

References 38 publications

National Practice Patterns of Obtaining Informed Consent for Stroke Thrombolysis

National Practice Patterns of Obtaining Informed Consent for Stroke Thrombolysis

Informed consent procedures for emergency interventional research in patients with traumatic brain injury and ischaemic stroke

Ethical Considerations during the Informed Consent Process for Acute Ischemic Stroke in International Clinical Trials

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