National Practice Patterns of Obtaining Informed Consent for Stroke Thrombolysis

Mendelson, Scott; Courtney, D. Mark; Gordon, Elisa J.; Thomas, Leena; Holl, Jane L.

doi:10.1161/strokeaha.117.020474

Cited by 22 publications

(21 citation statements)

References 11 publications

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“…She was informed that the stroke had affected a large vessel within the brain that governed functions such as attention, articulation, swallowing, and left-sided sensation and movement. The daughter indicated that at no point had she consented to tPA on her father's behalf (in emergency care settings, a model of presumed consent for emergency therapies, such as tPA, is common), 6 , 7 and was unclear why her father was transferred. The medical team underscored that, although tPA was one type of acute stroke therapy, EVT could also potentially remove the clot, possibly decreasing his neurologic deficits and preventing further disability.…”

Section: Case Descriptionmentioning

confidence: 99%

Goal-Concordant Care in the Era of Advanced Stroke Therapies

Sokol

Hauser

Lum

et al. 2021

Journal of Palliative Medicine

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Stroke is a leading cause of disability and mortality worldwide. Recent advances in stroke care now enable patients with severe ischemic stroke owing to large vessel occlusion to safely undergo endovascular thrombectomy (EVT) up to 24 hours since their time of last known well, with the goal of improving functional outcomes by recanalization of the occluded vessel and reperfusion of downstream ischemic brain tissue. The objective of this analysis is to highlight clinical and ethical challenges related to ensuring goal-concordant care in this era of unprecedented advances in acute stroke care. Specifically, there is a salient challenge of whether advanced therapies such as EVT may be justifiably considered comfort focused, given their potential to preempt accumulated neurologic disability and suffering at the end of life. Through the lens of a patient case, we discuss key challenges, lessons learned, and suggestions for future care and research endeavors at the intersection of acute stroke care and palliative care principles. Although therapies such as thrombolysis and EVT may be considered aggressive prima facie , their potential to ameliorate additional disability and potential suffering at the end of life prompt close consideration of the proper role of these therapies on a case-by-case basis in the context of comfort-focused care. Modification to the workflow for EVT evaluations may facilitate goal-concordant care and timely resource allocation, especially for cases that involve hospital-to-hospital transfers for advanced stroke care.

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Section: Case Descriptionmentioning

confidence: 99%

Goal-Concordant Care in the Era of Advanced Stroke Therapies

Sokol

Hauser

Lum

et al. 2021

Journal of Palliative Medicine

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“…Studying an alternative to tPA involves randomizing patients to tPA vs. investigational therapy; however, the brief informed consent process for administering tPA under high level recommendation alone without the added time burden of a formal consent process for a nonstandard-of-care therapy has been reported to delay treatment. (13) In addition, patients with severe stroke symptoms may not have the capacity to consent for research, and thus require All rights reserved. No reuse allowed without permission.…”

Section: Introductionmentioning

confidence: 99%

“…Studying an alternative to tPA involves randomizing patients to tPA vs. investigational therapy; however, the brief informed consent process for administering tPA under high level recommendation alone without the added time burden of a formal consent process for a non- standard-of-care therapy has been reported to delay treatment. (13) In addition, patients with severe stroke symptoms may not have the capacity to consent for research, and thus require consent by proxy (14), which has also been shown to delay treatment, especially when consensus is needed among multiple family members. (13,15) Another source of delay could be elderly patients with cognitive impairment, a population that commonly suffers from stroke.…”

Section: Introductionmentioning

confidence: 99%

“…(13) In addition, patients with severe stroke symptoms may not have the capacity to consent for research, and thus require consent by proxy (14), which has also been shown to delay treatment, especially when consensus is needed among multiple family members. (13,15) Another source of delay could be elderly patients with cognitive impairment, a population that commonly suffers from stroke. Not only do cognitive impairments complicate determination of capacity, but elderly patients may present to the emergency room unaccompanied, making it difficult to ascertain if they have a surrogate decision maker.…”

Section: Introductionmentioning

confidence: 99%

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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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“…Despite guideline recommendations that informed consent is indicated for thrombolysis, 1 there is no accepted standardized consent process for thrombolytic administration and wide variability has been reported. 2 Refusal of IV-tPA based on incorrect or incomplete understanding of its risks and benefits has the potential to affect morbidity after ischemic stroke, particularly for minority race/ethnic groups. 3 Although decisions about IV-tPA administration are usually made after consultation with a stroke fellow/attending at teaching hospitals, the process of obtaining IV-tPA consent is often assigned to neurology residents.…”

mentioning

confidence: 99%

Education Research: Simulation training for neurology residents on acquiring tPA consent

et al. 2018

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National Practice Patterns of Obtaining Informed Consent for Stroke Thrombolysis

Abstract: Most clinicians always or often require informed consent for stroke thrombolysis. Future research should focus on standardizing content and delivery of tPA information to reduce delays.

Cited by 22 publications

References 11 publications

Goal-Concordant Care in the Era of Advanced Stroke Therapies

Goal-Concordant Care in the Era of Advanced Stroke Therapies

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

Education Research: Simulation training for neurology residents on acquiring tPA consent

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