Getting the Gist Across Is Enough for Informed Consent for Acute Stroke Thrombolytics

Abstract

Acute stroke thrombolytics greatly reduce post-stroke disability, both in clinical trials and in clinical practice. 1-3 Too few patients, however, take advantage of these life-improving and cost-saving treatments. 4, 5 In fact, in the United States up to 7.5% of tissue plasminogen activator (tPA) eligible patients refuse this time limited stroke treatment, 6, 7 and even among stroke patients who receive tPA, up to 20% experience delayed treatment due to patient and family consent. 8 Currently in the United States, a recommended approach to tPA consent is shared decision making, which involves deliberative consideration of options, risks, benefits, and patient values. While shared decision making is highly valuable and appropriate in many medical decision making situations, we believe that full shared decision making is not well suited for the acute stroke scenario due to the lack of clinical equipoise regarding tPA administration, the time sensitive nature of this acute stroke treatment, and an inappropriate setting for in depth-discussions. tPA is approved by the United States Food and Drug Administration and the European Union, albeit with more restrictive eligibility criteria than the current guideline recommendations. 9 Current United States professional societies' recommendations on tPA administration vary in strength by specialty. For example, in the United States, Neurology and Neurosurgical societies strongly recommend tPA treatment, while Emergency Medicine societies are more tepid in their recommendations. The American Heart Association, with endorsements from American Association of Neurological Surgeons and Congress of Neurological Surgeons, gives tPA administration in the 3 hour window its strongest recommendation. 10 However, in 2015 the American College of Emergency Physicians'

Analysis of Thrombolysis Process for Acute Ischemic Stroke in Urban and Rural Hospitals in Nova Scotia Canada

“…This sentiment was echoed in a study conducted in 2010 in Michigan measuring the attitudes and beliefs of ED physicians, as only 49% of ED physicians surveyed indicated that science regarding the use of tPA in stroke is convincing ( 29 ). Another area that has different views among physicians is informed consent for thrombolysis, which can delay treatment, which is consistent with other studies ( 30 , 31 ). However, better more streamlined communication when obtaining consent for thrombolysis can improve treatment times ( 31 ).…”

“…Another area that has different views among physicians is informed consent for thrombolysis, which can delay treatment, which is consistent with other studies ( 30 , 31 ). However, better more streamlined communication when obtaining consent for thrombolysis can improve treatment times ( 31 ).…”

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

“…(16) Although there has been investigation of alternate methods such as targeted consent models to reduce delays in treatment (17), ethical considerations involved in conducting clinical research in the urgent setting with respect to the process of obtaining informed consent have been an area of ongoing deliberation. (12) In this study, we 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. To evaluate the impact of research study factors on patient care, we also collected information on door to treatment (DTT) times of both experimental and control arms of trials.…”

“…(6–8) Therefore, time constraints on informed consent make the consent process difficult and may pose a barrier to examining new and potentially more beneficial therapies. (9–12)…”

“…(16) Although there has been investigation of alternate methods such as targeted consent models to reduce delays in treatment (17), ethical considerations involved in conducting clinical research in the urgent setting with respect to the process of obtaining informed consent have been an area of ongoing deliberation. (12)…”