Abstract
BackgroundObtaining informed consent for intravenous thrombolysis in acute ischemic stroke can be challenging, and little is known about if and how the informed consent procedure is performed by neurologists in clinical practice. This study examines the procedure of informed consent for intravenous thrombolysis in acute ischemic stroke in high-volume stroke centers in the Netherlands.MethodsIn four high volume stroke centers, neurology residents and attending neurologists received an online questionnaire concerning informed consent for thrombolysis with tissue-type plasminogen activator (tPA). The respondents were asked to report their usual informed consent practice for tPA treatment and their considerations on whether informed consent should be obtained.ResultsFrom the 203 invited clinicians, 50% (n = 101) completed the questionnaire. One-third of the neurology residents (n = 21) and 21% of the neurologists (n = 8) reported that they always obtain informed consent for tPA treatment. If a patient is not capable of providing informed consent, 30% of the residents (n = 19) reported that they start tPA treatment without informed consent. In these circumstances, 53% of the neurologists (n = 20) reported that the resident under their supervision would start tPA treatment without informed consent. Most neurologists (n = 21; 55%) and neurology residents (n = 45; 72%) obtained informed consent within one minute. None of the respondents used more than five minutes for informed consent. Important themes regarding obtaining informed consent for treatment were patients’ capacity, and medical, ethical and legal considerations.ConclusionThe current practice of informed consent for thrombolysis in acute ischemic stroke varies among neurologists and neurology residents. If informed consent is obtained, most clinicians stated to obtain informed consent within one minute. In the future, a shortened information provision process may be applied, making a shift from informed consent to informed refusal, while still considering the patient’s capacity, stroke severity, and possible treatment delays.
Highlights
Obtaining informed consent for intravenous thrombolysis in acute ischemic stroke can be challenging, and little is known about if and how the informed consent procedure is performed by neurologists in clinical prac‐ tice
Design Questionnaires concerning the informed consent practice for thrombolysis were distributed among neurology residents and attending neurologists involved in acute stroke care in four high volume stroke centers in the Netherlands
Content of information provision The majority of the neurology residents reported that they always inform their patient about the diagnosis ischemic stroke (n = 55; 87%), treatment mechanism of action (n = 49; 78%), and about the benefits (n = 38; 60%) and risks (n = 42; 67%) of type plasminogen activator (tPA) administration, before starting tPA treatment
Summary
Obtaining informed consent for intravenous thrombolysis in acute ischemic stroke can be challenging, and little is known about if and how the informed consent procedure is performed by neurologists in clinical prac‐ tice. This study examines the procedure of informed consent for intravenous thrombolysis in acute ischemic stroke in high-volume stroke centers in the Netherlands. In specific cases of acute ischemic stroke with favorable stroke imaging characteristics, tPA treatment can be started within 9 h after onset [9, 10]. The procedure of informed consent for tPA treatment in acute ischemic stroke faces various challenges: 1) tPA treatment’s efficacy increases with earlier administration [11], 2) the decision-making process takes place in an acute setting, 3) in most cases, an alternative therapy is lacking [12], and 4) obtaining consent can be difficult in stroke patients with neurological deficits (e.g. aphasia) [13]. Patient autonomy is considered a ground principle in modern medicine and informed consent was constituted to protect this principle
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