Informed consent practices for acute stroke therapy: principles, challenges and emerging opportunities

• Published in: Journal of neurology Vol. 271; no. 1; pp. 188 - 197
• Main Authors: Mbonde, Amir, Young, Michael J., Dmytriw, Adam A., Moyer, Quentin J., Hirsch, Joshua A., Leslie-Mazwi, Thabele M., Rost, Natalia S., Patel, Aman B., Regenhardt, Robert W.
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer Berlin Heidelberg 2024; Springer Nature B.V
• Subjects: Brain Ischemia - therapy; Cardiovascular system; Consent; Decision making; Endovascular Procedures - adverse effects; Fibrinolytic Agents; Humans; Informed Consent; Ischemia; Ischemic Stroke - etiology; Medicine; Medicine & Public Health; Neurology; Neuroradiology; Neurosciences; Patients; Review; Stroke; Stroke - etiology; Thrombectomy - adverse effects; Thrombolysis; Thrombolytic Therapy - adverse effects; Treatment Outcome; Endovascular thrombectomy (EVT); Informed consent (IC); Acute ischemic stroke; Intravenous thrombolysis (IVT); Decision-making capacity
• ISSN: 0340-5354; 1432-1459
• DOI: 10.1007/s00415-023-12028-y

Importance Informed consent (IC) plays a crucial yet underexplored role in acute stroke treatment, particularly in the context of intravenous thrombolysis (IVT) and endovascular thrombectomy (EVT). This narrative review examines data on current IC practices in acute ischemic stroke management, specifically for patients treated with IVT or EVT, with the aim of identifying areas for improvement and strategies to enhance the IC process. Observations IC practices for IVT vary significantly among hospitals and physicians with the frequency of always requiring consent ranging from 21 to 37%. Factors influencing IC for IVT include patient decision-making capacity, standard of care, time sensitive nature of treatments, legal and moral obligations, risk of complications, physician age and speciality, treatment delays, and hospital size. Consent requirements tend to be stricter for patients presenting within the 3–4.5-h window. The content and style of information shared as part of the IC process revealed discrepancies in the disclosure of stroke diagnosis, IVT mechanism, benefits, and risks. Research on IC practices for EVT is scarce, highlighting a concerning gap in the available evidence base. Conclusions and relevance This review underscores the significant variability and knowledge gaps in IC for EVT and IVT. Challenges related to decision-making capacity assessment and the absence of standardised guidance substantially contributes to these gaps. Future initiatives should focus on simplifying information delivery to patients, developing formal tools for assessing capacity, standardising ethical frameworks to guide physicians when patients lack capacity and harmonizing IC standards across sites. The ultimate goal is to enhance IC practices and uphold patient autonomy, while ensuring timely treatment initiation.