SpringerLink
Log in

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

  • Review
  • Published:
Journal of Neurology Aims and scope Submit manuscript

Abstract

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, develo** 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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Subscribe and save

Springer+ Basic
EUR 32.99 /Month
  • Get 10 units per month
  • Download Article/Chapter or Ebook
  • 1 Unit = 1 Article or 1 Chapter
  • Cancel anytime
Subscribe now

Buy Now

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2

Similar content being viewed by others

References

  1. Varkey B (2021) Principles of clinical ethics and their application to practice. Méd Princ Pract 30(1):17–28. https://doi.org/10.1159/000509119

    Article  PubMed  Google Scholar 

  2. Schuster L, Essig F, Daneshkhah N et al (2022) Ability of patients with acute ischemic stroke to recall given information on intravenous thrombolysis: results of a prospective multicenter study. Eur Stroke J 8(1):241–250. https://doi.org/10.1177/23969873221143856

    Article  Google Scholar 

  3. Kraft AW, Awad A, Rosenthal JA et al (2022) In a hub-and-spoke network, spoke-administered thrombolysis reduces mechanical thrombectomy procedure time and number of passes. Interv Neuroradiol 29(3):315–320. https://doi.org/10.1177/15910199221087498

    Article  PubMed  Google Scholar 

  4. Meyer L, Bechstein M, Bester M et al (2021) Thrombectomy in extensive stroke may not be beneficial and is associated with increased risk for hemorrhage. Stroke 52(10):3109–3117. https://doi.org/10.1161/strokeaha.120.033101

    Article  CAS  PubMed  Google Scholar 

  5. Thomas L, Viswanathan A, Cochrane TI et al (2012) Variability in the perception of informed consent for IV-tPA during telestroke consultation. Front Neurol 3:128. https://doi.org/10.3389/fneur.2012.00128

    Article  PubMed  PubMed Central  Google Scholar 

  6. Roger VL, Go AS, Lloyd-Jones DM et al (2011) Heart disease and stroke statistics—2011 update. Circulation 123(4):e18–e209. https://doi.org/10.1161/cir.0b013e3182009701

    Article  PubMed  Google Scholar 

  7. Powers WJ, Rabinstein AA, Ackerson T et al (2019) Guidelines for the early management of patients with acute ischemic stroke: 2019 update to the 2018 guidelines for the early management of acute ischemic stroke: a guideline for healthcare professionals from the American heart association/American stroke association. Stroke 50(12):e344–e418. https://doi.org/10.1161/str.0000000000000211

    Article  PubMed  Google Scholar 

  8. Regenhardt RW, Turner AC, Hirsch JA et al (2022) Sex-specific differences in presentations and determinants of outcomes after endovascular thrombectomy for large vessel occlusion stroke. J Neurol 269(1):307–315. https://doi.org/10.1007/s00415-021-10628-0

    Article  PubMed  Google Scholar 

  9. Janssen PM, Chalos V, van den Berg SA et al (2019) Neurological deficits in stroke patients that may impede the capacity to provide informed consent for endovascular treatment trials. J Stroke Cerebrovasc Dis 28(12):104447. https://doi.org/10.1016/j.jstrokecerebrovasdis.2019.104447

    Article  PubMed  Google Scholar 

  10. Regenhardt RW, Nolan NM, Rosenthal JA et al (2022) Understanding delays in MRI-based Selection of large vessel occlusion stroke patients for endovascular thrombectomy. Clin Neuroradiol 32(4):979–986. https://doi.org/10.1007/s00062-022-01165-y

    Article  PubMed  Google Scholar 

  11. Kuriakose D, **ao Z (2020) Pathophysiology and treatment of stroke: present status and future perspectives. Int J Mol Sci 21(20):7609. https://doi.org/10.3390/ijms21207609

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  12. Takase H, Regenhardt RW (2020) Motor tract reorganization after acute central nervous system injury: a translational perspective. Neural Regen Res 16(6):1144–1149. https://doi.org/10.4103/1673-5374.300330

    Article  CAS  PubMed Central  Google Scholar 

  13. Regenhardt RW, Singhal AB, He J, Gonzalez RG, Lev MH (2023) Percent insular ribbon infarction for predicting infarct growth rate and 90-day outcomes in large-vessel occlusive stroke: secondary analysis of prospective clinical trial data. Am J Roentgenol 221(1):103–113. https://doi.org/10.2214/ajr.22.28852

    Article  Google Scholar 

  14. Schneider AM, Regenhardt RW, Dmytriw AA, Patel AB, Hirsch JA, Buchan AM (2023) Cerebroprotection in the endovascular era: an update. J Neurol, Neurosurg Psychiatry 94(4):267–271. https://doi.org/10.1136/jnnp-2022-330379

    Article  PubMed  Google Scholar 

  15. Kraft AW, Regenhardt RW, Awad A et al (2023) Spoke-administered thrombolysis improves large-vessel occlusion early recanalization: the real-world experience of a large academic hub-and-spoke telestroke network. Stroke: Vasc Interv Neurol. https://doi.org/10.1161/svin.122.000427

    Article  PubMed  Google Scholar 

  16. Singh N, Menon BK, Dmytriw AA, Regenhardt RW, Hirsch JA, Ganesh A (2023) Replacing alteplase with tenecteplase: is the time ripe? J Stroke 25(1):72–80. https://doi.org/10.5853/jos.2022.02880

    Article  PubMed  PubMed Central  Google Scholar 

  17. Group NI of ND and S rt PSS (1995) Tissue plasminogen activator for acute ischemic stroke. New Engl J Med 333(24):1581–1588. https://doi.org/10.1056/nejm199512143332401

    Article  Google Scholar 

  18. Hacke W, Kaste M, Bluhmki E et al (2008) Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. New Engl J Med 359(13):1317–1329. https://doi.org/10.1056/nejmoa0804656

    Article  CAS  PubMed  Google Scholar 

  19. Goyal M, Menon BK, van Zwam WH et al (2016) Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials. Lancet 387(10029):1723–1731. https://doi.org/10.1016/s0140-6736(16)00163-x

    Article  PubMed  Google Scholar 

  20. Nolan NM, Regenhardt RW, Koch MJ et al (2021) Treatment approaches and outcomes for acute anterior circulation stroke patients with tandem lesions. J Stroke Cerebrovasc Dis 30(2):105478. https://doi.org/10.1016/j.jstrokecerebrovasdis.2020.105478

    Article  PubMed  Google Scholar 

  21. Regenhardt RW, Awad A, Kraft AW et al (2021) Characterizing reasons for stroke thrombectomy ineligibility among potential candidates transferred in a hub-and-spoke network. Stroke: Vasc Interv Neurol. https://doi.org/10.1161/svin.121.000282

    Article  Google Scholar 

  22. Regenhardt RW, Rosenthal JA, Dmytriw AA et al (2021) Direct to angio-suite large vessel occlusion stroke transfers achieve faster arrival-to-puncture times and improved outcomes. Stroke: Vasc Interv Neurol. https://doi.org/10.1161/svin.121.000327

    Article  Google Scholar 

  23. Ahmed RA, Dmytriw AA, Patel AB et al (2022) Basilar artery occlusion: A review of clinicoradiologic features, treatment selection, and endovascular techniques. Interv Neuroradiol. https://doi.org/10.1177/15910199221106049

    Article  PubMed  PubMed Central  Google Scholar 

  24. Flite CA, Harman LB (2013) Code of ethics: principles for ethical leadership. Perspect Heal Inf Manag 10:1d

    Google Scholar 

  25. Demarquay G, Derex L, Nighoghossian N et al (2005) Ethical issues of informed consent in acute stroke. Cerebrovasc Dis 19(2):65–68. https://doi.org/10.1159/000083250

    Article  PubMed  Google Scholar 

  26. Sokol LL, Hauser JM, Lum HD et al (2021) Goal-concordant care in the era of advanced stroke therapies. J Palliat Med 24(2):297–301. https://doi.org/10.1089/jpm.2019.0667

    Article  PubMed  PubMed Central  Google Scholar 

  27. Regenhardt RW, Young MJ, Etherton MR et al (2021) Toward a more inclusive paradigm: thrombectomy for stroke patients with pre-existing disabilities. J NeuroInterventional Surg 13(10):865–868. https://doi.org/10.1136/neurintsurg-2020-016783

    Article  Google Scholar 

  28. Young MJ, Regenhardt RW, Sokol LL, Leslie-Mazwi TM (2021) When should neuroendovascular care for patients with acute stroke be palliative? AMA J Ethics 23(10):E783-793. https://doi.org/10.1001/amajethics.2021.783

    Article  PubMed  PubMed Central  Google Scholar 

  29. Courtwright A, Rubin E (2016) Who should decide for the unrepresented? Bioethics 30(3):173–180. https://doi.org/10.1111/bioe.12185

    Article  PubMed  Google Scholar 

  30. Young MJ (2020) Compassionate care for the unconscious and incapacitated. Am J Bioeth 20(2):55–57. https://doi.org/10.1080/15265161.2019.1701734

    Article  PubMed  Google Scholar 

  31. Sattin JA, Chiong W, Bonnie RJ, Kirschen MP, Russell JA, Law and HC a joint committee of the AA of NANA and CNS on behalf of the E (2022) Consent Issues in the management of acute ischemic stroke. Neurology 98(2):73–79. https://doi.org/10.1212/wnl.0000000000013040

    Article  PubMed  Google Scholar 

  32. Zonjee VJ, Slenders JPL, de Beer F et al (2021) Practice variation in the informed consent procedure for thrombolysis in acute ischemic stroke: a survey among neurologists and neurology residents. BMC Méd Ethics 22(1):114. https://doi.org/10.1186/s12910-021-00684-6

    Article  PubMed  PubMed Central  Google Scholar 

  33. Rosenbaum JR, Bravata DM, Concato J, Brass LM, Kim N, Fried TR (2004) Informed consent for thrombolytic therapy for patients with acute ischemic stroke treated in routine clinical practice. Stroke 35(9):e353–e355. https://doi.org/10.1161/01.str.0000136555.28503.55

    Article  PubMed  Google Scholar 

  34. Mendelson SJ, Courtney DM, Gordon EJ, Thomas LF, Holl JL, Prabhakaran S (2018) National practice patterns of obtaining informed consent for stroke thrombolysis. Stroke 49(3):765–767. https://doi.org/10.1161/strokeaha.117.020474

    Article  PubMed  PubMed Central  Google Scholar 

  35. Weintraub MI, Colello AD, Johnson SA et al (2017) Informed consent for intravenous tissue plasminogen activator in New York State designated stroke centers. J Stroke Cerebrovasc Dis 26(6):1274–1279. https://doi.org/10.1016/j.jstrokecerebrovasdis.2017.01.021

    Article  PubMed  Google Scholar 

  36. § 482.51 Condition of participation: Surgical services. https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-482/subpart-D/section-482.51

  37. Qureshi AI, Gilani S, Adil MM et al (2014) Pattern of informed consent acquisition in patients undergoing emergent endovascular treatment for acute ischemic stroke. J Vasc Interv Neurol 7(2):21–25

    PubMed  PubMed Central  Google Scholar 

  38. Wade DT, Kitzinger C (2019) Making healthcare decisions in a person’s best interests when they lack capacity: clinical guidance based on a review of evidence. Clin Rehabil 33(10):1571–1585. https://doi.org/10.1177/0269215519852987

    Article  PubMed  PubMed Central  Google Scholar 

  39. Akinsanya J, Diggory P, Heitz E, Jones V (2009) Assessing capacity and obtaining consent for thrombolysis for acute stroke. Clin Med 9(3):239–241. https://doi.org/10.7861/clinmedicine.9-3-239

    Article  Google Scholar 

  40. Etchells E, Darzins P, Silberfeld M et al (1999) Assessment of patient capacity to consent to treatment. J Gen Intern Med 14(1):27–34. https://doi.org/10.1046/j.1525-1497.1999.00277.x

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  41. Decker C, Chhatriwalla E, Gialde E et al (2015) Patient-centered decision support in acute ischemic stroke. Circ: Cardiovasc Qual Outcomes. 8(6 & lowbar;suppl_3):S109–S116. https://doi.org/10.1161/circoutcomes.115.002003

    Article  PubMed  Google Scholar 

  42. Schwamm LH (2018) Acute stroke. Circ: Cardiovasc Qual Outcomes 8(6 suppl 3):S69–S72. https://doi.org/10.1161/circoutcomes.115.002282

    Article  Google Scholar 

  43. Emberson J, Lees KR, Lyden P et al (2014) Effect of treatment delay, age, and stroke severity on the effects of intravenous thrombolysis with alteplase for acute ischaemic stroke: a meta-analysis of individual patient data from randomised trials. Lancet 384(9958):1929–1935. https://doi.org/10.1016/s0140-6736(14)60584-5

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  44. Kim JT, Fonarow GC, Smith EE et al (2017) Treatment with tissue plasminogen activator in the golden hour and the shape of the 4.5-hour time-benefit curve in the national united states get with the guidelines-stroke population. Circulation 135(2):128–139. https://doi.org/10.1161/circulationaha.116.023336

    Article  CAS  PubMed  Google Scholar 

  45. Jovin TG, Nogueira RG, Lansberg MG et al (2022) Thrombectomy for anterior circulation stroke beyond 6 h from time last known well (AURORA): a systematic review and individual patient data meta-analysis. Lancet 399(10321):249–258. https://doi.org/10.1016/s0140-6736(21)01341-6

    Article  PubMed  Google Scholar 

Download references

Funding

None.

Author information

Author notes

  1. Amir Mbonde and Michael J. Young have contributed equally to this work.

Authors and Affiliations

  1. Harvard Medical School, Boston, MA, USA

    Amir Mbonde, Michael J. Young, Natalia S. Rost & Robert W. Regenhardt

  2. Mayo Clinic Arizona, 13400 E Shea Blvd, Scottsdale, AZ, 85259, USA

    Amir Mbonde

  3. Harvard Medical School, Boston, MA, USA

    Adam A. Dmytriw, Quentin J. Moyer, Aman B. Patel & Robert W. Regenhardt

  4. Harvard Medical School, Boston, MA, USA

    Adam A. Dmytriw, Quentin J. Moyer & Joshua A. Hirsch

  5. University of Washington, Seattle, WA, USA

    Thabele M. Leslie-Mazwi

Authors
  1. Amir Mbonde
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Michael J. Young
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Adam A. Dmytriw
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Quentin J. Moyer
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Joshua A. Hirsch
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Thabele M. Leslie-Mazwi
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Natalia S. Rost
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Aman B. Patel
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Robert W. Regenhardt
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Amir Mbonde.

Ethics declarations

Conflicts of interest

AAM has no conflicts to report. MJH has no conflicts to report. AAD has no conflicts to report. QJM has no conflicts to report. JAH serves as a consultant for Medtronic on a DSMB for Rapid Medical. TLM serves on a DSMB for Rapid Medical. NSR has no conflicts to report. ABP serves as a consultant for Medtronic, Microvention, and Penumbra. RWR serves on a DSMB for Rapid Medical.

Rights and permissions

Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Mbonde, A., Young, M.J., Dmytriw, A.A. et al. Informed consent practices for acute stroke therapy: principles, challenges and emerging opportunities. J Neurol 271, 188–197 (2024). https://doi.org/10.1007/s00415-023-12028-y

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00415-023-12028-y

Keywords

Search

Navigation