Practice variation in the informed consent procedure for thrombolysis in acute ischemic stroke: a survey among neurologists and neurology residents

Zonjee, V J; Slenders, J. P. L.; Beer, Frank de; Visser, Marieke C.; Meulen, B. C. ter; Berg-Vos, Renske M. Van den; Schaik, Sander M. Van

doi:10.1186/s12910-021-00684-6

Cited by 6 publications

(4 citation statements)

References 32 publications

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“…The need to ensure patients' informed consent for IVT is a matter of debate. 10,13,15,16,22,26,27 This prospective multicenter observational study demonstrates that IVT-eligible patients with mild to moderate ischemic stroke are able to recall about half of the information provided by a trained physician during a SET within 4.5 h after stroke onset.…”

Section: Discussionmentioning

confidence: 84%

“…However, an online survey among Dutch neurologists reported a maximum of 5 min for information transfer. 27 The following limitations of our prospective multi-center observational study have to be considered: First, the prerequisite for study participation was the presumed ability to understand provided information on IVT as well as the ability to provide written informed consent after 60-90 min or 23-25 h later, respectively. This implies a selection bias toward patients with less severe stroke.…”

Section: Discussionmentioning

confidence: 99%

“…However, an online survey among Dutch neurologists reported a maximum of 5 min for information transfer. 27 …”

Section: Discussionmentioning

confidence: 99%

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Ability of patients with acute ischemic stroke to recall given information on intravenous thrombolysis: Results of a prospective multicenter study

Schuster

Essig

Daneshkhah

et al. 2023

European Stroke Journal

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Introduction: Intravenous thrombolysis (IVT) is an on label treatment for selected patients with acute ischemic stroke (AIS). As major bleeding or allergic shock may occur, the need to ensure patients’ informed consent for IVT is a matter of debate. Patients and methods: Prospective investigator-initiated multi-center observational study to assess the ability of AIS patients to recall information, provided by a physician during a standardized educational talk (SET) on IVT use. The recall of 20 pre-defined items was assessed in AIS after 60–90 min ( n = 93) or 23–25 h ( n = 40) after SET. About 40 patients with subacute stroke, 40 non-stroke patients, and 23 relatives of AIS patients served as controls, and were surveyed 60–90 min after SET. Results: Within 60–90 min after SET, AIS patients (median age 70 years, 31% female, median NIHSS score on admission 3 points) who were considered capable to provide informed consent recalled 55% (IQR 40%–66.7%) of the provided SET items. In multivariable linear regression analysis recapitulation by AIS patients was associated with their educational level (β = 6.497, p < 0.001), self-reported excitement level (β = 1.879, p = 0.011) and NIHSS score on admission (β = −1.186, p = 0.001). Patients with subacute stroke (70 years, 40% female, median NIHSS = 2) recalled 70% (IQR 55.7%–83.6%), non-stroke patients (75 years, 40% female) 70% (IQR 60%–78.7%), and AIS relatives (58 years, 83% female) 70% (IQR 60%–85%). Compared to subacute stroke patients, AIS patients less often recalled the frequency of IVT-related bleeding (21% vs 43%), allergic shock (15% vs 39%), and bleeding-related morbidity and mortality (44% vs 78%). AIS patients recalled 50% (IQR 42.3%–67.5%) of the provided items 23–25 h after SET. Conclusion: AIS patients eligible for IVT remember about half of all SET-items after 60–90 min or 23–25 h, respectively. The fact that the recapitulation of IVT-associated risks is particularly poor should be given special consideration.

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Section: Discussionmentioning

confidence: 84%

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Ability of patients with acute ischemic stroke to recall given information on intravenous thrombolysis: Results of a prospective multicenter study

Schuster

Essig

Daneshkhah

et al. 2023

European Stroke Journal

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“…The elderly and children are populations with specific needs regarding informed consent. Truly informed consent is particularly difficult in elderly patients because of their physical conditions ( 46 ), their medical conditions ( 47 ), the effects of medications ( 48 ), as well as their attitudes of passive acceptance rather than active involvement in their care ( 49 ).…”

Section: Medical Malpractice Liability Assessmentmentioning

confidence: 99%

AI and professional liability assessment in healthcare. A revolution in legal medicine?

Terranova,

Cestonaro,

Fava

et al. 2024

Front. Med.

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The adoption of advanced artificial intelligence (AI) systems in healthcare is transforming the healthcare-delivery landscape. Artificial intelligence may enhance patient safety and improve healthcare outcomes, but it presents notable ethical and legal dilemmas. Moreover, as AI streamlines the analysis of the multitude of factors relevant to malpractice claims, including informed consent, adherence to standards of care, and causation, the evaluation of professional liability might also benefit from its use. Beginning with an analysis of the basic steps in assessing professional liability, this article examines the potential new medical-legal issues that an expert witness may encounter when analyzing malpractice cases and the potential integration of AI in this context. These changes related to the use of integrated AI, will necessitate efforts on the part of judges, experts, and clinicians, and may require new legislative regulations. A new expert witness will be likely necessary in the evaluation of professional liability cases. On the one hand, artificial intelligence will support the expert witness; however, on the other hand, it will introduce specific elements into the activities of healthcare workers. These elements will necessitate an expert witness with a specialized cultural background. Examining the steps of professional liability assessment indicates that the likely path for AI in legal medicine involves its role as a collaborative and integrated tool. The combination of AI with human judgment in these assessments can enhance comprehensiveness and fairness. However, it is imperative to adopt a cautious and balanced approach to prevent complete automation in this field.

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

Mbonde,

Young,

Dmytriw

et al. 2023

J Neurol

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Practice variation in the informed consent procedure for thrombolysis in acute ischemic stroke: a survey among neurologists and neurology residents

Cited by 6 publications

References 32 publications

Ability of patients with acute ischemic stroke to recall given information on intravenous thrombolysis: Results of a prospective multicenter study

Ability of patients with acute ischemic stroke to recall given information on intravenous thrombolysis: Results of a prospective multicenter study

AI and professional liability assessment in healthcare. A revolution in legal medicine?

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

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