Informed Consent for Intravenous Tissue Plasminogen Activator in New York State Designated Stroke Centers

Weintraub, Michael; Colello, Anna; Johnson, Samantha A.; McClellan, Fabienne; Cole, Steven P.; Benesch, Curtis; Rudolph, Steven; Levine, Steven R.

doi:10.1016/j.jstrokecerebrovasdis.2017.01.021

Cited by 7 publications

(10 citation statements)

References 21 publications

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“…The difficulties in obtaining informed consent for IVT have been the subject of a number publications 37,39‐61 . Not even under the ideal circumstances of a randomised study can the process of informed consent be carried out in an unproblematic way 47 .…”

Section: Figurementioning

confidence: 99%

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Ethical issues in stroke thrombolysis revisited

Appelros

Svensson

Heidenreich

et al. 2021

Acta Neuro Scandinavica

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Ethical issues in stroke thrombolysis revisitedBack in 1997, a bioethical paper on intravenous thrombolysis in acute ischaemic stroke (IVT), authored by Anthony J. Furlan and George Kanoti, was published. 1 Based on the criteria modified from Schwartz 2 (safety, efficacy, effectiveness, efficiency and outcome), the authors found several ethical problems that were associated with IVT. They can be summarised as a weak proportionality between positive and negative outcomes, and a lack of relation to patient preferences.The literature on IVT has continued to grow after 1997. Most randomised studies on alteplase were published after that, and the debate on IVT has continued to be lively, even over the last decade. [3][4][5][6][7][8][9] Time has therefore come to revisit the ethical issues raised in 1997. The purpose of this paper is to analyse whether these issues have been resolved. More specifically, the following issues will be reviewed as follows:1. Lack of standardisation of outcome endpoints.2. A poorly substantiated beneficial effect.3. Unsolved safety problems, that is an increased risk of intracranial haemorrhage and death.4. Uncertainties regarding patient preferences. Difficulties in obtaining informed consent.As alteplase is the most studied thrombolytic drug, 10 we will solely deal with this drug. Each section will be commence with a

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Section: Figurementioning

confidence: 99%

“…Thus, there is no generally accepted way of obtaining informed consent. This has resulted in varying requirements regarding the need of informed consent in the United States 59,61 and probably wider. There is a palpaple possibility that the patient does not understand the risks of the treatment.…”

Section: Figurementioning

confidence: 99%

Ethical issues in stroke thrombolysis revisited

Appelros

Svensson

Heidenreich

et al. 2021

Acta Neuro Scandinavica

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“…8,[13][14][15] These observations were confirmed by a recent survey including 111 designated US stroke centers. 16 Of note, time-window after onset of stroke-related symptoms and even bed capacities of the treating hospital were found to impact on the physicians' belief that an informed consent procedure is needed for IVT. 16 Generally, the ability of a patient to provide consent requires the capacity and willingness to absorb new information, the ability to adequately process provided information and to memorize it even in the context of a potentially lifethreatening situation.…”

Section: Introductionmentioning

confidence: 99%

“…16 Of note, time-window after onset of stroke-related symptoms and even bed capacities of the treating hospital were found to impact on the physicians' belief that an informed consent procedure is needed for IVT. 16 Generally, the ability of a patient to provide consent requires the capacity and willingness to absorb new information, the ability to adequately process provided information and to memorize it even in the context of a potentially lifethreatening situation. 6 However, there are numerous reports demonstrating difficulties of information transfer to patients in the context of acute or even life-threatening illness, [17][18][19] as psychological and physical stress as well as the level of education significantly influences the ability of patients to understand provided information.…”

Section: Introductionmentioning

confidence: 99%

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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“…However, since the aspiration of a shorter time of DNT (Door to Needle Time), we have been focusing solely on the time spent on the informed consent, neglecting how decision-makers felt in the decision-making process and whether it caused prolonged decision-making. Researchers had reported that 1.2–98% of thrombolysis decision was made by proxies 15 , 16 . Guo found that most thrombolysis decisions were made by proxy decision makers, and patients with AIS and proxy decision makers did not feel and think exactly the same in the decision-making process in a qualitative study 17 .…”

Section: Introductionmentioning

confidence: 99%

Decision-making psychological state and characteristic of proxies of thrombolytic patients: a pilot study

Guo

Liu

Guo

et al. 2022

Sci Rep

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Intravenous thrombolysis is the preferred treatment modality for acute ischemic stroke. In China, written informed consent from patients or proxies must be obtained before intravenous thrombolysis is performed, which always leads to in-hospital delay of thrombolysis. To explore the relationship between characteristics of thrombolysis decision-making and psychological states of proxies of AIS patients. This was a pilot study. 231 proxies of AIS patients were recruited, including 147 males and 84 females. STAI, WFPTS, CAOT, CPS, C-DCS and time-consuming of decision-making were collected by trained nurses during the period from signing informed consent to thrombolysis finished. The general information was collected within 24 h after admission. Pearson correlation analysis and the Ridge regression analysis were used to explore the correlation and causality between psychological indicators (STAI, WFPTS, CAOT, CPS) and decision-making characteristics (C-DCS, Time consuming). Structural equation modeling was used to explore the direct and indirect effect of psychological factors on decision-making characteristics. The mean of anxiety, trust in physicians, and decision conflict were 49.20 ± 9.50, 37.83 ± 6.63 and 30.60 ± 14.77, respectively. The CAOT was associated with C-DCS through the mediation of STAI and WFPTS (p < 0.001). The CAOT was associated with time-consuming through the mediation of STAI, WFPTS and CPS (p < 0.05). The CAOT, STAI and WFPTS were associated with C-DCS (p < 0.05), and STAI, WFPTS and CPS were associated with time-consuming (p < 0.01). The proxy of patients with acute ischemic stroke had severe decision conflict in thrombolysis decision-making. The psychological state was associated with decision conflict and the time-consuming. Medical staff should explore methods to release the anxiety and increase the trust in physicians to reduce the decision-making conflict and time-consuming, which could promote the smooth progress of the informed consent.

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Informed Consent for Intravenous Tissue Plasminogen Activator in New York State Designated Stroke Centers

Cited by 7 publications

References 21 publications

Ethical issues in stroke thrombolysis revisited

Ethical issues in stroke thrombolysis revisited

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

Decision-making psychological state and characteristic of proxies of thrombolytic patients: a pilot study

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