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Observational Study
. 2023 Mar;8(1):241-250.
doi: 10.1177/23969873221143856. Epub 2023 Jan 6.

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

Luzie Schuster  1 , Fabian Essig  2 , Naeimeh Daneshkhah  2 , Juliane Herm  3   4   5 , Simon Hellwig  3   4   6 , Matthias Endres  3   4   5   6   7 , Ulrich Dirnagl  3   8 , Frank Hoffmann  9 , Dominik Michalski  1 , Waltraud Pfeilschifter  10   11 , Christian Urbanek  12 , Gabor C Petzold  13   14 , Timolaos Rizos  15 , Andrea Kraft  9 , Karl Georg Haeusler  2
Affiliations
Observational Study

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

Luzie Schuster et al. Eur Stroke J. 2023 Mar.

Abstract

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.

Trial registration: ClinicalTrials.gov NCT03246256.

Keywords: Ischemic stroke; alteplase; informed consent; intracranial bleeding; rt-PA.

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Conflict of interest statement

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: ME reports grants from Bayer and fees paid to the Charité from Abbot, Amgen, Bayer, Boehringer Ingelheim, Bristol-Myers-Squibb, Daiichi Sankyo, Novartis, Pfizer, and Sanofi. Also, ME received funding from DFG under Germany’s Excellence Strategy – EXC-2049 – 390688087, Collaborative Research Center ReTune TRR 295-424778381, BMBF, DZNE, DZHK, EU, Corona Foundation, and Fondation Leducq. FH reports consulting and/or speaking fees (Alexion, Bayer, Biogen, CSL Behring, DIAMED Medizintechnik, Grifols, Ipsen, Janssen, Merck, Novartis, Roche, Sanofi, and Teva) and grant/research support (Bayer, Biogen, Merck, Novartis). CU reports grants or speaker’s honoraria from Alexion, Boehringer Ingelheim, Bristol-Myers-Squibb, Daiichi Sankyo, and Pfizer. TR received consulting honoraria, speakers’ honoraria and travel support from BMS Pfizer, Boehringer Ingelheim, Bayer HealthCare, and Daiichi Sankyo, outside the submitted work. AK reports speaker’s honoraria, consulting fees and/or lecture honoraria from Bayer Healthcare, Sanofi, Boehringer Ingelheim, Daiichi Sankyo, Pfizer, Bristol-Myers Squibb, and Medtronic. KGH reports speaker’s honoraria, consulting fees, lecture honoraria, and/or study grants from Abbott, Amarin, Alexion, AstraZeneca, Bayer Healthcare, Sanofi, Biotronik, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Medronic, Pfizer, Portola, SUN Pharma, W. L. Gore and Associates, and Edwards Lifesciences. All other authors report no conflict of interests in relation to the submitted work.

Figures

Figure 1.
Figure 1.
Study groups according to inclusion and exclusion criteria and timing of recall. EVT: endovascular treatment; IVT: intravenous thrombolysis.
Figure 2.
Figure 2.
Percentage of recalled information on IVT in the respective study groups. Within boxplots, horizontal lines represent the median, boxes represent values within the 25th–75th percentiles and error bars indicate the range within 5th–95th percentile. Test for significance was performed by Kruskal-Wallis test with correction for multiple comparisons, *p < 0.05, **p < 0.01, ***p < 0.001.
Figure 3.
Figure 3.
Ability of patients with acute ischemic stroke to recall given information on IVT before the start of IVT at 60–90 min (left, stroke group A) or 23–25 h (right, stroke group B) after SET, respectively. Data is given in % of patients remembering the respective item.
See this image and copyright information in PMC

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