Research ExplorerPublicationsEffect of informed consent on patient characteristics in a s...

Effect of informed consent on patient characteristics in a stroke thrombolysis trial

Standard

Effect of informed consent on patient characteristics in a stroke thrombolysis trial. / Thomalla, Götz; Boutitie, Florent; Fiebach, Jochen B; Simonsen, Claus Z; Nighoghossian, Norbert; Pedraza, Salvador; Lemmens, Robin; Roy, Pascal; Muir, Keith W; Heesen, Christoph; Ebinger, Martin; Ford, Ian; Cheng, Bastian; Cho, Tae-Hee; Puig, Josep; Thijs, Vincent; Endres, Matthias; Fiehler, Jens; Gerloff, Christian.

In: NEUROLOGY, Vol. 89, No. 13, 26.09.2017, p. 1400-1407.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Thomalla, G, Boutitie, F, Fiebach, JB, Simonsen, CZ, Nighoghossian, N, Pedraza, S, Lemmens, R, Roy, P, Muir, KW, Heesen, C, Ebinger, M, Ford, I, Cheng, B, Cho, T-H, Puig, J, Thijs, V, Endres, M, Fiehler, J & Gerloff, C 2017, 'Effect of informed consent on patient characteristics in a stroke thrombolysis trial', NEUROLOGY, vol. 89, no. 13, pp. 1400-1407. https://doi.org/10.1212/WNL.0000000000004414

APA

Thomalla, G., Boutitie, F., Fiebach, J. B., Simonsen, C. Z., Nighoghossian, N., Pedraza, S., Lemmens, R., Roy, P., Muir, K. W., Heesen, C., Ebinger, M., Ford, I., Cheng, B., Cho, T-H., Puig, J., Thijs, V., Endres, M., Fiehler, J., & Gerloff, C. (2017). Effect of informed consent on patient characteristics in a stroke thrombolysis trial. NEUROLOGY, 89(13), 1400-1407. https://doi.org/10.1212/WNL.0000000000004414

Vancouver

Thomalla G, Boutitie F, Fiebach JB, Simonsen CZ, Nighoghossian N, Pedraza S et al. Effect of informed consent on patient characteristics in a stroke thrombolysis trial. NEUROLOGY. 2017 Sep 26;89(13):1400-1407. https://doi.org/10.1212/WNL.0000000000004414

Bibtex

@article{a201dfb65e7d49139f75289a7a7a56ae,
title = "Effect of informed consent on patient characteristics in a stroke thrombolysis trial",
abstract = "OBJECTIVE: To determine whether the manner of consent, i.e., informed consent by patients themselves or informed consent by proxy, affects clinical characteristics of samples of acute stroke patients enrolled in clinical trials.METHODS: We analyzed the manner of obtaining informed consent in the first 1,005 patients from WAKE-UP, an investigator-initiated, randomized, placebo-controlled trial of MRI-based thrombolysis in stroke patients with unknown time of symptom onset running in 6 European countries. Patients providing informed consent by themselves were compared with patients enrolled by proxy consent. Baseline clinical measures were compared between groups.RESULTS: In 359 (35.7%) patients, informed consent was by proxy. Patients with proxy consent were older (median 71 vs 66 years, p < 0.0001) and had a higher frequency of arterial hypertension (58.2% vs 43.4%, p < 0.0001). They showed higher scores on the NIH Stroke Scale (median 11 vs 5, p < 0.0001) and more frequently aphasia (73.7% vs 20.0%, p < 0.0001). The rate of proxy consent varied among countries (p < 0.0001), ranging from 77.1% in Spain to 1.2% in Denmark.CONCLUSIONS: Patients recruited by proxy consent were older, had more severe strokes, and had higher prevalence of aphasia than those with capacity to give personal consent. Variations in the manner of consent across countries may influence trial results.CLINICALTRIALSGOV AND CLINICALTRIALSREGISTEREU IDENTIFIERS: NCT01525290 (clinicaltrials.gov); 2011-005906-32 (clinicaltrialsregister.eu).",
keywords = "Journal Article",
author = "G{\"o}tz Thomalla and Florent Boutitie and Fiebach, {Jochen B} and Simonsen, {Claus Z} and Norbert Nighoghossian and Salvador Pedraza and Robin Lemmens and Pascal Roy and Muir, {Keith W} and Christoph Heesen and Martin Ebinger and Ian Ford and Bastian Cheng and Tae-Hee Cho and Josep Puig and Vincent Thijs and Matthias Endres and Jens Fiehler and Christian Gerloff",
note = "Copyright {\textcopyright} 2017 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.",
year = "2017",
month = sep,
day = "26",
doi = "10.1212/WNL.0000000000004414",
language = "English",
volume = "89",
pages = "1400--1407",
journal = "NEUROLOGY",
issn = "0028-3878",
publisher = "Lippincott Williams and Wilkins",
number = "13",

}

RIS

TY - JOUR

T1 - Effect of informed consent on patient characteristics in a stroke thrombolysis trial

AU - Thomalla, Götz

AU - Boutitie, Florent

AU - Fiebach, Jochen B

AU - Simonsen, Claus Z

AU - Nighoghossian, Norbert

AU - Pedraza, Salvador

AU - Lemmens, Robin

AU - Roy, Pascal

AU - Muir, Keith W

AU - Heesen, Christoph

AU - Ebinger, Martin

AU - Ford, Ian

AU - Cheng, Bastian

AU - Cho, Tae-Hee

AU - Puig, Josep

AU - Thijs, Vincent

AU - Endres, Matthias

AU - Fiehler, Jens

AU - Gerloff, Christian

N1 - Copyright © 2017 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.

PY - 2017/9/26

Y1 - 2017/9/26

N2 - OBJECTIVE: To determine whether the manner of consent, i.e., informed consent by patients themselves or informed consent by proxy, affects clinical characteristics of samples of acute stroke patients enrolled in clinical trials.METHODS: We analyzed the manner of obtaining informed consent in the first 1,005 patients from WAKE-UP, an investigator-initiated, randomized, placebo-controlled trial of MRI-based thrombolysis in stroke patients with unknown time of symptom onset running in 6 European countries. Patients providing informed consent by themselves were compared with patients enrolled by proxy consent. Baseline clinical measures were compared between groups.RESULTS: In 359 (35.7%) patients, informed consent was by proxy. Patients with proxy consent were older (median 71 vs 66 years, p < 0.0001) and had a higher frequency of arterial hypertension (58.2% vs 43.4%, p < 0.0001). They showed higher scores on the NIH Stroke Scale (median 11 vs 5, p < 0.0001) and more frequently aphasia (73.7% vs 20.0%, p < 0.0001). The rate of proxy consent varied among countries (p < 0.0001), ranging from 77.1% in Spain to 1.2% in Denmark.CONCLUSIONS: Patients recruited by proxy consent were older, had more severe strokes, and had higher prevalence of aphasia than those with capacity to give personal consent. Variations in the manner of consent across countries may influence trial results.CLINICALTRIALSGOV AND CLINICALTRIALSREGISTEREU IDENTIFIERS: NCT01525290 (clinicaltrials.gov); 2011-005906-32 (clinicaltrialsregister.eu).

AB - OBJECTIVE: To determine whether the manner of consent, i.e., informed consent by patients themselves or informed consent by proxy, affects clinical characteristics of samples of acute stroke patients enrolled in clinical trials.METHODS: We analyzed the manner of obtaining informed consent in the first 1,005 patients from WAKE-UP, an investigator-initiated, randomized, placebo-controlled trial of MRI-based thrombolysis in stroke patients with unknown time of symptom onset running in 6 European countries. Patients providing informed consent by themselves were compared with patients enrolled by proxy consent. Baseline clinical measures were compared between groups.RESULTS: In 359 (35.7%) patients, informed consent was by proxy. Patients with proxy consent were older (median 71 vs 66 years, p < 0.0001) and had a higher frequency of arterial hypertension (58.2% vs 43.4%, p < 0.0001). They showed higher scores on the NIH Stroke Scale (median 11 vs 5, p < 0.0001) and more frequently aphasia (73.7% vs 20.0%, p < 0.0001). The rate of proxy consent varied among countries (p < 0.0001), ranging from 77.1% in Spain to 1.2% in Denmark.CONCLUSIONS: Patients recruited by proxy consent were older, had more severe strokes, and had higher prevalence of aphasia than those with capacity to give personal consent. Variations in the manner of consent across countries may influence trial results.CLINICALTRIALSGOV AND CLINICALTRIALSREGISTEREU IDENTIFIERS: NCT01525290 (clinicaltrials.gov); 2011-005906-32 (clinicaltrialsregister.eu).

KW - Journal Article

U2 - 10.1212/WNL.0000000000004414

DO - 10.1212/WNL.0000000000004414

M3 - SCORING: Journal article

C2 - 28842449

VL - 89

SP - 1400

EP - 1407

JO - NEUROLOGY

JF - NEUROLOGY

SN - 0028-3878

IS - 13

ER -