Effect of informed consent on patient characteristics in a stroke thrombolysis trial
Identifieur interne : 000D56 ( Main/Exploration ); précédent : 000D55; suivant : 000D57Effect of informed consent on patient characteristics in a stroke thrombolysis trial
Auteurs : Götz Thomalla ; Florent Boutitie ; Jochen B. Fiebach ; Claus Z. Simonsen ; Norbert Nighoghossian ; Salvador Pedraza ; Robin Lemmens ; Pascal Roy ; Keith W. Muir ; Christoph Heesen ; Martin Ebinger ; Ian Ford ; Bastian Cheng ; Tae-Hee Cho ; Josep Puig ; Vincent Thijs ; Matthias Endres ; Jens Fiehler ; Christian GerloffSource :
- Neurology [ 0028-3878 ] ; 2017.
Descripteurs français
- KwdFr :
- Accident vasculaire cérébral (), Accident vasculaire cérébral (imagerie diagnostique), Accident vasculaire cérébral (traitement médicamenteux), Accident vasculaire cérébral (épidémiologie), Adulte d'âge moyen, Aphasie (épidémiologie), Aphasie (étiologie), Consentement libre et éclairé, Encéphale (imagerie diagnostique), Europe, Facteurs de l'âge, Femelle, Humains, Hypertension artérielle (), Hypertension artérielle (épidémiologie), Imagerie par résonance magnétique, Indice de gravité médicale, Mandataire, Mâle, Méthode en double aveugle, Prévalence, Sujet âgé, Traitement thrombolytique.
- MESH :
- imagerie diagnostique : Accident vasculaire cérébral, Encéphale.
- traitement médicamenteux : Accident vasculaire cérébral.
- épidémiologie : Accident vasculaire cérébral, Aphasie, Hypertension artérielle.
- étiologie : Aphasie.
- Accident vasculaire cérébral, Adulte d'âge moyen, Consentement libre et éclairé, Europe, Facteurs de l'âge, Femelle, Humains, Hypertension artérielle, Imagerie par résonance magnétique, Indice de gravité médicale, Mandataire, Mâle, Méthode en double aveugle, Prévalence, Sujet âgé, Traitement thrombolytique.
English descriptors
- KwdEn :
- Age Factors, Aged, Aphasia (epidemiology), Aphasia (etiology), Brain (diagnostic imaging), Double-Blind Method, Europe, Female, Humans, Hypertension (complications), Hypertension (epidemiology), Informed Consent, Magnetic Resonance Imaging, Male, Middle Aged, Prevalence, Proxy, Severity of Illness Index, Stroke (complications), Stroke (diagnostic imaging), Stroke (drug therapy), Stroke (epidemiology), Thrombolytic Therapy.
- MESH :
- complications : Hypertension, Stroke.
- diagnostic imaging : Brain, Stroke.
- drug therapy : Stroke.
- epidemiology : Aphasia, Hypertension, Stroke.
- etiology : Aphasia.
- Age Factors, Aged, Double-Blind Method, Europe, Female, Humans, Informed Consent, Magnetic Resonance Imaging, Male, Middle Aged, Prevalence, Proxy, Severity of Illness Index, Thrombolytic Therapy.
Abstract
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.
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.
In 359 (35.7%) patients, informed consent was by proxy. Patients with proxy consent were older (median 71 vs 66 years,
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.
NCT01525290 (
Url:
DOI: 10.1212/WNL.0000000000004414
PubMed: 28842449
PubMed Central: 5649757
Affiliations:
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Le document en format XML
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Effect of informed consent on patient characteristics in a stroke thrombolysis trial</title>
<author><name sortKey="Thomalla, Gotz" sort="Thomalla, Gotz" uniqKey="Thomalla G" first="Götz" last="Thomalla">Götz Thomalla</name>
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<author><name sortKey="Boutitie, Florent" sort="Boutitie, Florent" uniqKey="Boutitie F" first="Florent" last="Boutitie">Florent Boutitie</name>
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<author><name sortKey="Fiebach, Jochen B" sort="Fiebach, Jochen B" uniqKey="Fiebach J" first="Jochen B." last="Fiebach">Jochen B. Fiebach</name>
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<author><name sortKey="Simonsen, Claus Z" sort="Simonsen, Claus Z" uniqKey="Simonsen C" first="Claus Z." last="Simonsen">Claus Z. Simonsen</name>
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<author><name sortKey="Nighoghossian, Norbert" sort="Nighoghossian, Norbert" uniqKey="Nighoghossian N" first="Norbert" last="Nighoghossian">Norbert Nighoghossian</name>
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<author><name sortKey="Pedraza, Salvador" sort="Pedraza, Salvador" uniqKey="Pedraza S" first="Salvador" last="Pedraza">Salvador Pedraza</name>
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<author><name sortKey="Roy, Pascal" sort="Roy, Pascal" uniqKey="Roy P" first="Pascal" last="Roy">Pascal Roy</name>
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<author><name sortKey="Muir, Keith W" sort="Muir, Keith W" uniqKey="Muir K" first="Keith W." last="Muir">Keith W. Muir</name>
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<author><name sortKey="Cheng, Bastian" sort="Cheng, Bastian" uniqKey="Cheng B" first="Bastian" last="Cheng">Bastian Cheng</name>
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<author><name sortKey="Puig, Josep" sort="Puig, Josep" uniqKey="Puig J" first="Josep" last="Puig">Josep Puig</name>
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<author><name sortKey="Thijs, Vincent" sort="Thijs, Vincent" uniqKey="Thijs V" first="Vincent" last="Thijs">Vincent Thijs</name>
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<author><name sortKey="Endres, Matthias" sort="Endres, Matthias" uniqKey="Endres M" first="Matthias" last="Endres">Matthias Endres</name>
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<series><title level="j">Neurology</title>
<idno type="ISSN">0028-3878</idno>
<idno type="eISSN">1526-632X</idno>
<imprint><date when="2017">2017</date>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Age Factors</term>
<term>Aged</term>
<term>Aphasia (epidemiology)</term>
<term>Aphasia (etiology)</term>
<term>Brain (diagnostic imaging)</term>
<term>Double-Blind Method</term>
<term>Europe</term>
<term>Female</term>
<term>Humans</term>
<term>Hypertension (complications)</term>
<term>Hypertension (epidemiology)</term>
<term>Informed Consent</term>
<term>Magnetic Resonance Imaging</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Prevalence</term>
<term>Proxy</term>
<term>Severity of Illness Index</term>
<term>Stroke (complications)</term>
<term>Stroke (diagnostic imaging)</term>
<term>Stroke (drug therapy)</term>
<term>Stroke (epidemiology)</term>
<term>Thrombolytic Therapy</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Accident vasculaire cérébral ()</term>
<term>Accident vasculaire cérébral (imagerie diagnostique)</term>
<term>Accident vasculaire cérébral (traitement médicamenteux)</term>
<term>Accident vasculaire cérébral (épidémiologie)</term>
<term>Adulte d'âge moyen</term>
<term>Aphasie (épidémiologie)</term>
<term>Aphasie (étiologie)</term>
<term>Consentement libre et éclairé</term>
<term>Encéphale (imagerie diagnostique)</term>
<term>Europe</term>
<term>Facteurs de l'âge</term>
<term>Femelle</term>
<term>Humains</term>
<term>Hypertension artérielle ()</term>
<term>Hypertension artérielle (épidémiologie)</term>
<term>Imagerie par résonance magnétique</term>
<term>Indice de gravité médicale</term>
<term>Mandataire</term>
<term>Mâle</term>
<term>Méthode en double aveugle</term>
<term>Prévalence</term>
<term>Sujet âgé</term>
<term>Traitement thrombolytique</term>
</keywords>
<keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>Hypertension</term>
<term>Stroke</term>
</keywords>
<keywords scheme="MESH" qualifier="diagnostic imaging" xml:lang="en"><term>Brain</term>
<term>Stroke</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Stroke</term>
</keywords>
<keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Aphasia</term>
<term>Hypertension</term>
<term>Stroke</term>
</keywords>
<keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Aphasia</term>
</keywords>
<keywords scheme="MESH" qualifier="imagerie diagnostique" xml:lang="fr"><term>Accident vasculaire cérébral</term>
<term>Encéphale</term>
</keywords>
<keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Accident vasculaire cérébral</term>
</keywords>
<keywords scheme="MESH" qualifier="épidémiologie" xml:lang="fr"><term>Accident vasculaire cérébral</term>
<term>Aphasie</term>
<term>Hypertension artérielle</term>
</keywords>
<keywords scheme="MESH" qualifier="étiologie" xml:lang="fr"><term>Aphasie</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Age Factors</term>
<term>Aged</term>
<term>Double-Blind Method</term>
<term>Europe</term>
<term>Female</term>
<term>Humans</term>
<term>Informed Consent</term>
<term>Magnetic Resonance Imaging</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Prevalence</term>
<term>Proxy</term>
<term>Severity of Illness Index</term>
<term>Thrombolytic Therapy</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Accident vasculaire cérébral</term>
<term>Adulte d'âge moyen</term>
<term>Consentement libre et éclairé</term>
<term>Europe</term>
<term>Facteurs de l'âge</term>
<term>Femelle</term>
<term>Humains</term>
<term>Hypertension artérielle</term>
<term>Imagerie par résonance magnétique</term>
<term>Indice de gravité médicale</term>
<term>Mandataire</term>
<term>Mâle</term>
<term>Méthode en double aveugle</term>
<term>Prévalence</term>
<term>Sujet âgé</term>
<term>Traitement thrombolytique</term>
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<front><div type="abstract" xml:lang="en"><sec><title>Objective:</title>
<p>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.</p>
</sec>
<sec><title>Methods:</title>
<p>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.</p>
</sec>
<sec><title>Results:</title>
<p>In 359 (35.7%) patients, informed consent was by proxy. Patients with proxy consent were older (median 71 vs 66 years, <italic>p</italic>
< 0.0001) and had a higher frequency of arterial hypertension (58.2% vs 43.4%, <italic>p</italic>
< 0.0001). They showed higher scores on the NIH Stroke Scale (median 11 vs 5, <italic>p</italic>
< 0.0001) and more frequently aphasia (73.7% vs 20.0%, <italic>p</italic>
< 0.0001). The rate of proxy consent varied among countries (<italic>p</italic>
< 0.0001), ranging from 77.1% in Spain to 1.2% in Denmark.</p>
</sec>
<sec><title>Conclusions:</title>
<p>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.</p>
</sec>
<sec><title>Clinicaltrials.gov and Clinicaltrialsregister.eu identifiers:</title>
<p>NCT01525290 (<ext-link ext-link-type="uri" xlink:href="http://clinicaltrials.gov">clinicaltrials.gov</ext-link>
); 2011-005906-32 (<ext-link ext-link-type="uri" xlink:href="http://clinicaltrialsregister.eu">clinicaltrialsregister.eu</ext-link>
).</p>
</sec>
</div>
</front>
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<tree><noCountry><name sortKey="Boutitie, Florent" sort="Boutitie, Florent" uniqKey="Boutitie F" first="Florent" last="Boutitie">Florent Boutitie</name>
<name sortKey="Cheng, Bastian" sort="Cheng, Bastian" uniqKey="Cheng B" first="Bastian" last="Cheng">Bastian Cheng</name>
<name sortKey="Cho, Tae Hee" sort="Cho, Tae Hee" uniqKey="Cho T" first="Tae-Hee" last="Cho">Tae-Hee Cho</name>
<name sortKey="Ebinger, Martin" sort="Ebinger, Martin" uniqKey="Ebinger M" first="Martin" last="Ebinger">Martin Ebinger</name>
<name sortKey="Endres, Matthias" sort="Endres, Matthias" uniqKey="Endres M" first="Matthias" last="Endres">Matthias Endres</name>
<name sortKey="Fiebach, Jochen B" sort="Fiebach, Jochen B" uniqKey="Fiebach J" first="Jochen B." last="Fiebach">Jochen B. Fiebach</name>
<name sortKey="Fiehler, Jens" sort="Fiehler, Jens" uniqKey="Fiehler J" first="Jens" last="Fiehler">Jens Fiehler</name>
<name sortKey="Ford, Ian" sort="Ford, Ian" uniqKey="Ford I" first="Ian" last="Ford">Ian Ford</name>
<name sortKey="Gerloff, Christian" sort="Gerloff, Christian" uniqKey="Gerloff C" first="Christian" last="Gerloff">Christian Gerloff</name>
<name sortKey="Heesen, Christoph" sort="Heesen, Christoph" uniqKey="Heesen C" first="Christoph" last="Heesen">Christoph Heesen</name>
<name sortKey="Lemmens, Robin" sort="Lemmens, Robin" uniqKey="Lemmens R" first="Robin" last="Lemmens">Robin Lemmens</name>
<name sortKey="Muir, Keith W" sort="Muir, Keith W" uniqKey="Muir K" first="Keith W." last="Muir">Keith W. Muir</name>
<name sortKey="Nighoghossian, Norbert" sort="Nighoghossian, Norbert" uniqKey="Nighoghossian N" first="Norbert" last="Nighoghossian">Norbert Nighoghossian</name>
<name sortKey="Pedraza, Salvador" sort="Pedraza, Salvador" uniqKey="Pedraza S" first="Salvador" last="Pedraza">Salvador Pedraza</name>
<name sortKey="Puig, Josep" sort="Puig, Josep" uniqKey="Puig J" first="Josep" last="Puig">Josep Puig</name>
<name sortKey="Roy, Pascal" sort="Roy, Pascal" uniqKey="Roy P" first="Pascal" last="Roy">Pascal Roy</name>
<name sortKey="Simonsen, Claus Z" sort="Simonsen, Claus Z" uniqKey="Simonsen C" first="Claus Z." last="Simonsen">Claus Z. Simonsen</name>
<name sortKey="Thijs, Vincent" sort="Thijs, Vincent" uniqKey="Thijs V" first="Vincent" last="Thijs">Vincent Thijs</name>
<name sortKey="Thomalla, Gotz" sort="Thomalla, Gotz" uniqKey="Thomalla G" first="Götz" last="Thomalla">Götz Thomalla</name>
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