Longitudinal Study of Informed Consent in Innovative Therapy Research: Experience and Provisional Recommendations from a Multicenter Trial of Intracerebral Grafting
Identifieur interne : 000582 ( Main/Curation ); précédent : 000581; suivant : 000583Longitudinal Study of Informed Consent in Innovative Therapy Research: Experience and Provisional Recommendations from a Multicenter Trial of Intracerebral Grafting
Auteurs : Laurent Cleret De Langavant [France] ; Sophie Sudraud [France] ; Christophe Verny [France] ; Pierre Krystkowiak [France] ; Clémence Simonin [France] ; Philippe Damier [France] ; Jean-François Demonet [Suisse, France] ; Frédéric Supiot [Belgique] ; Amandine Rialland [France] ; David Schmitz [France] ; Patrick Maison [France] ; Katia Youssov [France] ; Anne-Catherine Bachoud-Lévi [France]Source :
- PLoS ONE [ 1932-6203 ] ; 2015.
Abstract
There is an urgent need to assess and improve the consent process in clinical trials of innovative therapies for neurodegenerative disorders.
We performed a longitudinal study of the consent of Huntington’s disease patients during the Multicenter Fetal Cell Intracerebral Grafting Trial in Huntington’s Disease (MIG-HD) in France and Belgium. Patients and their proxies completed a consent questionnaire at inclusion, before signing the consent form and after one year of follow-up, before randomization and transplantation. The questionnaire explored understanding of the protocol, satisfaction with the information delivered, reasons for participating in the trial and expectations regarding the transplant. Forty-six Huntington’s disease patients and 27 proxies completed the questionnaire at inclusion, and 27 Huntington’s disease patients and 16 proxies one year later.
The comprehension score was high and similar for Huntington’s disease patients and proxies at inclusion (72.6% vs 77.8%;
Cognitively impaired patients with Huntington’s disease were capable of consenting to participation in this trial. This consent procedure has presumably strengthened their understanding and should be proposed before signing the consent form in future gene or cell therapy trials for neurodegenerative disorders. Because of the potential cognitive decline, proxies should be designated as provisional surrogate decision-makers, even in competent patients.
Url:
DOI: 10.1371/journal.pone.0128209
PubMed: 26010368
PubMed Central: 4444138
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PMC:4444138Le document en format XML
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<author><name sortKey="Youssov, Katia" sort="Youssov, Katia" uniqKey="Youssov K" first="Katia" last="Youssov">Katia Youssov</name>
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<author><name sortKey="Bachoud Levi, Anne Catherine" sort="Bachoud Levi, Anne Catherine" uniqKey="Bachoud Levi A" first="Anne-Catherine" last="Bachoud-Lévi">Anne-Catherine Bachoud-Lévi</name>
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<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Créteil</settlement>
</placeName>
</affiliation>
<affiliation wicri:level="3"><nlm:aff id="aff004"><addr-line>Département d’Etudes Cognitives, Ecole Normale Supérieure, PSL Research University, Paris, France</addr-line>
</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>Département d’Etudes Cognitives, Ecole Normale Supérieure, PSL Research University, Paris</wicri:regionArea>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Sudraud, Sophie" sort="Sudraud, Sophie" uniqKey="Sudraud S" first="Sophie" last="Sudraud">Sophie Sudraud</name>
<affiliation wicri:level="3"><nlm:aff id="aff001"><addr-line>AP-HP, Hôpital Henri Mondor, Centre de Référence—Maladie de Huntington, Neurologie cognitive, Créteil, France</addr-line>
</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>AP-HP, Hôpital Henri Mondor, Centre de Référence—Maladie de Huntington, Neurologie cognitive, Créteil</wicri:regionArea>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Créteil</settlement>
</placeName>
</affiliation>
<affiliation wicri:level="3"><nlm:aff id="aff002"><addr-line>Université Paris Est, Faculté de médecine, Créteil, France</addr-line>
</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>Université Paris Est, Faculté de médecine, Créteil</wicri:regionArea>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Créteil</settlement>
</placeName>
</affiliation>
<affiliation wicri:level="3"><nlm:aff id="aff003"><addr-line>INSERM U955, Equipe 01, Neuropsychologie Interventionnelle, Créteil, France</addr-line>
</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>INSERM U955, Equipe 01, Neuropsychologie Interventionnelle, Créteil</wicri:regionArea>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Créteil</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Verny, Christophe" sort="Verny, Christophe" uniqKey="Verny C" first="Christophe" last="Verny">Christophe Verny</name>
<affiliation wicri:level="3"><nlm:aff id="aff005"><addr-line>CHU d'Angers, Centre de Référence des Maladies Neurogénétiques, service de neurologie, Angers, France</addr-line>
</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>CHU d'Angers, Centre de Référence des Maladies Neurogénétiques, service de neurologie, Angers</wicri:regionArea>
<placeName><region type="region">Pays de la Loire</region>
<region type="old region">Pays de la Loire</region>
<settlement type="city">Angers</settlement>
</placeName>
</affiliation>
<affiliation wicri:level="3"><nlm:aff id="aff006"><addr-line>UMR CNRS 6214 INSERM U1083, CHU d'Angers, Angers, France</addr-line>
</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>UMR CNRS 6214 INSERM U1083, CHU d'Angers, Angers</wicri:regionArea>
<placeName><region type="region">Pays de la Loire</region>
<region type="old region">Pays de la Loire</region>
<settlement type="city">Angers</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Krystkowiak, Pierre" sort="Krystkowiak, Pierre" uniqKey="Krystkowiak P" first="Pierre" last="Krystkowiak">Pierre Krystkowiak</name>
<affiliation wicri:level="3"><nlm:aff id="aff007"><addr-line>CHU d’Amiens, service de neurologie, Amiens, France</addr-line>
</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>CHU d’Amiens, service de neurologie, Amiens</wicri:regionArea>
<placeName><region type="region">Hauts-de-France</region>
<region type="old region">Picardie</region>
<settlement type="city">Amiens</settlement>
</placeName>
</affiliation>
<affiliation wicri:level="3"><nlm:aff id="aff008"><addr-line>EA 4559, Laboratoire de Neurosciences Fonctionnelles et Pathologies, Université de Picardie Jules Verne, Amiens, France</addr-line>
</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>EA 4559, Laboratoire de Neurosciences Fonctionnelles et Pathologies, Université de Picardie Jules Verne, Amiens</wicri:regionArea>
<placeName><region type="region">Hauts-de-France</region>
<region type="old region">Picardie</region>
<settlement type="city">Amiens</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Simonin, Clemence" sort="Simonin, Clemence" uniqKey="Simonin C" first="Clémence" last="Simonin">Clémence Simonin</name>
<affiliation wicri:level="3"><nlm:aff id="aff009"><addr-line>Université Lille Nord de France, Lille, France</addr-line>
</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>Université Lille Nord de France, Lille</wicri:regionArea>
<placeName><region type="region">Hauts-de-France</region>
<region type="old region">Nord-Pas-de-Calais</region>
<settlement type="city">Lille</settlement>
</placeName>
</affiliation>
<affiliation wicri:level="3"><nlm:aff id="aff010"><addr-line>INSERM UMR837, Institut de Recherches sur le Cancer de Lille (IRCL), Lille, France</addr-line>
</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>INSERM UMR837, Institut de Recherches sur le Cancer de Lille (IRCL), Lille</wicri:regionArea>
<placeName><region type="region">Hauts-de-France</region>
<region type="old region">Nord-Pas-de-Calais</region>
<settlement type="city">Lille</settlement>
</placeName>
</affiliation>
<affiliation wicri:level="3"><nlm:aff id="aff011"><addr-line>CHRU Lille, Département de Neurologie et des Mouvements Anormaux, Lille, France</addr-line>
</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>CHRU Lille, Département de Neurologie et des Mouvements Anormaux, Lille</wicri:regionArea>
<placeName><region type="region">Hauts-de-France</region>
<region type="old region">Nord-Pas-de-Calais</region>
<settlement type="city">Lille</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Damier, Philippe" sort="Damier, Philippe" uniqKey="Damier P" first="Philippe" last="Damier">Philippe Damier</name>
<affiliation wicri:level="3"><nlm:aff id="aff012"><addr-line>CHU Nantes, Service de Neurologie, Nantes, France</addr-line>
</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>CHU Nantes, Service de Neurologie, Nantes</wicri:regionArea>
<placeName><region type="region">Pays de la Loire</region>
<region type="old region">Pays de la Loire</region>
<settlement type="city">Nantes</settlement>
</placeName>
</affiliation>
<affiliation wicri:level="4"><nlm:aff id="aff013"><addr-line>UFR Médecine, Université de Nantes, Nantes, France</addr-line>
</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>UFR Médecine, Université de Nantes, Nantes</wicri:regionArea>
<placeName><region type="region">Pays de la Loire</region>
<region type="old region">Pays de la Loire</region>
<settlement type="city">Nantes</settlement>
</placeName>
<orgName type="university">Université de Nantes</orgName>
</affiliation>
</author>
<author><name sortKey="Demonet, Jean Francois" sort="Demonet, Jean Francois" uniqKey="Demonet J" first="Jean-François" last="Demonet">Jean-François Demonet</name>
<affiliation wicri:level="3"><nlm:aff id="aff014"><addr-line>Leenaards Memory Centre, Clinical Neuroscience Department, Lausanne University Hospital (CHUV), Lausanne, Switzerland</addr-line>
</nlm:aff>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea>Leenaards Memory Centre, Clinical Neuroscience Department, Lausanne University Hospital (CHUV), Lausanne</wicri:regionArea>
<placeName><settlement type="city">Lausanne</settlement>
<region nuts="3" type="region">Canton de Vaud</region>
</placeName>
</affiliation>
<affiliation wicri:level="3"><nlm:aff id="aff015"><addr-line>INSERM U825, Université de Toulouse, Toulouse, France</addr-line>
</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>INSERM U825, Université de Toulouse, Toulouse</wicri:regionArea>
<placeName><region type="region">Occitanie (région administrative)</region>
<region type="old region">Midi-Pyrénées</region>
<settlement type="city">Toulouse</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Supiot, Frederic" sort="Supiot, Frederic" uniqKey="Supiot F" first="Frédéric" last="Supiot">Frédéric Supiot</name>
<affiliation wicri:level="3"><nlm:aff id="aff016"><addr-line>Cliniques Universitaires de Bruxelles Hôpital Erasme, Bruxelles, Belgique</addr-line>
</nlm:aff>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>Cliniques Universitaires de Bruxelles Hôpital Erasme, Bruxelles</wicri:regionArea>
<placeName><settlement type="city">Bruxelles</settlement>
<region nuts="2">Région de Bruxelles-Capitale</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Rialland, Amandine" sort="Rialland, Amandine" uniqKey="Rialland A" first="Amandine" last="Rialland">Amandine Rialland</name>
<affiliation wicri:level="3"><nlm:aff id="aff017"><addr-line>AP-HP, Hôpital Henri Mondor, Unité de Recherche Clinique, Creteil, France</addr-line>
</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>AP-HP, Hôpital Henri Mondor, Unité de Recherche Clinique, Creteil</wicri:regionArea>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Créteil</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Schmitz, David" sort="Schmitz, David" uniqKey="Schmitz D" first="David" last="Schmitz">David Schmitz</name>
<affiliation wicri:level="3"><nlm:aff id="aff017"><addr-line>AP-HP, Hôpital Henri Mondor, Unité de Recherche Clinique, Creteil, France</addr-line>
</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>AP-HP, Hôpital Henri Mondor, Unité de Recherche Clinique, Creteil</wicri:regionArea>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Créteil</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Maison, Patrick" sort="Maison, Patrick" uniqKey="Maison P" first="Patrick" last="Maison">Patrick Maison</name>
<affiliation wicri:level="3"><nlm:aff id="aff017"><addr-line>AP-HP, Hôpital Henri Mondor, Unité de Recherche Clinique, Creteil, France</addr-line>
</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>AP-HP, Hôpital Henri Mondor, Unité de Recherche Clinique, Creteil</wicri:regionArea>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Créteil</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Youssov, Katia" sort="Youssov, Katia" uniqKey="Youssov K" first="Katia" last="Youssov">Katia Youssov</name>
<affiliation wicri:level="3"><nlm:aff id="aff001"><addr-line>AP-HP, Hôpital Henri Mondor, Centre de Référence—Maladie de Huntington, Neurologie cognitive, Créteil, France</addr-line>
</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>AP-HP, Hôpital Henri Mondor, Centre de Référence—Maladie de Huntington, Neurologie cognitive, Créteil</wicri:regionArea>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Créteil</settlement>
</placeName>
</affiliation>
<affiliation wicri:level="3"><nlm:aff id="aff002"><addr-line>Université Paris Est, Faculté de médecine, Créteil, France</addr-line>
</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>Université Paris Est, Faculté de médecine, Créteil</wicri:regionArea>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Créteil</settlement>
</placeName>
</affiliation>
<affiliation wicri:level="3"><nlm:aff id="aff003"><addr-line>INSERM U955, Equipe 01, Neuropsychologie Interventionnelle, Créteil, France</addr-line>
</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>INSERM U955, Equipe 01, Neuropsychologie Interventionnelle, Créteil</wicri:regionArea>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Créteil</settlement>
</placeName>
</affiliation>
<affiliation wicri:level="3"><nlm:aff id="aff004"><addr-line>Département d’Etudes Cognitives, Ecole Normale Supérieure, PSL Research University, Paris, France</addr-line>
</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>Département d’Etudes Cognitives, Ecole Normale Supérieure, PSL Research University, Paris</wicri:regionArea>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Bachoud Levi, Anne Catherine" sort="Bachoud Levi, Anne Catherine" uniqKey="Bachoud Levi A" first="Anne-Catherine" last="Bachoud-Lévi">Anne-Catherine Bachoud-Lévi</name>
<affiliation wicri:level="3"><nlm:aff id="aff001"><addr-line>AP-HP, Hôpital Henri Mondor, Centre de Référence—Maladie de Huntington, Neurologie cognitive, Créteil, France</addr-line>
</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>AP-HP, Hôpital Henri Mondor, Centre de Référence—Maladie de Huntington, Neurologie cognitive, Créteil</wicri:regionArea>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Créteil</settlement>
</placeName>
</affiliation>
<affiliation wicri:level="3"><nlm:aff id="aff002"><addr-line>Université Paris Est, Faculté de médecine, Créteil, France</addr-line>
</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>Université Paris Est, Faculté de médecine, Créteil</wicri:regionArea>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Créteil</settlement>
</placeName>
</affiliation>
<affiliation wicri:level="3"><nlm:aff id="aff003"><addr-line>INSERM U955, Equipe 01, Neuropsychologie Interventionnelle, Créteil, France</addr-line>
</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>INSERM U955, Equipe 01, Neuropsychologie Interventionnelle, Créteil</wicri:regionArea>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Créteil</settlement>
</placeName>
</affiliation>
<affiliation wicri:level="3"><nlm:aff id="aff004"><addr-line>Département d’Etudes Cognitives, Ecole Normale Supérieure, PSL Research University, Paris, France</addr-line>
</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>Département d’Etudes Cognitives, Ecole Normale Supérieure, PSL Research University, Paris</wicri:regionArea>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</affiliation>
</author>
</analytic>
<series><title level="j">PLoS ONE</title>
<idno type="eISSN">1932-6203</idno>
<imprint><date when="2015">2015</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc><textClass></textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en"><sec id="sec001"><title>Background</title>
<p>There is an urgent need to assess and improve the consent process in clinical trials of innovative therapies for neurodegenerative disorders.</p>
</sec>
<sec id="sec002"><title>Methods</title>
<p>We performed a longitudinal study of the consent of Huntington’s disease patients during the Multicenter Fetal Cell Intracerebral Grafting Trial in Huntington’s Disease (MIG-HD) in France and Belgium. Patients and their proxies completed a consent questionnaire at inclusion, before signing the consent form and after one year of follow-up, before randomization and transplantation. The questionnaire explored understanding of the protocol, satisfaction with the information delivered, reasons for participating in the trial and expectations regarding the transplant. Forty-six Huntington’s disease patients and 27 proxies completed the questionnaire at inclusion, and 27 Huntington’s disease patients and 16 proxies one year later.</p>
</sec>
<sec id="sec003"><title>Results</title>
<p>The comprehension score was high and similar for Huntington’s disease patients and proxies at inclusion (72.6% vs 77.8%; <italic>P</italic>
> 0.1) but only decreased in HD patients after one year. The information satisfaction score was high (73.5% vs 66.5%; <italic>P</italic>
> 0.1) and correlated with understanding in both patients and proxies. The motivation and expectation profiles were similar in patients and proxies and remained unchanged after one year.</p>
</sec>
<sec id="sec004"><title>Conclusions</title>
<p>Cognitively impaired patients with Huntington’s disease were capable of consenting to participation in this trial. This consent procedure has presumably strengthened their understanding and should be proposed before signing the consent form in future gene or cell therapy trials for neurodegenerative disorders. Because of the potential cognitive decline, proxies should be designated as provisional surrogate decision-makers, even in competent patients.</p>
</sec>
</div>
</front>
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</TEI>
</record>
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