title: Longitudinal study of informed consent in innovative therapy research: experience and provisional recommendations from a multicenter trial of intracerebral grafting.
abstract: BACKGROUND
  There is an urgent need to assess and improve the consent process in clinical trials of innovative therapies for neurodegenerative disorders.
  
  
  METHODS
  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.
  
  
  RESULTS
  The comprehension score was high and similar for Huntington's disease patients and proxies at inclusion (72.6% vs 77.8%; P > 0.1) but only decreased in HD patients after one year. The information satisfaction score was high (73.5% vs 66.5%; P > 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: AP-HP, Hôpital Henri Mondor, Centre de Référence-Maladie de Huntington, Neurologie cognitive, Créteil, France; Université Paris Est, Faculté de médecine, Créteil, France; INSERM U955, Equipe 01, Neuropsychologie Interventionnelle, Créteil, France; Département d'Etudes Cognitives, Ecole Normale Supérieure, PSL Research University, Paris, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Cleret de Langavant
authors.affiliation: AP-HP, Hôpital Henri Mondor, Centre de Référence-Maladie de Huntington, Neurologie cognitive, Créteil, France; Université Paris Est, Faculté de médecine, Créteil, France; INSERM U955, Equipe 01, Neuropsychologie Interventionnelle, Créteil, France.
authors.forename: Sophie
authors.initials: S
authors.lastname: Sudraud
authors.affiliation: CHU d'Angers, Centre de Référence des Maladies Neurogénétiques, service de neurologie, Angers, France; UMR CNRS 6214 INSERM U1083, CHU d'Angers, Angers, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Verny
authors.affiliation: CHU d'Amiens, service de neurologie, Amiens, France; EA 4559, Laboratoire de Neurosciences Fonctionnelles et Pathologies, Université de Picardie Jules Verne, Amiens, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Krystkowiak
authors.affiliation: Université Lille Nord de France, Lille, France; INSERM UMR837, Institut de Recherches sur le Cancer de Lille (IRCL), Lille, France; CHRU Lille, Département de Neurologie et des Mouvements Anormaux, Lille, France.
authors.forename: Clémence
authors.initials: C
authors.lastname: Simonin
authors.affiliation: CHU Nantes, Service de Neurologie, Nantes, France; UFR Médecine, Université de Nantes, Nantes, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Damier
authors.affiliation: Leenaards Memory Centre, Clinical Neuroscience Department, Lausanne University Hospital (CHUV), Lausanne, Switzerland; INSERM U825, Université de Toulouse, Toulouse, France.
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Demonet
authors.affiliation: Cliniques Universitaires de Bruxelles Hôpital Erasme, Bruxelles, Belgique.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Supiot
authors.affiliation: AP-HP, Hôpital Henri Mondor, Unité de Recherche Clinique, Creteil, France.
authors.forename: Amandine
authors.initials: A
authors.lastname: Rialland
authors.affiliation: AP-HP, Hôpital Henri Mondor, Unité de Recherche Clinique, Creteil, France.
authors.forename: David
authors.initials: D
authors.lastname: Schmitz
authors.affiliation: AP-HP, Hôpital Henri Mondor, Unité de Recherche Clinique, Creteil, France.
authors.forename: Patrick
authors.initials: P
authors.lastname: Maison
authors.affiliation: AP-HP, Hôpital Henri Mondor, Centre de Référence-Maladie de Huntington, Neurologie cognitive, Créteil, France; Université Paris Est, Faculté de médecine, Créteil, France; INSERM U955, Equipe 01, Neuropsychologie Interventionnelle, Créteil, France; Département d'Etudes Cognitives, Ecole Normale Supérieure, PSL Research University, Paris, France.
authors.forename: Katia
authors.initials: K
authors.lastname: Youssov
authors.affiliation: AP-HP, Hôpital Henri Mondor, Centre de Référence-Maladie de Huntington, Neurologie cognitive, Créteil, France; Université Paris Est, Faculté de médecine, Créteil, France; INSERM U955, Equipe 01, Neuropsychologie Interventionnelle, Créteil, France; Département d'Etudes Cognitives, Ecole Normale Supérieure, PSL Research University, Paris, France.
authors.forename: Anne-Catherine
authors.initials: AC
authors.lastname: Bachoud-Lévi
mesh_terms: D000328:Adult; D064591:Allografts; D001530:Belgium; D005260:Female; D005500:Follow-Up Studies; D005602:France; D006801:Humans; D006816:Huntington Disease / Q000628:therapy*; D007258:Informed Consent; D008297:Male; D008875:Middle Aged; D058953:Neural Stem Cells / Q000637:transplantation*; D033581:Stem Cell Transplantation; D011795:Surveys and Questionnaires