title: Disclosure of research results: a randomized study on GENEPSO-PS cohort participants.
abstract: There exist no recommendations as to how aggregate research results should best be disclosed to long-term cohort participants.
  
  
  
  To study the impact of cohort results disclosure documents of various kinds on participants' satisfaction.
  
  
  
  Randomized study with a 2x2 factorial design.
  
  
  
  The GENEPSO-PS cohort is used to study the psychosocial characteristics and preventive behaviour of both BRCA1/2 carriers and non-carriers; 235 participants wishing to receive 'information about the survey results' answered a self-administered questionnaire.
  
  
  
  The impact of providing the following items in addition to a leaflet about aggregate psychosocial research results was investigated (i) an up-to-date medical information sheet about BRCA1/2 genetic topics, (ii) a photograph with the names of the researchers.
  
  
  
  Satisfaction profiles drawn up using cluster analysis methods.
  
  
  
  Providing additional medical and/or research team information had no significant effect on satisfaction. The patients attributed to the 'poorly satisfied' group (n = 60, 25.5%) differed significantly from those in the 'highly satisfied' group (n = 51, 21.7%): they were younger [odds ratio (OR) = 0.96, 95% confidence interval (0.92-0.99), P = 0.028], less often had a daughter [OR = 4.87 (1.80-13.20), P = 0.002], had reached a higher educational level [OR = 2.94 (1.24-6.95), P = 0.014] and more frequently carried a BRCA1/2 mutation [OR = 2.73 (1.20-6.23), P = 0.017].
  
  
  
  This original approach to disclosing research results to cohort participants was welcomed by most of the participants, but less by the more educated and by BRCA1/2 carriers. Although an easily understandable document is necessary, it might also be worth providing some participants with more in-depth information.
authors.affiliation: Aix Marseille Université, UMR_S912, IRD, SESSTIM, Marseille, France. julien.mancini@univ-amu.fr.|INSERM, UMR912 (SESSTIM), Marseille, France. julien.mancini@univ-amu.fr.|APHM, Hôpital de la Timone, BiosTIC, Marseille, France. julien.mancini@univ-amu.fr.
authors.forename: Julien
authors.initials: J
authors.lastname: Mancini
authors.affiliation: Aix Marseille Université, UMR_S912, IRD, SESSTIM, Marseille, France.|INSERM, UMR912 (SESSTIM), Marseille, France.
authors.forename: Elodie
authors.initials: E
authors.lastname: Le Cozannet
authors.affiliation: Aix Marseille Université, UMR_S912, IRD, SESSTIM, Marseille, France.|INSERM, UMR912 (SESSTIM), Marseille, France.
authors.forename: Anne-Déborah
authors.initials: AD
authors.lastname: Bouhnik
authors.affiliation: Aix Marseille Université, UMR_S912, IRD, SESSTIM, Marseille, France.|INSERM, UMR912 (SESSTIM), Marseille, France.
authors.forename: Noémie
authors.initials: N
authors.lastname: Resseguier
authors.affiliation: Centre Léon Bérard, Lyon, France.
authors.forename: Christine
authors.initials: C
authors.lastname: Lasset
authors.affiliation: Institut Curie, Hôpital René Huguenin, Saint-Cloud, France.
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Mouret-Fourme
authors.affiliation: Institut Curie, Hôpital René Huguenin, Saint-Cloud, France.
authors.forename: Catherine
authors.initials: C
authors.lastname: Noguès
authors.affiliation: Aix Marseille Université, UMR_S912, IRD, SESSTIM, Marseille, France.|INSERM, UMR912 (SESSTIM), Marseille, France.|Institut Paoli-Calmettes, Marseille, France.
authors.forename: Claire
authors.initials: C
authors.lastname: Julian-Reynier
mesh_terms: D001943:Breast Neoplasms / Q000235:genetics* / Q000517:prevention & control* / Q000523:psychology*; D030881:Disclosure; D004522:Educational Status; D005260:Female; D005602:France; D019398:Genes, BRCA1; D024522:Genes, BRCA2; D020022:Genetic Predisposition to Disease; D005820:Genetic Testing; D015438:Health Behavior; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011795:Surveys and Questionnaires
keywords: BRCA1/2; cohort; disclosure; randomized controlled trials; research results; satisfaction