Disclosure of research results: a randomized study on GENEPSO‐PS cohort participants

BACKGROUND: There exist no recommendations as to how aggregate research results should best be disclosed to long‐term cohort participants. OBJECTIVE: To study the impact of cohort results disclosure documents of various kinds on participants’ satisfaction. DESIGN: Randomized study with a 2x2 factorial design. SETTING AND PARTICIPANTS: 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. INTERVENTIONS: 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. MAIN OUTCOME MEASURES: Satisfaction profiles drawn up using cluster analysis methods. RESULTS: 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]. CONCLUSIONS: 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.