Dataset Information

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

ABSTRACT:

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.

SUBMITTER: Mancini J

PROVIDER: S-EPMC5054914 | biostudies-literature |

REPOSITORIES: biostudies-literature

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