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 | 2016 Oct

REPOSITORIES: biostudies-literature

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Publications

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

Mancini Julien J Le Cozannet Elodie E Bouhnik Anne-Déborah AD Resseguier Noémie N Lasset Christine C Mouret-Fourme Emmanuelle E Noguès Catherine C Julian-Reynier Claire C

Health expectations : an international journal of public participation in health care and health policy 20150723 5

<h4>Background</h4>There exist no recommendations as to how aggregate research results should best be disclosed to long-term cohort participants.<h4>Objective</h4>To study the impact of cohort results disclosure documents of various kinds on participants' satisfaction.<h4>Design</h4>Randomized study with a 2x2 factorial design.<h4>Setting and participants</h4>The GENEPSO-PS cohort is used to study the psychosocial characteristics and preventive behaviour of both BRCA1/2 carriers and non-carriers ...[more]

PMID: 26205609

Similar Datasets

Project description:ImportanceResults of Alzheimer disease (AD) research assessments typically are not disclosed to participants. Recent research has suggested interest in disclosure, but, to our knowledge, few studies have accounted for awareness of potential benefits and limitations of disclosure.ObjectiveTo determine the attitudes of cognitively normal research participants and members of the general public regarding disclosure of AD research results.Design, setting, and participantsParticipants in a longitudinal aging study (Alzheimer Disease Research Center [ADRC]) were given preintervention and postintervention surveys about disclosure attitudes. In a general public sample (The American Panel Survey), participants responded to a similar survey about disclosure attitudes.InterventionsParticipants in the ADRC sample were randomly assigned to a group (n = 119) that read an education intervention about the usefulness of AD biomarkers or to a placebo group (n = 100) that read as its intervention general information about the ADRC. Participants in the general public sample read a brief vignette describing participation in a longitudinal AD study.Main outcome and measureInterest in disclosure of AD research results.ResultsCognitively normal ADRC participants (n = 219) were 60.7% (n = 133) female, 83.6% (n = 183) of white race, and reported a mean of 15.91 years of education. Twenty-nine individuals refused participation. The American Panel Survey participants (n = 1418) indicated they did not have AD and were 50.5% (n = 716) female, 76.7% (n = 1087) of white race, and reported a mean of 13.85 years of education. Overall, 77.6% of eligible participants (1583 of 2041) completed the survey in July 2014. Interest in disclosure was high among the ADRC participants (55.1% [119 of 216] were "extremely interested"). Viewing the education intervention predicted lower interest in disclosure (odds ratio, 2.01; 95% CI, 1.15-3.53; P = .02). High subjective risk of AD, a family history of AD, and minimal attendance at research meetings were associated with high interest after the intervention. In the general public, interest was lower overall (12.5% [174 of 1389] were "extremely interested"), but the subset of participants most likely to join an AD research study reported higher interest (43.5% [40 of 92] were extremely interested).Conclusions and relevanceExperience with AD appears to increase interest in disclosure of AD research results. Learning about potential limitations of disclosure somewhat tempered interest. These findings should inform the development of disclosure policies for asymptomatic individuals in AD studies.

Dataset Information

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

Background

Objective

Design

Setting and participants

Interventions

Main outcome measures

Results

Conclusions

Publications

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

Similar Datasets

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