5 research outputs found

    A randomized noninferiority trial of condensed protocols for genetic risk disclosure of Alzheimer’s disease

    Full text link
    IntroductionConventional multisession genetic counseling is currently recommended when disclosing apolipoprotein E (APOE) genotype for the risk of Alzheimer’s disease (AD) in cognitively normal individuals. The objective of this study was to evaluate the safety of brief disclosure protocols for disclosing APOE genotype for the risk of AD.MethodsA randomized, multicenter noninferiority trial was conducted at four sites. Participants were asymptomatic adults having a firstâ degree relative with AD. A standard disclosure protocol by genetic counselors (SPâ GC) was compared with condensed protocols, with disclosures by genetic counselors (CPâ GC) and by physicians (CPâ MD). Preplanned coâ primary outcomes were anxiety and depression scales 12 months after disclosure.ResultsThree hundred and fortyâ three adults (mean age 58.3, range 33â 86 years, 71% female, 23% African American) were randomly assigned to the SPâ GC protocol (n = 115), CPâ GC protocol (n = 116), or CPâ MD protocol (n = 112). Mean postdisclosure scores on all outcomes were well below cutâ offs for clinical concern across protocols. Comparing CPâ GC with SPâ GC, the 97.5% upper confidence limits at 12 months after disclosure on coâ primary outcomes of anxiety and depression ranged from a difference of 1.2 to 2.0 in means (all P < .001 on noninferiority tests), establishing noninferiority for condensed protocols. Results were similar between European Americans and African Americans.ConclusionsThese data support the safety of condensed protocols for APOE disclosure for those free of severe anxiety or depression who are actively seeking such information.Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/152725/1/alzjjalz201410014.pd

    A randomized noninferiority trial of condensed protocols for genetic risk disclosure of Alzheimer's disease

    Full text link
    IntroductionConventional multisession genetic counseling is currently recommended when disclosing apolipoprotein E (APOE) genotype for the risk of Alzheimer’s disease (AD) in cognitively normal individuals. The objective of this study was to evaluate the safety of brief disclosure protocols for disclosing APOE genotype for the risk of AD.MethodsA randomized, multicenter noninferiority trial was conducted at four sites. Participants were asymptomatic adults having a firstâ degree relative with AD. A standard disclosure protocol by genetic counselors (SPâ GC) was compared with condensed protocols, with disclosures by genetic counselors (CPâ GC) and by physicians (CPâ MD). Preplanned coâ primary outcomes were anxiety and depression scales 12 months after disclosure.ResultsThree hundred and fortyâ three adults (mean age 58.3, range 33â 86 years, 71% female, 23% African American) were randomly assigned to the SPâ GC protocol (n = 115), CPâ GC protocol (n = 116), or CPâ MD protocol (n = 112). Mean postdisclosure scores on all outcomes were well below cutâ offs for clinical concern across protocols. Comparing CPâ GC with SPâ GC, the 97.5% upper confidence limits at 12 months after disclosure on coâ primary outcomes of anxiety and depression ranged from a difference of 1.2 to 2.0 in means (all P < .001 on noninferiority tests), establishing noninferiority for condensed protocols. Results were similar between European Americans and African Americans.ConclusionsThese data support the safety of condensed protocols for APOE disclosure for those free of severe anxiety or depression who are actively seeking such information
    corecore