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A Randomized Controlled Trial of Disclosing Genetic Risk Information for Alzheimerâs Disease via Telephone
Purpose Telephone disclosure of genetic test results can improve access to services. To date, studies of its impact have focused on return of Mendelian risk information, principally hereditary cancer syndromes. Methods: In a multisite trial of Alzheimerâs disease genetic risk disclosure, asymptomatic adults were randomized to receive test results in-person or via telephone. Primary analyses examined patient outcomes 12 months after disclosure. Results: Data from 257 participants showed that telephone disclosure occurred 7.4 days sooner and were 30% shorter, on average, than in-person disclosure (both p<0.001). Anxiety and depression scores were well below cutoffs for clinical concern across protocols. Comparing telephone and in-person disclosure protocols, 99% CIs of mean differences were within non-inferiority margins on scales assessing anxiety, depression, and test-related distress, but inconclusive about positive impact. No differences were observed on measures of recall and subjective impact. Sub-analyses supported non-inferiority on all outcomes among APOE Îľ4-negative participants. Sub-analyses were inconclusive for APOE Îľ4-positive participants, although mean anxiety and depression scores were still well below cutoffs for clinical concern. Conclusion: Telephone disclosure of APOE results and risk for Alzheimerâs disease is generally safe and helps providers meet demands for services, even when results identify an increased risk for disease
Pâ004: Incorporating ethnicity into genetic risk assessment for Alzheimerâs disease: The reveal study experience
Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/152651/1/alzjjalz200704220.pd
A randomized noninferiority trial of condensed protocols for genetic risk disclosure of Alzheimer's disease
IntroductionConventional multisession genetic counseling is currently recommended when disclosing apolipoprotein E (APOE) genotype for the risk of Alzheimerâs 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 12Ă months after disclosure.ResultsThree hundred and fortyâ three adults (mean age 58.3, range 33â 86Ă years, 71% female, 23% African American) were randomly assigned to the SPâ GC protocol (nĂ =Ă 115), CPâ GC protocol (nĂ =Ă 116), or CPâ MD protocol (nĂ =Ă 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 12Ă months after disclosure on coâ primary outcomes of anxiety and depression ranged from a difference of 1.2 to 2.0 in means (all PĂ <Ă .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