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Neurology. 2013 Sep 24;81(13):1114-21. doi: 10.1212/WNL.0b013e3182a55f4a. Epub 2013 Aug 21.

Using AD biomarker research results for clinical care: a survey of ADNI investigators.

Author information

  • 1These authors shared the role of senior author.From the New York University Langone Medical Center (M.B.S.), Comprehensive Center on Brain Aging, Alzheimer's Disease Center, New York; University of Pennsylvania (K.H.), Department of Medicine, Alzheimer's Disease Center, Philadelphia; Brigham and Women's Hospital and Harvard Medical School (R.C.G.), Division of Genetics, Department of Medicine, Partners Center for Personalized Genetic Medicine, Boston, MA; and University of Pennsylvania (J.K.), Department of Medicine, Department of Medical Ethics and Health Policy, Alzheimer's Disease Center, Penn Neurodegenerative Disease Ethics and Policy Program, Philadelphia.

Abstract

OBJECTIVE:

To inform whether the Alzheimer's Disease Neuroimaging Initiative (ADNI) should change its policy of not returning research results to ADNI participants, we surveyed investigators and research staff about disclosing ADNI biomarker information to research participants, with particular emphasis on amyloid imaging results.

METHODS:

In April 2012, just before Food and Drug Administration approval of the amyloid-binding radiotracer, florbetapir, all ADNI investigators and personnel were recruited to complete an anonymous online survey that contained fixed choice and free-text questions.

RESULTS:

Although ADNI participants often requested amyloid imaging results (the proportions of investigators who reported requests from more than half of their participants with normal cognition or mild cognitive impairment were 20% and 22%, respectively), across all diagnostic groups, the majority of ADNI investigators (approximately 90%) did not return amyloid imaging results to ADNI participants. However, the majority of investigators reported that, if the Food and Drug Administration approved florbetapir, they would support the return of amyloid imaging results to participants with mild cognitive impairment and normal cognition, but they emphasized the need for guidance on how to provide these results to participants and for research to assess the value of returning results as well as how returning results will affect study validity and participant well-being.

CONCLUSIONS:

A majority of ADNI investigators support returning amyloid imaging results to ADNI participants. The findings that they want guidance on how to do this and research on the impact of disclosure suggest how to develop and monitor a disclosure process.

Comment in

PMID:
23966249
[PubMed - indexed for MEDLINE]
PMCID:
PMC3795601
[Available on 2014/9/24]
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