title: Development of a process to disclose amyloid imaging results to cognitively normal older adult research participants.
abstract: BACKGROUND
  The objective of this study was to develop a process to maximize the safety and effectiveness of disclosing Positron Emission Tomography (PET) amyloid imaging results to cognitively normal older adults participating in Alzheimer's disease secondary prevention studies such as the Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4) Study.
  
  
  METHODS
  Using a modified Delphi Method to develop consensus on best practices, we gathered and analyzed data over three rounds from experts in two relevant fields: informed consent for genetic testing or human amyloid imaging.
  
  
  RESULTS
  Experts reached consensus on (1) text for a brochure that describes amyloid imaging to a person who is considering whether to undergo such imaging in the context of a clinical trial, and (2) a process for amyloid PET result disclosure within such trials. Recommendations included: During consent, potential participants should complete an educational session, where they receive verbal and written information covering what is known and unknown about amyloid imaging, including possible results and their meaning, implications of results for risk of future cognitive decline, and information about Alzheimer's and risk factors. Participants should be screened for anxiety and depression to determine suitability to receive amyloid imaging information. The person conducting the sessions should check comprehension and be skilled in communication and recognizing distress. Imaging should occur on a separate day from consent, and disclosure on a separate day from imaging. Disclosure should occur in person, with time for questions. At disclosure, investigators should assess mood and willingness to receive results, and provide a written results report. Telephone follow-up within a few days should assess the impact of disclosure, and periodic scheduled assessments of depression and anxiety, with additional monitoring and follow-up for participants showing distress, should be performed.
  
  
  CONCLUSIONS
  We developed a document for use with potential study participants to describe the process of amyloid imaging and the implications of amyloid imaging results; and a disclosure process with attention to ongoing monitoring of both mood and safety to receive this information. This document and process will be used in the A4 Study and can be adapted for other research settings.
authors.affiliation: Department of Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA USA.
authors.forename: Kristin
authors.initials: K
authors.lastname: Harkins
authors.affiliation: Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA USA.
authors.forename: Pamela
authors.initials: P
authors.lastname: Sankar
authors.affiliation: Department of Neurology, Harvard Medical School, Center for Alzheimer Research and Treatment, Brigham & Women's Hospital Massachusetts ADRC, Massachusetts General Hospital, Boston, MA USA.
authors.forename: Reisa
authors.initials: R
authors.lastname: Sperling
authors.affiliation: Mary S. Easton Center for Alzheimer's Disease Research, University of California Los Angeles, Los Angeles, CA USA.
authors.forename: Joshua D
authors.initials: JD
authors.lastname: Grill
authors.affiliation: Department of Medicine, Division of Genetics, Brigham & Women's Hospital and Harvard Medical School, Boston, MA USA.
authors.forename: Robert C
authors.initials: RC
authors.lastname: Green
authors.affiliation: Departments of Neurology and Radiology, Harvard Medical School, Center for Alzheimer Research and Treatment, Brigham & Women's Hospital Massachusetts ADRC, Massachusetts General Hospital, Boston, MA USA.
authors.forename: Keith A
authors.initials: KA
authors.lastname: Johnson
authors.affiliation: Department of Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA USA.
authors.forename: Megan
authors.initials: M
authors.lastname: Healy
authors.affiliation: Departments of Medicine, Medical Ethics & Health Policy, University of Pennsylvania Perelman School of Medicine, Penn Neurodegenerative Disease Ethics & Policy Program, University of Pennsylvania, 3615 Chestnut St, Philadelphia, PA 19104 USA.
authors.forename: Jason
authors.initials: J
authors.lastname: Karlawish