Cargando…
Development of a process to disclose amyloid imaging results to cognitively normal older adult research participants
INTRODUCTION: 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-A...
Autores principales: | , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2015
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4428104/ https://www.ncbi.nlm.nih.gov/pubmed/25969699 http://dx.doi.org/10.1186/s13195-015-0112-7 |
_version_ | 1782370839726915584 |
---|---|
author | Harkins, Kristin Sankar, Pamela Sperling, Reisa Grill, Joshua D Green, Robert C Johnson, Keith A Healy, Megan Karlawish, Jason |
author_facet | Harkins, Kristin Sankar, Pamela Sperling, Reisa Grill, Joshua D Green, Robert C Johnson, Keith A Healy, Megan Karlawish, Jason |
author_sort | Harkins, Kristin |
collection | PubMed |
description | INTRODUCTION: 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. |
format | Online Article Text |
id | pubmed-4428104 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-44281042015-05-13 Development of a process to disclose amyloid imaging results to cognitively normal older adult research participants Harkins, Kristin Sankar, Pamela Sperling, Reisa Grill, Joshua D Green, Robert C Johnson, Keith A Healy, Megan Karlawish, Jason Alzheimers Res Ther Research INTRODUCTION: 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. BioMed Central 2015-05-12 /pmc/articles/PMC4428104/ /pubmed/25969699 http://dx.doi.org/10.1186/s13195-015-0112-7 Text en © Harkins et al.; licensee BioMed Central. 2015 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Research Harkins, Kristin Sankar, Pamela Sperling, Reisa Grill, Joshua D Green, Robert C Johnson, Keith A Healy, Megan Karlawish, Jason Development of a process to disclose amyloid imaging results to cognitively normal older adult research participants |
title | Development of a process to disclose amyloid imaging results to cognitively normal older adult research participants |
title_full | Development of a process to disclose amyloid imaging results to cognitively normal older adult research participants |
title_fullStr | Development of a process to disclose amyloid imaging results to cognitively normal older adult research participants |
title_full_unstemmed | Development of a process to disclose amyloid imaging results to cognitively normal older adult research participants |
title_short | Development of a process to disclose amyloid imaging results to cognitively normal older adult research participants |
title_sort | development of a process to disclose amyloid imaging results to cognitively normal older adult research participants |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4428104/ https://www.ncbi.nlm.nih.gov/pubmed/25969699 http://dx.doi.org/10.1186/s13195-015-0112-7 |
work_keys_str_mv | AT harkinskristin developmentofaprocesstodiscloseamyloidimagingresultstocognitivelynormalolderadultresearchparticipants AT sankarpamela developmentofaprocesstodiscloseamyloidimagingresultstocognitivelynormalolderadultresearchparticipants AT sperlingreisa developmentofaprocesstodiscloseamyloidimagingresultstocognitivelynormalolderadultresearchparticipants AT grilljoshuad developmentofaprocesstodiscloseamyloidimagingresultstocognitivelynormalolderadultresearchparticipants AT greenrobertc developmentofaprocesstodiscloseamyloidimagingresultstocognitivelynormalolderadultresearchparticipants AT johnsonkeitha developmentofaprocesstodiscloseamyloidimagingresultstocognitivelynormalolderadultresearchparticipants AT healymegan developmentofaprocesstodiscloseamyloidimagingresultstocognitivelynormalolderadultresearchparticipants AT karlawishjason developmentofaprocesstodiscloseamyloidimagingresultstocognitivelynormalolderadultresearchparticipants |