Biomarker Disclosure Toolkit
Biomarker testing is an important tool in the research and diagnosis of Alzheimer’s disease (AD). This toolkit is intended to assist researchers and provide guidance on best practices for communicating AD biomarker research results to participants and their families.
When a determination has been made that return of AD biomarker research results may be appropriate, it is important to engage participants and their families in discussions about the potential implications of the test results as they weigh the option of learning this information.
The example information sheets and disclosure guides below have been developed for research using amyloid PET, specifically Pittsburgh Compound-B (PiB), and are organized by the participant’s cognitive diagnosis. Note that pre-disclosure information sheets are not a substitute for informed consent. Sample informed consent language is included below.
Example Pre-Disclosure Information Sheets
Pre-disclosure counseling is considered a best practice before the release of biomarker results.
Mild Cognitive Impairment (MCI)
Example Disclosure Guides
Mild Cognitive Impairment (MCI)
Example addendum consent document
When AD biomarker testing is included in your research protocol, an addendum consent may help to secure informed consent prior to returning individual research results to participants.
Example addendum informed consent form
- Assessing capacity to consent
Sample rubric (coming soon)
- Assessing comprehension of results
Sample measure (coming soon)
Request an editable version of any of the above documents here.
Communication Before Testing
Importance of Discussion Before Testing:
- Researchers who conduct biomarker testing must be mindful of the ethical implications of testing, including the need to discuss the implications of test results with research participants and their families prior to testing.
- Discussing the implications of the test results beforehand can help the research participant and their study partner or family member(s) make an informed decision about whether or not to undergo testing and/or receive their results.
- This discussion can prepare affected individuals for potential outcomes of biomarker testing and help them understand the significance of their results.
Conducting Discussion Before Testing:
- The discussion should be conducted by a trained healthcare professional or research team member with strong communication skills and extensive knowledge of AD.
- Pre-disclosure communication should address the limitations of the test, the possibility of false-positive and false-negative results, and the potential risks of psychological harm, social stigma and discrimination in health, insurance or employment settings.
- Discussions should also emphasize participant’s rights and provide information about privacy, confidentiality, and how the results will be used.
- Use of an information sheet or decision tool can further enhance this discussion and promote participant understanding.
Communication After Testing (Disclosure of results)
- Remind the participant and their study partner or family of the discussion held before the testing, the purpose of the test, and the possible outcomes.
- When disclosing the results, it is important to use clear and accurate language.
- For amyloid PET scans, using the term “positive result” (indicating the presence of amyloid plaque) can lead to confusion because it may be interpreted as an indication of a favorable outcome. To avoid this confusion, it is recommended that a positive result be referred to as “elevated,” or described as a finding of “significant amyloid build up.”
- This can help to ensure that research participants and their families have an accurate understanding of the implications of the test results and can make informed decisions about their health.
- Explain what the results mean, the potential implications, and discuss how the results may affect the participant’s future.
- Describe available treatments, clinical trials, and support services as appropriate.
- Following a disclosure guide can help ensure all recommended topics are covered and appropriately frame the approach for participants with differing cognitive diagnoses.
Follow-up After Disclosure:
- After disclosure, provide a line of communication to answer any questions and provide additional support, if needed. This may also include providing contact information for support services, such as counseling or support groups.
The AgreeDementia Advisory Group on Risk Evidence Education for Dementia has developed decision aid tools to help patients and families decide whether to undergo biomarker testing (such as brain amyloid imaging and blood tests) and learn the results.
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Harkins, K., Sankar, P., Sperling, R., Grill, J. D., Green, R. C., Johnson, K. A., … & Karlawish, J. (2015). Development of a process to disclose amyloid imaging results to cognitively normal older adult research participants. Alzheimer’s research & therapy, 7(1), 1-9. https://doi.org/10.1186/s13195-015-0112-7
Lingler, J. H., & Klunk, W. E. (2013). Disclosure of amyloid imaging results to research participants: has the time come?. Alzheimer’s & dementia : the journal of the Alzheimer’s Association, 9(6), 741–744.e2. https://doi.org/10.1016/j.jalz.2012.09.014
Lingler, J. H., Butters, M. A., Gentry, A. L., Hu, L., Hunsaker, A. E., Klunk, W. E., … & Schulz, R. (2016). Development of a standardized approach to disclosing amyloid imaging research results in mild cognitive impairment. Journal of Alzheimer’s Disease, 52(1), 17-24. https://doi.org/10.3233/JAD-150985
Rosen, A. C., & AGREEDementia. (2022). The importance of Communication and Education: Lessons learned from AGREEDementia. Alzheimer’s & Dementia, 18, e066908. https://doi.org/10.1002/alz.066908
Seaman, J. B., Terhorst, L., Gentry, A., Hunsaker, A., Parker, L. S., & Lingler, J. H. (2015). Psychometric Properties of a Decisional Capacity Screening Tool for Individuals Contemplating Participation in Alzheimer’s Disease Research. Journal of Alzheimer’s disease : JAD, 46(1), 1–9. https://doi.org/10.3233/JAD-142559
Vanderschaeghe, G., Schaeverbeke, J., Bruffaerts, R., Vandenberghe, R., & Dierickx, K. (2018). From information to follow-up: Ethical recommendations to facilitate the disclosure of amyloid PET scan results in a research setting. Alzheimer’s & dementia (New York, N. Y.), 4, 243–251. https://doi.org/10.1016/j.trci.2018.04.002
How to cite this page:
University of Pittsburgh Alzheimer’s Disease Research Center (2023, April 24). Biomarker Disclosure Toolkit. https://www.adrc.pitt.edu/for-researchers/biomarker-disclosure-toolkit
If you use information from these materials in a publication, please note the University of Pittsburgh ADRC grant number: P30AG024827.
Last updated: April 24, 2023.