Recommended approaches to sharing individual research results in Alzheimer's disease research: A multidisciplinary expert Delphi consensus

Abstract

Background

As criteria for diagnosing Alzheimer's disease and Alzheimer's disease related dementias (AD/ADRD) evolves, AD-related biological measures of biomarkers (e.g., amyloid, tau) and genetic status (e.g., APOE) have gained heightened value in research, and, notably, increased personal significance for participants.

Objective

To identify recommended approaches for sharing individual research results with participants in AD/ADRD research and determine expert consensus on best practices for sharing individual research results to participants in AD/ADRD research.

Methods

This online, modified Delphi study consisted of four rounds of surveys conducted with Alzheimer's disease research experts, including neurologists, ethicists, neuropsychologists, geneticists, clinical trialists, and other research stakeholders. The Delphi survey was informed by a targeted literature review of previously published recommendations on sharing individual research results in AD/ADRD research. A total of 81 experts were surveyed across all rounds, ranking statements on a 7-point Likert scale and providing feedback in short answer responses. After each round, feedback reports were shared to inform subsequent responses. Proportion of agreement and qualitative feedback were analyzed, with consensus defined as 75% or greater agreement.

Results

41 initial statements were evaluated and refined based on consensus and feedback. Concluding the final round (round 3), consensus (≥75% agreement) was achieved on 25 statements, resulting in a set of recommendations related to: study design, clinical relevance, results sharing processes, communication and understanding of results, counseling and support, and follow-up.

Conclusions

The findings of this online, modified Delphi study provide a foundation for developing standardized, ethically grounded practices for returning individual research results in Alzheimer's disease studies.

Keywords

Alzheimer's disease biomarkers Delphi method research ethics return of results

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