Building Stakeholder Consensus Regarding Disclosure of Individual Research Results in ADRD Research: A Delphi Study Protocol

Abstract

AbstractBackgroundInformed decisions to enroll in clinical investigations of Alzheimer’s disease and related dementias (ADRD) require careful consideration of complex risks and uncertain benefits. Decisions regarding scope of research participation and whether to receive information about biomarker status are complicated by lack of scientific consensus regarding biomarkers as surrogate end points for Alzheimer’s disease. This Delphi protocol aims to establish stakeholder consensus regarding the content and features of ethically optimal informed consent support for ADRD research.MethodThis consensus‐building Delphi protocol consists of three rounds of online surveys conducted with three stakeholder groups: Alzheimer’s disease research experts (including ethicists, research oversight specialists, and clinical trialists), Alzheimer’s disease research participants, and study partners of individuals enrolled in ADRD research. Participants will be administered questionnaires developed from a synthesis of researcher‐ and participant‐endorsed decisional needs identified in published literature and a decisional needs assessment conducted with support from an Alzheimer’s Association Research Grant. Participants will also be asked their views on the design, content, and implementation of a decision support tool. ≥70% agreement will be required to achieve consensus. Response rates, level of agreement, medians, interquartile ranges, and group rankings will be analyzed. Following each round of data collection, our research team will undertake qualitative content analysis of open‐ended responses and forum interactions.ResultThis protocol will develop consensus regarding priorities for decision support for ADRD research participants and the key features and content of ethically optimal informed consent support interventions. The Delphi technique is appropriate to develop consensus between diverse stakeholders because of its ability to offer anonymity to other participants and minimize bias.ConclusionFindings will contribute to the development of a digital health research infrastructure that is inclusive of diverse individuals and attentive to the needs of cognitively vulnerable patient populations and their caregivers.