Ethical considerations within pragmatic randomized controlled trials in dementia: Results from a literature survey. Issue 1 (2nd May 2022)

• Record Type: Journal Article
• Authors: Nicholls, Stuart G.; Carroll, Kelly; Nix, Hayden P.; Li, Fan; Hey, Spencer Phillips; Mitchell, Susan L.; Weijer, Charles; Taljaard, Monica
• Is Part Of: Alzheimer's & dementia. Volume 8:Issue 1(2022)
• Page Start: n/a
• Page End: n/a
• Publication Date: 2022-05-02
• Subjects: capacity -- consent -- ethics -- research participant; Dementia -- Periodicals; Dementia -- Treatment -- Periodicals; Alzheimer's disease -- Treatment -- Periodicals; Alzheimer's disease -- Periodicals; 616.831
• DOI: 10.1002/trc2.12287
• Languages: English
• ISSNs: 2352-8737

Abstract

Abstract: Introduction: This review aims to describe the landscape of pragmatic randomized controlled trials (RCTs) in the context of Alzheimer's disease (AD) and related dementias with respect to ethical considerations. Methods: Searches of MEDLINE were performed from January 2014 until April 2019. Extracted information included: trial setting, interventions, data collection, study population, and ethical protections (including ethics approvals, capacity assessment, and informed consent). Results: We identified 62 eligible reports. More than two‐thirds (69%) included caregivers or health‐care professionals as research participants. Fifty‐eight (94%) explicitly identified at least one vulnerable group. Two studies did not report ethics approval. Of 57 studies in which patients were participants, 55 (96%) reported that consent was obtained but in 37 studies (67%) no mention was made regarding assessment of the patients' capacity to consent to research participation. Discussion: Few studies reported protections implemented when vulnerable participants were included. Shortcomings remain when reporting consent approaches and capacity assessment.