Ethical considerations within pragmatic randomized controlled trials in dementia: Results from a literature survey.

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 wer

SUBMITTER: Nicholls SG 

PROVIDER: S-EPMC9060321 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature