ArticleClinical trials (London, England)2022
Methodological challenges in pragmatic trials in Alzheimer's disease and related dementias: Opportunities for improvement.
Article in Clinical trials (London, England), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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Who cites it
6 citing papers in PubMed, 8 citations in OpenAlex.
- Selecting outcomes for pragmatic clinical trials in dementia care: The IMPACT Collaboratory iLibrary.Journal of the American Geriatrics Society · 2024Article
- Career development in pragmatic clinical trials to improve care for people living with dementia.Journal of the American Geriatrics Society · 2023Article
- Article
- Power analyses for stepped wedge designs with multivariate continuous outcomes.Statistics in medicine · 2023Article
- Ethical considerations within pragmatic randomized controlled trials in dementia: Results from a literature survey.Alzheimer's & dementia (New York, N. Y.) · 2022Article
- Health equity considerations in pragmatic trials in Alzheimer's and dementia disease: Results from a methodological review.Alzheimer's & dementia (Amsterdam, Netherlands)Article
Corrections and comments
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Authors and funding
8 authors at 4 institutions in 2 countries.
Funding
Abstract
BACKGROUND AND
aimsWe need more pragmatic trials of interventions to improve care and outcomes for people living with Alzheimer's disease and related dementias. However, these trials present unique methodological challenges in their design, analysis, and reporting-often, due to the presence of one or more sources of clustering. Failure to account for clustering in the design and analysis can lead to increased risks of Type I and Type II errors. We conducted a review to describe key methodological characteristics and obtain a "baseline assessment" of methodological quality of pragmatic trials in dementia research, with a view to developing new methods and practical guidance to support investigators and methodologists conducting pragmatic trials in this field.
methodsWe used a published search filter in MEDLINE to identify trials more likely to be pragmatic and identified a subset that focused on people living with Alzheimer's disease or other dementias or included them as a defined subgroup. Pairs of reviewers extracted descriptive information and key methodological quality indicators from each trial.
resultsWe identified
conclusionThere is a need and opportunity to improve the design, analysis, and reporting of pragmatic trials in dementia research. Investigators should pay attention to the potential presence of one or more sources of clustering. While methods for longitudinal and cluster randomized trials are well developed, accessible resources and new methods for dealing with multiple sources of clustering are required. Involvement of a statistician with expertise in longitudinal and clustered designs is recommended.
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