November 21, 2021
IMPACT members Monica Taljaard, PhD, Fan Li, PhD, and IMPACT multiple principal investigator Susan Mitchell, MD, MPH are among the authors of a new article addressing methodological challenges in pragmatic trails in Alzheimer’s disease in the November 2021 issue of Clinical Trials.
Acknowledging the need for more pragmatic trials of interventions to improve care and outcomes for people living with dementia and the unique methodological challenges in conducting this type of research, the authors conducted a review of the literature to inform the development of new methods and guidance for investigators conducting pragmatic trials with PLWD.
Using a published search filter in Medline, the authors identified trials more likely to be pragmatic and focus on people living with Alzheimer’s disease or other dementias. Pairs of reviewers extracted information from a total of 62 eligible primary trial reports and found a need and opportunity to improve the design, analysis, and reporting of pragmatic trials in dementia research. The authors suggest that investigators conducting pragmatic trials in dementia research 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. Read the full article here.