Table 1.

Selected Research Priorities to Address Contemporary Challenges in Designing and Analyzing Embedded Pragmatic Trials Among People with Dementia and Their Caregivers

Challenge	Research priorities
Evaluating multicomponent interventions	Methods that consider the influence of participant/caregiver interactions on treatment assignment and effect estimation and clarify population heterogeneity in treatment effects Methods or simulations informing sample size computations
Testing interventions on PLWD/caregiver dyads	Measures capturing complementary information from PLWD and caregivers Methods to clarify the influence of PLWD/caregiver interactions on treatment assignment and intervention effects Algorithms to identify caregivers in the electronic health record and link PLWD and caregiver data Models to estimate intervention effects in the context of secular declines in measurement quality
Developing methods and tools for contemporary cluster designs	Reliable, responsive, and reproducible measurement protocols leveraging the electronic health record and administrative data Sample size tools for noncontinuous outcomes and complex correlation structures Valid and efficient designs that reduce participant burden
Capturing protocol adherence in estimating effectiveness	Measurement for, and models incorporating the effects of, adherence for participants and caregivers Methods to address heterogeneity of adherence and follow-up at the participant and facility level Methods or simulations supporting sensitivity analyses, capturing the effects of adherence and attrition
Creating robust standards for embedded trials	Guidelines for design and reporting of embedded pilot trials

Abbreviation: PLWD, people living with dementia.