TY - JOUR
T1 - Health equity considerations in pragmatic trials in Alzheimer's and dementia disease
T2 - Results from a methodological review
AU - Nicholls, Stuart G.
AU - Al-Jaishi, Ahmed A.
AU - Niznick, Harrison
AU - Carroll, Kelly
AU - Madani, Mohamad Tarek
AU - Peak, Katherine D.
AU - Madani, Leen
AU - Nevins, Pascale
AU - Adisso, Lionel
AU - Li, Fan
AU - Weijer, Charles
AU - Mitchell, Susan L.
AU - Welch, Vivian
AU - Quiñones, Ana R.
AU - Taljaard, Monica
N1 - Publisher Copyright:
© 2023 The Authors. Alzheimer's & Dementia: Diagnosis, Assessment & Disease Monitoring published by Wiley Periodicals, LLC on behalf of Alzheimer's Association.
PY - 2023/1/1
Y1 - 2023/1/1
N2 - Introduction: To improve dementia care delivery for persons across all backgrounds, it is imperative that health equity is integrated into pragmatic trials. Methods: We reviewed 62 pragmatic trials of people with dementia published 2014 to 2019. We assessed health equity in the objectives; design, conduct, analysis; and reporting using PROGRESS-Plus which stands for Place of residence, Race/ethnicity, Occupation, Gender/sex, Religion, Education, Socioeconomic status, Social capital, and other factors such as age and disability. Results: Two (3.2%) trials incorporated equity considerations into their objectives; nine (14.5%) engaged with communities; 4 (6.5%) described steps to increase enrollment from equity-relevant groups. Almost all trials (59, 95.2%) assessed baseline balance for at least one PROGRESS-Plus characteristic, but only 10 (16.1%) presented subgroup analyses across such characteristics. Differential recruitment, attrition, implementation, adherence, and applicability across PROGRESS-Plus were seldom discussed. Discussion: Ongoing and future pragmatic trials should more rigorously integrate equity considerations in their design, conduct, and reporting. Highlights: Few pragmatic trials are explicitly designed to inform equity-relevant objectives. Few pragmatic trials take steps to increase enrollment from equity-relevant groups. Disaggregated results across equity-relevant groups are seldom reported. Adherence to existing tools (e.g., IMPACT Best Practices, CONSORT-Equity) is key.
AB - Introduction: To improve dementia care delivery for persons across all backgrounds, it is imperative that health equity is integrated into pragmatic trials. Methods: We reviewed 62 pragmatic trials of people with dementia published 2014 to 2019. We assessed health equity in the objectives; design, conduct, analysis; and reporting using PROGRESS-Plus which stands for Place of residence, Race/ethnicity, Occupation, Gender/sex, Religion, Education, Socioeconomic status, Social capital, and other factors such as age and disability. Results: Two (3.2%) trials incorporated equity considerations into their objectives; nine (14.5%) engaged with communities; 4 (6.5%) described steps to increase enrollment from equity-relevant groups. Almost all trials (59, 95.2%) assessed baseline balance for at least one PROGRESS-Plus characteristic, but only 10 (16.1%) presented subgroup analyses across such characteristics. Differential recruitment, attrition, implementation, adherence, and applicability across PROGRESS-Plus were seldom discussed. Discussion: Ongoing and future pragmatic trials should more rigorously integrate equity considerations in their design, conduct, and reporting. Highlights: Few pragmatic trials are explicitly designed to inform equity-relevant objectives. Few pragmatic trials take steps to increase enrollment from equity-relevant groups. Disaggregated results across equity-relevant groups are seldom reported. Adherence to existing tools (e.g., IMPACT Best Practices, CONSORT-Equity) is key.
KW - Alzheimer's disease
KW - cluster randomized trials
KW - covariate adjustment
KW - dementia
KW - health equity
KW - pragmatic trials
KW - randomization
KW - subgroup analyses
KW - treatment effect heterogeneity
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U2 - 10.1002/dad2.12392
DO - 10.1002/dad2.12392
M3 - Article
AN - SCOPUS:85151696158
SN - 2352-8729
VL - 15
JO - Alzheimer's and Dementia: Diagnosis, Assessment and Disease Monitoring
JF - Alzheimer's and Dementia: Diagnosis, Assessment and Disease Monitoring
IS - 1
M1 - e12392
ER -