Pragmatic trial design enhances diversity and retention among research participants with Lewy body diseases

务实的试验设计提高了路易体病研究参与者的多样性和保留率。

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Abstract

An ongoing pragmatic, randomized, unblinded clinical trial compares pimavanserin and quetiapine for psychosis in Lewy body diseases over 6 months (n = 60). Relative to local explanatory clinical trials, retention is higher (93% vs 40%, p < 0.001) and Hispanic enrollment greater (38% vs 21%, p = 0.043), reflecting the clinic demographics. Embedding pragmatic trials within routine care can enhance retention and diversity, thereby improving representativeness and real-world applicability of clinical research. Registry: ClinicalTrials.gov, TRN: NCT05590637; Registration Date: 18 October 2022.

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