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<p>An ongoing pragmatic, randomized, unblinded clinical trial compares pimavanserin and quetiapine for psychosis in Lewy body diseases over 6 months (<i>n</i> = 60). Relative to local explanatory clinical trials, retention is higher (93% vs 40%, <i>p</i> &lt; 0.001) and Hispanic enrollment greater (38% vs 21%, <i>p</i> = 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.</p>

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

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年2月2日

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  • Nghi Tran,
  • Chen-Pin Wang,
  • Sudha Seshadri,
  • Pablo Coss,
  • Okeanis E. Vaou,
  • Leila Saadatpour,
  • Carolyn Paiz,
  • Diana Solis,
  • Jessica Grimaldo,
  • Sarah Erskine,
  • Sarah Horn

摘要

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.