Assistant professor in the Center for Medical Ethics & Health Policy at Baylor College of Medicine.
Phoebe R. Berman Professor of Bioethics and Public Health at the Berman Institute of Bioethics and the Bloomberg School of Public Health at Johns Hopkins University.
Ethics Hum Res. 2021 Jan;43(1):17-24. doi: 10.1002/eahr.500075.
Pragmatic clinical trials (PCTs) may improve the efficiency, relevance, and representativeness of research. While prior research has indicated that willingness to join a PCT is high, it is not universal among those asked in surveys exploring attitudes toward hypothetical PCTs. The objective of this study was to examine what factors predict willingness to join a hypothetical low-risk PCT comparing two blood pressure medicines. In our study, 2,618 respondents, recruited from three populations (adult patients from an academic health system, adult patients from an integrated delivery system, and adults from an online nationally representative panel), completed an online survey. Most respondents (90%) expressed willingness to participate in the hypothetical PCT. The two key predictors of expressed willingness to join low-risk PCTs were respondents' understanding of key features of PCTs, including how they differ from traditional research, and the degree of importance respondents perceived comparative research to have. Increasing awareness of the rationale for PCTs and understanding of these trials, including how they differ from explanatory trials, may increase prospective participants' willingness to contribute to this effort.
实用临床试验（PCTs）可以提高研究的效率、相关性和代表性。虽然先前的研究表明，人们加入 PCT 的意愿很高，但在调查中询问那些对假设性 PCT 态度的人时，这种意愿并不是普遍存在的。本研究的目的是探讨哪些因素可以预测对比较两种降压药物的假设性低风险 PCT 的参与意愿。在我们的研究中，从三个群体（来自学术医疗系统的成年患者、来自综合交付系统的成年患者和来自全国在线代表性小组的成年患者）招募了 2618 名受访者，他们完成了在线调查。大多数受访者（90%）表示愿意参加假设性 PCT。表示愿意参加低风险 PCT 的两个关键预测因素是受访者对 PCT 关键特征的理解，包括它们与传统研究的区别，以及受访者认为比较研究的重要程度。提高对 PCT 基本原理的认识，并了解这些试验，包括它们与解释性试验的区别，可能会增加潜在参与者对这一努力的意愿。
