Nix Hayden P, Weijer Charles, Taljaard Monica
Department of Medicine, Dalhousie University, Halifax, NS, Canada.
Department of Medicine, Western University, London, ON, Canada.
Clin Trials. 2025 Feb;22(1):109-115. doi: 10.1177/17407745241284798. Epub 2024 Oct 15.
Randomized controlled trials with pragmatic intent aim to generate evidence that directly informs clinical decisions. Some have argued that the ethical protection of informed consent can be in tension with the goals of pragmatism. But the impact of other ethical protections on trial pragmatism has yet to be explored.
In this article, we analyze the relationship between additional ethical protections for vulnerable participants and the degree of pragmatism within the PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) domains of trial design.
We analyze three example trials with pragmatic intent that include vulnerable participants.
The relationship between ethical protections and trial pragmatism is complex. In some cases, additional ethical protections for vulnerable participants can promote the pragmatism of some of the PRECIS-2 domains of trial design. When designing trials with pragmatic intent, researchers ought to look for opportunities wherein ethical protections enhance the degree of pragmatism.
具有实用主义意图的随机对照试验旨在产生直接为临床决策提供依据的证据。一些人认为，知情同意的伦理保护可能与实用主义目标存在冲突。但其他伦理保护对试验实用主义的影响尚未得到探讨。
在本文中，我们分析了针对弱势参与者的额外伦理保护与试验设计的实用主义解释连续统指标总结-2（PRECIS-2）领域内实用主义程度之间的关系。
我们分析了三项具有实用主义意图且纳入了弱势参与者的示例试验。
伦理保护与试验实用主义之间的关系很复杂。在某些情况下，针对弱势参与者的额外伦理保护可以促进试验设计中一些PRECIS-2领域的实用主义。在设计具有实用主义意图的试验时，研究人员应寻找伦理保护提高实用主义程度的机会。
