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一个随机比较的两阶段与传统的一阶段同意低风险的随机试验的随机比较

Andrew J Vickers¹, Emily A Vertosick¹, Mia Austria¹

¹Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.

Clinical trials (London, England)

|July 5, 2023

概括

临床试验的两阶段知情同意与传统的一阶段方法相比,显示出类似的患者理解和决策质量. 一些证据表明,双阶段方法可以减少焦虑,特别是在较低风险的研究环境中.

科学领域:

临床研究方法论临床研究方法论
患者的决策能力

背景情况:

随机试验的知情同意对于伦理研究至关重要.
拟议的两阶段同意过程旨在减少信息过载和患者焦虑.
这项研究比较了两阶段同意与传统一阶段同意的有效性.

研究的目的:

为了比较两阶段和一阶段的知情同意过程之间的患者理解,焦虑和决策质量.
评估分阶段同意方法对临床试验中的患者体验的影响.

主要方法:

接受前列腺活检的患者被随机分配到一阶段或两阶段的同意中,接受低风险的心身干预试验.
共有125名患者 (66名单阶段,59名双阶段) 填写了验证的问卷,评估理解,焦虑和决策质量.
结果包括知情同意的质量,一般和同意特定的焦虑,决策冲突,负担和遗憾.

主要成果:

两组人之间客观或主观的知情同意质量得分没有显著差异.
焦虑和决策结果在一阶段同意和两阶段同意之间显示出类似的小差异.
后期分析表明,两阶段组的同意相关焦虑较低,可能是由于评估的时间.

结论:

在随机试验中,两阶段的知情同意似乎保持了患者的理解.
有一些证据表明,通过两阶段的方法,患者的焦虑可能会减少.
对于高风险的临床试验设置,建议对两阶段同意进行进一步调查.

关键词:

经过知情同意的同意.焦虑是一种焦虑.临床协议临床协议随机对照试验是随机对照试验.研究设计研究设计研究调查和问卷调查和问卷调查.

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