用于安慰剂控制的手术试验的患者信息传单:对当前实践的审查和开发人员的建议
S Cousins1, M Huttman1, N Blencowe1
1National Institute for Health Research Bristol Biomedical Research Centre Surgical Innovation Theme, Bristol Centre for Surgical Research, Bristol Medical School, University of Bristol, Bristol, UK.
Trials
|May 22, 2024
概括
手术试验的患者信息传单需要改进. 对安慰剂干预的更清晰的解释和平衡的风险益处信息对于在安慰剂控制的手术试验中获得知情同意至关重要.
科学领域:
- 医学伦理 医学伦理
- 临床试验设计 临床试验设计
- 手术研究的研究.
背景情况:
- 知情同意是随机对照试验 (RCT) 的关键伦理和法律要求.
- 用安慰剂控制的外科试验对知情同意过程提出了独特的挑战.
- 患者信息传单 (PIL) 对于提供知情同意的信息至关重要.
研究的目的:
- 分析最近完成的安慰剂控制的外科试验中的PILs的内容.
- 确定这些特定试验类型的PIL中的最佳实践和信息缺口.
- 在安慰剂控制的外科试验中提供改善 PIL 的建议.
主要方法:
- PIL来自于对安慰剂控制的侵入性手术试验的系统审查.
- 通过使用定向内容分析对14个PIL进行了内容分析.
- 分析的指导是监管标准和对安慰剂控制的手术试验的研究.
主要成果:
- 总体试验设计被包含在50%以上的PIL中.
- 只有43%的PIL解释了安慰剂干预与手术干预的区别.
- 关于手术干预的益处 (57%) 和风险 (57%) 的信息比安慰剂风险 (36%) 更常见.
- 用不同的术语来描述安慰剂干预 (例如",假冒"",模拟").
结论:
- 用于安慰剂控制的外科试验的PIL需要仔细选择语言 (例如",假冒"",模拟").
- 明确详细说明安慰剂和手术干预的差异/相似之处是必不可少的.
- 建议对手术和安慰剂干预的益处和风险进行平衡的介绍.
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