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对外科专业的临床试验同意表格的可读性评估
Amir H Karimi1, Maura R Guyler1, Christian J Hecht1
1Department of Orthopedic Surgery, Cleveland Clinic Foundation, Cleveland, Ohio.
手术试验同意表格过于复杂和冗长,超过了推的阅读水平. 提高可读性对于患者知情同意和保护其权利至关重要.
科学领域:
- 医学研究伦理学医学研究伦理学
- 临床试验的设计
- 患者倡导 患者倡导
背景情况:
- 评估外科临床试验同意表的可读性至关重要.
- 需要评估不同外科专业的可读性差异.
研究的目的:
- 量化评估外科临床试验同意表的可读性.
- 为了在不同外科专业中比较可读性,字数和长度.
主要方法:
- 从ClinicalTrials.gov.gov.gov网站对386个外科临床试验同意表的横截面分析.
- 在2022年11月至2023年1月期间进行的分析.
- 使用Flesch-Kincaid等级水平,Flesch阅读易度得分,枪击青指数等来评估可读性.
主要成果:
- 手术同意书的平均内容为2626个字,阅读时间超过12分钟.
- 没有一个外科专业达到六年级或更低的推阅读水平.
- 只有4%的表格符合推的可读性标准;专业之间没有显著差异.
结论:
- 目前的外科临床试验同意文件过长和复杂.
- 必须提高可读性,以确保道德实践和知情的患者决策.
- 增强可读性可以保护患者的权利和福祉.
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