临床结果评估在植入口牙科临床研究临床研究
Muhammad H A Saleh1, Frank Schwarz2, Hom-Lay Wang1
1Department of Periodontics and Oral Medicine, School of Dentistry, University of Michigan, Ann Arbor, Michigan, USA.
Clinical oral implants research
|February 24, 2026
概括
在植入式牙科研究中标准化术语至关重要. 这次审查澄清了结果和结果评估,使它们与更有意义的临床试验的监管标准保持一致.
科学领域:
- 牙科植入物学 牙科植入物学
- 生物材料科学 生物材料科学
- 临床研究方法论 临床研究方法论
背景情况:
- 精确的术语是植入式牙科 (ID) 研究的基础.
- 区分结果和结果评估对于清晰度至关重要.
- 现有的ID术语需要与已建立的监管框架保持一致.
研究的目的:
- 在植入式牙科中定义结果和结果评估.
- 将ID术语与监管框架保持一致,包括FDA认可的临床结果评估 (COA).
- 将各种结果映射到患者的意义和人类判断的频谱中.
主要方法:
- 对现有文献和监管指南进行叙述性审查.
- 将生存结果,生物标志物和COA (患者报告,临床医生报告,观察员报告,绩效结果) 映射到一个频谱上.
- 强调内容有效性,与有实践经验的人共同开发 (PWLE) 和使用基于共识的标准来选择健康测量仪器 (COSMIN) 标准进行评估.
主要成果:
- 提出了一种光谱,其中一端是确定的事件,另一端是客观的生物标志物,中间是COA.
- 内容有效性,PWLE共同开发和COSMIN标准对于强大的COA至关重要.
- 在测量 (工具) 和终点 (分析变量) 之间进行区分.
结论:
- 标准化定义对于增加ID共识陈述的意义至关重要.
- 通过标准化术语来加强临床试验的相关性和可比性.
- 采用明确的定义将提高植入式牙科研究的严谨性和影响.
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