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参与随机临床试验的2型糖尿病患者与一般患者有什么区别? 一个横截面的比较研究
Amandine Dugard1, Bruno Giraudeau2,3, Clarisse Dibao-Dina2,4
1UMR INSERM 1246 - SPHERE, University of Tours, Tours, Centre-Val de Loire, France amandinedugard@gmail.com.
BMJ open
|April 11, 2024
概括
在一般实践中,患有2型糖尿病的患者年龄较大,BMI高于临床试验中的患者,这影响了指南的适用性. 未来的试验需要更广泛的患者纳入更好的现实世界的应用.
科学领域:
- 临床医学 临床医学
- 糖尿病研究 糖尿病研究
- 基于证据的实践.
背景情况:
- 对2型糖尿病 (T2DM) 的临床实践指南主要基于随机对照试验 (RCT).
- 在初级保健机构中,RCT结果对现实世界患者群体的概括性经常受到质疑.
- 了解患者特征差异对于有效实施指南至关重要.
研究的目的:
- 为了比较在一般实践中管理的T2DM患者的特征与用于准则制定的RCT中注册的患者的特征.
- 识别可能影响当前临床实践指南适用性的差异.
主要方法:
- 采用了横截面的比较研究设计.
- 来自法国全科医院的675名T2DM患者的数据与来自23个RCT的36059名患者的数据进行了比较,这些患者被列入了柯克伦系统性审查.
- 计算了基线特征的标准化差异,以评估有意义的变化.
主要成果:
- 与RCT参与者相比,一般实践T2DM患者的年龄显著更大 (平均差异为0.8) 和BMI更高 (平均差异为0.5).
- 通用诊所患者吸烟较少 (差异为-0.6),使用抗高血压药物更频繁 (差异为-1.2),心肌梗塞较少 (差异为-1.1).
- 这些差异超过了有意义变化的值 (绝对差异>0.10).
结论:
- 在一般实践中的T2DM患者和在临床指南中提供信息的RCT患者之间存在显著差异.
- 这些差异可能会限制基于证据的指导方针在日常护理中的直接适用性.
- 未来的RCT应该旨在招募一个更具代表性的T2DM总体人口样本,以提高研究结果的转化到临床实践中.
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