通过盲目评估加强开放的临床试验:对糖尿病脚部感染的探索
Qingna Li1,2,3, Mengli Xiao1,2,3, Xingfang Liu4
1Institution of Clinical Pharmacology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing, China.
Trials
|November 10, 2023
概括
非盲目的临床试验评估可能会膨胀治疗疗效. 本研究提出了在试验中客观评估的策略,其中双盲是不可行的,提高研究的完整性.
科学领域:
- 临床研究 临床研究
- 医学试验 医学试验
- 传染性疾病 传染性疾病
背景情况:
- 临床试验中的失明可以最大限度地减少偏见,但在安慰剂生产方面面临挑战,通常可以防止双盲.
- 控制主观偏见对于可靠的试验结果至关重要.
研究的目的:
- 评估临床试验中非盲目的和盲目的评估之间的一致性.
- 制定策略来管理信息偏差,当双盲是不可能的.
主要方法:
- 使用了一项针对糖尿病足感染 (DFI) 的随机对照试验 (RCT).
- 美国传染病学会 (IDSA) 和糖尿病足国际工作组 (IWGDF) 准则的DFI评级是主要指标.
- 非盲目和盲目的中心读取调查人员评估了11名患者的样本中的DFI分级.
主要成果:
- 在非盲目的和盲目的评估之间发现了不一致的结果 (Kappa=0.248,p=0.384).
- 在27%的治疗后确定的分级中发生了分级差异.
- 提出了盲目的评估策略,涵盖人员,培训,参与者管理,药物管理和数据收集.
结论:
- 非盲目的评估可能会高估治疗的有效性,特别是在深层伤口.
- 在公开试验中,客观评估至关重要,特别是当伤口观察是主要结果时.
- 实施独立的盲人调查人员和标准操作程序可以减轻在公开临床试验中的偏见.
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