眼科随机对照试验 (TAO-RCT) 中的治疗分配:一个横截面的元研究研究
Arun James Thirunavukarasu1,2, Santosh Guru3, Henry Rocha3
1Nuffield Department of Clinical Neurosciences, Medical Sciences Division, University of Oxford, Oxford, UK. arun.thirunavukarasu@medsci.ox.ac.uk.
Eye (London, England)
|July 17, 2025
概括
在眼科随机对照试验 (RCT) 中,不受控制的治疗分配是常见的,这与不清楚的报告和特定的研究设计有关. 虽然不表明有故意的滥用,但可能会影响试验有效性,需要更清晰的报告和设计考虑.
科学领域:
- 眼科医生 眼科 眼科
- 临床试验方法论 临床试验方法论
- 生物统计学 生物统计学
背景情况:
- 眼科随机对照试验 (RCT) 面临着独特的挑战,包括眼间相关性和对侧交叉效应.
- 治疗分配模式的异质性可能会使RCT结果的解释变得复杂.
研究的目的:
- 检查眼科RCT中不受控制的治疗分配的患病率.
- 评估不受控制的治疗分配对研究结果和报告明确性的影响.
主要方法:
- 一项横截面研究分析了2022年发表的所有眼科RCT.
- 治疗分配模式和报告清晰度使用标准化命名系统进行评估.
- 在统计学上检查了不受控制的分配与研究特征,资金和结果之间的关联.
主要成果:
- 在359个RCT中,确定了42个分配模式;85.2%使用了受控分配.
- 不受控制的分配与不清晰的报告相关 (p < 0.001) 和双眼设计 (p < 0.001).
- 在非英语国家 (p=0.030) 和手术干预研究 (p=0.038) 中,不受控制的分配更频繁.
结论:
- 在眼科RCT中,不受控制的治疗分配很普遍,与报告问题和特定研究类型有关.
- 虽然没有明显的故意滥用,但不受控制的分配可能会损害试验有效性.
- 优先考虑透明的报告,谨慎的分配设计和标准化命名是提高RCT可靠性的关键.
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