Masking in Pragmatic Trials: Who, What, and When to Blind
Masking in Pragmatic Trials: Who, What, and When to Blind
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DOI：
10.1007/s43441-019-00073-7
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发表时间：
2020-03-01
影响因子：
1.5
通讯作者：
Dreyer, Nancy A.
中科院分区：
文献类型：
--
作者：
Christian, Jennifer B.;Brouwer, Emily S.;Dreyer, Nancy A.
在经典随机临床试验（RCT）中，常规实施治疗分配的设盲（或盲法），以隔离干预本身的影响，并最大限度地减少传统试验可能发生的偏倚。当治疗分配已知时，此类偏倚可能会随着行为、终点评估、疾病管理、分析和报告而引入。然而，治疗的掩蔽不仅复杂，而且它阻碍了这些发现对“真实的世界”临床环境的推广。实用性RCT（pRCT）旨在评价常规医疗护理中干预措施的效果，因此通常不会掩盖治疗组;此外，pRCT评估的是常规医疗实践中可用的对照药物，而不是设盲的安慰剂。最近有人质疑，如果pRCT用于监管或其他目的，是否应该设盲。关于pRCT的文献虽然广泛，但并未说明掩蔽结果可获得多少实际获益，以及掩蔽如何影响研究的“真实的世界”性质。在这里，我们提出了一种方法来评估偏见的来源，描述利益相关者在进行pRCT谁是最有可能受到影响，并提供了一个框架，考虑如何掩盖可能有效地实施，同时保持普遍性。
Masking (or blinding) of treatment assignment is routinely implemented in classical randomized clinical trials (RCTs) to isolate the effect of the intervention itself and to minimize the potential for bias that could occur with traditional trials. Such biases could be introduced with the conduct, assessment of endpoints, management of conditions, analysis, and reporting when the treatment assignments are known. However, masking of treatments is not only complex but it hinders how generalizable the findings are to the "real world" clinical setting. Pragmatic RCTs (pRCTs) are intended to evaluate the effects of interventions within routine medical care, and as such, do not typically mask treatment groups; moreover, pRCTs assess comparators that are available in routine medical practice, not masked placebos. Whether pRCTs should be masked if intended for regulatory or other purposes has recently been questioned. The literature on pRCTs, while extensive, does not address how much actual benefit is gained from masking outcomes and how masking may affect the "real world" nature of a study. Here, we propose an approach to evaluate sources of bias, describe stakeholders in the conduct of pRCTs who are most likely affected, and offer a framework for considering how masking may be implemented effectively while maintaining generalizability.