DESIGNS FOR EXPERIMENTS - PARALLEL COMPARISONS OF TREATMENT

DESIGNS FOR EXPERIMENTS - PARALLEL COMPARISONS OF TREATMENT
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DOI:
10.1056/nejm198311243092105
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发表时间:
1983-01-01
影响因子:
158.5
通讯作者:
POLANSKY, M
POLANSKY, M
中科院分区:
医学1区
文献类型:
--
作者:
LAVORI, PW;LOUIS, TA;POLANSKY, M

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医学治疗的临床试验经常将治疗组相互比较,或者将一个或多个治疗组与单独但同时进行的对照组进行比较。我们对1978-1979年发表在《新英格兰医学杂志》上的47项类似的连续系列研究进行了研究,其中包括35项随机分配到治疗组或对照组的研究,以发现这种方法实际上是如何使用的。 作为一个组,这些研究的主要优势是频繁使用随机治疗分配。常见的问题包括缺乏足够的随机化方法的细节,未能提供足够的细节病人的来源,以及不充分使用多元统计技术和统计建模。 我们强调通过在分配患者治疗时平衡预后因素来避免偏倚的重要性,通过建模预后因素对反应的影响来减少偏倚,并通过建模来提高精度。我们还主张仔细考虑研究中治疗比较与外部临床实践的相关性。
Clinical trials of medical treatments often compare treated groups with each other or compare one or more treated groups with a separate but concurrent control group. We have examined a consecutive series of 47 such parallel studies reported in the New England Journal of Medicine in 1978–1979, including 35 with random assignment to the treated or control group, to discover how this approach is actually used. A major strength of these studies as a group was the frequent use of randomized treatment assignment. Common problems included lack of sufficient detail about methods of randomization, failure to provide enough detail about patient sources, and insufficient use of multivariate statistical techniques and of statistical modeling. We emphasize the importance of avoiding bias by balancing prognostic factors when assigning patients to treatments, reducing bias by modeling the influence of prognostic factors on response, and increasing precision by modeling. We also advocate careful consideration of the relevance of a treatment comparison within the study to the external world of clinical practice.