HOW STUDY DESIGN AFFECTS OUTCOMES IN COMPARISONS OF THERAPY .1. MEDICAL
HOW STUDY DESIGN AFFECTS OUTCOMES IN COMPARISONS OF THERAPY .1. MEDICAL
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DOI：
10.1002/sim.4780080408
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发表时间：
1989-04-01
影响因子：
2
通讯作者：
MOSTELLER, F
中科院分区：
文献类型：
--
作者：
COLDITZ, GA;MILLER, JN;MOSTELLER, F
我们分析了1980年发表在医学期刊样本中的113份报告，将研究设计的特征与新疗法相对于旧疗法的收益幅度联系起来。总的来说，我们认为87%的新疗法比标准疗法有所改善。平均增益（通过Mann-Whitney统计量测量）在研究设计中相对恒定，但顺序分配治疗的非随机对照试验除外，该试验显示患者在创新治疗中比在标准治疗中表现更好的可能性显著更高（p = 0.004）。不使用双盲设计的随机对照试验比双盲试验显示创新收益的可能性更高（p = 0.02）。对创新的任何评价都可能包括偏倚和新疗法的真实疗效，因此我们可能会考虑对与研究设计相关的平均偏倚进行调整。在解释新疗法的评价时，读者应考虑以下平均调整对Mann-Whitney统计量的影响：对于非随机序贯分配的试验，减少0.15，对于非双盲随机对照试验，减少0.11。
We analysed 113 reports published in 1980 in a sample of medical journals to relate features of study design to the magnitude of gains attributed to new therapies over old. Overall we rated 87 per cent of new therapies as improvements over standard therapies. The mean gain (measured by the Mann-Whitney statistic) was relatively constant across study designs, except for non-randomized controlled trials with sequential assignment to therapy, which showed a significantly higher likelihood that a patient would do better on the innovation than on standard therapy (p = 0.004). Randomized controlled trials that did not use a double-blind design had a higher likelihood of showing a gain for the innovation than did double-blind trials (p = 0.02). Any evaluation of an innovation may include both bias and the true efficacy of the new therapy, therefore we may consider making adjustments for the average bias associated with a study design. When interpreting an evaluation of a new therapy, readers should consider the impact of the following average adjustments to the Mann-Whitney statistic: for trials with non-rndom sequential assignment a decrease of 0.15, for non-double-blind randomized controlled trials a decrease of 0.11.