Ethical and Empirical Limitations of Randomized Controlled Trials
Ethical and Empirical Limitations of Randomized Controlled Trials
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DOI：
10.1007/s00063-008-1132-x
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发表时间：
2008-12-01
影响因子：
--
通讯作者：
Kliemt, Hartmut
中科院分区：
文献类型：
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作者：
Porzsolt, Franz;Kliemt, Hartmut
在评估保健服务的效益时，假定可以用科学方法确定因果关系。一般来说，随机对照试验（RCT）被认为是产生科学证据的金标准。然而，越来越多的数据表明，并非在所有情况下，随机对照试验似乎都是产生证据的适当工具。事实上，在许多情况下，随机对照试验几乎不能反映卫生保健服务的真实情况。一些众所周知的，但大多数被忽视的局限性的随机对照试验进行了总结。缺乏明确的先验偏好的特定类型的干预（平衡）是一个必要的先决条件，医生和患者的同意参加随机对照试验。大量的定量研究证实，接受随机化的意愿在手术学科是有限的。如果诊断或治疗干预的侵入性确实与医生和患者的偏好相关，那么手术领域的随机对照试验数量较少是可以预期的。RCT重要概念的进一步发展应明确RCT产生显著结果的条件。关注这一点将为评估保健服务开辟新的视角。
In assessing the benefits of health services it is presumed that the relationship of cause and effect can be determined by scientific methods. In general, the randomized controlled trial (RCT) is considered the gold standard for the generation of scientific evidence. Yet there is an increasing amount of data indicating that not in all situations RCTs seem to be the adequate tool for generating evidence. In many instances, RCTs are, in fact, barely useful to reflect the real-world situation of health-care services. Some of the well-known yet mostly ignored limitations of RCTs are summarized.The absence of definite a priori preferences for a specific kind of intervention (equipoise) is an essential prerequisite for both physicians' and patients' consent to participate in an RCT. Numerous examples of quantitative studies confirm that the willingness to accept randomization is limited in operative disciplines. If it is true that the invasiveness of a diagnostic or therapeutic intervention correlates with the preferences of doctors and patients, the small number of RCTs in operative fields should be expected. Further development of the important concept of RCTs should specify the conditions under which RCTs can generate significant results. Paying attention to this will open up new perspectives for the assessment of health-care services.