Chard J A, Lilford R J
Department of Public Health and Epidemiology, University of Birmingham, Edgbaston, UK.
Soc Sci Med. 1998 Oct;47(7):891-8. doi: 10.1016/s0277-9536(98)00153-1.
Randomised control trials (RCTs) are the standard method for treatment evaluation. Unfortunately RCTs are inherently difficult to recruit for, precisely because of the randomisation element that makes them so statistically attractive. Problems of low recruitment are now beginning to impact on trials, with many either not being started or being forced to stop, due to lack of participation. This paper examines one issue that bears on the recruitment problem: equipoise. Equipoise is defined as the point where a rational, informed person has no preference between two (or more) available treatments (Lilford and Jackson, 1995). The use of equipoise as the fundamental criterion for eligibility for a trial seems to impose a hurdle to recruitment. Here we examine the various arguments surrounding its use and measurement. We conclude that effective equipoise based upon constructed "zones of indifference" offers the best chance for bridging the gap between the individual's right to decide and the need for clinical trials to benefit society.
随机对照试验（RCTs）是治疗评估的标准方法。不幸的是，随机对照试验本质上很难招募受试者，恰恰是因为随机化因素使其在统计学上颇具吸引力。现在，低招募率问题开始对试验产生影响，由于缺乏参与，许多试验要么无法启动，要么被迫停止。本文探讨了一个与招募问题相关的问题： equipoise。Equipoise被定义为一个理性、知情的人在两种（或更多）可用治疗方法之间没有偏好的点（Lilford和Jackson，1995）。将equipoise用作试验入选的基本标准似乎给招募工作设置了障碍。在此，我们审视围绕其使用和衡量的各种论点。我们得出结论，基于构建的“无差异区”的有效equipoise为弥合个人决定权与临床试验造福社会的需求之间的差距提供了最佳机会。
