McCleary Lynn
Kunin-Lunenfeld Applied Research Unit, Baycrest Centre for Geriatric Care, Toronto, Ontario, Canada.
Can J Nurs Res. 2002 Oct;34(3):49-60.
Equipoise, a state of uncertainty about the relative merits of 2 or more treatments or therapeutic approaches, is fundamental to the ethical conduct of clinical research. The degree of uncertainty necessary for ethical conduct of a clinical trial is the subject of ongoing debate. The concept of equipoise has not received sufficient attention from nurse authors. This paper examines the concept of equipoise by drawing on the author's experience with 3 trials of psychosocial interventions in mental health. Arguments for and against using equipoise in the evaluation of ethics of clinical research are summarized. Equipoise may be impossible to achieve in trials of psychosocial treatments with multiple outcomes for patients and relatives. In addition, the need to achieve equipoise may put nurses who provide psychosocial treatments in clinical trials in conflict. In order to provide the best treatment possible, they must believe that what they are doing is in the best interests of their client. Yet, in order to accept randomization, they must, to some extent, relinquish that belief. Case examples are used to examine how discrepancies with respect to the "equipoise status" of researchers, clinicians, and research participants may be problematic in achieving methodologically sound, ethical clinical nursing research.
equipoise是指对两种或更多治疗方法或治疗途径的相对优点存在不确定性的一种状态，它是临床研究伦理行为的基础。进行临床试验的伦理行为所需的不确定程度是一个持续争论的话题。equipoise的概念尚未得到护士作者的充分关注。本文通过借鉴作者在三项心理健康社会心理干预试验中的经验来审视equipoise的概念。总结了在临床研究伦理评估中支持和反对使用equipoise的论据。在针对患者及其亲属有多种结果的社会心理治疗试验中，可能无法实现equipoise。此外，实现equipoise的需求可能会使参与临床试验提供社会心理治疗的护士陷入冲突。为了尽可能提供最佳治疗，他们必须相信自己所做的符合患者的最大利益。然而，为了接受随机分组，他们必须在一定程度上放弃这种信念。通过案例来探讨研究人员、临床医生和研究参与者在“equipoise状态”方面的差异在开展方法合理、符合伦理的临床护理研究中可能会带来哪些问题。
