Cleveland Clinic Lerner School of Medicine, Case Western Reserve University, Cleveland, Ohio, USA.
Curr Opin Support Palliat Care. 2012 Dec;6(4):483-9. doi: 10.1097/SPC.0b013e32835843d7.
This review describes the advances in trial methodology and presents new methodologies to meet some of the challenges of conducting trials in a palliative care setting. To describe why this review is timely and relevant.
This review discusses the process required to conduct trials of complex interventions described by the Britain's Medical Research Council. It discusses the importance of feasibility trials and the quantitative research inherent in these trials. It describes the design alternatives to the classic randomized controlled trials (RCTs), including cluster randomization, step wedge and fast-track randomization, and n-of-1 trial design. The strengths and weaknesses of each are described.
An understanding of the limitations of RCTs is important. It is important that clinicians and researchers understand the need for alternative trial design and how and when to use them.
本文描述了试验方法学的进展,并提出了新的方法学来应对在姑息治疗环境中进行试验的一些挑战。以说明为什么这篇综述是及时和相关的。
本文讨论了英国医学研究理事会(Medical Research Council)所描述的复杂干预措施进行试验所需的过程。它讨论了可行性试验的重要性以及这些试验中固有的定量研究。它描述了经典随机对照试验(RCT)的替代设计,包括集群随机化、逐步楔形和快速随机化以及 n-of-1 试验设计。并描述了每种设计的优缺点。
了解 RCT 的局限性很重要。临床医生和研究人员必须了解替代试验设计的必要性以及如何以及何时使用这些设计。