Bower E, McLellan D L
University of Southampton, Rehabilitation Research Unit, UK.
Child Care Health Dev. 1994 Nov-Dec;20(6):409-19. doi: 10.1111/j.1365-2214.1994.tb00402.x.
The optimal design for most clinical trials of treatment is the randomized controlled group trial. This methodology is not, however, uniformly applicable or appropriate. The evaluation of physiotherapy in the management of cerebral palsy in childhood is a good example of treatment for which modification of this trial design is needed. Some of the problems with eight studies in this field published between 1960 and 1993 are reviewed here and an alternative approach proposed. A representative series of single case studies with individual goal setting and a validated outcome measurement, using randomized treatment, would overcome many of the disadvantages of published studies at a greatly reduced cost. The results would enable more effective group trials to be mounted in due course to evaluate the probable impact of providing treatment to a defined population of subjects.
大多数治疗性临床试验的最佳设计是随机对照分组试验。然而，这种方法并非普遍适用或合适。儿童脑瘫治疗中物理治疗的评估就是一个需要对这种试验设计进行调整的治疗实例。本文回顾了1960年至1993年间该领域发表的八项研究中存在的一些问题，并提出了一种替代方法。一系列具有代表性的单病例研究，采用随机治疗，设定个体目标并进行经过验证的结果测量，将以大幅降低的成本克服已发表研究的许多缺点。这些结果将使在适当的时候能够开展更有效的分组试验，以评估为特定受试者群体提供治疗可能产生的影响。
