Sancho-Garnier H, Benhamou E, Avril M F, Chassagne D, Petit J Y, Prade M
Rev Epidemiol Sante Publique. 1984;32(3-4):249-53.
A clinical trial is generally defined by a comparison of two or more treatments. This definition encloses two radically different viewpoints: problems of knowledge (explanatory approach) and problems of decision (pragmatic approach). The pragmatic approach is still not used very often; we describe a clinical trial using this approach in order to discuss its advantages and drawbacks; the trial compares radiotherapy and surgery in basal cell carcinoma of the skin. These two techniques are likely to give similar carcinological results, so that the therapeutic decision will have to take into account other criteria such as the aesthetic factor, the fonction and the cost not only in terms of money but also in terms of the psychological burden of the treatment, as side effects, etc. The choice of the weights to be attributed to these various criteria raises a problem, especially since the results of the trial may be different when varying the weights. This prompts a discussion of the possibility of extrapolating the therapeutic choice after the trial.
临床试验通常定义为两种或更多治疗方法的比较。这一定义包含了两种截然不同的观点:知识问题(解释性方法)和决策问题(实用性方法)。实用性方法的使用频率仍然不高;我们描述了一项采用这种方法的临床试验,以讨论其优缺点;该试验比较了皮肤基底细胞癌的放射治疗和手术治疗。这两种技术可能会产生相似的肿瘤学结果,因此治疗决策将不得不考虑其他标准,如美学因素、功能以及不仅在金钱方面而且在治疗的心理负担(如副作用等)方面的成本。如何为这些不同标准赋予权重是个问题,特别是因为改变权重时试验结果可能会有所不同。这引发了关于在试验后推断治疗选择可能性的讨论。