van der Linden W
Acta Chir Scand. 1980;146(4):229-34.
The generalization of trial results is based on assumptions regarding the distribution of the unknown disease factors affecting the outcome of the treatment. To minimize the uncertainty which this implies, trials should have rigorous entry requirements and as few exclusions as possible. In surgical trials this cannot be achieved with the design at present in use, in which each surgeon performs the operations to be compared in a random order. The reason is that exclusions are an integral part of this design. Neither can it be achieved by keeping deviants from protocol in the groups to which they are randomized. A different design is therefore proposed. In this design the patients are randomly allocated to two groups of surgeons who perform their operation of choice.
试验结果的推广基于有关影响治疗结果的未知疾病因素分布的假设。为了尽量减少由此带来的不确定性，试验应具备严格的入选标准且尽可能减少排除情况。在外科试验中，目前使用的设计无法做到这一点，即每位外科医生以随机顺序进行待比较的手术。原因在于排除是该设计不可或缺的一部分。将偏离方案的患者留在其被随机分配的组中也无法做到这一点。因此，提出了一种不同的设计。在这种设计中，患者被随机分配到两组外科医生中，由他们进行各自选择的手术。
