Evaluating the role of expertise-based trial designs in trials of surgical interventions

随机对照试验(RCT)通过与标准治疗相比较，能够准确地评估新的治疗方法，在促进医疗保健方面发挥了非常重要的作用。外科领域使用随机对照试验的速度一般要慢于医学领域。如何进行这样的研究有不同的选择。常规参与的外科医生被期望在评估中执行这两种治疗方法。另一种方法是要求参与手术的医生进行他们最满意的干预。这被称为基于专业知识的方法。从外科医生的角度来看，这是有吸引力的，尽管这样的方法确实带来了一些科学(这样的研究可能需要更大规模)和实际挑战(组织相应的专业外科医生可用)。这项研究的目的是评估不同方法的相对优点，特别是在从实践和科学的角度来看都更可取的基于专门知识的方法的情况下。

Randomised Controlled Trials (RCTs) have played a very important role in advancing health care by allowing accurate assessment of a new treatment by comparison with a standard treatment. The field of surgery has been slower to use RCTs than medicine in general. Different options for how to run such studies exist. Conventionally participating surgeons have been expected to perform both treatments under assessment. An alternative approach is to require a participating surgeon to perform the intervention they are most comfortable with. This has been called an expertise-based approach. This is attractive from a surgeon‘s perspective though such an approach does raise some scientific (such a study may need to be larger) and practical challenges (organising corresponding expertise surgeons to be available). The aim of this research is to evaluate the relative merit of the different approaches and specifically, in which circumstances is an expertise-based approach preferable from both a practical and scientific perspective.