A consensus regarding the therapeutic role of lymphadenectomy in endometrial cancer has not been reached because of conflicting negative results of randomized controlled trials and positive results of a cohort study. Since the effects of new treatments tend to be overestimated in observational studies, positive results of an observational study should be validated by a future trial. However, special difficulties are presented in randomized controlled trials in surgery. External validity is important for guaranteeing the reliability of a result of the trial. Physicians' recruitment of eligible patients into a trial depends on the confidence of those physicians for a surgical procedure, workplace environment and feelings of personal responsibility relevant to patients' risk of recurrence. When two surgical procedures are compared in a randomized controlled trial, technical quality control may be reduced in the complicated surgery group due to experienced surgeons' non-participation. It is highly possible that the recruitment issue is a threat to external validity. Therefore, a randomized controlled trial may not be the best format for demonstrating the full benefits of complicated surgery. Multiple studies have demonstrated that the results of well-designed observational studies can be reliable and are comparable with those of randomized controlled trials. Journal editors and funding sources are requested to become more generous with observational studies, especially prospective cohort studies.

译文

由于随机对照试验的阴性结果与队列研究的阳性结果相互矛盾,因此尚未就淋巴结清扫术在子宫内膜癌中的治疗作用达成共识。由于在观察性研究中往往高估了新疗法的效果,因此观察性研究的阳性结果应通过未来的试验来验证。然而,在外科手术的随机对照试验中存在特殊困难。外部有效性对于保证试验结果的可靠性很重要。医生是否招募合格的患者参加试验取决于这些医生对外科手术,工作场所环境以及与患者复发风险相关的个人责任感的信心。在随机对照试验中比较两种手术方法时,由于经验丰富的外科医生不参与,复杂手术组的技术质量控制可能会降低。招聘问题很有可能威胁到外部有效性。因此,随机对照试验可能不是证明复杂手术的全部益处的最佳形式。多项研究表明,精心设计的观察性研究的结果是可靠的,并且与随机对照试验的结果相当。要求期刊编辑和资金来源对观察性研究,尤其是前瞻性队列研究更加慷慨。

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