Health Sciences Department, Worcester State University, Worcester, Massachusetts.
Department of Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts.
Ann Surg. 2021 Dec 1;274(6):e616-e624. doi: 10.1097/SLA.0000000000003631.
Despite persistent critiques of the rigor of surgical research, surgeons have actually pursued careful empirical studies for centuries. Their work has enriched not only surgical science but also the development of evidencebased medicine. From conducting landmark controlled trials, to using statistics, alternate patient allocation, randomization, and sham controls, surgeons have long embraced innovative trial approaches and played important roles in the development of key methods of RCTs. However, historical contexts unique to surgery have shaped the implementation of RCTs in this field. Unlike the history of pharmaceuticals, in which substantial research funding has been devoted to testing new drugs before their approval, surgical trials have followed a different trajectory. New operations have repeatedly come into wide use in the absence of RCTs. On many occasions, when established procedures have become controversial, surgeons have then marshaled the resources to conduct RCTs reassessing the operations. Such trials have triggered powerful debates in which proponents of surgical RCTs battled against ingrained practices and preferences. In such cases, RCTs often were not decisive factors in determining the fate of surgical practices but supporting tools that followed and reflected changes in surgical judgment already underway. Surgical trialists also have encountered specific, recurring challenges, especially with the methodological and ethical complexity of blinded and sham-controlled trials. The history of surgical trials thus reveals major contributions from surgeons to the advancement of evidence-based medicine, as well as ongoing challenges. Strengthened and systematic trial support could advance the future of surgical RCTs.
尽管人们一直批评外科研究的严谨性，但外科医生实际上几个世纪以来一直在进行精心的实证研究。他们的工作不仅丰富了外科学，也为循证医学的发展做出了贡献。从进行具有里程碑意义的对照试验，到使用统计学、替代患者分配、随机化和假对照，外科医生长期以来一直采用创新的试验方法，并在外科 RCT 关键方法的发展中发挥了重要作用。然而，外科领域独特的历史背景塑造了 RCT 在该领域的实施。与药物历史不同，在药物获得批准之前，大量的研究资金都用于测试新药，外科试验遵循了不同的轨迹。新的手术在没有 RCT 的情况下反复被广泛应用。在许多情况下，当既定的手术程序引起争议时，外科医生会调动资源进行 RCT，重新评估这些手术。此类试验引发了激烈的辩论，支持外科 RCT 的人反对根深蒂固的做法和偏好。在这种情况下，RCT 通常不是决定外科手术实践命运的决定性因素，而是支持已经在进行的外科判断变化的工具。外科试验人员还遇到了具体的、反复出现的挑战，尤其是在盲法和假对照试验的方法学和伦理复杂性方面。外科试验的历史因此揭示了外科医生对循证医学发展的重大贡献，以及持续存在的挑战。加强和系统的试验支持可以促进未来外科 RCT 的发展。
