Buchwald H
Department of Surgery, University of Minnesota, Minneapolis 55455, USA.
Control Clin Trials. 1997 Dec;18(6):478-87. doi: 10.1016/s0197-2456(96)00114-6.
This paper is a personal essay that starts and ends with the message that surgical procedures and devices should be evaluated in the same way as medical therapies, namely, by randomized clinical trials (RCTs). I discuss, with particular attention to surgical procedures and devices, the objections raised against RCTs in medical decision-making, a schema for utilizing the traditional phases of RCTs in the evaluation of surgical procedures and devices, the importance of RCTs to FDA approval, financial compensation, and health care costs, the impact of RCTs on clinical practice, the role of RCTs in academia, teaching, and research, and the surgeon's obligation to participate in a leadership role in RCTs. The belief is expressed that national funding of health care should mandate allocations for RCTs and that such expenditures, as well as the spending of health care dollars on the basis of the outcomes of such trials, will not only improve patient management in the shortest time but will eventually reduce health care costs. The RCT, by selecting effective and safe surgical procedures and devices, as well as diets and drugs, is the best means science has to assess the validity of patient management.
本文是一篇个人随笔，开篇和结尾都传达了这样一个信息：外科手术和器械应与药物治疗一样，通过随机临床试验（RCT）进行评估。我特别针对外科手术和器械，讨论了在医疗决策中对RCT提出的反对意见、在评估外科手术和器械时利用RCT传统阶段的方案、RCT对美国食品药品监督管理局（FDA）批准、经济补偿和医疗成本的重要性、RCT对临床实践的影响、RCT在学术界、教学和研究中的作用，以及外科医生在RCT中发挥领导作用的义务。文中表达了这样一种观点，即国家医疗保健资金应规定为RCT拨款，并且此类支出以及基于此类试验结果的医疗保健资金支出，不仅将在最短时间内改善患者管理，最终还将降低医疗成本。通过选择有效且安全的外科手术和器械以及饮食和药物，RCT是科学评估患者管理有效性的最佳手段。
