Soucacos Panayotis N, Johnson Elizabeth O, Babis George
Department of Orthopaedic Surgery, University of Athens, School of Medicine, K.A.T Accident Hospital, Athens, Greece.
Injury. 2008 Jun;39(6):636-42. doi: 10.1016/j.injury.2008.02.011.
There is a growing consensus that randomised controlled clinical trial (RCT) provide a secure basis for determining treatment effects. Prospective randomised clinical trials can be a powerful tool in medical science and evidence-based medicine. A well-defined study hypothesis, with a prospectively applied study design, blinded and randomised treatment allocation and assessment, with appropriate control groups can provide strong evidence in support of treatment decisions. However, the recent reviews of the medical literature indicate that the study design itself does not ensure the quality of science or useful and valid scientific data. Thus, regardless of the study design or level of evidence, it remains imperative for the physician and surgeon to critically evaluate a scientific report. Moreover, as randomisation, concealment of treatment allocation and blinding are difficult issues to resolve in orthopaedic surgery, future trials should focus on detailed and correct reporting of outcome measures.
越来越多的人达成共识，即随机对照临床试验（RCT）为确定治疗效果提供了可靠依据。前瞻性随机临床试验可以成为医学科学和循证医学中的有力工具。一个明确界定的研究假设，采用前瞻性应用的研究设计、盲法和随机治疗分配与评估，并设有适当的对照组，可以为支持治疗决策提供有力证据。然而，最近对医学文献的综述表明，研究设计本身并不能确保科学质量或有用且有效的科学数据。因此，无论研究设计或证据水平如何，医生和外科医生批判性地评估一份科学报告仍然至关重要。此外，由于随机化、治疗分配的隐匿和盲法在骨科手术中是难以解决的问题，未来的试验应侧重于详细且正确地报告结局指标。
