Bajammal Sohail, Dahm Philipp, Scarpero Harriette M, Orovan William, Bhandari Mohit
Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
J Urol. 2008 Nov;180(5):1904-11. doi: 10.1016/j.juro.2008.07.026. Epub 2008 Sep 17.
Most surgical interventions have inherent benefits and associated risks. Before implementing a new therapy we should ascertain the benefits and risks of the therapy and assure ourselves that the resources consumed in the intervention will not be exorbitant.
We suggest a 3-step approach to using an article from the urological literature to guide patient care. We recommend asking whether the study can provide valid results, reviewing the results and considering how the results can be applied to patient care.
Key methodological characteristics that have an impact on the validity of a surgical trial include randomization, allocation concealment, stratification, blinding, completeness of followup and intent to treat analysis. To the extent that the quality is poor inferences from this study are weakened. However, if its quality is acceptable, one must determine the range within which the true treatment effect lies (95% CI). One must then consider whether this result can be generalized to a patient and whether the investigators have provided information about all clinically important outcomes. It is then necessary to compare the relative benefits of the intervention with its risks. If one perceives that the benefits outweigh the risks, the intervention may be of use to the patient.
Given the time constraints of busy urological practices and training programs, applying this analysis to every relevant article would be challenging. However, the basics of this process are essentially what we all do hundreds of times each week when treating patients. Making this process explicit with guidelines to assess the strength of the available evidence will serve to improve patient care. It will also allow us to defend therapeutic interventions based on available evidence and not on anecdote.
大多数外科手术都有其固有的益处和相关风险。在实施一种新疗法之前,我们应该确定该疗法的益处和风险,并确保我们自己相信该干预措施所消耗的资源不会过高。
我们建议采用一种三步法,利用泌尿外科文献中的一篇文章来指导患者护理。我们建议询问该研究是否能提供有效的结果,审查结果,并考虑如何将结果应用于患者护理。
对手术试验有效性有影响的关键方法学特征包括随机化、分配隐藏、分层、盲法、随访完整性和意向性分析。该研究的质量越差,由此得出的推论就越弱。然而,如果其质量是可接受的,就必须确定真实治疗效果所在的范围(95%可信区间)。然后必须考虑这个结果是否可以推广到某个患者,以及研究者是否提供了所有临床重要结局的信息。接着有必要比较该干预措施的相对益处与其风险。如果有人认为益处大于风险,那么该干预措施可能对患者有用。
鉴于繁忙的泌尿外科临床实践和培训项目的时间限制,将这种分析应用于每一篇相关文章将具有挑战性。然而,这个过程的基本要点本质上就是我们每周在治疗患者时都会做数百次的事情。通过制定评估现有证据强度的指南来明确这个过程,将有助于改善患者护理。这也将使我们能够基于现有证据而不是轶事来为治疗干预措施辩护。