Abraham Ned S
Coffs Harbour Health Campus, The Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.
ANZ J Surg. 2006 Sep;76(9):855-60. doi: 10.1111/j.1445-2197.2006.03879.x.
Exponents of evidence-based medicine do not undermine the importance of clinical expertise and skills, but they emphasize that decision-making in medicine should be based on the best available evidence derived from the systematic analysis of observations made in an objective, unbiased and a reproducible fashion. The randomized controlled trial (RCT) is the most scientifically rigorous means of hypothesis testing in epidemiology. Discrepancies between established surgical and other interventions and best available evidence are common. These can be in the form of significant delay in adopting a new intervention despite strong supportive evidence, adopting an intervention before supportive evidence becomes available for reasons of novelty or pear pressure and the lack of supportive evidence for many established common practices. This is compounded further by the paucity of good quality evidence for most surgical procedures. This is arguably because of the inherent difficulties in conducting surgical RCT. The practical, ethical and financial ramifications are complex and the nature of surgical disease often compromise the chances of success or completion of RCT. Carrying out surgical RCT may have more implications on the clinician's authority, autonomy and income and their results are more likely to be influenced by his/her expertise and competence than medical RCT. Furthermore, the success of surgical RCT is often jeopardized by very low recruitment rates. The aim of this study is to discuss the dilemma of producing evidence in surgery.
循证医学的支持者并不否定临床专业知识和技能的重要性,但他们强调医学决策应基于以客观、无偏见且可重复的方式对观察结果进行系统分析得出的最佳现有证据。随机对照试验(RCT)是流行病学中检验假设最科学严谨的方法。既定的外科手术及其他干预措施与最佳现有证据之间存在差异是常见的。这些差异可能表现为:尽管有强有力的支持证据,但采用新干预措施却出现显著延迟;因新奇性或同行压力,在支持性证据尚未可得时就采用某种干预措施;以及许多既定的常见做法缺乏支持性证据。大多数外科手术高质量证据的匮乏使这种情况更加复杂。这可以说是由于进行外科随机对照试验存在固有困难。实际、伦理和财务方面的影响很复杂,而且外科疾病的性质常常会影响随机对照试验成功或完成的几率。开展外科随机对照试验可能对临床医生的权威、自主性和收入有更多影响,而且其结果比医学随机对照试验更有可能受到临床医生专业知识和能力的影响。此外,外科随机对照试验的成功率常常因招募率极低而受到危及。本研究的目的是探讨外科手术中产生证据的困境。