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The 'hierarchy of evidence' and the structure of medical research: Implications for evidence-based medicine.

机译：“证据的层次结构”和医学研究的结构：对循证医学的启示。

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摘要

Evidence-based medicine (EBM) has been defined as "the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients" (Sackett et al., 1996). EBM has had great influence, particularly on the development of "secondary resources" that summarize the medical literature in order to make it more readily available to practicing clinicians. These secondary resources are based on the idea that there is a "hierarchy of evidence" so that the higher on this hierarchy a study ranks, the stronger the evidence it provides. At the top of the hierarchy is the randomized controlled trial (RCT). It is the central contention of this thesis that, while RCTs may in many cases be necessary tests of the efficacy and safety of a treatment, they are far from sufficient. Moreover, I argue that the hierarchy of evidence should be replaced by a view of evidence that (1) classifies population-level (or epidemiological) studies on a variety of methodological criteria, rather than solely on whether or not the study subjects were randomly assigned to their study groups and (2) is sensitive to the potential of variation within study groups to affect the results of a study, as well as to the need to identify demographic or physiological differences associated with these differences in clinical outcome. In making my case for the need for a richer view of medical evidence than that currently provided by EBM, I draw on research in philosophy of science. In particular, I use Nancy Cartwright's concept of a nomological machine to show that (and why) the results of RCTs cannot easily be extrapolated to a broader clinical context, and I build on recent work on the importance of mechanisms in science to illustrate the close relationship between epidemiological research (including RCTs) and laboratory studies. Based on these arguments, I sketch an alternative approach to the nature of medical research that I argue is superior to EBM's hierarchy of evidence for both epistemological and ethical reasons. Finally, I consider the implications of my proposed alternative for the way in which secondary resources should be compiled.
机译：循证医学（EBM）被定义为“在做出有关个别患者护理决策时认真，明确和明智地使用当前最佳证据”（Sackett等，1996）。 EBM产生了巨大的影响，特别是在总结医学文献的“二次资源”的发展上，以使临床医生更容易获得。这些辅助资源基于“证据层次”的思想，因此研究在此层次上排名越高，它提供的证据就越强。层次结构的顶部是随机对照试验（RCT）。本论文的中心论点是，尽管在许多情况下RCT可能是治疗有效性和安全性的必要测试，但远远不够。此外，我认为证据等级应替换为以下观点的证据：（1）根据各种方法学标准对人群水平（或流行病学）研究进行分类，而不是仅根据是否随机分配研究对象（2）对研究组内部变异影响研究结果的潜力以及识别与这些临床结果差异相关的人口统计学或生理学差异的需求敏感。在论证需要比EBM目前提供的医学证据更为丰富的观点时，我借鉴了科学哲学方面的研究。特别是，我使用南希·卡特赖特（Nancy Cartwright）的法理学机器概念来证明，（以及为什么）不能轻易将RCT的结果推论到更广泛的临床环境中，并且我以最近关于科学机制重要性的研究为基础来阐明流行病学研究（包括RCT）与实验室研究之间的关系。基于这些论点，我提出了一种医学研究性质的替代方法，出于认识论和伦理的原因，我认为该方法优于EBM的证据层次。最后，我考虑了我建议的替代方案对于应如何编译辅助资源的含义。

著录项

  • 作者

    Bluhm, Robyn L.;

  • 作者单位

    The University of Western Ontario (Canada).;

  • 授予单位 The University of Western Ontario (Canada).;
  • 学科 Philosophy.
  • 学位 Ph.D.
  • 年度 2005
  • 页码 152 p.
  • 总页数 152
  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类 哲学理论;
  • 关键词

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