The critique of evidence-based medicine and the diversification of medical evidence practices

对循证医学的批判和医学证据实践的多样化

• 批准号: 334895556
• 负责人: Professorin Dr. Mariacarla Gadebusch Bondio
• 金额: --
• 依托单位: Institute for Medical Humanities
• 依托单位国家: 德国
• 项目类别: Research Units
• 财政年份: 2017
• 资助国家: 德国
• 起止时间: 2016-12-31 至 2023-12-31
• 项目状态: 已结题
• 来源: https://gepris.dfg.de/gepris/projekt/334895556?language=en
• 关键词: critique; evidence; based; medicine; diversification

In the first phase of the research project, we examined how growing patient participation through digital technologies in the context of personalized medicine influences the production of medical evidence. In this second phase, we intend to investigate the criticisms that have arisen against evidence-based medicine (EBM). After its inception in 1992, EBM has become the dominant paradigm for both clinical research and decision making in clinical practice, thereby forming an evidence regime. However, destabilizing criticisms of EBM have emerged in different contexts over the last three decades and have reached a new high point in the latest years, precipitating the so-called crisis of EBM. Personalized medicine has played an important role in the formation of these criticisms. This project intends to historically reconstruct these phenomena in both the English- and the German-speaking worlds and to analyze their implications for medical ethics and the philosophy of medicine. Satisfying the standards of EBM in research and clinical practice through the adherence to EBM-based guidelines has become a hallmark of quality on which professional success and publication on peer-reviewed scientific journals depend. As a result, EBM has assumed a strong normative dimension. At the same time, evidence is increasingly experienced as a problem in medical specialties in which it is only partially possible to satisfy the EBM requirements. The project aims to examine how this issue has been discussed so far in both the medical and the medical humanities literature and to investigate the evidence practices of specialties in which the traditional evidence hierarchy is not applicable. For instance, how can patients make evidence-based decisions if the relevant evidence is poor and it is not easy to acquire better evidence, as in the case of carriers of mutations to the BRCA1/2 genes? How do surgeons manage to assert the epistemic value of their studies, which are often not randomized? In some domains, like rare diseases, the patients themselves initiate alternative modalities of evidence generation whose product is the so-called “real-world evidence”. However, these complementary forms of evidence are not widely accepted in institutionalized medicine, and look destabilizing to many practitioners. But could real-world evidence contribute to the re-stabilization of EBM? Our research hypothesis is that, with a gradual and specialty-specific modulation of evidence standards, EBM could be bolstered and counter at least some criticisms. The project will involve the context-sensitive analysis of the dynamics of destabilization and potential re-stabilization of medical evidence. This would greatly contribute to an ethical and epistemic examination of alternative evidence production modalities and satisfy an urgent research need.

在研究项目的第一阶段，我们研究了在个性化医学背景下通过数字技术参与的患者参与如何影响医学证据的产生。在第二阶段，我们打算调查针对循证医学（EBM）出现的关键主义。 EBM于1992年成立后，EBM已成为临床实践中临床研究和决策的主要范式，从而形成了证据制度。然而，在过去的三十年中，EBM的不稳定的EBM的稳定已经出现在不同的情况下，并且在最近几年达到了一个新的高点，引发了EBM所谓的危机。个性化医学在这些批评主义的形成中发挥了重要作用。该项目旨在在英语和德语世界中重建这些现象，并分析它们对医学伦理和医学哲学的影响。通过遵守基于EBM的准则，满足研究和临床实践中EBM的标准已成为质量的标志，在同行评审的科学期刊上，专业成功和出版的依赖于该标准。结果，EBM假设了强大的正常维度。同时，作为医学专业的问题，证据越来越多地经验，其中只有部分满足EBM要求。该项目旨在研究到目前为止如何在医学和医学人文文献中讨论这个问题，并调查不适用传统证据层次结构的专业证据实践。例如，如果相关证据很差并且不容易获得更好的证据，那么患者如何做出基于循证的决定，例如对于BRCA1/2基因的突变载体而言？外科医生如何设法断言他们的研究的认知价值，而这些价值通常不是随机的？在某些领域，例如稀有疾病，患者本身启动了替代性的证据产生方式，其产品是所谓的“现实世界证据”。但是，这些互补的证据形式在制度化医学中并未被广泛接受，并且对许多从业人员看上去不稳定。但是，现实世界的证据可以促进EBM的重新稳定吗？我们的研究假设是，通过对证据标准的等级和特殊的调节，EBM可以得到加固，至少对抗一些批评主义。该项目将涉及上下文敏感的分析，对不稳定的动态和医学证据的潜在重新稳定。这将极大地有助于对替代证据生产方式和紧急研究需求满意的道德和认识论检查。