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

在研究项目的第一阶段，我们研究了在个性化医疗背景下，通过数字技术日益增长的患者参与如何影响医学证据的产生。在第二阶段，我们打算调查对循证医学（EBM）提出的批评。自1992年成立以来，循证医学已经成为临床研究和临床实践决策的主导范式，从而形成了一个证据体系。然而，在过去的三十年中，对循证医学不稳定的批评在不同的背景下出现，并在最近几年达到了一个新的高点，从而引发了所谓的循证医学危机。个性化医疗在这些批评的形成中发挥了重要作用。本项目旨在从历史上重建英语和德语世界的这些现象，并分析它们对医学伦理和医学哲学的影响。通过遵守循证医学指南，在研究和临床实践中满足循证医学的标准，已经成为职业成功和在同行评议的科学期刊上发表论文所依赖的质量标志。因此，循证医学具有很强的规范性维度。与此同时，证据越来越成为医学专业的一个问题，在这些专业中，只有部分可能满足循证医学的要求。该项目旨在研究迄今为止在医学和医学人文文献中是如何讨论这个问题的，并调查传统证据层次不适用的专业的证据实践。例如，如果相关证据不足且不易获得更好的证据，例如BRCA1/2基因突变携带者，患者如何做出循证决策？外科医生是如何维护他们的研究的认知价值的，这些研究往往不是随机的？在某些领域，如罕见疾病，患者自己发起了证据生成的替代方式，其产品是所谓的“真实世界的证据”。然而，这些补充形式的证据在制度化的医学中没有被广泛接受，并且对许多从业者来说看起来不稳定。但是，真实世界的证据会有助于EBM的重新稳定吗？我们的研究假设是，随着证据标准的逐步和特定的调整，EBM可以得到支持，并至少反驳一些批评。该项目将涉及根据具体情况对医疗证据不稳定的动态和可能的重新稳定进行分析。这将极大地有助于对替代证据生产方式进行伦理和认识上的审查，并满足迫切的研究需要。

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.