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疗的背景下，通过数字技术不断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）的批评。循证医学自1992年问世以来，已成为临床研究和临床决策的主导范式，形成了一个证据体系。然而，在过去的三十年里，对循证医学的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，加速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。该项目旨在历史上重建这些现象在英语和德语世界，并分析其对医学伦理学和医学哲学的影响。通过遵守基于循证医学的指南，在研究和临床实践中满足循证医学的标准，已成为专业成功和在同行评审的科学期刊上发表文章所依赖的质量标志。因此，循证管理具有很强的规范性。与此同时，证据越来越多地被认为是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。该项目的目的是研究如何这个问题已经讨论到目前为止，在医学和医学人文文献，并调查证据的专业实践中，传统的证据等级是不适用的。例如，如果相关证据不足，不容易获得更好的证据，例如BRCA 1/2基因突变携带者，患者如何进行循证决策？外科医生如何设法维护他们的研究的认识价值，而这些研究往往不是随机的？在某些领域，如罕见疾病，患者自己启动了证据生成的替代模式，其产品是所谓的“真实世界证据”。然而，这些补充形式的证据在制度化医学中并没有被广泛接受，并且对许多从业者来说看起来不稳定。但是，现实世界的证据是否有助于EBM的重新稳定？我们的研究假设是，随着证据标准的逐步和专业特定的调制，循证医学可以得到支持，并反驳至少一些批评。该项目将涉及对医疗证据的不稳定和可能重新稳定的动态进行有背景的分析。这将极大地有助于对替代证据制作方式进行道德和认识上的审查，并满足紧迫的研究需求。