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背景下通过数字技术增加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）的批评。自1992年诞生以来，EBM已成为临床研究和临床实践决策的主导范式，从而形成了证据制度。然而，过去三十年来，对循证医学的不稳定批评在不同背景下出现，并在最近几年达到新的高点，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。该项目旨在历史性地重建英语和德语世界中的这些现象，并分析它们对医学伦理和医学哲学的影响。通过遵守基于 EBM 的指南来满足研究和临床实践中的 EBM 标准已成为专业成功和同行评审科学期刊上发表所依赖的质量标志。因此，EBM 具有很强的规范性。与此同时，证据越来越成为医学专业中的一个问题，在这些专业中，证据只能部分满足 EBM 要求。该项目旨在研究迄今为止在医学和医学人文文献中如何讨论这个问题，并调查传统证据层次不适用的专业的证据实践。例如，对于BRCA1/2基因突变携带者来说，如果相关证据较差且不易获得更好的证据，患者如何做出基于证据的决定？外科医生如何设法断言他们的研究的认知价值，这些研究通常不是随机的？在某些领域，例如罕见疾病，患者自己启动证据生成的替代方式，其产品就是所谓的“现实世界证据”。然而，这些补充形式的证据并未在制度化医学中得到广泛接受，并且对许多从业者来说似乎不稳定。但现实世界的证据能否有助于 EBM 的重新稳定？我们的研究假设是，通过逐步且针对特定专业的证据标准调整，循证医学可以得到支持并至少反击一些批评。该项目将涉及对医学证据不稳定和潜在重新稳定的动态进行上下文敏感分析。这将极大地有助于对替代证据生产方式进行伦理和认识论审查，并满足紧迫的研究需求。