Social Studies of Medicine, McGill University, 3647 Peel Street, Montreal, Quebec, H3A 1X1, Canada.
Soc Sci Med. 2010 Aug;71(4):685-92. doi: 10.1016/j.socscimed.2010.05.019. Epub 2010 Jun 4.
Both critics and supporters of evidence-based medicine view clinical practice guidelines as an important component of this self-defined "new paradigm" whose goal is to rationalize medicine by grounding clinical decision-making in a careful assessment of the medical literature. We present an analysis of the debates within a guideline development group (GDG) that led to the drafting, revision and publication of a French cancer guideline. Our ethnographic approach focuses on the various aspects of the dispositif (or apparatus) that defines the nature and roles of participants, procedures, topics and resources within the GDG. Debates between GDG members are framed (but not dictated) by procedural and methodological rules as well as by the reflexive critical contributions of the GDG members themselves, who justify their (tentative) recommendations by relating to its (possible or intended) audiences. Guideline production work cannot be reduced to an exchange of arguments and to consensus-seeking between pre-defined professional interests. It is about the production of a text in the material sense of the term, i.e. as a set of sentences, paragraphs, statements and formulations that GDG members constantly readjust and rearrange until closure is achieved. As such, guidelines partake in the emergence and stabilization of a new configuration of biomedical knowledge and practices grounded in the establishment of mutually constitutive links between two processes: on the one hand, the re-formatting of clinical trials into a device for producing carefully monitored evidence statements targeting specific populations and clinical indications and, on the other hand, the increasingly pervasive role of regulatory processes.
无论是循证医学的批评者还是支持者,都将临床实践指南视为其自我定义的“新模式”的一个重要组成部分,其目标是通过在仔细评估医学文献的基础上为临床决策提供依据,从而使医学合理化。我们对一个指南制定小组(GDG)内部的辩论进行了分析,这些辩论导致了一份法国癌症指南的起草、修订和出版。我们的人种学方法侧重于定义小组成员、程序、主题和资源性质和角色的装置(或仪器)的各个方面。GDG 成员之间的辩论受到程序和方法规则以及 GDG 成员自身的反思性批判性贡献的框架(但不是规定),他们通过与可能或预期的受众相关联来证明他们(暂定)建议的合理性。指南制定工作不能简化为在预先定义的专业利益之间进行论点交流和寻求共识。它涉及到术语意义上的文本的生产,即一系列句子、段落、陈述和表述,GDG 成员不断对其进行调整和重新安排,直到达到最终结果。因此,指南参与了基于两个过程之间相互构成的联系的新的生物医学知识和实践配置的出现和稳定化:一方面,将临床试验重新格式化为用于针对特定人群和临床适应症生成精心监测的证据陈述的设备,另一方面,监管过程的作用越来越普遍。