Clinical practice guidelines are now ubiquitous. This article describes the emergence of such guidelines in a way that differs from the two dominant explanations, one focusing on administrative cost-cutting and the other on the need to protect collective professional autonomy. Instead, this article argues that the spread of guidelines represents a new regulation of medical care resulting from a confluence of circumstances that mobilized many different groups. Although the regulation of quality has traditionally been based on the standardization of professional credentials, since the 1960s it has intensified and been supplemented by efforts to standardize the use of medical procedures. This shift is related to the spread of standardization within medicine and especially in research, public health, and large bureaucratic health care organizations.

This study resulted in an overview of strategies to adapt clinical practice guidelines to facilitate shared decision making. Some strategies seemed more contentious than others. Future research should assess the feasibility and impact of these strategies to make clinical practice guidelines more conducive to facilitate shared decision making.

Since the emergence of the Evidence-Based Medicine (EBM) movement, the nature and role of evidence in medicine has been much debated. The formal classification of evidence that is unique to Evidence-Based Medicine, referred to as the Evidence hierarchy, has been fiercely criticized. Yet studies that examine how Evidence is classified in EBM practice are rare. This article presents an observational study of the nature of Evidence and Evidence-Based Medicine as understood and performed in practice. It does this by examining how an absence of Evidence is defined and managed in Evidence-Based Guideline development. The EBM label does not denote the quantity or quality of evidence found, but the specific management of the absence of evidence, requiring a transparently reported process of evidence searching, selection and presentation. I propose the term ‘Evidence Searched Guidelines’ to better capture this specific way of ‘being’ EBM. Moreover, what counts as Evidence depends not just on the Evidence hierarchy, but requires agreement between the members of each guideline development group who mobilize a range of ‘other’ knowledges, such as biological principles and knowledge of the clinic. In addition, I distinguish four non-Evidentiary justifications that are relied upon in the formulation of recommendations (literature, qualified opinions, ethical principles, and practice standards). These are not always secondary to Evidence but may be positioned outside the hierarchy, allowing them to trump Evidence. The legitimacy of Evidence-Based Medicine relies neither on experts nor numbers, but on distinct procedures for handling (non-)Evidence, reflecting its ‘regulatory objectivity’. Finally, the notion of transparency is central for understanding how Evidence-Based Medicine regulates, and is regulated within, contemporary biomedicine.

Evidence-based medicine (EBM), which advocates clinical decisions are based on evidence from medical research, has become an important ideal pursued in contemporary medicine. EBM relies on two key principles: the evidence hierarchy and clinical practice guidelines. Both principles have been fiercely criticized, and critics often invoke the term 'Cookbook medicine' to stress the dangers and limitations of EBM. This article reviews diverse critical literature on EBM by drawing on the newly proposed subfield of "Sociology of Standards." It reframes the manifold critiques on EBM as concerns over the harm that standardization can bring about and demonstrates how empirical sociological studies have contributed to a better understanding of EBM's justificatory basis and regulatory impact. First, it discusses the 'politics of Evidence' inherent in EBM's epistemological basis, secondly, explores the actual 'evidence-base' of its tools in practice, and third, addresses sociological debates on EBM's regulatory impact. In the concluding section, I argue that a 'Sociology of Standards' opens up new research avenues by allowing scholars to challenge -or at least empirically investigate -a host of dichotomies. By doing so, the role of the patient in EBM can be reframed to allow for more productive empirical investigations.

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