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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Clinical practice guidelines have been critiqued for prescribing standardized care that neglects patients' personal circumstances and knowledge in health care decisions. To make care more patient centred, standard-setters are urged to involve patients and the public in guideline development and use. Despite widespread principled support for such Patient and Public Involvement (PPI), the underlying principles guiding PPI in standardization of care are mired on confusion and contradiction. Based on the PPI literature in general, and informed by empirical research on guideline development, it is possible to identify three rationales that justify PPI in clinical standard setting. Each rationale gives rise to a conceptual model which outlines a distinct purpose of participation, who is to be included, and what they are expected to contribute. The Consumer Choice model aims to involve autonomous consumers to personalize clinical care. The Democratic Voice model aims for health care recommendations to better reflect collective values of citizens. The Lay Expertise model aims to re-contextualize universal evidence by including experiential patient knowledge. However, these models can and should not function as 'Gold Standards' to be consistently followed in practice. First, the models rely on two distinct types of representation, resulting in contradictory notions of how to be a good representative. Second, imposing models on practice requires a top-down control that is practically and politically problematic. Not only is control difficult to achieve, it may compromise the participatory ideal of participants co-determine practice, and may result in excluding the values and views of 'real' patients and public entirely.