INTRODUCTION

This chapter presents the existing scholarship which engages with medical guidelines. The issues the literature presents are discussed with the aim of presenting the field of study. It is important to connect the research featured here with literature from different disciplines to allow for a broad analysis of the development of medical practice guidelines in a comparative perspective. The literature that is instrumental in understanding the process of development of medical guidelines can be positioned under four broad categories: evidence, regulation, institutions and group decision making.

An important element here is an engagement with the notion of evidence. Evidence is used in the medical field in a specific technical sense. It is understood to refer to a body of knowledge; not just (medical) knowledge but knowledge that conforms to standards in the methods that were used to create it. This is important for understanding the development of evidence-based medical guidelines because those responsible for drafting the guidelines will be influenced by their conception of evidence. This influence comes in at least three ways: a conception of what evidence is informs what drafters see as informing a guideline; it shapes their understanding of the process of making a guideline; and it influences their ideas about what constitutes a good guideline. The debates in the literature about what counts as evidence, the process of using evidence and measures of success in drafting guidelines will be explored.

Regulatory literature is a second source of information that helps to understand the drivers and the processes that influence the development of medical guidelines. It will be argued that guidelines are not just forms of advice which can be easily ignored, but rather they are regulatory tools used by professionals for two distinct purposes: to ward off the influence of the state on the profession; and to influence other professionals and steer the quality of their practice of medicine. The regulatory literature provides interesting theories and debates on the nature of self-regulation by professionals; this book will be positioned as a contribution to a better understanding of these aspects of the regulatory state.

At least in theory, the work of a guideline group, purports to be independent. An essential aspect of the development of guidelines can be explained by specific features of its institutional embedding within a guideline-making organisation.