In search of standards that avoid standardization: the production and regulation of evidence based guidelines

This dissertation examines a novel type of standardization in medicine by investigating the production and regulation of clinical practice guidelines. As an important tool of the Evidence Based Medicine (EBM) movement, guidelines have been at the center of polarized debates in which they are praised for rationalizing medicine and criticized for undermining humanism in health care. Based on document analysis, interviews and (participant) observation, this dissertation examines how 'evidence based' guideline developers respond to such contradictory demands and critiques. In doing so, I present an empirical examination of the way EBM practices construct, avoid or reconcile tensions between supposed binaries such as universal/local, evidence/values, standards/individuality, science/care. After the introduction and a review of the existing literature on the epistemological basis and regulatory impact of EBM guidelines, the findings are presented in two parts. The first part analyzes how formal EBM principles are understood and performed during guideline production, with Chapter three highlighting the diversity of knowledge, procedures and materials required to classify Evidence and formulate the guideline text. Chapter four analyzes how an absence of Evidence is handled and proposes the term 'Evidence Searched Guidelines' to capture the distinctive character of EBM guidelines. The second part focuses on 'guidelines for guidelines' that regulate guideline development. Chapter five presents the Guidelines International Network, which aims for a 'universal' procedure for standard-setting, but objects to the standardization of guidelines. Chapter six presents four models of Patient & Public Involvement that aim to integrate evidence with 'values' and 'context', making guidelines more personalized, democratic, locally relevant and/or objective. In aiming for Gold Standards that avoid standardization, EBM guideline developers challenge the accounts of EBM proponents and critics alike. The contested relation between the standardized (or universal) and the individualized (or local) at the heart of Evidence Based Medicine is managed not by the quantity, quality or universality of evidence, but by standardization of procedures.Cette thèse étudie la production et la réglementation des lignes directrices pour la pratique clinique, afin d'examiner un type de standardisation médicale novateur. Servant d'outil important dans le mouvement de la médecine basée sur les données probantes (Evidence Based Medicine ou EBM), les lignes directrices ont été au centre de débats polarisés dans lesquels on fait l'éloge d'elles pour avoir rationalisées la médecine et on les critique d'avoir minées l'humanisme dans les soins de santé. Basée sur l'analyse de documents, des interviews et l'observation (participative), cette thèse examine comment les développeurs des lignes directrices répondent aux telles demandes et critiques contradictoires. Ce faisant, je présente un examen empirique des façons que les pratiques de la EBM construisent, évitent et réconcilient les tensions entre de présumés binaires, tels universel/local, données probantes/valeurs, standards/individualité et sciences/soins. Après l'introduction et l'analyse de la littérature existante sur les bases épistémologiques et l'impact de la réglementation des lignes directrices de la EBM, les résultats sont présentés en deux parties. La première partie analyse la compréhension et la performance des principes formels de la EBM durant la production des lignes directrices, le troisième chapitre mettant l'accent sur la diversité des connaissances, des procédures et des matériels nécessaires pour classifier les données probantes et formuler le texte des lignes directrices. Le quatrième chapitre analyse comment l'absence de données probantes est gérée et propose le terme «Evidence Searched Guidelines» (lignes directrices cherchantes les données probantes) pour saisir le caractère distinctif des lignes directrices de la EBM. La deuxième partie met l'accent sur les «lignes directrices pour les lignes directrices», qui régularisent le développement des lignes directrices. Le cinquième chapitre présente le Guidelines International Network, visant une procédure universelle pour l'établissement des normes, mais s'opposant à la standardisation des lignes directrices. Le sixième chapitre présente quatre modèles d'Implication du Public visant à intégrer les données probantes à des «valeurs» et des «contextes», afin de rendre les lignes directrices plus personnalisées, démocratiques, pertinentes et/ou objectives. Visant des Étalons-or qui évitent la standardisation, les développeurs des lignes directrices de la EBM mettent au défi à la fois les explications des défenseurs de la EBM et celles des détracteurs. Le rapport contesté entre standardisé (ou universel) et personnalisé (ou local) au cœur de la médecine fondée sur les données probantes n'est pas gouverné par la quantité, la qualité ou l'universalité des données probantes, mais par la standardisation des procédures

Diagnosing and treating premenstrual syndrome in five western nations

Premenstrual syndrome (PMS) and its derivative Premenstrual Dysphoric Disorder (PMDD) are controversial medical diagnoses. On one hand they are ubiquitous in English-language cultures; on the other they are for many emblematic of unnecessary medicalization of natural physiological processes. In this paper, we use data produced by IMS, a health care information and research firm, to analyze office-based medical practice related to PMS/PMDD in five countries. We come to several conclusions: 1. Relatively few doctors in any country diagnose women as suffering from PMS/PMDD, despite significant national variations in frequency of diagnosis; 2. Women diagnosed with this condition are usually prescribed a medication no matter what kind of specialist they see; and 3. In North America and the UK, practitioners generally follow USA practice guidelines which favour use of anti-depressive drugs like SSRIs but this is not the case in France and Germany which exhibit unique prescription patterns. In France hormonal treatment and analgesics dominate; in Germany the plant extract Vitex agnus-castus, considered an alternative therapy in much of the English-speaking world, is most common. We go on to discuss the relevance of these conclusions to discussions of variations in medical practices, to the existing PMS literature that claims high rates of prevalence for this condition, and to recent studies of "demedicalization" in certain domains.USA UK Canada France Germany Premenstrual syndrome Premenstrual dysphoric disorder Medicalization

Pragmatic evidence and textual arrangements: a case study of French clinical cancer guidelines

International audienceBoth 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

Pragmatic evidence and textual arrangements: A case study of French clinical cancer guidelines

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.France Evidence-based medicine Clinical practice guidelines Oncology Pragmatic sociology Dispositif Regulation

Pragmatic evidence and textual arrangements: a case study of French clinical cancer guidelines

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 lead 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 met. 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

The Emergence of Clinical Practice Guidelines

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

Premenstrual Syndrome (PMS) and the Myth of the Irrational Female

King’s chapter begins by describing the historical context of ‘premenstrual’ symptoms, which were first formally described in 1931. She then questions the prioritization of mood-based symptoms in the diagnostic criteria for Premenstrual Syndrome (PMS). King argues that population studies suggest that mood-based symptoms are not the most common nor most disruptive of menstrual changes. She then proposes that the trend of ‘psychologizing’ premenstrual symptoms is influenced by the sexist historical assumption of ‘the myth of the irrational female’—the idea that women, due to their reproductive biology, are pathologically emotional and thus have a reduced capacity for reason. The author concludes by calling for a more integrated and rigorous approach to PMS definitions and research to support people who experience cyclical symptoms, without unintentionally pathologizing the menstrual cycle or stigmatizing an entire gender