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Le Concept De Biais En Épidémiologie Nicolas Brault Le concept de biais en épidémiologie Nicolas Brault To cite this version: Nicolas Brault. Le concept de biais en épidémiologie. Philosophie. Université Sorbonne Paris Cité, 2017. Français. NNT : 2017USPCC229. tel-02167196v2 HAL Id: tel-02167196 https://tel.archives-ouvertes.fr/tel-02167196v2 Submitted on 23 May 2019 (v2), last revised 27 Jan 2020 (v3) HAL is a multi-disciplinary open access L’archive ouverte pluridisciplinaire HAL, est archive for the deposit and dissemination of sci- destinée au dépôt et à la diffusion de documents entific research documents, whether they are pub- scientifiques de niveau recherche, publiés ou non, lished or not. The documents may come from émanant des établissements d’enseignement et de teaching and research institutions in France or recherche français ou étrangers, des laboratoires abroad, or from public or private research centers. publics ou privés. Thèse de doctorat de l’Université Sorbonne Paris Cité Préparée à l’Université Paris Diderot Ecole doctorale 400 : « Savoirs scientifiques» Laboratoire SPHERE / UMR 7219 Le concept de biais en épidémiologie Par Nicolas Brault Thèse de doctorat d’Épistémologie, histoire des sciences et des techniques Dirigée par Alain Leplège et Joël Coste Présentée et soutenue publiquement le 12 décembre 2017 Présidente du jury : Laurence Meyer, Professeur des universités-Praticien hospitalier de santé publique, Université Paris-Sud. Rapporteurs : Isabelle Drouet, Maître de conférences en philosophie, Université Paris-Sorbonne. Maël Lemoine, Maitre de conférences (HDR) en philosophie des sciences biologiques et médicales, Université de Tours. Examinateur : Elodie Giroux, Maître de conférences en philosophie, Université Lyon III-Jean Moulin Directeur de thèse : Alain Leplège, Professeur d’histoire et de philosophie des sciences, Université Paris-Diderot. Co-directeur de thèse : Joël Coste, Professeur des universités-Praticien hospitalier de biostatistique et d’épidémiologie, Université Paris-Descartes. Cette œuvre est mise à disposition sous licence Attribution - Pas d’Utilisation Commerciale - Pas de Modification 3.0 France. Pour voir une copie de cette licence, visitez http://creativecommons.org/licenses/by-nc-nd/3.0/fr/ Nicolas Brault - Thèse de doctorat- 2017 Titre : Le concept de biais en épidémiologie. Résumé : Cette thèse, qui s’inscrit dans la tradition méthodologique de l’épistémologie historique, porte sur l’histoire et la formation du concept de biais dans l’épidémiologie moderne. Elle montre que la fonction opératoire du concept de biais est essentiellement critique, au sens où ce concept, que les épidémiologistes opposent au cours de l’histoire aux concepts d’objectivité, de preuve et de causalité, joue un rôle décisif dans la constitution de l’épidémiologie comme science, mais aussi dans l’avènement d’une médecine scientifique. Un éclairage historique et critique est apporté à la définition actuelle du biais, conçu comme une erreur ou un écart systématique par rapport à la vérité, ainsi qu’aux différentes taxinomies des biais qui jalonnent l’histoire de ce concept, dont l’origine se situe chez les fondateurs de la statistique mathématique. Le biais apparait ainsi comme une menace aussi bien à la validité du plan d’expérience d’une étude épidémiologique qu’à la validité de l’inférence statistique et du raisonnement médical. En d’autres termes, ce sont les conséquences que la révolution probabiliste a eues sur l’épidémiologie et sur la médecine qui sont ici étudiées, et qui ont conduit les épidémiologistes et les médecins à une forme de scepticisme et même de criticisme envers leurs propres inférences, ce qui donnera naissance au mouvement de la médecine fondée sur des preuves. Mots clefs : Histoire et épistémologie de la médecine, Histoire et épistémologie de l’épidémiologie, Biais, Erreur aléatoire et erreur systématique, Vérité, Validité, Niveaux de preuve, Causalité, Plan d’expérience, Etude cas-témoins, Etude de cohorte. Title : The concept of bias in epidemiology Abstract: This PhD thesis, belonging to the tradition of historical epistemology, deals with the history and the formation of the concept of bias in epidemiology. It shows that the operational function of the concept of bias is essentially critical, in the sense that this concept, used by epidemiologists throughout history as an antonym to both objectivity, causality and evidence, is central to both the construction of epidemiology as a scientific discipline and the advent of scientific medicine. An historical and critical account is given of the actual definition of bias, conceived as a systematic error or deviation from the truth, and to the various taxonomies of bias which marked the history of this concept, whose origin goes back to the founders of mathematical statistics. Bias thus appears as a threat to the validity of the design of an epidemiological study, and to the validity of statistical inference and medical reasoning. In other words, what is studied here is the consequences of the probabilistic revolution on both epidemiology and medicine, which led epidemiologists and physicians to a kind of scepticism or even criticism about their own inferences, which would ultimately give birth to the evidence-based medicine’s movement. Keywords : History and Philosophy of Medicine, History and Philosophy of Epidemiology, Bias, Random Error and Systematic Error, Truth, Validity, Hierarchy of Evidence, Causation, Design of Experiment, Case-control Study, Cohort Study. 2 Nicolas Brault - Thèse de doctorat- 2017 3 Nicolas Brault - Thèse de doctorat- 2017 SOMMAIRE REMERCIEMENTS ..................................................................................................... 8 AVERTISSEMENT .................................................................................................... 10 INTRODUCTION ....................................................................................................... 12 PARTIE 1 : DE L’IDEE DE BIAIS AU CONCEPT DE BIAIS .................................... 34 1. Chapitre 1 : Archéologie du concept de biais ................................................... 36 1.1 La notion de biais chez Francis Galton. ................................................... 39 1.1.1 Galton et la « Loi suprême de la Déraison ». ..................................... 39 1.1.2 Loi normale, hérédité et sélection naturelle : ...................................... 40 1.1.3 Le biais dans le mariage et la sélection sexuelle................................ 42 1.2 L’expérience du lancer de dés de Weldon : ............................................. 46 1.2.1 Le contexte scientifique de l’expérience de Weldon. .......................... 46 1.2.2 L’analyse de l’expérience de Weldon par Pearson. ........................... 50 1.2.3 L’analyse de l’expérience de Weldon par Fisher ................................ 53 1.3 Le biais comme erreur systématique du plan d’expérience : ................... 56 1.3.1 Le biais et la loi normale. .................................................................... 56 1.3.2 Le biais et la randomisation. ............................................................... 61 1.3.3 Le biais est-il un problème d’estimation ou de signification ? ............. 66 2. Chapitre 2 : L’introduction du concept de biais dans l’épidémiologie .............. 74 2.1 A.B. Hill et les Principles of Medical Statistics: le biais comme problème de sélection. .............................................................................................................. 74 2.1.1 Comment disposer d’un échantillon représentatif ? De l’allocation alternée à la randomisation. ............................................................................. 74 2.1.2 De la randomisation à la procédure en aveugle : la lutte contre les biais subjectifs. .......................................................................................................... 79 2.1.3 Biais ou sélection ? ............................................................................. 81 2.2 Les premières études cas-témoins sur le lien entre tabagisme et cancer du poumon (1950-1952) : biais de sélection, biais d’information et biais d’enregistrement. ................................................................................................. 90 2.2.1 Le biais comme sélection : représentativité et comparabilité des échantillons. ...................................................................................................... 91 2.2.2 Le biais lié au patient et le biais lié à l’enquêteur. .............................. 95 4 Nicolas Brault - Thèse de doctorat- 2017 2.2.3 Quelle est la fonction opératoire du concept de biais chez Hill ? Randomisation et aveugle. ............................................................................. 100 2.3 La conceptualisation du biais par les sciences sociales ........................ 104 2.3.1 Le biais de l’intervieweur ................................................................... 104 2.3.2 Naissance de l’opinion publique : sondages et biais. ....................... 107 2.3.3 La première définition du concept de biais : ..................................... 110 3. Chapitre 3 : Du problème de l’échantillonnage au problème de la validité de l’inférence statistique. .............................................................................................. 117 3.1 Le biais de Berkson. ............................................................................... 118 3.1.1 Méthode statistique et méthode expérimentale. ..............................
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