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4. Données et preuves en vie réelle dans l’évaluation des technologies de santé : dans quels cas sont-elles complémentaires, substitutives, ou les seules sources de données par rapport aux essais cliniques ?

Author

de Pouvourville, Gérard, Armoiry, Xavier, Lavorel, Aurélie, Bilbault, Pascal, Maugendre, Philippe, Bensimon, Lionel, Beziz, Dan, Blin, Patrick, Borget, Isabelle, Bouée, Stéphane, Collignon, Cécile, Dervaux, Benoît, Durand-Zaleski, Isabelle, Julien, Marc, de Léotoing, Lucie, Majed, Laureen, Martelli, Nicolas, Séjourné, Thomas, and Viprey, Marie

Published
2023
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6. Mortality and comorbidities in a Nationwide cohort of HIV-infected adults: comparison to a matched non-HIV adults' cohort, France, 2006–18.

Author

Vallée, Alexandre, Majerholc, Catherine, Zucman, David, Livrozet, Jean-Michel, Laurendeau, Caroline, Bouée, Stéphane, and Clary, François Prevoteau du

Subjects
HEALTH status indicators, ANTIRETROVIRAL agents, DEATH, GENDER specific care, SEX distribution, HIV-positive persons, HEALTH policy, HIV infections, AGE distribution, DESCRIPTIVE statistics, MULTIVARIATE analysis, LONGITUDINAL method, STATISTICS, COMPARATIVE studies, COMORBIDITY, PROPORTIONAL hazards models, REGRESSION analysis, ADULTS
Abstract

Background Human immunodeficiency virus (HIV) remains a significant cause of morbidity and mortality worldwide. The aim of this study was to describe the mortality rate and associated comorbidities in a nationwide population-based cohort of persons living with HIV (PLWHIV) and to compare it with mortality in an age and gender-matched cohort of non-HIV individuals in France. Methods Using data from the French national health data system, we identified and included 173 712 PLWHIV (66.5% men) and 173 712 non-HIV participants (66.5% men) matched for age and gender. PLHIV were identified based on ICD-10 HIV diagnoses, HIV-specific laboratory tests, and/or prescriptions for antiretroviral therapy specific to HIV. Hazard ratios (HRs) of mortality were assessed using multiple Cox regression models. Results During the 13 years of follow-up (2006–18), we observed 20 018 deaths among PLWHIV compared with 6262 deaths among non-HIV participants (11.52% vs. 3.60%, P  < 0.001). The over-mortality of PLWHIV was expressed by univariable HR = 2.135 (2.072–2.199), which remained significant after adjustment for region, Complementary Universal Health Insurance and AME, with multivariable HR = 2.182 (2.118–2.248). The results remained significant after adjusting for comorbidities, including infectious diseases [HR = 1.587 (1.538–1.638)]. Notably, PLWHIV were more importantly associated with mortality in women [HR = 2.966 (2.767–3.180)], compared in men [HR = 1.961 (1.898–2.027)]. Conclusion Although the life expectancy of PLWHIV has globally increased, the causes of death should be prioritized in prevention policies and care management. Gender-specific policies should be highlighted, as we observed a higher impact of HIV mortality in women. [ABSTRACT FROM AUTHOR]

Published
2024
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7. Real-world data and evidence in health technology assessment: When are they complementary, substitutes, or the only sources of data compared to clinical trials?

Author

de Pouvourville, Gérard, Armoiry, Xavier, Lavorel, Aurélie, Bilbault, Pascal, Maugendre, Philippe, Bensimon, Lionel, Beziz, Dan, Blin, Patrick, Borget, Isabelle, Bouée, Stéphane, Collignon, Cécile, Dervaux, Benoît, Durand-Zaleski, Isabelle, Julien, Marc, de Léotoing, Lucie, Majed, Laureen, Martelli, Nicolas, Séjourné, Thomas, and Viprey, Marie

Published
2022
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17. Real-world data and evidence in health technology assessment: When are they complementary, substitutes, or the only sources of data compared to clinical trials?

Author

de Pouvourville, Gérard, primary, Armoiry, Xavier, additional, Lavorel, Aurélie, additional, Bilbault, Pascal, additional, Maugendre, Philippe, additional, Bensimon, Lionel, additional, Beziz, Dan, additional, Blin, Patrick, additional, Borget, Isabelle, additional, Bouée, Stéphane, additional, Collignon, Cécile, additional, Dervaux, Benoît, additional, Durand-Zaleski, Isabelle, additional, Julien, Marc, additional, de Léotoing, Lucie, additional, Majed, Laureen, additional, Martelli, Nicolas, additional, Séjourné, Thomas, additional, and Viprey, Marie, additional

Published
2023
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18. Survival of patients with advanced hepatocellular carcinoma treated with sorafenib in France during 2009–2018: analysis of the French hospital and claim database

Author

Bronowicki, Jean-Pierre, primary, Dupin, Julien, additional, Tanang, Alexandre Pissewoewoe, additional, Gilbert-Marceau, Anika, additional, Blanc, Jean-Frédéric, additional, Nahon, Pierre, additional, Laurendeau, Caroline, additional, Bouée, Stéphane, additional, and Gilberg, Mélina, additional

Published
2022
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31. Qualité de vie des patients atteints de pneumopathie interstitielle diffuse associée à la sclérodermie systémique : impact de l’atteinte pulmonaire et des autres atteintes d’organes

Author

Jeanbat, Viviane, primary, Teissier, Clément, additional, Allanore, Yannick, additional, Constans, Joël, additional, Godard, Dominique, additional, de Pouvourville, Gérard, additional, Chollet, Julien, additional, Hachulla, Eric, additional, and Bouée, Stéphane, additional

Published
2021
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32. The Multifaceted Interplay between Atrial Fibrillation and Myocardial Infarction: A Review

Author

Hanon, Olivier, Vidal, Jean-Sébastien, Pisica-Donose, George, Orvoën, Galdric, David, Jean-Philippe, Chaussade, Edouard, Caillard, Laure, de Jong, Laura, Boulloche, Nicolas, Vinsonneau, Ulric, Bouée, Stéphane, Krolak-Salmon, Pierre, Fauchier, Laurent, Jouanny, Pierre, Sacco, Guillaume, Bellarbre, Fabienne, Belmin, Joël, Puisieux, François, Lilamand, Matthieu, Paillaud, Elena, Boureau, Anne Sophie, Belkouche, Alban, Yao, Hermann, Putot, Alain, Chagué, Frédéric, Rochette, Luc, Danchin, Nicolas, Zeller, Marianne, Cottin, Yves, AP-HP - Hôpital Cochin Broca Hôtel Dieu [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université Paris Cité (UPC), Maladie d'Alzheimer : marqueurs génétiques et vasculaires, neuropsychologies (URP_4468), Groupe hospitalier Broca-Université Paris Cité (UPC), DomusVi [Suresnes] (Maisons de retraite), Hôpital Vaugirard-Gabriel Pallez, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Laboratoire d'Ecologie Alpine (LECA), Université Joseph Fourier - Grenoble 1 (UJF)-Centre National de la Recherche Scientifique (CNRS)-Université Savoie Mont Blanc (USMB [Université de Savoie] [Université de Chambéry]), Neurologie et Explorations Fonctionnelles du Système Nerveux [Toulouse], Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse], Service de Cardiologie (HIA BREST - Cardio), HIA - BREST, Pôle Real World Evidence [Bourg-la-Reine] (CEMKA), Cemka-eval [Bourg La Reine], Centre de recherche en neurosciences de Lyon - Lyon Neuroscience Research Center (CRNL), Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lyon-Université Jean Monnet [Saint-Étienne] (UJM)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon, Elderly Health Service, Hôpital des Charpennes [CHU - HCL], Hospices Civils de Lyon (HCL), CHU Trousseau [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Éducation Éthique Santé EA 7505 (EES), Université de Tours (UT), Service de médecine gériatrique (CHU de Dijon - Centre gériatrique de Champmaillot - EHPAD), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Laboratoire de Psychologie des Pays de la Loire (LPPL), Université d'Angers (UA)-Université de Nantes - UFR Lettres et Langages (UFRLL), Université de Nantes (UN)-Université de Nantes (UN), CHU Charles Foix [AP-HP], Pôle de gérontologie [CHRU de Lille], Hôpital Roger Salengro [Lille]-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre de Neurologie Cognitive [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)-Hôpitaux Universitaires Saint-Louis, Lariboisière, Fernand-Widal, Institut Mondor de Recherche Biomédicale (IMRB), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12)-IFR10, Hôpital Européen Georges Pompidou [APHP] (HEGP), Service de Cardiologie [CHU de Dijon], Physiopathologie et épidémiologie cérébro-cardiovasculaire [Dijon] (PEC2), Université de Bourgogne (UB)-Université Bourgogne Franche-Comté [COMUE] (UBFC), European Atherosclerosis Society [Göteborg, Sweden] (EAS), and Dorogoichenko, Aleksandra

Subjects
medicine.medical_specialty, lcsh:Medicine, Review, 030204 cardiovascular system & hematology, Coronary artery embolism, [SHS]Humanities and Social Sciences, Pathogenesis, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, Hospital discharge, atrial fibrillation, 030212 general & internal medicine, Myocardial infarction, Excess mortality, chronic coronary syndrome, business.industry, lcsh:R, Atrial fibrillation, General Medicine, medicine.disease, bleeding, Coronary arteries, medicine.anatomical_structure, type 1 and type 2 myocardial infarction, Cardiology, [SHS] Humanities and Social Sciences, business, Ischemic heart
Abstract

International audience; This review was conducted to emphasize the complex interplay between atrial fibrillation (AF) and myocardial infraction (MI). In type 1 (T1) MI, AF is frequent and associated with excess mortality. Moreover, AF after hospital discharge for T1MI is not rare, suggesting the need to improve AF screening and to develop therapeutic strategies for AF recurrence. Additionally, AF is a common trigger for type 2 MI (T2MI), and recent data have shown that tachyarrhythmia or bradyarrhythmia could be a causal factor in, respectively, 13–47% or 2–7% of T2MI. In addition, AF is involved in T2MI pathogenesis as a result of severe anemia related to anticoagulants. AF is also an underestimated and frequent cause of coronary artery embolism (CE), as a situation at risk of myocardial infarction with non-obstructive coronary arteries. AF-causing CE is difficult to diagnose and requires specific management. Moreover, patients with both AF and chronic coronary syndromes represent a therapeutic challenge because the treatment of AF include anticoagulation, depending on the embolic risk, and ischemic heart disease management paradoxically includes antiplatelet therapy.

Published
2021

35. Bleeding risk with rivaroxaban compared with vitamin K antagonists in patients aged 80 years or older with atrial fibrillation

Author

Hanon, Olivier, primary, Vidal, Jean-Sébastien, additional, Pisica-Donose, George, additional, Orvoën, Galdric, additional, David, Jean-Philippe, additional, Chaussade, Edouard, additional, Caillard, Laure, additional, de Jong, Laura W, additional, Boulloche, Nicolas, additional, Vinsonneau, Ulric, additional, Bouée, Stéphane, additional, Krolak-Salmon, Pierre, additional, Fauchier, Laurent, additional, Jouanny, Pierre, additional, Sacco, Guillaume, additional, Bellarbre, Fabienne, additional, Belmin, Joël, additional, Puisieux, François, additional, Lilamand, Matthieu, additional, Paillaud, Elena, additional, and Boureau, Anne Sophie, additional

Published
2020
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39. Mepolizumab in a population with severe eosinophilic asthma and corticosteroid dependence: results from a French early access programme

Author

Taillé, Camille, primary, Chanez, Pascal, additional, Devouassoux, Gilles, additional, Didier, Alain, additional, Pison, Christophe, additional, Garcia, Gilles, additional, Charriot, Jeremy, additional, Bouée, Stéphane, additional, Gruber, Alina, additional, Pribil, Celine, additional, Bourdin, Arnaud, additional, and Humbert, Marc, additional

Published
2020
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41. Bleeding risk with rivaroxaban compared with vitamin K antagonists in patients aged 80 years or older with atrial fibrillation.

Author

Hanon, Olivier, Vidal, Jean-Sébastien, Pisica-Donose, George, Orvoën, Galdric, David, Jean-Philippe, Chaussade, Edouard, Caillard, Laure, de Jong, Laura W., Boulloche, Nicolas, Vinsonneau, Ulric, Bouée, Stéphane, Krolak-Salmon, Pierre, Fauchier, Laurent, Jouanny, Pierre, Sacco, Guillaume, Bellarbre, Fabienne, Belmin, Joël, Puisieux, François, Lilamand, Matthieu, and Paillaud, Elena

Subjects
APIXABAN, DABIGATRAN, ANTICOAGULANTS, ATRIAL fibrillation, STROKE, GASTROINTESTINAL hemorrhage, RIVAROXABAN
Abstract

Objective: Direct oral anticoagulants have been evaluated in the general population, but proper evidence for their safe use in the geriatric population is still missing. We compared the bleeding risk of a direct oral anticoagulant (rivaroxaban) and vitamin K antagonists (VKAs) among French geriatric patients with non-valvular atrial fibrillation (AF) aged ≥80 years.Methods: We performed a sequential observational prospective cohort study, using data from 33 geriatric centres. The sample comprised 908 patients newly initiated on VKAs between September 2011 and September 2014 and 995 patients newly initiated on rivaroxaban between September 2014 and September 2017. Patients were followed up for up to 12 months. One-year risks of major, intracerebral, gastrointestinal bleedings, ischaemic stroke and all-cause mortality were compared between rivaroxaban-treated and VKA-treated patients with propensity score matching and Cox models.Results: Major bleeding risk was significantly lower in rivaroxaban-treated patients (7.4/100 patient-years) compared with VKA-treated patients (14.6/100 patient-years) after multivariate adjustment (HR 0.66; 95% CI 0.43 to 0.99) and in the propensity score-matched sample (HR 0.53; 95% CI 0.33 to 0.85). Intracerebral bleeding occurred less frequently in rivaroxaban-treated patients (1.3/100 patient-years) than in VKA-treated patients (4.0/100 patient-years), adjusted HR 0.59 (95% CI 0.24 to 1.44) and in the propensity score-matched sample HR 0.26 (95% CI 0.09 to 0.80). Major lower bleeding risk was largely driven by lower risk of intracerebral bleeding.Conclusions: Our study findings indicate that bleeding risk, largely driven by lower risk of intracerebral bleeding, is lower with rivaroxaban than with VKA in stroke prevention in patients ≥80 years old with non-valvular AF. [ABSTRACT FROM AUTHOR]

Published
2021
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42. Treatment sequence of first and second generation tyrosine kinase inhibitor followed by osimertinib in -mutated non-small-cell lung cancer: a real life study.

Author

Girard, Nicolas, Moro-Sibilot, Denis, Bouée, Stéphane, Emery, Corinne, Torreton, Elodie, Le Lay, Katell, Luciani, Laura, Maritaz, Christophe, and Chouaid, Christos

Abstract

Background: We aimed to assess the effectiveness and cost of patients with first line tyrosine kinase inhibitors (TKIs) sequence of first (1G) and second generation (2G) followed by osimertinib. Materials & methods: Using the French nationwide claims and hospitalization database, we analyzed non-small-cell lung cancer patients who had been treated with osimertinib between April 2015 and December 2017, after a first line treatment with a TKI-1G/2G. Results: The median time on treatment for sequential TKI-1G/2G followed by osimertinib was 34 months (95% CI: 31-46); 13 and 12months, respectively for TKI 1G or 2G and TKI 3G, respectively. The median overall survival for sequential TKI 1G or 2G followed by osimertinib was 37 months (95% CI: 34-42). The mean monthly costs per patient was €5162. Conclusion: These results, in line with those observed during clinical trials, confirm the effectiveness of the sequence TKI-1G/2G followed by osimertinib in EGFR-mutated non-small-cell lung cancer. [ABSTRACT FROM AUTHOR]

Published
2020
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44. Prevalence of fibrodysplasia ossificans progressiva (FOP) in France: an estimate based on a record linkage of two national databases

Author

Baujat, Geneviève, primary, Choquet, Rémy, additional, Bouée, Stéphane, additional, Jeanbat, Viviane, additional, Courouve, Laurène, additional, Ruel, Amélie, additional, Michot, Caroline, additional, Le Quan Sang, Kim-Hanh, additional, Lapidus, David, additional, Messiaen, Claude, additional, Landais, Paul, additional, and Cormier-Daire, Valérie, additional

Published
2017
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46. Prevalence of Gout in the Adult Population of France

Author

Bardin, Thomas, Bouée, Stéphane, Clerson, Pierre, Chales, Gérard, Flipo, René-Marc, Lioté, Frédéric, Perez, Vincent, Poiraud, Thierry, Schaeverbeke, Thierry, Richette, Pascal, Service de rhumatologie, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Lariboisière-Fernand-Widal [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Orgamétrie biostatistiques, Service de rhumatologie [Rennes] = Rheumatology [Rennes], CHU Pontchaillou [Rennes], Foie, métabolismes et cancer, Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Département de Rhumatologie (LILLE - Rhumatologie), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Os et articulations, Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service Rhumatologie, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), CHU Bordeaux [Bordeaux], UFR Médicale, Université Paris Diderot - Paris 7 (UPD7), Fédération de rhumatologie, Hôpital Lariboisière-Fernand-Widal [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Ménarini France, Association Rhumatisme et Travail, Université de Rennes 1 (UR1), and Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique )

Subjects
Adult, Male, Adolescent, Gout, [SDV]Life Sciences [q-bio], Age Factors, Middle Aged, Young Adult, Cross-Sectional Studies, Sex Factors, Prevalence, Humans, Female, France, Aged
Abstract

International audience; OBJECTIVE: To estimate adult gout prevalence in France. METHODS: We used a previously established phone questionnaire that allowed for classifying patients as gouty or non-gouty by 2 logistic regression models and 1 Classification and Regression Tree (CART) method, the sensitivity and specificity of which were all more than 80%. The full questionnaire was administered by phone to subjects who acknowledged present or past non-traumatic acute pain in a peripheral joint, the others being classified as non-gouty. A random sample of adults residing in France was derived from the national telephone (home and mobile) directory by the quota method and further redressed to match the French population. The target size for the interview survey conducted in March and June 2013 was 10,000 participants. RESULTS: We interviewed 10,026 participants. All three models (2 logistic regression and CART models) converged to an estimated gout prevalence of 0.9%. This was lower than that estimated by self-reporting only (3.7%; 95% CI: 3.3-4.1). The prevalence was higher for males than females and increased with age but did not differ by area of France. CONCLUSION: Gout prevalence in the adult population of France in 2013 was estimated at 0.9%. Studies using self-reporting only might overestimate the prevalence. This article is protected by copyright. All rights reserved

Published
2015

49. Prevalence of Gout in the Adult Population of France.

Author

Bardin, Thomas, Bouée, Stéphane, Clerson, Pierre, Chalès, Gérard, Flipo, René-Marc, Lioté, Frédéric, Perez, Vincent, Poiraud, Thierry, Schaeverbeke, Thierry, Richette, Pascal, Bouée, Stéphane, Chalès, Gérard, Flipo, René-Marc, and Lioté, Frédéric

Subjects
AGE distribution, GOUT, SEX distribution, DISEASE prevalence, CROSS-sectional method
Abstract

Objective: To estimate adult gout prevalence in France.Methods: We used a previously established phone questionnaire that allowed for classifying patients as gouty or nongouty by 2 logistic regression models and 1 classification and regression tree (CART) model, the sensitivity and specificity of which were all more than 80%. The full questionnaire was administered by phone to subjects who acknowledged present or past nontraumatic acute pain in a peripheral joint, the others being classified as nongouty. A random sample of adults residing in France was derived from the national telephone directory (home and mobile) by the quota method and further redressed to match the French population. The target size for the interview survey conducted in March and June 2013 was 10,000 participants.Results: We interviewed 10,026 participants. All 3 models (2 logistic regression models and a CART model) converged to an estimated gout prevalence of 0.9%. This prevalence was lower than that estimated by self-reporting only (3.7% [95% confidence interval 3.3-4.1]). The prevalence was higher for men than women and increased with age but did not differ by area of France.Conclusion: Gout prevalence in the adult population of France in 2013 was estimated at 0.9%. Studies using self-reporting only might overestimate the prevalence. [ABSTRACT FROM AUTHOR]

Published
2016
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