Recherche clinique ville-hôpital, Méthodologies et Société
Présentation
L’équipe 7334 REMES (Recherche Clinique ville-hôpital, Méthodologies et Société) sous la direction du Pr Olivier Chassany a la particularité de regrouper des médecins de ville et des hôpitaux, autour de travaux de recherche clinique qui placent le patient au centre de la prise en charge et des décisions médicales le concernant.
- Le 1er axe de recherche de l’équipe dirigé par le Dr Martin Duracinsky analyse la qualité de vie des personnes en situation de pathologie et mesure leurs perceptions (« Patient-Centered Outcomes ») afin d’améliorer leur parcours de vie avec la maladie. Comment vivent-ils avec cette pathologie ? Supportent-ils les traitements associés ? Comment leur prise en charge pourrait être améliorée, facilitée ?...
- Le 2e axe de recherche est quant à lui destiné à améliorer le parcours de soins du patient avec pour ambition de jeter un pont entre la médecine de ville et l’hôpital. Cet axe est rendu possible par la mobilisation des médecins généralistes universitaires de Paris-Diderot et leur collaboration avec d’autres enseignants-chercheurs exerçant à l’hôpital. Du fait de sa spécificité, cet axe est sous la responsabilité de 2 chercheurs, le Pr Isabelle Mahé du côté hôpital et le Pr Jean-Pierre Aubert pour la ville.
Pour finir, les chercheurs de l’EA 7334 REMES travaillent sur deux autres axes.
- Dans le 3e axe, sous la responsabilité de la juriste Mihaela Matei, ils se demandent comment améliorer la législation qui encadre la recherche clinique, en intégrant la notion d’approche basée sur le risque (« risk-based approach »).
- Le 4e axe, confié à Philippe Lechat, concerne le développement d’outils électroniques d’aide à la prescription. Ce projet comporte notamment une recherche sur l’élaboration et la faisabilité des algorithmes nécessaires à la construction d’un logiciel permettant de vérifier la validité, la cohérence et l’adéquation d’une ordonnance médicale des médicaments prescrits pour un patient donné dans une indication thérapeutique définie.
Thèmes de recherche
Axe Patient-Centered Outcomes
Responsable : Dr Martin Duracinsky (duracinsky.m@gmail.com)
Axe Recherche clinique Ville-Hôpital
Responsables : Pr Isabelle Mahé (Isabelle.Mahe@lmr.aphp.fr) & Pr jean Pierre Aubert (docteur.aubert@gmail.com)
Axe Législation et recherche clinique
Responsable : Mihaela Matei
Axe Outils électroniques d’aide à la prescription
Responsable : Pr Philippe Lechat (philippe.lechat@drc.aphp.fr)
[hal-01887022] General practitioners’ justifications for therapeutic inertia in cardiovascular prevention: an empirically grounded typology
Date: 11 oct 2018 - 11:09
Desc: OBJECTIVE: To construct a typology of general practitioners' (GPs) responses regarding their justification of therapeutic inertia in cardiovascular primary prevention for high-risk patients with hypertension. DESIGN: Empirically grounded construction of typology. Types were defined by attributes derived from the qualitative analysis of GPs' reported reasons for inaction. PARTICIPANTS: 256 GPs randomised in the intervention group of a cluster randomised controlled trial. SETTING: GPs members of 23 French Regional Colleges of Teachers in General Practice, included in the EffectS of a multifaceted intervention on CArdiovascular risk factors in high-risk hyPErtensive patients (ESCAPE) trial. DATA COLLECTION AND ANALYSIS: The database consisted of 2638 written responses given by the GPs to an open-ended question asking for the reasons why drug treatment was not changed as suggested by the national guidelines. All answers were coded using constant comparison analysis. A matrix analysis of codes per GP allowed the construction of a response typology, where types were defined by codes as attributes. Initial coding and definition of types were performed independently by two teams. RESULTS: Initial coding resulted in a list of 69 codes in the final codebook, representing 4764 coded references in the question responses. A typology including seven types was constructed. 100 GPs were allocated to one and only one of these types, while 25 GPs did not provide enough data to allow classification. Types (numbers of GPs allocated) were: 'optimists' (28), 'negotiators' (20), 'checkers' (15), 'contextualisers' (13), 'cautious' (11), 'rounders' (8) and 'scientists' (5). For the 36 GPs that provided 50 or more coded references, analysis of the code evolution over time and across patients showed a consistent belonging to the initial type for any given GP. CONCLUSION: This typology could provide GPs with some insight into their general ways of considering changes in the treatment/management of cardiovascular risk factors and guide design of specific physician-centred interventions to reduce inappropriate inaction.
[hal-01913569] Utilisation du fondaparinux 2,5mg pour la prévention des évènements thromboemboliques veineux en médecine générale. ArchiMed Ville
Date: 6 nov 2018 - 13:57
Desc: OBJECTIVE: To evaluate the mean duration of treatment course with fondaparinux 2.5 mg (ARIXTRA(®)) in the setting of ambulatory general medicine, with respect to its indication in thromboprophylaxis for medically ill patients and to describe the population treated. METHODS: Observational, prospective, national, multicenter, pharmaco-epidemiological study, performed in France, at the request of the Transparency Commission (a division of the French Health Regulatory Authority). The general practitioners had to include the first three adult patients, considered as patients at high risk of venous thromboembolic events and immobilized for acute medical illness, treated with initiation of thromboprophylaxis by fondaparinux 2.5 mg. RESULTS: Two hundred and seventeen general practitioners included 840 patients. The mean age of patients was 63.6±18.1 years, and 63% of patients (n=520/831) were females. The real total administration duration of the treatment by fondaparinux 2.5 mg was known for 797 patients and was 15.8±12.4 days on average (range: 1-90 days, median: 10 days). In 40% of patients, the duration ranged from 6 to 14 days [duration consistent with the summary of product characteristics (SmPC)]. Among the 834 patients analyzed, 569 (68%) suffered from at least one acute illness and had at least one risk factor for venous thromboembolism (VTE). The indication did fully comply with the summary of product characteristics of fondaparinux 2.5 mg in 52% of the patients (n=434/834 patients). CONCLUSION: The results of the ArchiMed study support that the thromboprophylaxis treatment with fondaparinux 2.5 mg in ambulatory general medicine, and the associated medical conditions were usually consistent with the SmPC or guidelines. However, a difference was found for the duration and the initial indication, in situations that may be regarded as presenting a risk by the prescriber.
[hal-01740290] Four-days-a-week antiretroviral maintenance therapy in virologically controlled HIV-1-infected adults: the ANRS 162-4D trial
Date: 21 Mar 2018 - 17:50
Desc: Background: Intermittent treatment could improve the convenience, tolerability and cost of ART, as well as patients' quality of life. We conducted a 48 week multicentre study of a 4-days-a-week antiretroviral regimen in adults with controlled HIV-1-RNA plasma viral load (VL). Methods: Eligible patients were adults with VL < 50 copies/mL for at least 1 year on triple therapy with a ritonavir-boosted PI (PI/r) or an NNRTI. The study protocol consisted of the same regimen taken on four consecutive days per week followed by a 3 day drug interruption. The primary outcome was the proportion of participants remaining in the strategy with VL < 50 copies/mL up to week 48. The study was designed to show an observed success rate of > 90%, with a power of 87% and a 5% type 1 error. The study was registered with ClinicalTrials.gov (NCT02157311) and EudraCT (2014-000146-29). Results: One hundred patients (82 men), median age 47 years (IQR 40-53), were included. They had been receiving ART for a median of 5.1 (IQR 2.9-9.3) years and had a median CD4 cell count of 665 (IQR 543-829) cells/mm3. The ongoing regimen included PI/r in 29 cases and NNRTI in 71 cases. At 48 weeks, 96% of participants (95% CI 90%-98%) had no failure while remaining on the 4-days-a-week regimen. Virological failure occurred in three participants, who all resumed daily treatment and became resuppressed. One participant stopped the strategy. No severe treatment-related events occurred. Conclusions: Antiretroviral maintenance therapy 4 days a week was effective for 48 weeks in 96% of patients, leading to potential reduction of long-term toxicities, high adherence to the antiretroviral regimen and drug cost saving.
[hal-02081094] Recommandations de bonne pratique pour la prise en charge de la maladie veineuse thromboembolique chez l’adulte. Version courte
Date: 27 Mar 2019 - 11:44
Desc: [...]
[hal-01987723] Prévention des évènements thromboemboliques veineux par fondaparinux 2,5mg chez des patients hospitalisés pour une affection médicale aiguë. Étude ArchiMed. ArchiMed hôpital étude observationnelle d'usage du fondaparinux 2,5mg en vie réelle ; 718 patients inclus par 107 pharmaciens hospitaliers.
Date: 21 jan 2019 - 15:02
Desc: OBJECTIVE: To evaluate the average duration of in-hospital treatment with fondaparinux 2.5mg prescribed for venous thromboprophylaxis in acutely ill medical patients and to describe the treatment population. METHODS: Prospective, observational, national, multicentre, epidemiological study, performed in France at the request of the Transparency Commission of the French National Health Authority (Haute Autorité de Santé). This is part of a larger study program that also included a study with similar design in the general practice setting. The hospital practice part of the study was conducted by hospital pharmacists who were asked to include the first 15 adult subjects hospitalized in a non-surgical ward for whom fondaparinux 2.5mg was initiated for prophylaxis. RESULTS: Fifty-three pharmacists (49.5%) included a total of 718 patients. The average age was 71 ± 16 years (47%<75 years old); 54% were women. For 41% of patients, duration of fondaparinux 2.5mg administration ranged from 6 to 14 days. Eighty-five percent of patients had at least one acute illness related to the prescription of fondaparinux 2.5mg for thromboprophylaxis. Ten percent of the population had at least one risk factor listed on the Case Report Form. Characteristics of patients from the hospital practice study differ from those included in the general practice part of the ArchiMed Study program. CONCLUSION: The hospital practice part of the ArchiMed Study, which is similar to "audits of practices", shows that the real-life conditions of prescription of fondaparinux 2.5mg in patients hospitalized are generally in line with guidelines with respect to indication for thromboprophylaxis in acute medical illness.