The main objective of the study was to evaluate the rates of de novo stress urinary (SUI) and pos... more The main objective of the study was to evaluate the rates of de novo stress urinary (SUI) and postoperative dyspareunia after both sacrocolpopexy/hysteropexy (SCP) and vaginal mesh surgery. A prospective, multicenter, randomized, open-label study with two parallel groups treated by either SCP or Uphold Lite vaginal mesh was carried out. Study participants were ≥ 50 and < 80 years old patients with Pelvic Organ Prolapse Quantification (POP-Q) stage ≥2 who were considered eligible for reconstructive surgery and who were sexually active with no dyspareunia and free from bothersome SUI at presentation. Women were assessed before surgery and at 4–8 weeks and 11–13 months after using validated measures including POP-Q, Pelvic Floor Disability Index (PFDI-20), Pelvic Floor Impact Questionnaire (PFIQ-7), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR), and Patient Global Impression of Improvement (PGI-I). Data were also collected for health economics evaluation. Of the required sample of 156 women, 42 women (19 SCP and 23 vaginal mesh) were only recruited owing to the discontinuation of vaginal mesh worldwide. The median follow-up was 376 days. The rates of bothersome de novo SUI were similar in the SCP and Uphold vaginal mesh groups (15.79 vs 15.00%, OR 0.95 [95% CI 0.22–4.14]). Among 30 sexually active patients at follow-up, the rates of women reporting de novo dyspareunia “usually or always” were 6.7% after SCP vs 13.3% after vaginal mesh (p = 1). Health economics evaluation showed a cost saving of 280€ in favor of the Uphold vaginal mesh technique, but no significant difference in the total cost (2,934.97€ for SCP vs 3,053.26€ for Uphold vaginal mesh). Bothersome de novo SUI and de novo dyspareunia occurred in approximately 15% and 23% of our study cohorts, with no significant difference between sacrocolpopexy/hysteropexy and anterior/apical vaginal mesh surgery. However, these results should be interpreted with caution owing to the small sample size.
Journal de gestion et d'economie de la santé, 2021
Introduction - L’étude OCCO (Outpatient Care-Cost Optimization) porte sur l’optimisation du finan... more Introduction - L’étude OCCO (Outpatient Care-Cost Optimization) porte sur l’optimisation du financement des prises en charge ambulatoires non couvertes par la circulaire frontière. Son objectif est de proposer un modèle innovant d’organisation et de financement de ces prises en charge. Le présent travail, vise à quantifier l’impact de la mise en œuvre d’une nouvelle solution de financement à travers l’exemple de la prise en charge diagnostique de la syncope. Méthodes – La méthodologie des arbres de décision a été utilisée pour estimer et comparer les coûts globaux des différentes stratégies de financement. Une analyse de Monte Carlo probabiliste a été réalisée et une analyse de sensibilité a permis d’appréhender la robustesse des résultats. Résultats - Le coût moyen de prise en charge dans la stratégie actuelle est estimé à 888€ (sd=92€) contre 854€ (sd=73€) dans la stratégie de demain incluant la nouvelle solution de financement des soins à hauteur d’un financement forfaitaire comp...
Additional file 1: Table S1. Profile of subjects from the EPICAP cohort contacted and included in... more Additional file 1: Table S1. Profile of subjects from the EPICAP cohort contacted and included in this study.
SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related docu... more SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents*. (DOCX 48 kb)
67 Background: Prostate cancer (PCa) is the most common cancer in men. Former studies showed a ti... more 67 Background: Prostate cancer (PCa) is the most common cancer in men. Former studies showed a time-dependent worsening of sexual or urinary long term side effects following surgery or radiotherapy that affected patients’ quality of life (QoL). These studies could not discriminate between age-related and treatment-related symptoms, as patients were their own controls. We conducted a case-control study evaluating at 3 years QoL and physical/psychological dysfunctions, whereas patients were on watchful waiting or received a treatment. Methods: We used data from the EPICAP population-based case-control carried out by INSERM and including 1700 participants. Eligible cases were men < 75 years old newly diagnosed with PCa in 2012-2014 living in the Hérault geographic area. Controls were men of the same age recruited in the general population of the same area. Participants answered a QoL questionnaire 3 years after intervention. Primary objective was to compare the impact of diagnosis o...
Le manque de temps a consacrer aux soins est une doleance frequente dans les equipes en charge de... more Le manque de temps a consacrer aux soins est une doleance frequente dans les equipes en charge des soins infirmiers et aides-soignants Les resultats d’une etude suggerent qu’une amelioration de l’etat nutritionnel des residents d’Ehpad pourrait contribuer a ameliorer leur qualite de vie et a optimiser le temps de travail des equipes soignantes, grâce a la reduction des escarres, des diarrhees, des chutes, des fractures et des infections. (R.E.)
Clinical pharmaceutical care has long played an important role in the improvement of healthcare s... more Clinical pharmaceutical care has long played an important role in the improvement of healthcare safety. Pharmaceutical care is a collaborative care approach, implicating all the actors of the medication circuit in order to prevent and correct drug-related problems that can lead to adverse drug events. The collaborative pharmaceutical care performed during patients' hospitalization requires two mutually reinforcing activities: medication reconciliation and medication review. Until now, the impact of the association of these two activities has not been clearly studied. This is a multicentric stepped wedge randomized study involving six care units from six French University Hospitals (each unit corresponding to a cluster) over seven consecutive 14-day periods. Each hospital unit will start with a control period and switch to an experimental period after a randomized number of 14-day periods. Patients aged at least 65 years hospitalized in one of the participating care units and hav...
Introduction Les alterations de la sante orale aggravent le risque de denutrition, avec une lassi... more Introduction Les alterations de la sante orale aggravent le risque de denutrition, avec une lassitude liee aux aliments mous et mixes. C’est pourquoi un CNO solide sous forme de petites galettes hyperprotidiques et hypercaloriques ayant une texture innovante lui permettant d’etre croque et mastique meme par des personnes ayant un mauvais etat bucco-dentaire (Galettes Protibis, Solidages, France) a ete mis au point. Un essai clinique randomise multicentrique aupres de 175 residents d’Ehpad a valide son efficacite avec une augmentation du poids, une diminution des diarrhees et une cicatrisation plus rapide des escarres (Pouyssegur et al., 2014). Les sujets du groupe Galettes ont recu en supplement huit galettes de 6,5 g/j (11,5 g de proteines, 244 kcal) pendant six semaines. L’objectif est d’effectuer une evaluation medico-economique pour estimer l’impact de l’introduction des galettes « Protibis » sur le cout de prise en charge et de comparer ce cout de prise en charge a celui des patients ne recevant pas ce type de galettes. Methodes (1) Etude a posteriori de minimisation de couts a partir de la base de donnees de l’etude clinique (simulation de Monte-Carlo) ; (2) Avis d’experts (methode Delphi) pour estimer le cout de la prise en charge des diarrhees, escarres, infections et chutes ; (3) Methodologie des arbres de decision, simulation de Monte Carlo, analyse de sensibilite et graphique de Tornado. Resultats Pour l’Assurance maladie, la difference de cout moyen par patient avec une prise en charge standard etait de −191 € [−660,47 € ; 265,89 €], p = 0,76 (versus −312€ [−989€ ; 355€], p = 0,82 en prise en charge a 100 %) sur 18 semaines en faveur de la strategie Galettes. Cette difference n’etait pas significative, mais sur les 10 000 simulations realisees, la strategie Galettes etait preferee dans 79 % des cas (versus 81 % en prise en charge a 100 %). Les couts etaient principalement des frais d’hospitalisation (67,5 %) et de consultations (26,3 %). L’analyse de sensibilite montre que les resultats obtenus sont robustes malgre les variations introduites sur les parametres influencant. Pour l’Ehpad, l’etude a montre une difference de 30 mn/jour/patient en moyenne en faveur du bras Galettes en temps de sollicitation du personnel infirmier/aide-soignant. Discussion La revue de la litterature a montre l’absence de donnees de couts concernant les evenements valorises (escarres, diarrhees, infections, chutes). Le recours a la methodologie Delphi dans notre etude apporte des elements de reponse non negligeables. Le caractere declaratif de ces donnees devrait cependant donner lieu a de nouvelles etudes basees sur des donnees observees. Conclusion L’etude medico-economique a montre que la strategie Galettes etait aussi dominante en termes de cout et de temps passe par le personnel infirmier/aide-soignant sur un horizon temporel fixe a 18 semaines. Ainsi, le cout supplementaire genere par ce nouveau CNO solide dans les soins habituels a ete compense par des economies realisees grâce a l’amelioration de l’etat nutritionnel des residents.
BackgroundChronic obstructive pulmonary disease (COPD) is an irreversible chronic respiratory dis... more BackgroundChronic obstructive pulmonary disease (COPD) is an irreversible chronic respiratory disease whose evolution depends on the patient’s adherence to inhaler devices. Pharmacists may play a role in adherence to medication therapy in hospital and in primary care interacting with patients to provide advice on proper use. This paper presents the protocol for a randomized controlled trial conducted at a university hospital to assess the clinical impact of pharmaceutical consultations on COPD exacerbations, medical care, adherence to inhaler devices and quality of life. MethodsThis trial will include 226 COPD patients treated with inhaler devices: 94 in a control group with the usual hospital care, 66 receiving a pharmaceutical consultation at the hospital and 66 receiving several pharmaceutical consultations at their community pharmacy. The aim of these interventions is to inform patients about COPD and medication therapy, train them in the proper use of inhaler devices and make t...
The main objective of the study was to evaluate the rates of de novo stress urinary (SUI) and pos... more The main objective of the study was to evaluate the rates of de novo stress urinary (SUI) and postoperative dyspareunia after both sacrocolpopexy/hysteropexy (SCP) and vaginal mesh surgery. A prospective, multicenter, randomized, open-label study with two parallel groups treated by either SCP or Uphold Lite vaginal mesh was carried out. Study participants were ≥ 50 and < 80 years old patients with Pelvic Organ Prolapse Quantification (POP-Q) stage ≥2 who were considered eligible for reconstructive surgery and who were sexually active with no dyspareunia and free from bothersome SUI at presentation. Women were assessed before surgery and at 4–8 weeks and 11–13 months after using validated measures including POP-Q, Pelvic Floor Disability Index (PFDI-20), Pelvic Floor Impact Questionnaire (PFIQ-7), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR), and Patient Global Impression of Improvement (PGI-I). Data were also collected for health economics evaluation. Of the required sample of 156 women, 42 women (19 SCP and 23 vaginal mesh) were only recruited owing to the discontinuation of vaginal mesh worldwide. The median follow-up was 376 days. The rates of bothersome de novo SUI were similar in the SCP and Uphold vaginal mesh groups (15.79 vs 15.00%, OR 0.95 [95% CI 0.22–4.14]). Among 30 sexually active patients at follow-up, the rates of women reporting de novo dyspareunia “usually or always” were 6.7% after SCP vs 13.3% after vaginal mesh (p = 1). Health economics evaluation showed a cost saving of 280€ in favor of the Uphold vaginal mesh technique, but no significant difference in the total cost (2,934.97€ for SCP vs 3,053.26€ for Uphold vaginal mesh). Bothersome de novo SUI and de novo dyspareunia occurred in approximately 15% and 23% of our study cohorts, with no significant difference between sacrocolpopexy/hysteropexy and anterior/apical vaginal mesh surgery. However, these results should be interpreted with caution owing to the small sample size.
Journal de gestion et d'economie de la santé, 2021
Introduction - L’étude OCCO (Outpatient Care-Cost Optimization) porte sur l’optimisation du finan... more Introduction - L’étude OCCO (Outpatient Care-Cost Optimization) porte sur l’optimisation du financement des prises en charge ambulatoires non couvertes par la circulaire frontière. Son objectif est de proposer un modèle innovant d’organisation et de financement de ces prises en charge. Le présent travail, vise à quantifier l’impact de la mise en œuvre d’une nouvelle solution de financement à travers l’exemple de la prise en charge diagnostique de la syncope. Méthodes – La méthodologie des arbres de décision a été utilisée pour estimer et comparer les coûts globaux des différentes stratégies de financement. Une analyse de Monte Carlo probabiliste a été réalisée et une analyse de sensibilité a permis d’appréhender la robustesse des résultats. Résultats - Le coût moyen de prise en charge dans la stratégie actuelle est estimé à 888€ (sd=92€) contre 854€ (sd=73€) dans la stratégie de demain incluant la nouvelle solution de financement des soins à hauteur d’un financement forfaitaire comp...
Additional file 1: Table S1. Profile of subjects from the EPICAP cohort contacted and included in... more Additional file 1: Table S1. Profile of subjects from the EPICAP cohort contacted and included in this study.
SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related docu... more SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents*. (DOCX 48 kb)
67 Background: Prostate cancer (PCa) is the most common cancer in men. Former studies showed a ti... more 67 Background: Prostate cancer (PCa) is the most common cancer in men. Former studies showed a time-dependent worsening of sexual or urinary long term side effects following surgery or radiotherapy that affected patients’ quality of life (QoL). These studies could not discriminate between age-related and treatment-related symptoms, as patients were their own controls. We conducted a case-control study evaluating at 3 years QoL and physical/psychological dysfunctions, whereas patients were on watchful waiting or received a treatment. Methods: We used data from the EPICAP population-based case-control carried out by INSERM and including 1700 participants. Eligible cases were men < 75 years old newly diagnosed with PCa in 2012-2014 living in the Hérault geographic area. Controls were men of the same age recruited in the general population of the same area. Participants answered a QoL questionnaire 3 years after intervention. Primary objective was to compare the impact of diagnosis o...
Le manque de temps a consacrer aux soins est une doleance frequente dans les equipes en charge de... more Le manque de temps a consacrer aux soins est une doleance frequente dans les equipes en charge des soins infirmiers et aides-soignants Les resultats d’une etude suggerent qu’une amelioration de l’etat nutritionnel des residents d’Ehpad pourrait contribuer a ameliorer leur qualite de vie et a optimiser le temps de travail des equipes soignantes, grâce a la reduction des escarres, des diarrhees, des chutes, des fractures et des infections. (R.E.)
Clinical pharmaceutical care has long played an important role in the improvement of healthcare s... more Clinical pharmaceutical care has long played an important role in the improvement of healthcare safety. Pharmaceutical care is a collaborative care approach, implicating all the actors of the medication circuit in order to prevent and correct drug-related problems that can lead to adverse drug events. The collaborative pharmaceutical care performed during patients' hospitalization requires two mutually reinforcing activities: medication reconciliation and medication review. Until now, the impact of the association of these two activities has not been clearly studied. This is a multicentric stepped wedge randomized study involving six care units from six French University Hospitals (each unit corresponding to a cluster) over seven consecutive 14-day periods. Each hospital unit will start with a control period and switch to an experimental period after a randomized number of 14-day periods. Patients aged at least 65 years hospitalized in one of the participating care units and hav...
Introduction Les alterations de la sante orale aggravent le risque de denutrition, avec une lassi... more Introduction Les alterations de la sante orale aggravent le risque de denutrition, avec une lassitude liee aux aliments mous et mixes. C’est pourquoi un CNO solide sous forme de petites galettes hyperprotidiques et hypercaloriques ayant une texture innovante lui permettant d’etre croque et mastique meme par des personnes ayant un mauvais etat bucco-dentaire (Galettes Protibis, Solidages, France) a ete mis au point. Un essai clinique randomise multicentrique aupres de 175 residents d’Ehpad a valide son efficacite avec une augmentation du poids, une diminution des diarrhees et une cicatrisation plus rapide des escarres (Pouyssegur et al., 2014). Les sujets du groupe Galettes ont recu en supplement huit galettes de 6,5 g/j (11,5 g de proteines, 244 kcal) pendant six semaines. L’objectif est d’effectuer une evaluation medico-economique pour estimer l’impact de l’introduction des galettes « Protibis » sur le cout de prise en charge et de comparer ce cout de prise en charge a celui des patients ne recevant pas ce type de galettes. Methodes (1) Etude a posteriori de minimisation de couts a partir de la base de donnees de l’etude clinique (simulation de Monte-Carlo) ; (2) Avis d’experts (methode Delphi) pour estimer le cout de la prise en charge des diarrhees, escarres, infections et chutes ; (3) Methodologie des arbres de decision, simulation de Monte Carlo, analyse de sensibilite et graphique de Tornado. Resultats Pour l’Assurance maladie, la difference de cout moyen par patient avec une prise en charge standard etait de −191 € [−660,47 € ; 265,89 €], p = 0,76 (versus −312€ [−989€ ; 355€], p = 0,82 en prise en charge a 100 %) sur 18 semaines en faveur de la strategie Galettes. Cette difference n’etait pas significative, mais sur les 10 000 simulations realisees, la strategie Galettes etait preferee dans 79 % des cas (versus 81 % en prise en charge a 100 %). Les couts etaient principalement des frais d’hospitalisation (67,5 %) et de consultations (26,3 %). L’analyse de sensibilite montre que les resultats obtenus sont robustes malgre les variations introduites sur les parametres influencant. Pour l’Ehpad, l’etude a montre une difference de 30 mn/jour/patient en moyenne en faveur du bras Galettes en temps de sollicitation du personnel infirmier/aide-soignant. Discussion La revue de la litterature a montre l’absence de donnees de couts concernant les evenements valorises (escarres, diarrhees, infections, chutes). Le recours a la methodologie Delphi dans notre etude apporte des elements de reponse non negligeables. Le caractere declaratif de ces donnees devrait cependant donner lieu a de nouvelles etudes basees sur des donnees observees. Conclusion L’etude medico-economique a montre que la strategie Galettes etait aussi dominante en termes de cout et de temps passe par le personnel infirmier/aide-soignant sur un horizon temporel fixe a 18 semaines. Ainsi, le cout supplementaire genere par ce nouveau CNO solide dans les soins habituels a ete compense par des economies realisees grâce a l’amelioration de l’etat nutritionnel des residents.
BackgroundChronic obstructive pulmonary disease (COPD) is an irreversible chronic respiratory dis... more BackgroundChronic obstructive pulmonary disease (COPD) is an irreversible chronic respiratory disease whose evolution depends on the patient’s adherence to inhaler devices. Pharmacists may play a role in adherence to medication therapy in hospital and in primary care interacting with patients to provide advice on proper use. This paper presents the protocol for a randomized controlled trial conducted at a university hospital to assess the clinical impact of pharmaceutical consultations on COPD exacerbations, medical care, adherence to inhaler devices and quality of life. MethodsThis trial will include 226 COPD patients treated with inhaler devices: 94 in a control group with the usual hospital care, 66 receiving a pharmaceutical consultation at the hospital and 66 receiving several pharmaceutical consultations at their community pharmacy. The aim of these interventions is to inform patients about COPD and medication therapy, train them in the proper use of inhaler devices and make t...
Uploads
Papers by Sophie Bouvet