Dead Space Closure with Quilting Suture versus Conventional Closure with Drainage for the Prevention of Seroma after Mastectomy for Breast Cancer (QUISERMAS): Protocol for a Multicentre Randomised Controlled Trial

International audienceINTRODUCTION: Postoperative wound seroma is common after mastectomy. This complication is associated with significant impact on patient outcomes and healthcare costs. The optimal closure approach for seroma prevention remains unknown but some evidence suggests that quilting suture of the dead space could lower the incidence of seroma. The aim of this trial is to compare seroma formation using quilting suture versus conventional closure with drainage in patients undergoing mastectomy. METHODS AND ANALYSIS: This is a multicentre, superiority, randomised controlled trial in women undergoing mastectomy with or without axillary involvement. Exclusion criteria include indication of bilateral mastectomy or immediate reconstruction and any physical or psychiatric condition that could impair patient's ability to cooperate with postoperative data collection or that do not allow an informed consent. 320 participants will be randomised in a 1:1 ratio to receive either quilting suture or conventional wound closure with drain. The primary outcome is seroma requiring either aspiration or surgical intervention within 21\hspace0.25emdays following mastectomy. Secondary outcomes include seroma regardless of whether or not it requires an intervention, surgical site infection, pain score, cosmetic result, patient's quality of life, costs and cost-effectiveness. The primary analysis will be an intention-to treat analysis performed with a χ(2) test (or Fisher's exact test). ETHICS AND DISSEMINATION: Written informed consent will be obtained from all participants. This study was approved by Tours Research ethics committee (CPP TOURS-Region Centre-Ouest 1, 2014-R20, 16 December 2014). Study findings will be published in peer-reviewed journals and presented at relevant national and international breast cancer conferences. TRIAL REGISTRATION NUMBER: NCT02263651

Connaissances, attitudes et pratiques des parents face à la vaccination contre la poliomyélite à Abéché-Tchad

Introduction: au Tchad, la transmission de la poliomyélite a été interrompue en 2000, mais les importations à partir du Nigéria et la faiblesse des couvertures vaccinales constituent un risque majeur de relance de la maladie. L'objectif de ce travail était d'analyser les connaissances, attitudes et pratiques des parents vis-à-vis de la vaccination contre la poliomyélite des enfants âgés de 0 à 5 ans au Tchad. Méthodes: cette étude transversale a été réalisée dans les six arrondissements d'Abéché. Seuls les ménages qui avaient des enfants de moins de 5 ans ont été inclus. Les données ont été recueillies par des entretiens avec les parents et tuteurs d'enfants éligibles à l'aide d'un questionnaire testé et validé. Résultats: nous avons interrogé 210 ménages. Aucune famille ne possédait de carnet de vaccination de leurs enfants. Cependant, 97% ont déclaré avoir des enfants ayant participé aux campagnes de vaccination de masse. Près de 97% connaissaient la poliomyélite et 98% avaient entendu parler des campagnes de vaccination. Les canaux d'information les plus cités étaient la radio (98%) et les agents vaccinateurs (72%). Seul 3% des parents interrogés ont déclaré avoir refusé la vaccination. Il existait une association entre l'influence négative de l'entourage et la non vaccination des enfants (p = 0,005). Conclusion: les connaissances sur la maladie et le vaccin sont bonnes au Tchad malgré l'existence de rumeurs concernant notamment les effets des vaccins. L'absence de carnet de vaccination a limité l'analyse des résultats de l'enquête, uniquement déclarative avec un taux de vaccination très élevé déclaré. Dans le cadre de l'éradication, le carnet est indispensable pour accompagner la politique de prévention

Connaissances, attitudes et pratiques des parents face à la vaccination contre la poliomyélite à Abéché-Tchad

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Obstacles à l’utilisation de la planification familiale dans les pays en développement : revue systématique de la littérature.

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Vers l’éradication de la poliomyélite dans les pays en développement : freins et leviers.

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Use of Female Contraception, Mixed and Multicentric Study in Chad

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Implementing a personalized pharmaceutical plan in kidney or liver transplant patients: study protocol for a stepped-wedge cluster randomized trial (GRePH)

International audienceBackground: Nowadays, the main challenge of transplantation is the improvement of long-term care, aiming at reducing treatment-related complications and at decreasing rejection rates. Patients' adherence to both treatment and hygienic-dietary measures is mandatory to achieve these objectives. Adherence to immunosuppressive drugs is estimated to be only 70%. We hypothesized that the implementation of a personalized pharmaceutical plan (PPP) would increase adherence and therefore graft survival.Methods/design: This study is a stepped-wedge cluster randomized trial with transplantation units defining clusters. Twelve clusters from 10 university hospitals were recruited. All centres started on the same day in the control phase. Every 7 weeks, one centre will switch to the intervention phase and remain there until the end of inclusions. We plan to recruit 1716 kidney and/or liver transplant patients. The intervention phase consists in setting up the PPP: development of the patient's hospital and community pharmaceutical follow-up. In the hospital, the pharmacist will carry out drug reconciliation upon admission, daily pharmaceutical follow-up of prescriptions and pharmaceutical interviews with the patient in order to explain the modalities of taking immunosuppressive drugs and hygienic-dietary measures. After hospitalization, during the post-transplantation year, pharmaceutical meetings will take place, prior to medical consultations in order to check the patient's understanding of the prescription, his adherence, to remind them of hygienic-dietary measures and to look for adverse effects. The hospital pharmacist will also be in charge of establishing a close link with the community pharmacist (CP) and general practitioner, especially providing discharge medication reconciliation, an e-learning and a checklist. Moreover, prior to each pharmaceutical consultation, the hospital pharmacist will contact the CP to discuss patient adherence. The primary outcome is adherence to immunosuppressive treatments 1 year post-transplantation assessed by using the BAASIS questionnaire and the health insurance data from the national health data system. A medico-economic study will measure the efficiency of this plan.Discussion: GRePH aims to increase adherence of liver and/or kidney transplant patients to their immunosuppressive therapies in order to reduce transplant rejections. To this end, a new clinical pharmacy model, the PPP, will be set up in 10 university hospitals

A Home-Mailed Versus General Practitioner-Delivered Vaginal Self-Sampling Kit for Cervical Cancer Screening: A Cluster Randomized Controlled Trial with a Cost-Effectiveness Analysis

International audienceObjective: We assessed whether general practitioner (GP) delivery of a vaginal self-sampling kit was non-inferior to home-mailed delivery on cervical cancer screening (CCS) participation. Methods: Two hundred and ten French GPs from Indre-et-Loire French department were randomized into two groups, and their unscreened women patients aged 30-65 were included in February-March 2015. In the GP delivery group (n = 105 GPs; 1,806 women), women were sent a reminder letter inviting them to collect a vaginal self-sampling kit at their regular GP's practice. In the home-mailed delivery group (n = 105 GPs; 1,806 women), women were sent a reminder letter with a vaginal self-sampling kit directly at home. The primary outcome was participation in complete CCS within 9 months. A cost-effectiveness analysis was also performed. Results: At 9 months, 14.9% (95% CI: 12.9-16.9) and 27.9% (95% CI: 25.7-30.0) of women in the GP and home-mailed delivery groups participated in complete CCS. The absolute between-group difference was -13.0 percentage points (95% CI: -15.9 to -10.0) in favor of the home-mailed delivery group, crossing the non-inferiority pre-defined non-inferiority margin of 5%. The home-mailed delivery strategy cost 50.81€ more per additional woman screened. Conclusions: The GP delivery was inferior to home-mailed delivery in increasing participation in CCS. Home-mailed delivery of a vaginal self-sampling kit is a cost-effective way to increase CCS in that the additional cost of this strategy seems acceptable. This study is registered at www.Clinicaltrials.gov NCT02255084

Relevance of Adopting a Hybrid Strategy Mixing Single-Use and Reusable Ureteroscopes for Stones Management: An Economic Study to Support the Best Strategy

International audienceEndoscopic procedures such as ureteroscopy (URS) have seen a recent increase in single-use devices. Despite all the advantages provided by disposable ureteroscopes (sURSs), their cost effectiveness remains questionable, leading most teams to use a hybrid strategy combining reusable (rURS) and disposable devices. Our study aimed to create an economic model that estimated the cut-off value of rURS procedures needed to support the profitability of a hybrid strategy (HS) for ureteroscopy. We used a budget impact analysis (BIA) model that estimated the financial impact of an HS compared to 100% sURS use. The model included hospital volume, sterilization costs and the private or public status of the institution. Although the hybrid strategy generally remains the best economic and clinical option, a predictive BIA model is recommended for the decision-making. We found that the minimal optimal proportion of rURS procedures in an HS was mainly impacted by the activity volume and overall number of sterilization procedures. Private and public institutions must consider these variables and models in order to adapt their HS and remain profitable