Impact of RSV test positivity, patient characteristics, and treatment characteristics on the cost of hospitalization for acute bronchiolitis in a French university medical center (2010-2015).

Background: In young children, respiratory syncytial virus (RSV)-related bronchiolitis is typically more severe than other respiratory tract infections, with a greater need for oxygen therapy and respiratory support. Few studies have compared the cost of hospitalization with regard to virological status. The objective of this study was to compare the costs of hospitalization for RSV-positive vs.

Economic burden and health-related quality-of-life among infants with respiratory syncytial virus infection: A multi-country prospective cohort study in Europe.

Background: Respiratory syncytial virus (RSV) causes a considerable disease burden in young children globally, but reliable estimates of RSV-related costs and health-related quality-of-life (HRQoL) are scarce. This study aimed to evaluate the RSV-associated costs and HRQoL effects in infants and their caregivers in four European countries.

Methods: Healthy term-born infants were recruited at birth and actively followed up in four European countries.

The Optimal Sample Size for Usability Testing, From the Manufacturer's Perspective: A Value-of-Information Approach.

Objectives: For medical devices, a usability assessment is mandatory for market access; the objective is to detect potentially harmful use errors that stem from the device's design. The manufacturer assesses the final version of the device and determines the risk-benefit ratio for remaining errors. Nevertheless, the decision rule currently used to determine the sample size for this testing has statistical limitations and the lack of a clear decision-making perspective.

Estimating the number of usability problems affecting medical devices: modelling the discovery matrix.

Background: Usability testing of medical devices are mandatory for market access. The testings' goal is to identify usability problems that could cause harm to the user or limit the device's effectiveness. In practice, human factor engineers study participants under actual conditions of use and list the problems encountered.

Efficacy and Safety of the Duodeno-Jejunal Bypass Liner in Patients With Metabolic Syndrome: A Multicenter Randomized Controlled Trial (ENDOMETAB).

Objective: The aim of this study was to compare the efficacy and safety of 12-month implantation of a duodeno-jejunal bypass liner (DJBL) with conventional medical care in patients with metabolic syndrome (MS).

Summary Background Data: DJBL is an endoscopic device for treating obesity and related disorders. The persistence of favorable results after 6 months has not been tested in a controlled study.

Optical Coherence Tomography Contribution Assessment in the Revascularization of Long Femoropopliteal Occlusive Lesions (TASC C and D): A Randomized Trial.

Background: Endovascular treatment has become the first-line revascularization technique for femoropopliteal lesions. This technique lacks reliable and accurate morphological control of the arterial segment treated. Intraoperative 2-dimensional angiogram consumes iodinated contrast media and increases X-ray exposure; this subsequently provides no 3-dimensional information on the quality of the revascularization completed, what could explain some of the early and late failures of the technique.

Enteral versus parenteral nutrition in the conservative treatment of upper gastrointestinal fistula after surgery: a multicenter, randomized, parallel-group, open-label, phase III study (NUTRILEAK study).

Background: Postoperative upper gastrointestinal fistula (PUGIF) is a devastating complication, leading to high mortality (reaching up to 80%), increased length of hospital stay, reduced health-related quality of life and increased health costs. Nutritional support is a key component of therapy in such cases, which is related to the high prevalence of malnutrition. In the prophylactic setting, enteral nutrition (EN) is associated with a shorter hospital stay, a lower incidence of severe infectious complications, lower severity of complications and decreased cost compared to total parenteral nutrition (TPN) following major upper gastrointestinal (GI) surgery.

Effect of multi-lumen perfusion line on catheter-related bacteremia in premature infants: study protocol for a cluster-randomized crossover trial.

Background: Catheter-related bacteremia (CRB) is the most frequent nosocomial infection in neonatal intensive care unit (NICU) patients, especially in very low-birth-weight infants. Administration of injectable drugs in premature newborn infants has many particularities and several types of infusion incidents have been reported. The Edelvaiss® Multiline NEO device is a novel multi-lumen access infusion device adapted to the specificities of infusion in neonatology.

Impact of Centralized Management of Bariatric Surgery Complications on 90-day Mortality.

Background And Aims: The potential benefit of the centralization of Bariatric surgery (BS) remains debated. The aim of this study was to evaluate the impact on 90-day mortality of an innovative organization aiming at centralizing the care of severe postoperative complications of BS.

Study Design: The centralization of care for postoperative complication after BS was implemented by French Authorities in 2013 in the Nord-Pas-de-Calais Region, France.

Resurgence risk for measles, mumps and rubella in France in 2018 and 2020.

BackgroundLarge measles and mumps outbreaks recently occurred throughout Europe and the United States. : Our aim was to estimate and map the risk of resurgence for measles, mumps and rubella in France. : We used a multi-cohort model combining seroprevalence information, vaccine coverage and social contact data.

Requests for post-registration studies (PRS), patients follow-up in actual practice: Changes in the role of databases.

Early market access of health products is associated with a larger number of requests for information by the health authorities. Compared with these expectations, the growing expansion of health databases represents an opportunity for responding to questions raised by the authorities. The computerised nature of the health system provides numerous sources of data, and first and foremost medical/administrative databases such as the French National Inter-Scheme Health Insurance Information System (SNIIRAM) database.

Biomarker-based strategy for early discontinuation of empirical antifungal treatment in critically ill patients: a randomized controlled trial.

Purpose: The aim of this study was to determine the impact of a biomarker-based strategy on early discontinuation of empirical antifungal treatment.

Methods: Prospective randomized controlled single-center unblinded study, performed in a mixed ICU. A total of 110 patients were randomly assigned to a strategy in which empirical antifungal treatment duration was determined by (1,3)-β-D-glucan, mannan, and anti-mannan serum assays, performed on day 0 and day 4; or to a routine care strategy, based on international guidelines, which recommend 14 days of treatment.

What is the budget impact of a new treatment or new health technology arriving on the market?

In France, market access for innovative drugs (level I, II & III improvement of medical service rendered having significant impact on health insurance expenditure) involves medico-economic evaluation. In addition to cost-effectiveness analysis (CEA), budget impact analysis (BIA) can be performed, especially since the sustainability of the health insurance system has become a growing concern for all stakeholders. The members of the Giens 2016 round table discussed the contribution of BIA based on a review of the literature on distribution models, the participants' experiences including experience related to the modalities of hospital assessments, and examples from other countries.

Cost-Effectiveness Analysis of Five Competing Strategies for the Management of Multiple Recurrent Community-Onset Clostridium difficile Infection in France.

Background: Clostridium difficile infection (CDI) is characterized by high rates of recurrence, resulting in substantial health care costs. The aim of this study was to analyze the cost-effectiveness of treatments for the management of second recurrence of community-onset CDI in France.

Methods: We developed a decision-analytic simulation model to compare 5 treatments for the management of second recurrence of community-onset CDI: pulsed-tapered vancomycin, fidaxomicin, fecal microbiota transplantation (FMT) via colonoscopy, FMT via duodenal infusion, and FMT via enema.

What timing of vaccination is potentially dangerous for children younger than 2 years?

Vaccine-preventable diseases still occur although measured coverage rates at 2 y of age are high. The occurrence of these diseases may be explained in part by untimely, that is, late vaccination. Our objective was to identify potentially dangerous vaccination delays for each dose of each vaccine in children younger than 2 y.

Epidemiological impact and cost-effectiveness of introducing vaccination against serogroup B meningococcal disease in France.

Introduction: Despite its low incidence in France, invasive serogroup B meningococcal disease remains a public health concern. A new vaccine against the disease, Bexsero(®), has been licensed in the EU. We studied the epidemiological impact and cost-effectiveness of routine vaccination using Bexsero(®) in order to inform the decision-making process regarding its potential inclusion in the vaccination schedule.

Transfusion strategy in hematological intensive care unit: study protocol for a randomized controlled trial.

Background: Packed red blood cell (PRBC) transfusion is required in hematology patients treated with chemotherapy for acute leukemia, autologous (auto) or allogeneic (allo) hematopoietic stem cell transplantation (HSCT). In certain situations like septic shock, hip surgery, coronary disease or gastrointestinal hemorrhage, a restrictive transfusion strategy is associated with a reduction of infection and death. A transfusion strategy using a single PRBC unit has been retrospectively investigated and showed a safe reduction of PRBC consumption and costs.