Clinical Trial Protocol for ACCURATE: A CCafU-UroCCR Randomized Trial: Three-dimensional Image-guided Robot-assisted Partial Nephrectomy for Renal Complex Tumor (UroCCR 99).

Background And Objective: Renal cancer often requires nephron-sparing surgery for optimal patient outcomes. Despite advances in imaging and robot-assisted surgery, there is a need to enhance surgical precision and renal preservation. This trial evaluates the effectiveness of three-dimensional image-guided robot-assisted partial nephrectomy versus standard methods in improving surgical outcomes.

Rationale and design of the multicentric randomized EVAOLD trial: Evaluation of a strategy guided by imaging versus routine invasive strategy in elderly patients with ischemia.

Background: The management of myocardial infarction without ST segment elevation (NSTEMI) in elderly patients remains challenging, in particular the benefit/risk balance of routine revascularization remains uncertain.

Study Design: EVAOLD is s a multicenter, prospective, open-label trial with 2 parallel arms in NSTEMI patients ≥80 years of age. The aim of the trial is to test whether a strategy of selective invasive management guided by ischemia stress imaging (IMG group) will be noninferior in preventing Major Adverse Cardiac and Cerebrovascular Events (MACCE, ie all-cause death, nonfatal myocardial infarction, nonfatal stroke) rates at 1 year compared with a routine invasive strategy (INV Group).

The Incident Feedback Committee (IFC): A Useful Tool to Investigate Errors in Clinical Research.

Unlabelled: In clinical practice, an objective of safety management is to identify preventable causes of adverse events to avoid the incidents from recurring. Likewise, in the field of clinical research adequate methods to investigate incidents that impair the quality of a clinical trial are needed. Understanding the causes of errors and undesirable incidents can help guarantee participant safety, improve the practices of research coordinators, investigators, and clinical research assistants and help to minimize research costs.

Biostatistics Disruptive Acculturation Through Serious Gaming: A New Hope.

Biostatistics is one of the transversal subjects that all future doctors must acquire and master. Nonetheless, it is a subject that has the reputation of being difficult, which has not been able to be corrected even with the application of new pedagogical methods such as blended learning. We address this problem with our acculturative and disruptive approach in the form of a serious game scenario in clinical research that integrates biostatistics with our R4Web adapted tools.

Patient-Reported Outcome Measures (PROMs) for Two Implant Placement Techniques in Sinus Region (Bone Graft versus Computer-Aided Implant Surgery): A Randomized Prospective Trial.

Purpose: To assess patient-reported outcomes measures (PROMs) for two implant placement techniques in cases of sinus bone atrophy (bone graft surgery (BGS) versus computer-aided implant surgery (CAIS)), after surgery and one year later, and to evaluate the clinical success of both treatments.

Methods: Sixty patients with bone atrophy in the posterior maxilla and in need of implant placement were randomly assigned to two groups, and in accordance with the case report form (CRF), 30 were treated with BGS and 30 with CAIS. Immediately after treatment and one year later, PROMs were assessed, and the clinical success of both treatments was evaluated.

Non-invasive fibrosis tests to predict complications in compensated post-hepatitis C cirrhosis.

Background And Aims: Markers predicting complications of post-hepatitis C cirrhosis are needed. We asked whether changes in noninvasive markers of fibrosis can predict liver-related complications.

Methods: This was a case-controlled study using a prospective national cohort (ANRS-CO12-CIRVIR) of 1323 HCV-infected patients with compensated cirrhosis: 97 patients who developed liver-related complications such as hepatocellular carcinoma or hepatic decompensation (cases) matched in age, sex and follow-up duration were compared with 257 patients without complications (controls).

Impact of Cone Beam Computed Tomography Dose in Pre-Surgical Implant Analysis.

Objectives: Cone-Beam Computed Tomography (CBCT) produces vital information required for the accurate and prudent placement of dental implants. Lack of standardization between CBCT machines may result in unsafe patient exposure to harmful radiation; higher doses are not necessarily associated with improved image quality.

Aim: The study aimed to assess the influence of low- and high-dose milliamperage settings on CBCT images for objective and subjective implant planning.

Randomised, prospective, medico-economic nationwide French study of islet transplantation in patients with severely unstable type 1 diabetes: the STABILOT study protocol.

Introduction: Islet transplantation may be an appropriate treatment option for patients with severely unstable type 1 diabetes experiencing major glucose variability with severe hypoglycaemia despite intensive insulin therapy. Few data are available on the costs associated with islet transplantation in relation to its benefits. The STABILOT study proposes to assess the economic impact of islet transplantation in comparison with the current best medical treatment defined as sensor-augmented pump (SAP) therapy.

Clinical impact of the disposable ventouse iCup® versus a metallic vacuum cup: a multicenter randomized controlled trial.

Background: Assisted vaginal delivery by vacuum extraction is frequent. Metallic resterilizible metallic vacuum cups have been routinely used in France. In the last few years a new disposable semi-soft vacuum extraction cup, the iCup, has been introduced.

Naturally Occurring Resistance-Associated Variants of Hepatitis C Virus Protease Inhibitors in Poor Responders to Pegylated Interferon-Ribavirin.

The pretherapeutic presence of protease inhibitor (PI) resistance-associated variants (RAVs) has not been shown to be predictive of triple-therapy outcomes in treatment-naive patients. However, they may influence the outcome in patients with less effective pegylated interferon (pegIFN)-ribavirin (RBV) backbones. Using hepatitis C virus (HCV) population sequence analysis, we retrospectively investigated the prevalence of baseline nonstructural 3 (NS3) RAVs in a multicenter cohort of poor IFN-RBV responders (i.

Computer-assisted navigation in ACL reconstruction is attractive but not yet cost efficient.

Purpose: Conventional reconstruction of the anterior cruciate ligament (ACL) has a high success rate. Computer-assisted navigation systems (CANSs) have been developed to further improve the accuracy of tunnel positioning. What is the economic impact from the hospital perspective?

Methods: Patients having a first ACL reconstruction procedure were included in a prospective multicentre open controlled study comparing two groups: CANS versus conventional surgery.

Contribution of the ELFG test in algorithms of non-invasive markers towards the diagnosis of significant fibrosis in chronic hepatitis C.

Background And Aims: We aimed to determine the best algorithms for the diagnosis of significant fibrosis in chronic hepatitis C (CHC) patients using all available parameters and tests.

Patients And Methods: We used the database from our study of 507 patients with histologically proven CHC in which fibrosis was evaluated by liver biopsy (Metavir) and tests: Fibrometer®, Fibrotest®, Hepascore®, Apri, ELFG, MP3, Forn's, hyaluronic acid, tissue inhibitor of metalloproteinase-1 (TIMP1), MMP1, collagen IV and when possible Fibroscan™. For the first test we used 90% negative predictive value to exclude patients with F≤1, next an induction algorithm was applied giving the best tests with at least 80% positive predictive value for the diagnosis of F≥2.

Impact of information leaflets on behavior of patients with gastroenteritis or tonsillitis: a cluster randomized trial in French primary care.

Objective: To assess the impact of four patient information leaflets on patients' behavior in primary care.

Design: Cluster randomized multicenter controlled trial between November 2009 and January 2011.

Participants: French adults and children consulting a participating primary care physician and diagnosed with gastroenteritis or tonsillitis.

Morbidity and mortality conferences: their place in quality assessments.

Purpose: This article aims to analyze morbidity and mortality conferences (M&MCs) in a university-affiliated hospital, notably their format and progression since the 1990s.

Design/methodology/approach: A cross-sectional study was conducted and M&MC characteristics were collected using three methods: a questionnaire to all department heads to identify past M&MCs; semi-structured interviews with each M&MC leader; and when available, meeting reports were analyzed.

Findings: Of 189 questionnaires sent to department heads, 105 were completed and returned (55.

A multiplicative hazard regression model to assess the risk of disease transmission at hospital during community epidemics.

Background: During community epidemics, infections may be imported within hospital and transmitted to hospitalized patients. Hospital outbreaks of communicable diseases have been increasingly reported during the last decades and have had significant consequences in terms of patient morbidity, mortality, and associated costs. Quantitative studies are thus needed to estimate the risks of communicable diseases among hospital patients, taking into account the epidemiological process outside, hospital and host-related risk factors of infection and the role of other patients and healthcare workers as sources of infection.

Automated drug dispensing system reduces medication errors in an intensive care setting.

Objectives: We aimed to assess the impact of an automated dispensing system on the incidence of medication errors related to picking, preparation, and administration of drugs in a medical intensive care unit. We also evaluated the clinical significance of such errors and user satisfaction.

Design: Preintervention and postintervention study involving a control and an intervention medical intensive care unit.