PERC rule to exclude the diagnosis of pulmonary embolism in emergency low-risk patients: study protocol for the PROPER randomized controlled study.

BACKGROUND: The diagnosis of Pulmonary Embolism (PE) in the emergency department (ED) is crucial. As emergency physicians fear missing this potential life-threatening condition, PE tends to be over-investigated, exposing patients to unnecessary risks and uncertain benefit in terms of outcome. The Pulmonary Embolism Rule-out Criteria (PERC) is an eight-item block of clinical criteria that can identify patients who can safely be discharged from the ED without further investigation for PE. The endorsement of this rule could markedly reduce the number of irradiative imaging studies, ED length of stay, and rate of adverse events resulting from both diagnostic and therapeutic interventions. Several retrospective and prospective studies have shown the safety and benefits of the PERC rule for PE diagnosis in low-risk patients, but the validity of this rule is still controversial. We hypothesize that in European patients with a low gestalt clinical probability and who are PERC-negative, PE can be safely ruled out and the patient discharged without further testing. METHODS/DESIGN: This is a controlled, cluster randomized trial, in 15 centers in France. Each center will be randomized for the sequence of intervention periods: a 6-month intervention period (PERC-based strategy) followed by a 6-month control period (usual care), or in reverse order, with 2 months of "wash-out" between the 2 periods. Adult patients presenting to the ED with a suspicion of PE and a low pre test probability estimated by clinical gestalt will be eligible. The primary outcome is the percentage of failure resulting from the diagnostic strategy, defined as diagnosed venous thromboembolic events at 3-month follow-up, among patients for whom PE has been initially ruled out. DISCUSSION: The PERC rule has the potential to decrease the number of irradiative imaging studies in the ED, and is reported to be safe. However, no randomized study has ever validated the safety of PERC. Furthermore, some studies have challenged the safety of a PERC-based strategy to rule-out PE, especially in Europe where the prevalence of PE diagnosed in the ED is high. The PROPER study should provide high-quality evidence to settle this issue. If it confirms the safety of the PERC rule, physicians will be able to reduce the number of investigations, associated subsequent adverse events, costs, and ED length of stay for patients with a low clinical probability of PE. TRIAL REGISTRATION: NCT02375919

Residual rates of mortality in patients with severe sepsis: a fatality or a new challenge?

International audiencePhase III clinical trials on severe sepsis and septic shock published during the past decade have failed to reveal the superiority of any therapeutic intervention on mortality compared with evolving standards of care, with the exception of the Early-Goal Directed Therapy reported in 2001. This viewpoint paper presents an analysis of these studies in order to understand what lessons can be learned and proposes perspectives for future study designs. A total of 102 studies were selected among clinical trials published in the field of severe sepsis and septic shock from 2001 to 2013, based on the assessment of a therapeutic intervention and mortality as an outcome. Studies were further selected according to randomized, controlled trial (RCT) quality criteria and analysed according to reported data. Most (n = 61) were excluded because they did not comply with RCT quality criteria or did not report inclusion criteria or patient severity (n = 22). The 19 remaining studies were categorized into three groups depending on whether the intervention assessed led to better, worse, or equivalent outcomes. It appears that the mortality rate in the control arm, ranging from 17% to 61%, impacted the results, with a benefit reported in the studies with the highest rates. Both heterogeneous studied populations and uncontrolled diversity of care among participating centres probably contributed to discrepancies between studies assessing the same intervention. The new challenge to enhance the probability of decreasing mortality rates should include a more appropriate definition of sepsis based on more specific criteria involving biomarker use and accurate patient phenotypes

Viruses Detected By Systematic Multiplex Polymerase Chain Reaction In Adults With Suspected Community-Acquired Pneumonia Attending Emergency Departments In France

International audienc

Viruses Detected By Systematic Multiplex Polymerase Chain Reaction In Adults With Suspected Community-Acquired Pneumonia Attending Emergency Departments In France

International audienc

Role of biomarkers in the management of antibiotic therapy: an expert panel review: I - currently available biomarkers for clinical use in acute infections

International audienceIn the context of worldwide increasing antimicrobial resistance, good antimicrobial prescribing in more needed than ever; unfortunately, information available to clinicians often are insufficient to rely on. Biomarkers might provide help for decision-making and improve antibiotic management. The purpose of this expert panel review was to examine currently available literature on the potential role of biomarkers to improve antimicrobial prescribing, by answering three questions: 1) Which are the biomarkers available for this purpose?; 2) What is their potential role in the initiation of antibiotic therapy?; and 3) What is their role in the decision to stop antibiotic therapy? To answer these questions, studies reviewed were limited to recent clinical studies ( 50) and restricted to controlled trials and meta-analyses for answering questions 2 and 3. With regard to the first question concerning routinely available biomarkers, which might be useful for antibiotic management of acute infections, these are currently limited to C-reactive protein (CRP) and procalcitonin (PCT). Other promising biomarkers that may prove useful in the near future but need to undergo more extensive clinical testing include sTREM-1, suPAR, ProADM, and Presepsin. New approaches to biomarkers of infections include point-of-care testing and genomics