Sylvie Chevret

Paris Diderot University, Lutetia Parisorum, Île-de-France, France

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Publications (447)2757.38 Total impact

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    ABSTRACT: Improved mortality prediction for patients in intensive care units is a big challenge. Many severity scores have been proposed, but findings of validation studies have shown that they are not adequately calibrated. The Super ICU Learner Algorithm (SICULA), an ensemble machine learning technique that uses multiple learning algorithms to obtain better prediction performance, does at least as well as the best member of its library. We aimed to assess whether the Super Learner could provide a new mortality prediction algorithm for patients in intensive care units, and to assess its performance compared with other scoring systems. From January, 2001, to December, 2008, we used the Multiparameter Intelligent Monitoring in Intensive Care II (MIMIC-II) database (version 26) including all patients admitted to an intensive care unit at the Beth Israel Deaconess Medical Centre, Boston, MA, USA. We assessed the calibration, discrimination, and risk classification of predicted hospital mortality based on Super Learner compared with SAPS-II, APACHE-II, and SOFA. We calculated performance measures with cross-validation to avoid making biased assessments. Our proposed score was then externally validated on a dataset of 200 randomly selected patients admitted at the intensive care unit of Hôpital Européen Georges-Pompidou, Paris, France, between Sept 1, 2013, and June, 30, 2014. The primary outcome was hospital mortality. The explanatory variables were the same as those included in the SAPS II score. 24 508 patients were included, with median SAPS-II of 38 (IQR 27-51) and median SOFA of 5 (IQR 2-8). 3002 of 24 508 (12%) patients died in the Beth Israel Deaconess Medical Centre. We produced two sets of predictions based on the Super Learner; the first based on the 17 variables as they appear in the SAPS-II score (SL1), and the second, on the original, untransformed variables (SL2). The two versions yielded average predicted probabilities of death of 0·12 (IQR 0·02-0·16) and 0·13 (0·01-0·19), whereas the corresponding value for SOFA was 0·12 (0·05-0·15) and for SAPS-II 0·30 (0·08-0·48). The cross-validated area under the receiver operating characteristic curve (AUROC) for SAPS-II was 0·78 (95% CI 0·77-0·78) and 0·71 (0·70-0·72) for SOFA. Super Learner had an AUROC of 0·85 (0·84-0·85) when the explanatory variables were categorised as in SAPS-II, and of 0·88 (0·87-0·89) when the same explanatory variables were included without any transformation. Additionally, Super Learner showed better calibration properties than previous score systems. On the external validation dataset, the AUROC was 0·94 (0·90-0·98) and calibration properties were good. Compared with conventional severity scores, Super Learner offers improved performance for predicting hospital mortality in patients in intensive care units. A user-friendly implementation is available online and should be useful for clinicians seeking to validate our score. Fulbright Foundation, Assistance Publique-Hôpitaux de Paris, Doris Duke Clinical Scientist Development Award, and the NIH. Copyright © 2014 Elsevier Ltd. All rights reserved.
    The Lancet Respiratory Medicine. 11/2014;
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    ABSTRACT: A prospective phase II multicentric trial was performed to obtain less than 25% non-relapse mortality (NRM) after unrelated cord blood transplantation (UCBT) for adults with acute myeloid leukemia (AML) using reduced intensity conditioning regimen (RIC) consisting of total body irradiation (TBI 2Gy), cyclophosphamide (50mg/kg) and fludarabine (200mg/m2) (TCF). From 2007 to 2009, 79 UCBT recipients were enrolled. Patients transplanted in first complete remission (CR1) (n=48) had a higher frequency of unfavorable cytogenetics, secondary AML and greater number of induction courses of chemotherapy to achieve CR1 compared to the others. The median infused total nucleated cells (TNC) was 3.4 x107/kg; 60% received double UCBT; 77% were HLA mismatched (4/6) and 40% had major ABO-incompatibility. Cumulative incidence (CI) of neutrophil recovery at day-60 was 87% and CI of 100-day acute-GVHD (II-IV) was 50%. At 2-years, CI of NRM and relapse incidence were 20% and 46%, respectively. In a multivariate analysis, major ABO incompatibility (p=0.001) and TNC (<3.4x107/kg; p=0.001) were associated with increased NRM and use of 2 or more induction courses to obtain CR1 with increased relapse incidence (p=0.04). Leukemia-free survival (LFS) at 2-years was 35%, and the only factor associated with decreased LFS was secondary AML (p=0.04). In conclusion, despite the decreased NRM observed, other RIC regimens with higher myelosuppression should be evaluated to decrease relapse in high risk AML. (EUDRACT 2006-005901-67). Copyright © 2014 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.
    Biology of blood and marrow transplantation: journal of the American Society for Blood and Marrow Transplantation 11/2014; · 3.15 Impact Factor
  • Leslie Pibouleau, Sylvie Chevret
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    ABSTRACT: Rationale: Bayesian methods provide an interesting approach to assessing an implantable medical device (IMD) that has evolved through successive versions because they allow for explicit incorporation of prior knowledge into the analysis. However, the literature is sparse on the feasibility and reliability of elicitation in cases where expert beliefs are used to form priors. Objectives: To develop an Internet-based method for eliciting experts' beliefs about the success rate of an intracranial stenting procedure and to assess their impact on the estimated benefit of the latest version. Study Design and Setting: The elicitation questionnaire was administered to a group of nineteen experts. Elicited experts' beliefs were used to inform the prior distributions of a Bayesian hierarchical meta-analysis model, allowing for the estimation of the success rate of each version.
    International Journal of Technology Assessment in Health Care 11/2014; · 1.55 Impact Factor
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    ABSTRACT: Background & Aims: In cirrhosis, portal vein thrombosis (PVT) could be a cause or a consequence of the progression of liver disease. We analyzed data from a prospective trial of ultrasound screening for hepatocellular carcinoma in order to identify risk factors for, and the impact of PVT in patients with cirrhosis.Methods: 1243 adults with cirrhosis without PVT were enrolled from 43 liver units in France and Belgium, between June 2000 and March 2006. Mean follow-up was 47 months. Doppler ultrasonography was used to check portal vein. Progression of liver disease was defined by the development of: ascites, hepatic encephalopathy, variceal bleeding, prothrombin <45%, serum bilirubin >45 μmol/L, albumin <28 g/L, and/or creatinine >115 μmol/L. G20210A prothrombin and factor V gene mutations were assessed in sera stored in 3 large centers.Results: Five-year cumulative incidence of PVT was 10.7%. PVT was mostly partial and varied over time. The development of PVT was independently associated with baseline esophageal varices (P = 0.01) and prothrombin time (P = 0.002), but not with disease progression before PVT, or prothrombotic mutations. Disease progression was independently associated with baseline age (HR 1.55; 95%CI 1.11-2.17), body mass index (HR 1.40; 95%CI 1.01-1.95), prothrombin time (HR 0.79; 95%CI 0.70-0.90), serum albumin (HR 0.97; 95%CI 0.94-0.99), and esophageal varices (HR 1.70; 95%CI 1.21-2.38) but not with the prior development of PVT (HR 1.32; 95%CI 0.68-2.65).Conclusions: In patients with cirrhosis, the development of PVT is associated with the severity of liver disease at baseline, but does not follow a recent progression of liver disease. There is no evidence that the development of PVT is responsible for further progression of liver disease. (Hepatology 2014;)
    Hepatology 10/2014; · 12.00 Impact Factor
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    ABSTRACT: Agreement between two assays is usually based on the concordance correlation coefficient (CCC), estimated from the means, standard deviations, and correlation coefficient of these assays. However, such data will often suffer from left-censoring because of lower limits of detection of these assays. To handle such data, we propose to extend a multiple imputation approach by chained equations (MICE) developed in a close setting of one left-censored assay. The performance of this two-step approach is compared with that of a previously published maximum likelihood estimation through a simulation study. Results show close estimates of the CCC by both methods, although the coverage is improved by our MICE proposal. An application to cytomegalovirus quantification data is provided. Copyright © 2014 John Wiley & Sons, Ltd.
    Statistics in Medicine 10/2014; · 2.04 Impact Factor
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    ABSTRACT: Background Various late-onset noninfectious pulmonary complications may occur after allogeneic hematopoietic stem cell transplantation (HSCT). Interstitial lung diseases (ILD) are often overlooked, and few data are available. Methods We retrospectively analyzed the clinical features, pulmonary function tests, radiological features and outcomes of allogeneic HSCT recipients who were diagnosed with a noninfectious ILD and were managed in our center between 2001 and 2010. Results Forty patients were analyzed. The median time from transplant to ILD was 11.3 months. The donor hematopoietic stem cell source was peripheral blood stem cells in 75% of the cases. Seventy percent of the patients had extra-thoracic chronic graft versus host disease at ILD diagnosis. We identified two lung computed tomography (CT) scan patterns according to the predominance of ground glass opacities or alveolar consolidations. Restrictive ventilatory defect was the main pulmonary function pattern. Lung histology was available for seven patients and showed diffuse alveolar damage, non-specific interstitial pneumonia, organizing pneumonia or lymphoid interstitial pneumonia. Thirty-five patients (87.5%) were treated with systemic steroids. Thirteen patients died (32.5%), 10 of respiratory failure. The median survival rate at 24 months was 61%. Conclusion This study highlights the existence of noninfectious post-allogeneic HSCT ILD and provides new insights into the characteristics of these illnesses.
    Respiratory Medicine. 09/2014;
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    ABSTRACT: We sought to identify risk factors for mechanical ventilation in patients with malignancies and acute respiratory failure (ARF).
    Respiratory care 07/2014; · 2.03 Impact Factor
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    ABSTRACT: We analysed the prognostic significance of minimal residual disease (MRD) level in adult patients with acute myeloid leukemia (AML) treated in the randomized gemtuzumab ozogamicin (GO) ALFA-0701 trial. Levels of WT1 and NPM1 gene transcripts were assessed using cDNA-based real-time quantitative PCR in 183 patients with WT1 overexpression and in 77 patients with NMP1 mutation (NPM1mut) at diagnosis. Positive WT1 MRD (defined as > 0.5% in the peripheral blood) after induction and at the end of treatment were both significantly associated with a higher risk of relapse and a shorter overall survival (OS). Positive NPM1mut MRD (defined as > 0.1% in the bone marrow) after induction and at the end of treatment also predicted a higher risk of relapse, but did not influence OS. Interestingly, the achievement of a negative NPM1mut MRD was significantly more frequent in patients treated in the GO arm compared to those treated in control arm (39 % versus 7% (p=0.006) after induction and 91% versus 61% (p=0.028) at the end of treatment). However, GO did not influence WT1 MRD levels. Our study supports the prognostic significance of MRD assessed by WT1 and NPM1mut transcript levels and show that NPM1 MRD is decreased by GO treatment.
    Oncotarget 07/2014; · 6.64 Impact Factor
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    ABSTRACT: Gemtuzumab ozogamicin was the first example of antibody-directed chemotherapy in cancer, and was developed for acute myeloid leukaemia. However, randomised trials in which it was combined with standard induction chemotherapy in adults have produced conflicting results. We did a meta-analysis of individual patient data to assess the efficacy of adding gemtuzumab ozogamicin to induction chemotherapy in adult patients with acute myeloid leukaemia.
    The Lancet Oncology 07/2014; · 25.12 Impact Factor
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    ABSTRACT: Background Kidney transplant recipients are at risk for life-threatening infections, which may affect the long-term prognosis.Methods We retrospectively included all kidney transplant recipients admitted for sepsis, severe sepsis, or septic shock to the medical intensive care unit (ICU) of the Saint-Louis Hospital, Paris, France, between 2000 and 2010. The main objective was to identify factors associated with survival without graft impairment 90 days after ICU discharge.ResultsData were available for 83 of 100 eligible patients. The main sites of infection were the lungs (54%), urinary tract (24%), and bloodstream (22%). Among documented infections (55/83), 80% were bacterial. Fungal infections were more common among patients transplanted after 2005 (5% vs. 23%, P = 0.02). Mechanical ventilation was used in 46 (56%) patients, vasopressors in 39 (47%), and renal replacement therapy (RRT) in 34 (41%). In-hospital and day-90 mortality rates were 20% and 22%, respectively. On day 90, among the 65 survivors, 39 (47%) had recovered their previous graft function and 26 (31%) had impaired graft function, including 16 (19%) who were dependent on RRT. Factors independently associated with day-90 survival and graft function recovery were baseline serum creatinine (odds ratio [OR] for a 10 μmol/L increase 0.94, 95% confidence interval [CI] 0.88–1.00) and cyclosporine therapy (OR 0.30, 95% CI 0.11–0.79).Conclusion Sepsis was chiefly related to bacterial pneumonia or urinary tract infection. Pneumocystis jirovecii was the leading opportunistic agent, with a trend toward an increase over time. Infections often induced severe graft function impairment. Baseline creatinine and cyclosporine therapy independently predicted the outcome.
    Transplant Infectious Disease 06/2014; · 1.98 Impact Factor
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    ABSTRACT: With intensified pediatric-like therapy and genetic disease dissection, the field of adult acute lymphoblastic leukemia (ALL) has evolved recently. In this new context, we aimed to reassess the value of conventional risk factors with regard to new genetic alterations and early response to therapy, as assessed by Ig/TCR minimal residual disease (MRD) levels. The study was performed in 423 younger adults with Philadelphia chromosome-negative ALL in first remission (265 B-cell precursor [BCP] and 158 T-cell ALL), with cumulative incidence of relapse (CIR) as primary endpoint. In addition to conventional risk factors, the most frequent currently available genetic alterations were included in the analysis. A higher specific hazard of relapse was independently associated with post-induction MRD level ≥ 10(-4) and unfavorable genetic characteristics (i.e. MLL gene rearrangement or focal IKZF1 gene deletion in BCP-ALL; and no NOTCH1/FBXW7 mutation and/or N/K-RAS mutation and/or PTEN gene alteration in T-ALL). These two factors allowed definition of a new risk classification, which is strongly associated with higher CIR and shorter relapse-free and overall survival. These results indicate that genetic abnormalities are important predictors of outcome in adult ALL, not fully recapitulated by early response to therapy. Patients included in this study were treated in the multicenter GRAALL-2003 and 2005 trials. Both trials were registered at ClinicalTrials.gov (GRAALL-2003, NCT00222027; GRAALL-2005, NCT00327678).
    Blood 04/2014; · 9.78 Impact Factor
  • Djillali Annane, Sylvie Chevret
    JAMA The Journal of the American Medical Association 03/2014; 311(10):1069-70. · 29.98 Impact Factor
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    ABSTRACT: We recently showed that the addition of fractionated doses of gemtuzumab ozogamicin (GO) to standard chemotherapy improves clinical outcome of acute myeloid leukemia (AML) patients. In the present study, we performed mutational analysis of 11 genes (FLT3, NPM1, CEBPA, MLL, WT1, IDH1/2, RUNX1, ASXL1, TET2, DNMT3A), EVI1 overexpression screening, and 6.0 single-nucleotide polymorphism array (SNP-A) analysis in diagnostic samples of the 278 AML patients enrolled in the ALFA-0701 trial. In cytogenetically normal (CN) AML (n=146), 38% of the patients had at least 1 SNP-A lesion and 89% of the patients had at least 1 molecular alteration. In multivariate analysis, the independent predictors of higher cumulative incidence of relapse were unfavorable karyotype (P = 0.013) and randomization in the control arm (P = 0.007) in the whole cohort, and MLL partial tandem duplications (P = 0.014) and DNMT3A mutations (P = 0.010) in CN-AML. The independent predictors of shorter overall survival (OS) were unfavorable karyotype (P <0.001) and SNP-A lesion(s) (P = 0.001) in the whole cohort, and SNP-A lesion(s) (P = 0.006), DNMT3A mutations (P = 0.042) and randomization in the control arm (P = 0.043) in CN-AML. Interestingly, CN-AML patients benefited preferentially more from GO treatment as compared to AML patients with abnormal cytogenetics (hazard ratio for death, 0.52 versus 1.14; test for interaction, P = 0.04). Although the interaction test was not statistically significant, the OS benefit associated with GO treatment appeared also more pronounced in FLT3 internal tandem duplication positive than in negative patients.
    Oncotarget 01/2014; · 6.64 Impact Factor
  • Jérôme Lambert, Sylvie Chevret
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    ABSTRACT: Assessments of the discriminative performance of prognostic models have led to the development of several measures that extend the concept of discrimination as evaluated by the receiver operating characteristics curve and the area under the receiver operating characteristic curve (AUC) of diagnostic settings. Thus, several time-dependent-receiver operating characteristic curve and AUC(t) have been proposed. One of the most used, the cumulative/dynamic AUC(C,D)(t) is the probability that, given two randomly chosen patients, one having failed before t and the other having failed after t, the prognostic marker will be correctly ranked. In this paper, we propose a weighted AUC(C,D)(t) with time- and data-dependent weights as a summary measure of the mean AUC(C,D)(t), restricted to a finite time range to ensure its clinical relevance. A simulation study shows that estimated restricted mean AUC increased with the strength of association of the covariate with the outcome, with low impact of censoring, and adequate coverage of bootstrap confidence intervals. We illustrate this methodology to two real datasets from two randomized clinical trials to assess the prognostic factors of the overall mortality in patients who have compensated cirrhosis and to assess the prognostic factors of event-free survival in patients who have acute myeloid leukemia.
    Statistical Methods in Medical Research 01/2014; · 2.36 Impact Factor
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    ABSTRACT: Purpose Hypocitrullinemia has been suggested to be a prognostic factor for patients in intensive care. The aim of this ancillary study of the Corticosteroids and Intensive Insulin Therapy for Septic Shock prospective study was to investigate plasma l-citrulline concentrations and its relationship with inflammation and digestive bacterial translocation in patients with septic shock multiorgan failure and without primary intestinal disease or chronic renal failure. Methods Sixteen adult patients were selected. They were studied on day (D) 0 at hours (H) 0, 6, 12, 18, and 24 and on D4 (H96). Selected plasma amino acids and proteins, proinflammatory (tumor necrosis factor α [TNF-α]) and anti-inflammatory (interleukin [IL] 10) cytokine concentrations, and bacterial translocation were measured. Results Eight D14 survivors and 8 D14 nonsurvivors patients were studied. Citrulline was decreased on D0 (H0: 29 ± 10 vs nadir: 18 ± 6 μmol/L; P < .05). The citrulline nadir was lower (P < .01) in patients with digestive bacterial translocation than that in those without. Mean citrulline concentrations at H0 to H96 were not significantly different between survivors and nonsurvivors. In both groups, citrulline was significantly inversely correlated with C-reactive protein (r2 = 0.10, P < .01) on D0. No significant correlations were found between citrulline and albumin, transthyretin, TNF-α, IL-10, or TNF-α/IL-10 ratio. Conclusions At the onset of septic shock, plasma citrulline decreases and varies inversely with C-reactive protein and is lower when digestive bacterial translocation occurs. This finding could reflect an early acute intestinal dysfunction, but measurement of citrulline concentration does not appear to be able to predict the patients' mortality.
    Journal of Critical Care. 01/2014; 29(2):315.e1–315.e6.
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    ABSTRACT: Mantle cell lymphoma (MCL) is usually an aggressive disease. However, a few patients do have an "indolent" evolution (iMCL) defined by a long survival time without intensive therapy. Many studies highlight the prognostic role of additional genetic abnormalities, but these abnormalities are not routinely tested for and do not yet influence the treatment decision. We aimed to evaluate the prognostic impact of these additional abnormalities detected by conventional cytogenetic testing, as well as their relationships with the clinical characteristics and their value in identifying iMCL. All consecutive MCL cases diagnosed between 1995 and 2011 at four institutions were retrospectively selected on the basis of an informative karyotype with a t(11;14) translocation at the time of diagnosis. A total of 125 patients were included and followed for an actual median time of 35 months. The median overall survival (OS) and survival without treatment (TFS) were 73.7 and 1.3 months, respectively. In multivariable Cox models, a high mantle cell lymphoma international prognostic index score, a complex karyotype, and blastoid morphology were independently associated with a shortened OS. Spleen enlargement, nodal presentation, extra-hematological involvement, and complex karyotypes were associated with shorter TFS. A score based on these factors allowed for the identification of "indolent" patients (median TFS 107 months) from other patients (median TFS: 1 month). In conclusion, in this multicentric cohort of MCL patients, a complex karyotype was associated with a shorter survival time and allowed for the identification of iMCL at the time of diagnosis. © 2013 Wiley Periodicals, Inc.
    Genes Chromosomes and Cancer 01/2014; 53(1):106-16. · 3.55 Impact Factor
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    ABSTRACT: Hypocitrullinemia has been suggested to be a prognostic factor for patients in intensive care. The aim of this ancillary study of the Corticosteroids and Intensive Insulin Therapy for Septic Shock prospective study was to investigate plasma l-citrulline concentrations and its relationship with inflammation and digestive bacterial translocation in patients with septic shock multiorgan failure and without primary intestinal disease or chronic renal failure. Sixteen adult patients were selected. They were studied on day (D) 0 at hours (H) 0, 6, 12, 18, and 24 and on D4 (H96). Selected plasma amino acids and proteins, proinflammatory (tumor necrosis factor α [TNF-α]) and anti-inflammatory (interleukin [IL] 10) cytokine concentrations, and bacterial translocation were measured. Eight D14 survivors and 8 D14 nonsurvivors patients were studied. Citrulline was decreased on D0 (H0: 29 ± 10 vs nadir: 18 ± 6 μmol/L; P < .05). The citrulline nadir was lower (P < .01) in patients with digestive bacterial translocation than that in those without. Mean citrulline concentrations at H0 to H96 were not significantly different between survivors and nonsurvivors. In both groups, citrulline was significantly inversely correlated with C-reactive protein (r(2) = 0.10, P < .01) on D0. No significant correlations were found between citrulline and albumin, transthyretin, TNF-α, IL-10, or TNF-α/IL-10 ratio. At the onset of septic shock, plasma citrulline decreases and varies inversely with C-reactive protein and is lower when digestive bacterial translocation occurs. This finding could reflect an early acute intestinal dysfunction, but measurement of citrulline concentration does not appear to be able to predict the patients' mortality.
    Journal of critical care 11/2013; · 2.13 Impact Factor
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    ABSTRACT: Objective Propensity score matching is typically used to estimate the average treatment effect for the treated while inverse probability of treatment weighting aims at estimating the population average treatment effect. We illustrate how different estimands can result in very different conclusions.Study designWe applied the two propensity score methods to assess the effect of continuous positive airway pressure on mortality in patients hospitalized for acute heart failure. We used Monte Carlo simulations to investigate the important differences in the two estimates.ResultsContinuous positive airway pressure application increased hospital mortality overall, but no continuous positive airway pressure effect was found on the treated. Potential reasons were (1) violation of the positivity assumption; (2) treatment effect was not uniform across the distribution of the propensity score. From simulations, we concluded that positivity bias was of limited magnitude and did not explain the large differences in the point estimates. However, when treatment effect varies according to the propensity score (E[Y(1)-Y(0)|g(X)] is not constant, Y being the outcome and g(X) the propensity score), propensity score matching ATT estimate could strongly differ from the inverse probability of treatment weighting-average treatment effect estimate. We show that this empirical result is supported by theory.Conclusion Although both approaches are recommended as valid methods for causal inference, propensity score-matching for ATT and inverse probability of treatment weighting for average treatment effect yield substantially different estimates of treatment effect. The choice of the estimand should drive the choice of the method.
    Statistical Methods in Medical Research 11/2013; · 2.36 Impact Factor
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    ABSTRACT: IMPORTANCE Evidence supporting the choice of intravenous colloid vs crystalloid solutions for management of hypovolemic shock remains unclear. OBJECTIVE To test whether use of colloids compared with crystalloids for fluid resuscitation alters mortality in patients admitted to the intensive care unit (ICU) with hypovolemic shock. DESIGN, SETTING, AND PARTICIPANTS A multicenter, randomized clinical trial stratified by case mix (sepsis, trauma, or hypovolemic shock without sepsis or trauma). Therapy in the Colloids Versus Crystalloids for the Resuscitation of the Critically Ill (CRISTAL) trial was open label but outcome assessment was blinded to treatment assignment. Recruitment began in February 2003 and ended in August 2012 of 2857 sequential ICU patients treated at 57 ICUs in France, Belgium, North Africa, and Canada; follow-up ended in November 2012. INTERVENTIONS Colloids (n = 1414; gelatins, dextrans, hydroxyethyl starches, or 4% or 20% of albumin) or crystalloids (n = 1443; isotonic or hypertonic saline or Ringer lactate solution) for all fluid interventions other than fluid maintenance throughout the ICU stay. MAIN OUTCOMES AND MEASURES The primary outcome was death within 28 days. Secondary outcomes included 90-day mortality; and days alive and not receiving renal replacement therapy, mechanical ventilation, or vasopressor therapy. RESULTS Within 28 days, there were 359 deaths (25.4%) in colloids group vs 390 deaths (27.0%) in crystalloids group (relative risk [RR], 0.96 [95% CI, 0.88 to 1.04]; P = .26). Within 90 days, there were 434 deaths (30.7%) in colloids group vs 493 deaths (34.2%) in crystalloids group (RR, 0.92 [95% CI, 0.86 to 0.99]; P = .03). Renal replacement therapy was used in 156 (11.0%) in colloids group vs 181 (12.5%) in crystalloids group (RR, 0.93 [95% CI, 0.83 to 1.03]; P = .19). There were more days alive without mechanical ventilation in the colloids group vs the crystalloids group by 7 days (mean: 2.1 vs 1.8 days, respectively; mean difference, 0.30 [95% CI, 0.09 to 0.48] days; P = .01) and by 28 days (mean: 14.6 vs 13.5 days; mean difference, 1.10 [95% CI, 0.14 to 2.06] days; P = .01) and alive without vasopressor therapy by 7 days (mean: 5.0 vs 4.7 days; mean difference, 0.30 [95% CI, -0.03 to 0.50] days; P = .04) and by 28 days (mean: 16.2 vs 15.2 days; mean difference, 1.04 [95% CI, -0.04 to 2.10] days; P = .03). CONCLUSIONS AND RELEVANCE Among ICU patients with hypovolemia, the use of colloids vs crystalloids did not result in a significant difference in 28-day mortality. Although 90-day mortality was lower among patients receiving colloids, this finding should be considered exploratory and requires further study before reaching conclusions about efficacy. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00318942.
    JAMA The Journal of the American Medical Association 10/2013; · 29.98 Impact Factor
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    ABSTRACT: As a result of reporting bias, or frauds, false or misunderstood findings may represent the majority of published research claims. This article provides simple methods that might help to appraise the quality of the reporting of randomized, controlled trials (RCT). This evaluation roadmap proposed herein relies on four steps: evaluation of the distribution of the reported variables; evaluation of the distribution of the reported p values; data simulation using parametric bootstrap and explicit computation of the p values. Such an approach was illustrated using published data from a retracted RCT comparing a hydroxyethyl starch versus albumin-based priming for cardiopulmonary bypass. Despite obvious nonnormal distributions, several variables are presented as if they were normally distributed. The set of 16 p values testing for differences in baseline characteristics across randomized groups did not follow a Uniform distribution on [0,1] (p = 0.045). The p values obtained by explicit computations were different from the results reported by the authors for the two following variables: urine output at 5 hours (calculated p value < 10-6, reported p >= 0.05); packed red blood cells (PRBC) during surgery (calculated p value = 0.08; reported p < 0.05). Finally, parametric bootstrap found p value > 0.05 in only 5 of the 10,000 simulated datasets concerning urine output 5 hours after surgery. Concerning PRBC transfused during surgery, parametric bootstrap showed that only the corresponding p value had less than a 50% chance to be inferior to 0.05 (3,920/10,000, p value < 0.05). Such simple evaluation methods might offer some warning signals. However, it should be emphasized that such methods do not allow concluding to the presence of error or fraud but should rather be used to justify asking for an access to the raw data.
    Annals of intensive care. 09/2013; 3(1):29.

Publication Stats

14k Citations
2,757.38 Total Impact Points

Institutions

  • 2008–2014
    • Paris Diderot University
      Lutetia Parisorum, Île-de-France, France
    • Centre Hospitalier Universitaire d'Angers
      • Département de neurologie
      Angers, Pays de la Loire, France
  • 2007–2014
    • Hôpitaux Universitaires La Pitié salpêtrière - Charles Foix
      Lutetia Parisorum, Île-de-France, France
    • Centre Hospitalier Intercommunal Creteil
      Créteil, Île-de-France, France
  • 2004–2014
    • Université de Versailles Saint-Quentin
      Versailles, Île-de-France, France
    • Centre Hospitalier Régional Universitaire de Lille
      Lille, Nord-Pas-de-Calais, France
  • 2013
    • University Hospital Estaing of Clermont-Ferrand
      Clermont, Auvergne, France
    • Hôpital Européen Georges-Pompidou (Hôpitaux Universitaires Paris-Ouest)
      Lutetia Parisorum, Île-de-France, France
  • 2012
    • Hôpital Saint-Louis (Hôpitaux Universitaires Saint-Louis, Laboisière, Fernand-Widal)
      • Service de Pneumologie
      Paris, Ile-de-France, France
  • 2003–2012
    • Assistance Publique – Hôpitaux de Paris
      Lutetia Parisorum, Île-de-France, France
    • Clinique Ambroise Paré
      Tolosa de Llenguadoc, Midi-Pyrénées, France
  • 1992–2012
    • Université René Descartes - Paris 5
      • Faculty of medicine
      Lutetia Parisorum, Île-de-France, France
    • Hôpital Raymond-Poincaré – Hôpitaux universitaires Paris Ile-de-France Ouest
      Île-de-France, France
  • 2011
    • Mercy Hospital St. Louis
      San Luis, Missouri, United States
    • Centre Hospitalier Universitaire de Saint-Étienne
      Saint-Étienne, Rhône-Alpes, France
    • University Joseph Fourier - Grenoble 1
      Grenoble, Rhône-Alpes, France
    • Hôpital Jean-Verdier – Hôpitaux Universitaires Paris-Seine-Saint-Denis
      Bondy, Île-de-France, France
  • 2002–2011
    • Unité Inserm U1077
      Caen, Lower Normandy, France
    • University of Franche-Comté
      Becoinson, Franche-Comté, France
    • Hôpital Antoine-Béclère – Hôpitaux universitaires Paris-Sud
      Clamart, Île-de-France, France
  • 2004–2010
    • Centre Hospitalier de Versailles
      • Department of Onco-Hematology
      Versailles, Île-de-France, France
  • 2009
    • Université Paris 13 Nord
      Île-de-France, France
    • Pierre and Marie Curie University - Paris 6
      Lutetia Parisorum, Île-de-France, France
  • 2006
    • University of Glasgow
      Glasgow, Scotland, United Kingdom
    • Hôpital Avicenne – Hôpitaux Universitaires Paris-Seine-Saint-Denis
      Bobigny, Île-de-France, France
    • Université Paris-Est Créteil Val de Marne - Université Paris 12
      Créteil, Île-de-France, France
  • 2005
    • Hôpital Saint-Vincent-de-Paul – Hôpitaux universitaires Paris Centre
      Lutetia Parisorum, Île-de-France, France
  • 1992–2002
    • Hôpital Paris Saint Joseph
      Lutetia Parisorum, Île-de-France, France
  • 2001
    • Centre Hospitalier Universitaire de Caen
      Caen, Lower Normandy, France
    • American Hospital of Paris
      Lutetia Parisorum, Île-de-France, France
  • 2000
    • Institut de Cancérologie Gustave Roussy
      Île-de-France, France
  • 1999
    • Hôpital Bichat - Claude-Bernard (Hôpitaux Universitaires Paris Nord Val de Seine)
      • Service de Réanimation Médicale et des Maladies Infectieuses
      Lutetia Parisorum, Île-de-France, France
    • Hôpital La Pitié Salpêtrière (Groupe Hospitalier "La Pitié Salpêtrière - Charles Foix")
      • Service d’Hépato - Gastro - Entérologie
      Paris, Ile-de-France, France
  • 1996–1997
    • Hôtel-Dieu de Paris – Hôpitaux universitaires Paris Centre
      Lutetia Parisorum, Île-de-France, France