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J Bénichou

Publications and source records attributed to J Bénichou.

At least 19 recordsLinked to original sources
PubMed2007

The CADEUS study: methods and logistics.

PURPOSE: At the request of the French Health authorities, a study called CADEUS (COX-2 inhibitors and NSAIDs: description of users) aimed to describe the users of cyclo-oxygenase (COX)-2 inhibitors and traditional non-selective non-steroidal anti-inflammatory drugs (tNSAIDs). We report here the methodology, logistics and study design performances. METHODS: CADEUS is a cohort study designed to include 40,000 patients randomly sampled monthly in the French National Healthcare Insurance database, who received at least one dispensation of celecoxib, rofecoxib or tNSAIDs (1:1:2), from September 2003 to August 2004. Patients and prescribers were asked to fill a questionnaire on indication, medical history, risk factors and hospitalizations since drug acquisition. There was no reminder. For each respondent, healthcare resources used for the 6 months before and after inclusion were extracted from the database. Response rate, response delay, responders and non-responders characteristics were assessed. RESULTS: Of the 222,879 patients and their prescribers contacted, 20.8% patients and 32.6% prescribers responded. Median response delay was 16 days for patients and 17 days for physicians. Factors associated with patient response were age, cohort, type of prescriber and period of inclusion. CONCLUSION: This is the first study of this design in France, combining data from a claims database and direct patient and prescriber questionnaires.

Adult↗
PubMed2006

Magnesium sulphate given before very-preterm birth to protect infant brain: the randomised controlled PREMAG trial*.

OBJECTIVE: To evaluate whether magnesium sulphate (MgSO(4)) given to women at risk of very-preterm birth would be neuroprotective in preterm newborns and would prevent neonatal mortality and severe white-matter injury (WMI). DESIGN: A randomised study. SETTING: Eighteen French tertiary hospitals. Population Women with fetuses of gestational age < 33 weeks whose birth was planned or expected within 24 hours were enrolled from July 1997 to July 2003 with follow up of infants until hospital discharge. METHODS Five hundred and seventy-three mothers were randomly assigned to receive a single 40-ml infusion of 0.1 g/ml of MgSO(4) (4 g) solution or isotonic 0.9% saline (placebo) over 30 minutes. This study is registered as an International Standard Randomised Controlled Trial, number 00120588. MAIN OUTCOME MEASURES: The primary endpoints were rates of severe WMI or total mortality before hospital discharge, and their combined outcome. Analyses were based on intention to treat. RESULTS: After 6 years of enrolment, the trial was stopped. Data from 688 infants were analysed. Comparing infants who received MgSO(4) or placebo, respectively, total mortality (9.4 versus 10.4%; OR: 0.79, 95% CI 0.44-1.44), severe WMI (10.0 versus 11.7%; OR: 0.78, 95% CI 0.47-1.31) and their combined outcomes (16.5 versus 17.9%; OR: 0.86, 95% CI 0.55-1.34) were less frequent for the former, but these differences were not statistically significant. No major maternal adverse effects were observed in the MgSO(4) group. CONCLUSION: Although our results are inconclusive, improvements of neonatal outcome obtained with MgSO(4) are of potential clinical significance. More research is needed to assess the protective effect of MgSO(4) alone or in combination with other neuroprotective molecules.

Adult↗
PubMed2005

Dependency on mask ventilation after acute respiratory failure in the intermediate care unit.

The predictive factors for long-term dependency (LTD) on noninvasive ventilation (NIV) immediately after acute hypercapnic respiratory failure (AHRF) have not been identified. The present authors studied 42 patients with chronic obstructive pulmonary disease (COPD) and 58 non-COPD patients successfully treated by NIV for an AHRF episode. Parameters at stable state, at admission for AHRF and during a 1-yr follow-up were compared in patients with or without LTD-NIV at discharge. The incidence of LTD-NIV was 39% in non-COPD patients and 19% in COPD patients. Based on multivariate analysis with stepwise logistic regression, lower baseline pH values and noninfectious causes of AHRF were independently associated with LTD-NIV. Mutually adjusted odds ratios were found to be 1.316 (95% confidence interval (CI) = 1.127-1.536) for a 0.01 decrease of baseline pH value and 5.1 (95% CI = 1.8-14.0) for a noninfectious cause of AHRF. Outcome after 1 yr was poor in COPD patients. Long-term dependency on noninvasive ventilation is not an uncommon situation after resolution of an acute hypercapnic respiratory failure episode, especially in patients with non-chronic obstructive pulmonary disease causes of respiratory failure. The present study raises the need for prospective validation of a weaning protocol in patients managed by noninvasive ventilation for an acute hypercapnic respiratory failure episode.

Acute Disease↗
PubMed2004

[Adjustment for energy intake in the assessment of dietary risk factors].

Epidemiologic studies assessing the association between health status and nutritional factors raise the issue of adjusting for energy intake. Indeed, as most nutrients are highly correlated with energy intake which can itself be associated with disease risk, energy intake needs to be adjusted for upon assessing the effect of a specific nutrient. To avoid problems of estimation and interpretation incurred by the use of the standard method which rests on directly adjusting for energy intake, several other methods have been suggested. Namely, the density method uses the ratio of nutrient intake over total energy intake, the residual method relies on the residuals from the regression of nutrient intake on total energy intake, and the partition method fits energy from the nutrient and energy from other sources. These methods yield estimates of different effects but do not allow direct estimation of specific nutrient effects. Estimated effects combine specific and generic energy effects of nutrients and reflect effects of adding or substituting one nutrient for another. We review and apply these methods to the assessment of the association between protein intake and colorectal adenoma occurrence in the E3N-EPIC cohort. This example illustrates how considering findings from all of these methods rather than one single method can lead to a more in-depth understanding of such associations and provide useful guidance for nutritional recommendations.

Adenoma↗
PubMed2000

Distribution of alpha(1)-antitrypsin alleles in patients with bronchiectasis.

STUDY OBJECTIVES: Bronchiectasis has been reported in a few patients with homozygous alpha(1)-antitrypsin (AAT) deficiency, but the distribution of AAT alleles among bronchiectatic patients is not known. PATIENTS AND DESIGN: Two hundred two patients, 104 men and 98 women, with a mean age (SD) of 63.7 +/- 15.4 years, had bronchiectasis diagnosed by CT scan alone (n = 178), bronchography with or without CT scan (n = 17), or radiography alone (n = 7). AAT phenotypes (classified according to the protease inhibitor [PI] system) were determined by isoelectric focusing in blood samples obtained from all patients. Bronchiectasis was primary in 121 cases and secondary in 81 patients. Allele and phenotype frequencies were compared retrospectively between bronchiectatic patients and healthy blood donors living in the same geographic area. RESULTS: The PI phenotype frequencies among patients were the following: MM, 81.18%; MS, 11.88%; MZ, 3.46%; IZ, 0.49%; IM, 0.49%; SS, 1.48%; SZ, 0.49%; and ZZ, 0.49%. The allelic frequencies among patients were the following: M, 89.1%; S, 7.67%; Z, 2.72%; and I, 0.49%. There was no difference in the distribution of alleles or phenotypes either between patients and control subjects or between patients with secondary and primary bronchiectasis. A significant difference was found between bronchiectatic patients with and without coexisting emphysema (p = 0.028). This difference was caused by an overrepresentation of PI*Z alleles in bronchiectatic patients with coexisting emphysema. CONCLUSIONS: Our results do not support a physiopathologic implication of the AAT genes in the development of bronchiectasis. We suggest that bronchiectasis may be a consequence of emphysema in PI*Z patients rather than a primary effect.

Adolescent↗
PubMed1999

Amniotic fluid alpha-fetoprotein is not a useful biological marker of pregnancy outcome.

The aim of our study was to determine if the amniotic fluid alpha-fetoprotein (AFP) level could be a useful predictive biochemical marker of pregnancy outcome. Amniotic fluid AFP measurement was prospectively carried out over a three-year period. After excluding factors susceptible to modifying AFP measurements, 587 subjects with gestational age between 14 and 20 weeks were selected to compare the amniotic fluid AFP mean levels depending on the occurrence of an adverse outcome. No significant associations between amniotic fluid AFP level and poor pregnancy outcome, i.e. pre-eclampsia, preterm delivery, premature rupture of fetal membranes, fetal growth retardation and placental abnormalities were observed. The routine measurement of amniotic fluid alpha-fetoprotein during an amniocentesis procedure was not considered useful in predicting pregnancy complications.

Adult↗
PubMed1996

The group sequential triangular test for phase II cancer clinical trials.

In cancer, phase II clinical trials are usually noncomparative. Their purpose is to determine whether a new chemotherapy is effective enough to warrant further evaluation in phase III. Therefore, in order to meet ethical requirements, decision-making methods must allow for early termination when inefficacy (or efficacy) is clear. We previously extended the Triangular Test, a group sequential method initially proposed for phase III trials, to phase II trials and demonstrated its advantages (i.e., type I error rate alpha and power close to the nominal values, reduction of the sample size) over other methods. The aim of this paper is to present the Triangular Test from a practical standpoint that will facilitate its application to phase II clinical trials in oncology. After summarizing the minimal theoretical knowledge required to use the method appropriately, we discuss its use in the design and analysis of a phase II cancer trial.

Algorithms↗
PubMed1987

[Prognostic factors in operated non-small cell cancer of the lung. Study from a randomized therapeutic trial].

This article presents the results of a prognostic study of primary resected lung cancer (non-small cell). The data result from a randomised clinical trial of immunotherapy with a non-specific adjuvant; the follow-up was between four to seven years. Thirty-five clinical, biological and anatomo-pathological parameters were gathered at the time of inclusion in the trial. The response criteria used were survival without recurrence and total survival. A multivariate analysis using the Cox's model was carried out for each criterion. At the reference date of the 1st April 1985, 125 relapses and 132 deaths were counted amongst 219 patients; there was only one patient lost to follow-up and only 39 missing data were observed. The negative therapeutic results of the immunotherapy used were confirmed by this new intermediate analysis. The rate of survival without recurrence at 5 years was 43% and the overall survival at five years was 42%. The use of Cox's model to show the prognostic information at the 5% level for survival without recurrence could be summarised by five factors: main staging (the prognostic factor), leucocytosis, the cutaneous reaction to proteus, Karnofsky index and presence of physical signs. For stages I and II the outcome was identical and no factor was predictive at the 5% level. For stage III the cutaneous reaction to proteus and leucocytosis were prognostic. For overall survival, the prognostic information at the 5% level could be summarised by five factors: staging (main prognostic factor), leucocytosis, Karnofsky index, presence of physical signs and lymphocytosis. For stages I and II whose outcome was identical only Karnofsky index and lymphocytosis were predictive at the 5% level.(ABSTRACT TRUNCATED AT 250 WORDS)

Carcinoma, Non-Small-Cell Lung↗
PubMed1987

[Clinical study of double-chamber stimulation. Apropos of 50 cases followed-up for 1 to 5 years].

The authors report their experience of dual chamber pacing in 29 men and 21 women of mean age 71 +/- 4 years. 35 had sinus node dysfunction associated with node-His bundle conduction disorders; 31 presented with neurological symptoms and 4 with heart failure (due to pacemaker syndrome in 1 case). Sinus node dysfunction was diagnosed by surface ECG in 25 cases and after electrophysiological studied in only 10 cases. Fifteen patients had atrioventricular block without sinus node dysfunction: 2 of them were young subjects, 1 had pacemaker syndrome and 12 were actual or potential heart failure patients for whom preservation of the atrial systole was justified. Nine patients presented with neurological symptoms. 43 (86%) had cardiac or arterial disease associated with cardiac rhythm and conduction disorders. The percutaneous single subclavian vein approach was used in 36 cases (78%). 41 active and 9 passive fixation electrodes were utilized. The mean follow-up period was 25 months (12 to 70 months), with a cumulative figure of 1,253 months/patients. Two late re-operations for displacement of the atrial electrode were performed. Dual chamber pacing was abandoned, 14 months on average after implantation, in 9 patients (18%), on account of arrhythmias in 4 of them. Three cases of tachycardia from "electronic re-entry" and 6 cases of supraventricular arrhythmia transferred to the ventricle by the pacemaker were observed. Sixteen patients (32%) died 12 +/- 4 months on average after surgery: 12 (33%) had sinus node dysfunction and 4 (26%) had AV block. Death was caused by a cardiovascular disease in 12 cases.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1987

[Termination rules in therapeutic trials. Application of sequential methods in 2 clinical trials in hematology].

In haematology, randomized clinical trials often use survival or disease-free interval as response criterion (censored data). For ethical reasons, interim analyses are usually performed, but these interim analyses lead to an increasing Type I error. Sequential methods allow for repeated testing. Three sequential methods are well-adapted to censored data: group sequential analysis, the sequential probability ratio test and the triangular test. The triangular test has the best properties: it allows an early termination of the trial whatever the difference between the treatment groups and without the risk of long duration trials. Sequential analyses can be performed at the same frequency as the usual interim analyses. These three sequential procedures have been applied to the analysis of two cooperative trials in haematology. It appears that the use of sequential methods has to be recommended in the design of randomized clinical trials with a censored response criterion.

Antibiotics, Antineoplastic↗