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Le Touquet – Paris-Plage, France

Gillaizeau F.,French Cochrane Center
The Cochrane database of systematic reviews | Year: 2013

Maintaining therapeutic concentrations of drugs with a narrow therapeutic window is a complex task. Several computer systems have been to identify specific therapeutic areas where the computerized advice on drug dosage was beneficial compared with routine care:1. it increased target peak serum concentrations (standardized mean difference (SMD) 0.79, 95% CI 0.46 to 1.13) and the proportion of people with plasma drug concentrations within the therapeutic range after two days (pooled risk ratio (RR) 4.44, 95% CI 1.94 to 10.13) for aminoglycoside antibiotics;2. it led to a physiological parameter more often within the desired range for oral anticoagulants (SMD for percentage of time spent in target international normalized ratio +0.19, 95% CI 0.06 to 0.33) and insulin (SMD for percentage of time in target glucose range: +1.27, 95% CI 0.56 to 1.98);3. it decreased the time to achieve stabilization for oral anticoagulants (SMD -0.56, 95% CI -1.07 to -0.04);4. it decreased the thromboembolism events (rate ratio 0.68, 95% CI 0.49 to 0.94) and tended to decrease bleeding events for anticoagulants although the difference was not significant (rate ratio 0.81, 95% CI 0.60 to 1.08). It tended to decrease unwanted effects for aminoglycoside antibiotics (nephrotoxicity: RR 0.67, 95% CI 0.42 to 1.06) and anti-rejection drugs (cytomegalovirus infections: RR 0.90, 95% CI 0.58 to 1.40);5. it tended to reduce the length of time spent in the hospital although the difference was not significant (SMD -0.15, 95% CI -0.33 to 0.02) and to achieve comparable or better cost-effectiveness ratios than usual care;6. there was no evidence of differences in mortality or other clinical adverse events for insulin (hypoglycaemia), anaesthetic agents, anti-rejection drugs and antidepressants.For all outcomes, statistical heterogeneity quantified by I(2) statistics was moderate to high. This review update suggests that computerized advice for drug dosage has some benefits: it increases the serum concentrations for aminoglycoside antibiotics and improves the proportion of people for which the plasma drug is within the therapeutic range for aminoglycoside antibiotics.It leads to a physiological parameter more often within the desired range for oral anticoagulants and insulin. It decreases the time to achieve stabilization for oral anticoagulants. It tends to decrease unwanted effects for aminoglycoside antibiotics and anti-rejection drugs, and it significantly decreases thromboembolism events for anticoagulants. It tends to reduce the length of hospital stay compared with routine care while comparable or better cost-effectiveness ratios were achieved.However, there was no evidence that decision support had an effect on mortality or other clinical adverse events for insulin (hypoglycaemia), anaesthetic agents, anti-rejection drugs and antidepressants. In addition, there was no evidence to suggest that some decision support technical features (such as its integration into a computer physician order entry system) or aspects of organization of care (such as the setting) could optimize the effect of computerized advice.Taking into account the high risk of bias of, and high heterogeneity between, studies, these results must be interpreted with caution. Source


Escalas C.,French Institute of Health and Medical Research | Dalichampt M.,Assistance Publique Hopitaux de Paris | Combe B.,Montpellier University Hospital Center | Fautrel B.,University Pierre and Marie Curie | And 5 more authors.
Annals of the Rheumatic Diseases | Year: 2012

Objective: To assess the association of adherence to the 2007 recommendations of the European League Against Rheumatism (EULAR) for managing early arthritis and radiographic progression and disability in patients Methods: The authors conducted a prospective population-based cohort study. The ESPOIR cohort was a French cohort of 813 patients with early arthritis not receiving disease-modifying antirheumatic drugs (DMARDs). Adherence to the 2007 EULAR recommendations was defined by measuring adherence to three of the recommendations concerning the initiation and early adjustment of DMARDs. The study endpoints were radiographic progression, defined as the presence of at least one new erosion between baseline and 1 year, and disability as a heath assessment questionnaire score ≥1 at 2 years. A propensity score of being treated according to the recommendations was developed. Results: After adjustment for propensity score, treatment centre and the main confounding factors, patients without recommendation adherence were at increased risk of radiographic progression at 1 year, and of functional impairment at 2 years (OR 1.98, (95% CI: 1.08 to 3.62 and OR: 2.36, (95% CI: 1.17 to 4.67), respectively). Conclusions: Early arthritis patients whose treatment adhered to the 2007 EULAR recommendations seemed to benefit from such treatment in terms of risk of clinical and radiographic progression. Using a propensity score of being treated according to recommendations in observational studies may be useful in assessing the potential impact of these recommendations on outcome. Copyright Article author (or their employer) 2012. Source


Lonjon G.,French Institute of Health and Medical Research | Boutron I.,French Institute of Health and Medical Research | Boutron I.,Center dEpidemiologie Clinique | Boutron I.,University of Paris Descartes | And 14 more authors.
Annals of Surgery | Year: 2014

OBJECTIVE: We aimed to compare treatment effect estimates from NRSs with PS analysis and RCTs of surgery. BACKGROUND: Evaluating a surgical procedure in randomized controlled trials (RCTs) is challenging. Nonrandomized studies (NRSs) involving use of propensity score (PS) analysis to limit bias are of increasing interest. DESIGN: Meta-epidemiological study. METHODS: We systematically searched MEDLINE via PubMed for all prospective NRSs with PS analysis evaluating a surgical procedure. Related RCTs, addressing the same clinical questions, were systematically retrieved. Our primary outcome of interest was all-cause mortality. We also selected 1 subjective outcome. We calculated the summary odds ratios (OR) for each study design, the ratio of OR (ROR) between the designs and the summary ROR across clinical questions. An ROR < 1 indicated that the experimental intervention is more favorable in NRSs with PS analysis than RCTs. RESULTS: We retrieved 70 reports of NRSs with PS analysis and 94 related RCTs evaluating 31 clinical questions, of which 22 assessed all-cause mortality and 26 a subjective outcome. The combined ROR for all-cause mortality was 0.83 (95% confidence interval: 0.65-1.04). For subjective outcomes, the combined ROR was 1.07 (0.87-1.33). CONCLUSIONS: There was no statistically significant difference in treatment effect between NRSs with PS analysis and RCTs. Prospective NRSs with suitable and careful PS analysis can be relied upon as evidence when RCTs are not possible. Copyright © 2013 by Lippincott Williams & Wilkins. Source


Hrobjartsson A.,Nordic Cochrane Center | Thomsen A.S.S.,Nordic Cochrane Center | Emanuelsson F.,Nordic Cochrane Center | Tendal B.,Nordic Cochrane Center | And 4 more authors.
CMAJ | Year: 2013

Background: Clinical trials are commonly done without blinded outcome assessors despite the risk of bias. We wanted to evaluate the effect of nonblinded outcome assessment on estimated effects in randomized clinical trials with outcomes that involved subjective measurement scales. Methods: We conducted a systematic review of randomized clinical trials with both blinded and nonblinded assessment of the same measurement scale outcome. We searched PubMed, EMBASE, PsycINFO, CINAHL, Cochrane Central Register of Controlled Trials, HighWire Press and Google Scholar for relevant studies. Two investigators agreed on the inclusion of trials and the outcome scale. For each trial, we calculated the difference in effect size (i.e., standardized mean difference between nonblinded and blinded assessments). A difference in effect size of less than 0 suggested that nonblinded assessors generated more optimistic estimates of effect. We pooled the differences in effect size using inverse variance random-effects meta-analysis and used metaregression to identify potential reasons for variation. Results: We included 24 trials in our review. The main meta-analysis included 16 trials (involving 2854 patients) with subjective outcomes. The estimated treatment effect was more beneficial when based on nonblinded assessors (pooled difference in effect size -0.23 [95% confidence interval (CI) -0.40 to -0.06]). In relative terms, nonblinded assessors exaggerated the pooled effect size by 68% (95% CI 14% to 230%). Heterogeneity was moderate (I2 = 46%, p = 0.02) and unexplained by metaregression. Interpretation: We provide empirical evidence for observer bias in randomized clinical trials with subjective measurement scale outcomes. A failure to blind assessors of outcomes in such trials results in a high risk of substantial bias. © 2013 Canadian Medical Association or its licensors. Source


Riveros C.,French Institute of Health and Medical Research | Riveros C.,University of Paris Descartes | Riveros C.,Center dEpidemiologie Clinique | Dechartres A.,French Institute of Health and Medical Research | And 15 more authors.
PLoS Medicine | Year: 2013

Background:The US Food and Drug Administration Amendments Act requires results from clinical trials of Food and Drug Administration-approved drugs to be posted at ClinicalTrials.gov within 1 y after trial completion. We compared the timing and completeness of results of drug trials posted at ClinicalTrials.gov and published in journals.Methods and Findings:We searched ClinicalTrials.gov on March 27, 2012, for randomized controlled trials of drugs with posted results. For a random sample of these trials, we searched PubMed for corresponding publications. Data were extracted independently from ClinicalTrials.gov and from the published articles for trials with results both posted and published. We assessed the time to first public posting or publishing of results and compared the completeness of results posted at ClinicalTrials.gov versus published in journal articles. Completeness was defined as the reporting of all key elements, according to three experts, for the flow of participants, efficacy results, adverse events, and serious adverse events (e.g., for adverse events, reporting of the number of adverse events per arm, without restriction to statistically significant differences between arms for all randomized patients or for those who received at least one treatment dose).From the 600 trials with results posted at ClinicalTrials.gov, we randomly sampled 50% (n = 297) had no corresponding published article. For trials with both posted and published results (n = 202), the median time between primary completion date and first results publicly posted was 19 mo (first quartile = 14, third quartile = 30 mo), and the median time between primary completion date and journal publication was 21 mo (first quartile = 14, third quartile = 28 mo). Reporting was significantly more complete at ClinicalTrials.gov than in the published article for the flow of participants (64% versus 48% of trials, p<0.001), efficacy results (79% versus 69%, p = 0.02), adverse events (73% versus 45%, p<0.001), and serious adverse events (99% versus 63%, p<0.001).The main study limitation was that we considered only the publication describing the results for the primary outcomes.Conclusions:Our results highlight the need to search ClinicalTrials.gov for both unpublished and published trials. Trial results, especially serious adverse events, are more completely reported at ClinicalTrials.gov than in the published article.Please see later in the article for the Editors' Summary. © 2013 Riveros et al. Source

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