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Sainte-Foy-lès-Lyon, France

Fautrel B.,APHP | Fautrel B.,University Pierre and Marie Curie | Benhamou M.,APHP | Benhamou M.,University Pierre and Marie Curie | And 10 more authors.
Annals of the Rheumatic Diseases | Year: 2010

Objective: To determine the incremental cost-effectiveness ratios (ICERs) of two therapeutic regimens of infliximab for ankylosing spondylitis (AS). Methods: 230 patients with active AS who were participating in a randomised controlled trial comparing two infliximab infusion modalities - every 6 weeks (Q6) and on demand (DEM) - were included in an economic evaluation within the trial. Data were collected by phone every 3 months for 1 year. Direct and indirect costs were calculated from a payer perspective. Health-related quality of life was assessed with a general health rating scale. ICERs were calculated for one 20% improvement (ASAS20), for one partial remission and for one qualityadjusted life year (QALY) gained. Results: The Q6 regimen was significantly more efficacious than the DEM regimen but also more costly (€22 388 vs €17 596; p<0.001), because it required significantly more infliximab infusions per patient (8.4 vs 6.2). The ICERs of the Q6 to DEM regimen were €15 841 for one ASAS20 response, €23 296 for one partial remission and €50 760 for one QALY gained. Conclusion: The administration of infliximab every 6 weeks is cost effective as compared with a DEM regimen; however, the ICER is close to the acceptability threshold of €50 000 for one QALY gained. Trial registration number: NCT 00439283. Source

Soubrier M.,Hopital G Montpied | Fautrel B.,Hopital La Pitie Salpetriere | Roux F.,RCTs
Annals of the Rheumatic Diseases | Year: 2011

Objectives: To compare the efficacy of disease activity score in 28 joints (DAS28ESR)-driven therapy with antitumour necrosis factor (patients from the GUEPARD trial) and routine care in patients with recent-onset rheumatoid arthritis (patients of the ESPOIR cohort). Results: After matching GUEPARD and ESPOIR patients on the basis of a propensity score and a 1:2 ratio, at baseline all patients had comparable demographic characteristics, rheumatoid factor, anticyclic citrullinated peptide antibody positivity and clinical disease activity parameters: erythrocyte sedimentation rate, C-reactive protein, mean DAS (6.26±0.87), Sharp/van der Heijde radiographic score (SHS), health assessment questionnaire (HAQ). Disease duration was longer in GUEPARD patients (5.6±4.6 vs 3.5±2.0 months, p<0.001). After 1 year, the percentage of patients in remission with an HAQ (<0.5) and an absence of radiological progression was higher in the tight control group (32.3% vs 10.2%, p=0.011) as well as the percentage of patients in low DAS with an HAQ (<0.5) and an absence of radiological progression (36.1% vs 18.9%, p=0.045). However, there was no difference in the decrease in DAS, nor in the percentage of EULAR (good and moderate), ACR20, ACR50 and ACR70 responses. More patients in the tight control group had an HAQ below 0.5 (70.2% vs 45.2%, p=0.005). Overall, pain, patient and physician assessment and fatigue decreased more in the tight control group. The mean SHS progression was similar in the two groups as was the percentage of patients without progression. Conclusions: In patients with recent onset active rheumatoid arthritis, a tight control of disease activity allows more patients to achieve remission without disability and radiographic progression. Source

Tabet J.-Y.,Les Grands Pres | Malergue M.-C.,Institute Jacques Cartier | Meurin P.,Les Grands Pres | Not D.,RCTs | And 2 more authors.
Archives of Cardiovascular Diseases | Year: 2010

Background: The distribution of left ventricular ejection fraction (LVEF) - a key factor in coronary artery disease (CAD) patient management and prognostication - is poorly documented. Objective: To determine LVEF and heart rate (HR) values, and describe the management of stable CAD patients in France. Methods: The INDYCE survey was a prospective, multicentre registry of consecutive stable CAD outpatients attending a cardiology consultation. The survey focused on LVEF values measured using the echocardiographic Simpson biplane method. Drug therapy, resting HR, blood pressure and symptoms were also recorded. Results: Overall, 3119 patients (68.4 ± 11.0 years; 80% men) were enrolled. LVEF was 56.1 ± 11.8% on average, and was poor (< 40%) and moderately impaired (40-50%) in 9.6% (n = 298) and 19.8% (n = 619) of cases, respectively. Symptomatic angina pectoris was present in 19.2% of cases and only 40.6% of patients were asymptomatic (no angina and NYHA class ≤ I) despite relatively aggressive management (79.0% of patients had undergone coronary angioplasty and/or bypass graft). Interestingly, 14.1% of patients with LVEF less than 40% were asymptomatic. In multivariable analysis, LVEF less than 40% was associated most strongly with symptomatic status (odds ratio 3.82; 95% CI 2.59-5.63; P < 0.0001), together with female sex, age greater than 75 years, diabetes, HR greater or equal to 70 bpm, sedentariness, obesity and disease duration. Conclusion: Only 9.6% of stable CAD patients had severe left ventricular dysfunction; among them, 14.1% were strictly asymptomatic. This could justify regular LVEF measurement in CAD patients. Three potentially reversible factors (HR ≥ 70 bpm, being overweight and sedentariness) were linked independently to the presence of symptoms. © 2010 Elsevier Masson SAS. Source

Franc S.,Center for Study and Research for Improvement of the Treatment of Diabetes | Daoudi A.,Center for Study and Research for Improvement of the Treatment of Diabetes | Pochat A.,Center for Study and Research for Improvement of the Treatment of Diabetes | Petit M.-H.,Center for Study and Research for Improvement of the Treatment of Diabetes | And 10 more authors.
Diabetes, Obesity and Metabolism | Year: 2015

Aims: To validate strategies to prevent exercise-induced hypoglycaemia via insulin-dose adjustment in adult patients with type 1 diabetes (T1D) on pump therapy. Methods: A total of 20 patients randomly performed four 30-min late post-lunch (3 h after lunch) exercise sessions and a rest session: two moderate sessions [50% maximum oxygen consumption (VO2max)] with 50 or 80% basal rate (BR) reduction during exercise + 2 h and two intense sessions (75% VO2max) with 80% BR reduction or with their pump stopped. Two additional early post-lunch sessions (90 min after lunch) were analysed to compare hypoglycaemia incidence for BR reduction versus bolus reduction. Results: In all, 100 late post-lunch sessions were analysed. Regardless of exercise type and BR reduction, no more hypoglycaemic events occurred in the period until the next morning than occurred after the rest sessions. In the afternoon, no more hypoglycaemic events occurred with 80% BR reduction/moderate exercise or with pump discontinuation/intense exercise than for the rest session, whereas more hypoglycaemic events occurred with 50% BR reduction/moderate exercise and 80% BR reduction/intense exercise. After early post-lunch exercise (n = 37), a trend towards fewer hypoglycaemic episodes was observed with bolus reduction versus BR reduction (p = 0.07). Mean blood glucose fell by ∼3.3 mmol/l after 30 min of exercise, irrespective of dose reduction, remaining stable until the next morning with no rebound hyperglycaemia. Conclusion: In adults with T1D, to limit the hypoglycaemic risk associated with 30 min of exercise 3 h after lunch, without carbohydrate supplements, the best options seem to be to reduce BR by 80% or to stop the pump for moderate or intense exercise, or for moderate exercise 90 min after lunch, to reduce the prandial bolus rather than the BR. © 2015 John Wiley & Sons Ltd. Source

News Article
Site: http://www.nature.com/nature/current_issue/

A satirical study1 showing that a mother’s kisses didn’t help injured children to feel better contained several clues that it was fake. The funder was Proctor and Johnson, a made-up medical company, and one of the references was entitled “So what the hell is going on here?” The paper, describing a fictional randomized controlled trial (RCT) of mothers kissing their toddlers, was designed to illustrate the limitations of evidence-based medicine, which uses data from such clinical trials to direct the practice of medicine. Many people who shared the article on Twitter played along with it. Angela Smith, a urologist at the University of North Carolina School of Medicine at Chapel Hill, tweeted: But some commenters said that the article, which the editor of the Journal of Evaluation in Clinical Practice knowingly published in his journal, could be misleading and needs to be clearly labelled as satirical. RCTs are widely considered to be the gold standard for evidence-based medicine. But recent years have seen some doctors and researchers push back against the emphasis on RCTs, arguing that such studies sideline anecdotal evidence and professional experience, which they say is not always inferior to evidence obtained from clinical trials. To point out some of the drawbacks of evidence-based medicine, Mark Tonelli, a physician and researcher at the University of Washington Medical Center in Seattle, made up a clinical trial to test whether mothers kissing their children’s injuries — or “boo-boos” — helped to relieve the pain. He was inspired by his experiences as a father of a toddler a decade ago. “We were a boo-boo-kissing family,” says Tonelli. His paper, by a fictional collaboration called The Study of Maternal and Child Kissing (SMACK) Working Group, suggested that out of 943 mother–toddler pairs, children in the kissing group were actually “significantly more distressed” than those in the no-kissing group. The authors concluded by recommending a moratorium on boo-boo kissing. Tonelli meant to criticize RCTs, particularly their failure to consider the importance of person-to-person interactions – a cornerstone of medicine. “Writing a report of a fictional clinical trial as satire allowed multiple limitations and pitfalls of clinical research to be addressed,” he says. Tonelli hopes that medical trainees will use the paper “to prime themselves to find similar issues in authentic research reports”. Pierre Azoulay, an economist at the Massachusetts Institution of Technology in Cambridge, reflected on the irony of the paper, tweeting: Andrew Miles, editor-in-chief of the Journal of Evaluation in Clinical Practice, points out that the spoof article was published at the end of 2015, and that medical satire is commonplace in the Christmas editions of journals such as the British Medical Journal. The paper’s underlying message is in line with the journal’s philosophy, says Miles, who is also senior vice-president of the European Society for Person Centered Healthcare in London and Madrid. In medicine, he notes, scientific research is only one type of knowledge, which must sit alongside other forms, such as professional medical experience, and not above them. “Over-reliance on science is a very dangerous thing,” Miles says. Next month, the journal will publish another article unpacking the lessons contained in the satirical paper, he adds. Carl von Baeyer, a psychologist and paediatrician at the University of Saskatchewan in Saskatoon, Canada, thinks that allowing spoof papers to creep into academic literature may mislead readers. “I thought the article itself was clever and funny,” he says. “But the PubMed abstract had nothing that would mark it as a joke, and some readers took it seriously.” He also pointed out that some readers might make judgements solely on the paper’s abstract, which is “too plausible”. Miles says that he has explained the reasons for commissioning the spoof paper in an editorial that will soon be published. He is now considering including a link to it from the PubMed abstract. “Satire is an ancient tool to inspire deep thought and critical debate,” he says, but “clearly we would not wish to pack our journals full of it”.

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