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Guy-Robert Auleley

Publications and source records attributed to Guy-Robert Auleley.

5 recordsLinked to original sources
PubMed2006

Geographical variations of inflammatory bowel disease in France: a study based on national health insurance data.

BACKGROUND AND AIM: A north-south gradient in inflammatory bowel disease (IBD) incidence has been found in Europe and the United States. Its existence is inferred from comparisons of registries that cover only small portions of territories. Several studies suggest that IBD incidence in the north has reached a plateau, whereas in the south it has risen sharply. This evolution tends to reduce the north-south gradient, and it is uncertain whether it still exists. In France, patients with IBD are fully reimbursed for their health expenses by the national health insurance system, which is a potential source of data concerning the incidence of IBD at the national level. The aim of this study was to assess the geographical distribution of Crohn's disease (CD) and ulcerative colitis (UC) in France and to test the north-south gradient hypothesis. METHODS: This study was conducted in metropolitan France and included patients to whom IBD reimbursement was newly attributed between January 1, 2000 and December 31, 2002. Data provided relate to age, sex, postcode area of residence, and IBD type. The mapping of geographical distribution of smoothed relative risks (RR) of CD and UC was carried out using a Bayesian approach, taking into account autocorrelation and population size in each département. RESULTS: In the overall population, incidence rates were 8.2 for CD and 7.2 for UC per 100,000 inhabitants. A clear north-south gradient was shown for CD. Départements with the highest smoothed RR were located in the northern third of France. By contrast, the geographical distribution of smoothed RR of UC was homogeneous. CONCLUSIONS: This study shows a north-south gradient in France for CD but not for UC.

Adolescent↗
PubMed2005

[Selective cyclooxygenase-2 inhibitors. A population-based analysis of use in France over a three-year period and comparison with randomised clinical trials].

OBJECTIVES: The use of selective cyclooxygenase-2 (COX-2) inhibitors is highly controversial today, mainly because of doubts about cardiovascular tolerance. Few studies have assessed the use of these drugs in daily clinical practice. This study aims to assess the changes in their use in daily practice in France and to compare it with their use in randomized clinical trials. METHODS: The French National Health Insurance Fund AMPI database of self-employed workers in non-agricultural occupations was used to obtain the following information: patients requesting reimbursement for celecoxib and rofecoxib between November 2000 and October 2003, morbidity assessed by enrollment on the lists of chronic diseases for which care is fully (100%) reimbursed, pregnancy (assessed by the payment of physicians' or hospital fees for delivery or by maternity benefits), and concomitant drugs (by claims for reimbursement). We compared these patients with those in randomized clinical trials (RCT) of celecoxib or rofecoxib published in either English or French before November 2003; we focused on their demographic characteristics, morbidity, pregnancy and concomitant drug use. RESULTS: Use of COX-2 inhibitors in France did not vary over the study period, except for patients' mean age (range: 64.2-62.9 years), proportion of women (56.7%-54.7%) and use of gastroprotective drugs (18.2%-28.4%). The mean age of patients in our study was 10 years older than that of RCT patients, and the proportion of women in our study was 15% lower. The percentage of women who took these drugs while pregnant was 0.02% in our study and 0.09% in the RCT. The percentage of patients with long-term chronic disorders overall was higher in our study than in the RCT, and the percentage for all specific long-term diseases except rheumatoid arthritis was also higher (for example, more patients had cardiovascular diseases or diabetes in our study [15%] than in the RCT [6%]). Patients in our study also used concomitant drugs from 9 of the 14 principal Anatomical Therapeutic Chemical classification groups more frequently than RCT patients: for cardiovascular drugs, for example, the figures were 55% and 5%, respectively. CONCLUSION: The demographic characteristics, prevalence of chronic morbidity and use of concomitant drugs among COX-2 inhibitor users in France varied little over the three years after marketing approval. Compared with RCT patients, these users were less often female, were older and more often had cardiovascular diseases. Cardiovascular events occurring among COX-2 inhibitor users in France should be evaluated.

Adolescent↗
PubMed2004

The methods for handling missing data in clinical trials influence sample size requirements.

OBJECTIVE: Results of studies estimating osteoarthritis progression may be affected by missing values. In clinical trials assessing disease-modifying osteoarthritis drugs, sample sizes should be calculated using close estimates of outcome variables. STUDY DESIGN AND SETTING: Supposing a two-parallel group design in hip osteoarthritis clinical trials, we estimated sample sizes using the joint space width (JSW), number of patients with JSW progression >0.5 mm (JSN), time to total hip arthroplasty (THA), and time to JSN or THA using several approaches to deal with missing data. RESULTS: Three-year clinical trials testing a treatment effect of 50%, with a power of 80%, could require sample sizes of 121 patients for JSW, 57 for JS progression using multiple imputation for handling missing values; 200 for THA; and 47 for JSN or THA. These numbers vary greatly depending on the approach chosen for handling missing data. CONCLUSIONS: These results can help investigators plan clinical trials to select the primary outcome and a priori specify the way missing data will be handled.

Aged↗
PubMed2002

Evaluation of the smallest detectable difference in outcome or process variables in ankylosing spondylitis.

OBJECTIVE: To evaluate the smallest detectable difference (SDD) of symptomatic outcome or process variables in ankylosing spondylitis (AS) patients from various countries. METHODS: Thirty consecutive AS patients with axial involvement were recruited from 1 center in each of 4 countries (Spain, Morocco, France, The Netherlands), for a total of 120 patients. Fourteen variables were studied in 6 domains: pain (3 variables), stiffness (1 variable), function (2 variables), spinal mobility (3 variables), patient global assessment (4 variables), and the domain of enthesiopathy (1 variable). All patients were evaluated twice within a 1-week period during which no clinical or therapeutic change occurred. Intracenter reliability was evaluated using the intraclass correlation coefficient (ICC). The SDD was determined using the Bland-Altman method. RESULTS: Of the 14 variables evaluated in the 120 patients (82% males, 42 +/- 12 years old, with a mean disease duration of 17 +/- 13 years), only the SDD for the variable occiput-to-wall distance showed statistically significant difference among centers. For the entire group, the SDD, expressed as percentage of the range of the variable, varied from 10% (Mander enthesis index) to 39% (spinal pain at night last week). The intraobserver reliability was good (ICC > 0.80) except for the variables morning stiffness and modified Schober test (ICCs of 0.76 and 0.60, respectively). CONCLUSION: This study suggests that the evaluation of AS patients is homogenous and reliable in different centers of different European and North African countries. Evaluation of the SDD of the symptomatic outcome or process variables is a starting point to determine the minimum clinically important difference, permitting the presentation of results of clinical studies on an individual basis.

Adult↗