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Biomedical subjects

C Le Gales

Publications and source records attributed to C Le Gales.

At least 19 recordsLinked to original sources

Treatment of high risk medulloblastomas in children above the age of 3 years: a SFOP study.

AIM: Improvement of EFS of children older than 3 years with high risk medulloblastoma. METHODS: Between 1993 and 1999, 115 patients (3-18 years, mean 8 years) with high risk medulloblastoma were included. After surgery treatment consisted of chemotherapy ('8in1' and etoposide/carboplatin) before and after craniospinal radiotherapy. RESULTS: Patients were staged using Chang-criteria (PF residue only, M1 and M2/M3) by local investigator as well as by central review panel (82.4% concordance). Chemotherapy was well tolerated without major delays in radiotherapy. With a mean follow up of 81 months (9-119), 5-year EFS was 49.8% and OS 60.1%. In detail according to subgroups EFS was 68.8% for PF residue only, 58.8% for M1 disease and 43.1% for M2/M3. CONCLUSION: M1 patients are legitimate high risk patients. Survival rates are still very low for high risk medulloblastoma patients and future trials should therefore focus on more intensive (chemotherapy/radiotherapy) treatment.

Adolescent↗

Standard-risk medulloblastoma treated by adjuvant chemotherapy followed by reduced-dose craniospinal radiation therapy: a French Society of Pediatric Oncology Study.

OBJECTIVE: The primary objective of this study was to decrease the late effects of prophylactic radiation without reducing survival in standard-risk childhood medulloblastoma. PATIENTS AND METHODS: Inclusion criteria were as follows: children between the ages of 3 and 18 years with total or subtotal tumor resection, no metastasis, and negative postoperative lumbar puncture CSF cytology. Two courses of eight drugs in 1 day followed by two courses of etoposide plus carboplatin (500 and 800 mg/m(2) per course, respectively) were administered after surgery. Radiation therapy had to begin 90 days after surgery. Delivered doses were 55 Gy to the posterior fossa and 25 Gy to the brain and spinal canal. RESULTS: Between November 1991 and June 1998, 136 patients (median age, 8 years; median follow-up, 6.5 years) were included. The overall survival rate and 5-year recurrence-free survival rate were 73.8% +/- 7.6% and 64.8% +/- 8.1%, respectively. Radiologic review showed that 4% of patients were wrongly included. Review of radiotherapy technical files demonstrated a correlation between the presence of a major protocol deviation and treatment failure. The 5-year recurrence-free survival rate of patients included in this study with all optimal quality controls of histology, radiology, and radiotherapy was 71.8% +/- 10.5%. In terms of sequelae, 31% of patients required growth hormone replacement therapy and 25% required special schooling. CONCLUSION: Reduced-dose craniospinal radiation therapy can be proposed in standard-risk medulloblastoma provided staging and radiation therapy are performed under optimal conditions.

Adolescent↗

Costs and outcomes of liver transplantation in adults: a prospective, 1-year, follow-up study. GRETHECO study group.

BACKGROUND: Orthotopic liver transplantation (OLT) is widely used to treat patients with end-stage liver disease. However, data on the cost of the procedure are fragmentary. We evaluated the costs, as calculated from resource use, and outcomes of OLT in adults, from registration on the transplant waiting list to the end of the 1st-year of follow-up after the transplant. METHODS: Two parallel cohort studies were conducted from 1994 to 95. All patients ages 18 years and older, on the waiting list (n=33) according to national criteria or having undergone transplants (n=38) were followed for 1 year or until either the transplant (waiting list cohort) or death (waiting list and transplantation cohorts). RESULTS: Eighty percent of the patients undergoing transplants were alive after 1 year, and no patient died while on the waiting list. However, the estimated cost of the procedure was high: more than 55,000 pound silver for the 1st year after OLT, to be added to 5,500 pound silver for evaluation and further costs motivated by the planned transplant during an average 6.5 months on the waiting list. Age over 40 and a baseline Child-Pugh score of 10 and over were predictive of high costs. The proportion of costs associated with immunosuppressive therapy and rejection were very high. CONCLUSIONS: This medical and economic cohort study suggests that OLT is still expensive; the study identifies sources of extra cost that could be limited either by improved selection of patients or, in the future, by technological advances in immunosuppressive therapy that help avoid medical complications. It also suggests the situation is precarious, with outcomes and costs being very sensitive to variation in graft availability.

Adolescent↗

Social and economic aspects of osteoporosis.

The first part of this article draws together descriptive studies on the direct medical costs of osteoporosis. The second part is devoted to economic evaluation of 1) osteoporosis treatment on the basis of clinical criteria and 2) preventive strategies, some of them including bone mineral density screening. These analyses point out the importance of taking into account quality of life and compliance issues. Research into dependency of the elderly has made it possible to obtain knowledge of the long-term economic consequences of osteoporosis. Development of research into dependency and its causes leads to the question as to whether the treatment and prevention of osteoporosis should be regulated in an isolated manner or whether it should be part of a larger health care policy with respect to aging.

Aged↗

[Cost-effectiveness analysis of the treatment of chronic hepatitis C].

OBJECTIVES: Chronic active hepatitis C is an important public health issue because of its prevalence, evolution, and overall cost. Treatment by recombinant alpha-interferon is both expensive and exacting and its effectiveness is limited. We report the results of a cost-effectiveness analysis of alpha-interferon treatment in patients with chronic active hepatitis C. METHODS: Direct medical costs of caring for patients with chronic active hepatitis C and its complications, based on treatment or no treatment, were assessed with retrospective data collected from the files of 137 hospital patients. Seventy-seven patients were treated with alpha-interferon between 1988 and 1994. The overall costs of caring for chronic active hepatitis C patients, without treatment or with alpha-interferon treatment (3 millions units three times a week) for 6 months (strategy A), 12 months (strategy B), or 12 months but discontinuing treatment when there was no response (strategy C), was reported and compared to the respective effectiveness of each. RESULTS: With an actualization rate of 5%, the real overall cost of caring for a chronic active hepatitis C patient was 143290 FF. Considering the contraindication rate (15%), the treatment acceptance (85%), the response rate to treatment (50%), and the prolonged response rate (25 to 30%), treating patients with strategy A induced a real overall cost of caring to 140731 FF to avoid 0.11 cases of cirrhosis, to 150277 FF to avoid 0.13 cases of cirrhosis with strategy B, and to 136947 FF to avoid 0.13 cases of cirrhosis with strategy C. CONCLUSION: Alpha-interferon treatment in patients with chronic active hepatitis C provides a long-term saving compared to cases which receive no treatment. Strategy C was the most cost-effective, inducing the reduction of both the number of cases of cirrhosis and the cost of care.

Adolescent↗

Economic assessment of maternal serum screening for Down's syndrome using human chorionic gonadotropin.

The effectiveness and costs of prenatal screening programmes for Down's syndrome using maternal serum markers will vary significantly depending on the biological cut-off values chosen in order to select women, at each maternal age, who will be sent for amniocentesis. On the basis of the first French prospective study of human chorionic gonadotropin (hCG) measurement in maternal serum, this paper shows that the screening protocol currently used in France, where hCG cut-off values are defined in order to offer amniocentesis to women of all ages with a 1 per cent fetal risk of Down's syndrome, would detect 64.06 per cent of all cases of trisomy 21 at birth and would be highly profitable for the French social security system. On the basis of a representative sample of 100,000 pregnant women, the total costs of screening would reach $8,302,000 but would generate net potential savings of $32,186,000 in terms of life-long costs of care for trisomic 21 children which would be 'avoided' by termination of pregnancy following a positive diagnosis of Down's syndrome. Economic assessment shows that cost-benefit analysis would justify lower hCG cut-off values and a higher detection rate of fetal Down's syndrome (74.45 per cent) than the current French protocol. This paper concludes that it is ethical and value-laden issues, such as the consequences for women and couples of false positives and false negatives of screening, rather than economic and financial arguments that may set limits to the utilization of screening for Down's syndrome using maternal serum markers like hCG.

Chorionic Gonadotropin↗

[Cost effectiveness analysis of prenatal screening of trisomy 21 by maternal serum markers (hCG)].

Introduction of maternal serum markers for prenatal screening of Down's syndrome leads to a redefinition of the criteria used for identifying at risk women (i.e. in France, mainly based on maternal age of 38 and over). Effectiveness and costs of prenatal screening of Down's syndrome using such maternal serum markers will vary depending on the biological cut-off values defined, at each maternal age, to identify the population of pregnant women that will be sent to amniocentesis. On the basis of the first French prospective study of the use of human chorionic gonadotropin (hCG) measurement in maternal serum as a predictor of an increased risk of Down's syndrome, this paper shows that a screening policy combining maternal age with hCG measurement is more cost-effective than screening on the basis of maternal age alone. However, final decisions about hCG cut-off values should take into account the complex ethical dilemmas involved, especially the potential consequences of "false positives" and "false negatives", of this marker.

Adult↗

[Economic evaluation of interventions in public health: potentials and limitations].

One of the main principles of economic evaluation refers to the scarcity of resources. So, choices must and will be made concerning the commitment of these resources to one use instead another. Economic evaluation can assume different methodological forms regarding the kind and complexity of programme to be assessed and the issue of outcome valuation, but each analytic technique compares the resources consumed by different relevant alternatives with the health improvements and other consequences arising from them. From a pragmatic point of view, four types of economic evaluation can be distinguished associated with different measurement and valuation of consequences: cost-minimization, cost-effectiveness, cost-utility and cost-benefit analysis. A first step of economic appraisal is definition and description of each competing alternative. Then, there are difficulties associated with measurement and valuation of both costs and effectiveness of alternatives. The assessment of public health interventions poses some special problems in terms of time profiles of cost and consequences. Most of the costs of a health programme incurred in the present while benefits will come later in the future. Therefore, cost and consequences must be discounted to reflect the existence of time preference. The last important point concerns the assessment of health consequences. Ideally, evaluation of efficacy takes the form of a well controlled randomized trial designed for this purpose. But, in many situations, this approach is not relevant, appropriate or feasible and efficacy appraisal must be developed on the basis of available data and "realistic" assumptions. So, every evaluation will contain some degree of uncertainty or imprecision and a sensibility analysis must be performed in order to test sensitivity of the results to alternative assumptions and uncertainty.

Cost Allocation↗

Socio-cultural inequities in access to prenatal diagnosis: the role of insurance coverage and regulatory policies.

The article presents the results of a 4-month-period survey by questionnaire among all women attending the Marseille Centre for Prenatal Diagnosis for amniocentesis. Socio-cultural status of women getting access to amniocentesis is significantly higher than in the general population of pregnant women in the same geographic area of south-eastern France. Socio-cultural status is also higher among women who have to cover costs of procedure to get access to amniocentesis than among those who benefit from it free-of-charge according to French Social Security regulations. In contrast, risk perception and attitudes toward termination of pregnancy are similar in these two groups. A total of 24.4 per cent of respondents declared that they got access to amniocentesis 'on their own initiative', the remaining 75.6 per cent declaring that they 'were following medical advice'. Multidimensional analysis shows that the women who do not benefit from free-of-charge amniocentesis, and who have a high level of education and no antecedents of fetal and perinatal deaths, are more likely to perceive themselves as 'self-referring'. The study indicates that institutional coverage may be effective in reducing socio-cultural inequities in access to prenatal diagnosis. But such a policy may conflict with the respect of women's individual autonomy in the amniocentesis decision.

Adult↗

Cost-effectiveness of HIV screening of pregnant women in hospitals of the Paris area. The Paris-Tours study group of antenatal transmission of HIV, Group '9 maternites'.

In the context of an epidemiologic multicentric study about perinatal transmission of HIV, screening was systematically proposed to all pregnant women attending nine maternities clinics of the Paris region (n = 7600, between August 1987 and July 1988) at their first prenatal visit. Among them, 2145 had already been tested and 45 were known to be HIV positive. So, 5660 tests were performed during the first 6 months (period 1), and 17 pregnant women were discovered to be positive. The total cost of screening has been estimated between FF. 720,000 and 775,000, resulting in a mean cost per pregnant woman found to be HIV positive of about FF. 42,000 to 45,000. A similar calculation over the following 5 months (period 2) gave a mean cost of between FF. 165,000 and 178,000. Since the women, before being screened, had to answer a short questionnaire about risk factors; cost and effectiveness of a selective screening strategy could be simulated. The preference of systematic screening to selective screening enabled the discovery of two HIV positive cases in each period, the marginal cost, i.e., cost per extra pregnant woman found to be HIV positive was thus FF. 303,320 to 327,540 for period 1, and FF. 572,240 to 619,000 for period 2. Although these figures seem high, an estimation of the cost-effectiveness does not allow us to conclude whether it is in society's interest to devote the funds necessary to move away from selective screening towards systematic screening.(ABSTRACT TRUNCATED AT 250 WORDS)

Blotting, Western↗

Searching for consensus through multi-criteria decision analysis. Assessment of screening strategies for hemoglobinopathies in southeastern France.

Until now, no systematic strategy for the prevention of major hemoglobinopathies has been implemented in southeastern France, in spite of frequencies of beta-thalassemia trait and HbS trait as high as 2.5-8% in some ethnic populations. The purpose of the study was to help a group of experts, brought together by the Regional Center for Disease Control, to reach a consensus about screening for carriers of heterozygote hemoglobinopathies. A multicriteria decision-analysis model was used to take into account not only the costs and effectiveness of potential screening strategies, but also five other qualitative criteria: technical and practical feasibilities, ethical acceptability, information follow-up in time, and global impact on health education. Conclusions differ significantly from those of a pure cost-effectiveness analysis, but a multicriteria approach seems best suited to medical experts' preferences.

Costs and Cost Analysis↗

Social acceptability of HIV screening among pregnant women.

The paper presents the results of a survey about risk perception, knowledge, and attitudes towards HIV infection among 397 pregnant women in France. The survey was carried out between December 1987 and March 1988 in two Paris-region maternity hospitals where HIV testing is routinely proposed during the first prenatal visit. Uptake of HIV prenatal testing has been rapid in France: before coming to the maternity hospitals, 26.5% of women had already been tested. Social acceptability of testing is high, 68.8% of the sample even supporting mandatory prenatal HIV screening. Such acceptability appears to be based less on an in-depth knowledge about the risks of transmission from mother-to-fetus than on the general French context of free-of-charge mandatory prenatal care and on the potentially reassuring effect of a true negative test. Consensus about abortion for HIV-infected pregnant women is strong (80.1%) and is not influenced by religious beliefs, in contrast to attitudes toward abortion in the case of fetal handicaps. This social environment creates special difficulties for the management of the complex dilemmas regarding pregnancy and childbearing for HIV-infected women.

AIDS Serodiagnosis↗

[Cost-benefit analysis of amniocentesis in the prenatal diagnosis of chromosome abnormalities].

The article presents a cost-benefit analysis of amniocentesis for detection of chromosomal anomalies based on data (1985/87) collected in the Marseille area. In this geographic area, it is possible to confront, in an exhaustive manner, pregnant women's access to amniocentesis and incidence of fetal anomalies due to chromosomal aberrations. Results show that prenatal diagnosis is highly cost-beneficial, the average cost of one "avoided" case of Down's syndrome being lower than the lifelong costs of care for such a child. However, the study emphasizes that the cost-benefit ratio is highly sensitive to the implicit value society affects to the loss of "normal" fetuses through spontaneous abortions provoked by amniocentesis and because of terminations of pregnancy following diagnosis of minor fetal anomalies. The study also shows that lowering maternal age limit for access to free-of-charge amniocentesis from the current 38 years of age to 35 would have been cost-beneficial. Such lowering of the maternal age limit is discussed and compared with other indications which might be used for systematic access to amniocentesis.

Amniocentesis↗

[Evaluation of the cost-effectiveness of school screening for hereditary hemoglobin abnormalities: prospective study in Bouches-du-Rhône. School screening for hemoglobinopathies].

Screening in schools for heterozygote carriers of haemoglobinopathies traits has been carried out experimentally in southeast France ("Bouches du Rhône", the Marseille region) since 1977. The study compares, in cost-effectiveness terms, the screening strategy now followed with 27 alternative strategies in all the pupils (14-16 years). Although the frequency of heterozygote carriers in this school population as a whole is only 7.9% carriers for beta-thalassaemia gene and 2.5% carriers for HbS, prospective costs per diagnosis still seem reasonable: from 1544 to 4997 French francs (1987) depending on the strategy, and 2099 to 7380 francs if beta-thalassaemia alone is screened. In comparison with the current screening strategy, cost-effectiveness ratios could be improved by using haemoglobin electrophoresis as a preselection test, or a blood count if beta-thalassaemia alone is screened. Further improvement of cost-effectiveness ratios could be obtained by limiting screening to ethnic groups most "at risk"; but such strategies raise ethical and acceptability issues.

Adolescent↗

[The practice of x-ray computed tomography during a period of rapid growth. A survey on the Provence-Alpes-Côte d'Azur region in 1986].

From May to September 1986, a sample of 748 CT-scanner examinations, representative of the total annual activity, has been collected in Provence-Alpes-Côte d'Azur Region. The regional activity of CT-scanner has been estimated to 91,200 examinations in 1986 (total France: 628,500 in 1985) or 22.7 procedures per 1,000 inhabitants (total France: 11,4 in 1985). CT-scanner is now a routine diagnostic imaging device with an annualized average of 6,080 procedures per machine (5,770 in public sector and 8,415 in the for-profit private one). The mean effective utilization time for a machine in one year was 2,700 hours in a regional, public, teaching hospital (PTH) and 3,100 in private, for-profit establishment (PPE). The number of procedures per machine-use hour was 2,4 in PTH and 2.8 PPE. No procedural difference has been observed between the two sectors in carrying out the technique. CT-Scanner diffusion in the private for profit sector has meant: - an increase in the demand from general medical practionners (more than 1/4 examinations); - a larger range of indications concerning less serious health conditions.

France↗

[Medical characteristics of cases of pulmonary tuberculosis and the place of systematic radiography screening among the means of discovery. Cross-sectional survey of 984 cases of pulmonary tuberculosis reported in France in 1984].

We present the results of a study conducted in 1984 in 31 DDASS centres which enabled us to constitute a standardized sample representative of all cases of tuberculosis currently notified in France. An analysis of the patients' characteristics showed that cases of tuberculosis were discovered in equal numbers in three branches of medicine: industrial medicine and welfare centres, general medicine including (to a very small extent) private specialists, and hospital medicine (in-patients and out-patients). Most of the subjects in our study had clinical signs of tuberculosis at the time of diagnosis, and it was these signs that prompted them to consult. About 28% of the cases (25% in an undifferentiated population) were detected by systematic radiography, and 25 to 50% of these patients (45-66% for the whole of the population notified) were contagious. From the results of this study, the number of patients detected by systematic radiography in 1982 was estimated at approximately 3,000; of these, 800 to 1,580 might have been contagious. In that same year, 9 million systematic radiological examinations were performed, which means that the yield of these examinations was 9 to 17.6 in 100,000 for contagious pulmonary tuberculosis and 34 in 100,000 for all cases of pulmonary tuberculosis.

Cross-Sectional Studies↗

[Evaluation of the policies for detection of pulmonary tuberculosis in France].

A survey of 984 cases of pulmonary tuberculosis was carried out to assist French public health authorities in determining policies for pulmonary tuberculosis detection. The adjusted sample was representative of the totality of pulmonary tuberculosis cases reported. The survey made it possible to define the economic and socio-demographic characteristics (age, nationality, lack of social security coverage, living conditions) which, when combined, represent high-risk attributes with regard to pulmonary tuberculosis. Nonetheless, over half the subjects studied presented no risk factors. Systematic X-ray screening of an undifferentiated population permits detection of about 23% of reported cases; among them, 26 or 50% (depending on the definition of contagiousness chosen) were contagious. In 1982, 9 million systematic X-ray screenings were performed and about 13,100 cases of pulmonary tuberculosis reported. When extrapolated to these 1982 figures, our survey conclusions point to an effectiveness rate for systematic X-ray screening of 33.7 per 100,000 for the overall tuberculosis population, and between 8.9 and 17.4 per 100,000 for contagious cases. On the other hand, high-risk groups (female immigrants, the aged, etc.) do not seem to be particularly well covered by systematic X-ray screening. Thus, maintaining such a program no longer appears justified either in terms of the overall tuberculosis population or that of high-risk subgroups.

Adolescent↗

[Prevention of occupational carcinogens: perspectives opened by the evaluation of risks and preventive actions].

The first part of the review deals with the present situation in terms of prevention against potential carcinogenic substances in France. A significant effort should be devoted to the measurement of contaminants--not only carcinogenic substances--in the workplace. This is a prerequisite for setting a data base in terms of potential occupational risk. Moreover gaps exist also as far as the definition of the technical means aimed at the reduction of risk is concerned. These conclusions put into light the importance of the contribution that "industrial hygienists" would bring in France. In the second part of the review, the methodological content of the risk assessment and risk management procedures is described and illustrated. Risk assessment of carcinogens deals: with the identification of potential carcinogens through epidemiology, animal bio-assays and short term tests; with the quantitative estimation of the magnitude of the potential carcinogenic risk among the exposed workers. It appears necessary to carry out systematic surveys of the number of workers exposed to the carcinogenic substances. The risk assessment procedure is applied to 5 substances BCME, MOCA, Acrylonitrile, Chromium, Nickel and some compounds of these metals. The number of potential excess cancers related to a unit lifelong exposure to Nickel compounds is estimated. This requires exposure-response models which are critically analysed. Risk management is devoted to the choice of primary health care policies. The methodology of risk management consists of: identifying various control policies; quantitative estimation of their efficiency--indicators of the efficiency are discussed--and of their cost; choice among these policies with the help of a cost-effectiveness analysis when necessary. The procedure is illustrated in the case of Acrylonitrile control in a facility.

Carcinogens↗