[Contracts including performance and management of uncertainty]. / Contrats de performance et management de l'incertitude.

Since many decades in France, the most important part of ambulatory health care expenditure is represented by drug consumption. By the fact, French patient is indeed the greatest world consumer of pharmaceuticals treatments. Therefore, the regulation authorities by successive strategies, attempt to limit or even restrict market access for new drugs in the health care sector secured by public social insurance coverage. Common objectives are to assess the reimbursement to scientific studies and to fix the price of therapeutics at an acceptable level for both industries and government. New trends try then to determine recently the drug price in a dual approach, as a component of global and effective contract, including performance and outcome. The first diffusion authorization is diffusion concerned, but this concept takes into account the eventual success of new produces in long-term survey. Signed for a fixed period as reciprocal partnership between regulation authorities and pharmaceutics industries, the contract integrates two dimensions of incertitude. The first one is represented by the strategy of new treatments development according to efficacy and adapted price, and the second one is linked to the result of diffusion and determines adapted rules if eventual non-respects of the previous engagement are registered. This paper discusses problems related to this new dimension of incertitude affected by conditional drug prices in market access strategy and the adapted follow-up of new treatment diffusion fixed by "outcome" contract between French regulation administration and pharmaceutics industries in our recent economic context.

Prevalence and clinical characteristics of migraine in France.

OBJECTIVE: To determine the prevalence and clinical features of migraine and related headache types in France. METHODS: The authors recruited a population of subjects with headache representative of the national population using a stratified sampling method. They screened 10,585 subjects aged 15 and older who were representative of the general population. They identified 1,486 of these as having headaches, and these subjects were subsequently interviewed for information on clinical features, natural history, and functional impact of headache. The authors categorized subjects based on the International Headache Society (IHS) classification and assessed disability using the MIDAS questionnaire. RESULTS: The authors found a standardized prevalence for migraine (IHS categories 1.1 and 1.2) of 7.9% (11.2% for women and 4.0% for men) and 9.1% for migrainous disorder (IHS category 1.7). Migraine attacks were associated with a considerable degree of handicap in activities of daily living, with a MIDAS grade distribution of 74.7% (grade 1), 13.3% (grade 2), 7.7% (grade 3), and 4.3% (grade 4). The prevalence of migraine with MIDAS grade 3 or 4 was 1.6%. CONCLUSIONS: The prevalence of migraine (IHS categories 1.1 and 1.2) in France is 7.9%, and that of total migraine is 17.0%; this does not seem to have evolved over the past 10 years.

On the choice of an organization for a pathology laboratory.

The study describes an approach to the optimal allocation of sample analysis in a pathology laboratory. The paper consists of three parts: identification of the problem to be resolved; description of the model and application of the model to the organization of a specific laboratory.

[Which measures are to be taken in the prevention of prematurity in working women?]. / Quelles mesures de prévention de la prématurité en milieu professionnel?

The aim of this study was to determine the best preventive measures for employed pregnant women. Assuming that certain working conditions constitute a risk factor for preterm birth, should we give time off to women whose jobs are strenuous, reduce their weekly hours of work, or lengthen their antenatal maternity leave in an attempt to reduce risk of preterm birth? To answer this question, a survey carried out in 50 factories showed that a reduction of weekly working hours (routinely granted in many factories at present) appears helpful in reducing the preterm birth rate : this is also true for sick leaves granted for fatigue without pathological reason : on the other hand, the lengthening of antenatal maternity leave for fatigue, without medical reason, seems without effect. In the absence of experimental evaluation of preventive measures proposed at the end of this study, we provide a model for evaluating, theoretically, the relationship efficiency/cost/acceptability of such measures. Consequently, instead of lengthening antenatal maternity leave, we suggest prescribing 1 rest week (as sick leave) per month, beginning with the 4th month of pregnancy, for women working in strenuous conditions.

[Quality of life and economic cost of multiple sclerosis]. / L'évaluation médico-économique dans la sclérose en plaques.

In multiple sclerosis, evaluation of quality of life is important because the patients are usually confronted with a decrease in physical, cognitive and social functioning. Apart from the personal suffering, the financial consequences for these patients and their family and the economic burden for society are enormous. Measurement of health related quality of life is important for the understanding of disease burden and the impact of specific MS treatments. Rising costs associated with new treatments and spending limits have prompted a search for gratter efficiency. Although health economics research can suggest ways to maximize health benefits within fixed budgets it is currently underused in MS. The purpose of this review of the literature is to explain some of the basic principles underlying both quality of life and economic evaluations, and analyse their contribution to understanding and managing patients with MS. Neurologists should not underestimate how dramatic their contributions can be to this maturing field that will influence the future of MS patients care.

[A new tool for evaluation of medication errors applied to pediatric hematology]. / Un nouvel outil d'évaluation de l'iatrogénie médicamenteuse, appliqué à l'hématologie pédiatrique.

This study was conducted in a haematological paediatric department and was aimed at evaluating drug medication errors. Their frequency was studied, but also and mainly their degree of severity and preventability. Only adverse drug events that were identified as possibly due to pharmacological properties of drugs or medication errors were collected. An original method was used, based on a multidimensional mathematical tool, called Factorial Analysis of Multiple Correspondences (FAMC), in order to assess the grade of severity and preventability for each adverse drug event. A total of 155 adverse drug events were detected for 34 out of 52 patients hospitalized during the study period. The prevalence rate was 65 per cent and among these adverse drug events, 16 per cent were serious and 53 per cent were avoidable. Apart from the fact that the FAMC helped to determine the grade of preventability, FAMC allowed one to demonstrate that allergy and medication errors were the most avoidable adverse drug events. In this way the method used was validated. This study permitted the assessment of drug medication errors in this department and helped to choose the priorities for the management of preventive actions.

[Transfer of adenovirus DNA into the nucleus at the beginning of infection of HeLa cells]. / Transfert de l'ADN d'adénovirus dans le noyau au début de l'infection des cellules HeLa

2 hrs after infection of HeLa cells with Ad 7, viral DNA was found in the nuclei. Inactivation of the virus with ultraviolet or antiserum, or pretreatment of the cells with chloroquine, did not affect the localisation of the DNA. The intranuclear DNA originated at least partly from viral particles passing through lysosomes. The appearance of Ad 7 DNA in the nucleus was delayed as compared to Ad 5 DNA.

Deoxyribonuclease activity associated with adenovirus 5 and 7.

A DNase activity was found associated with isolated components of adenovirus types 5 and 7. The enzymatic activity was associated with the purified virus and viral components extracted from the soluble material of infected cells. The DNase activity of adenovirus type 5 was maximum at pH 5.5 and 7.0 whereas adenovirus 7 was active only at pH 7.0. Both DNases were shown to be located in the penton fraction.

Cost-effectiveness modelling of recombinant FSH versus urinary FSH in assisted reproduction techniques in the UK.

BACKGROUND: The purpose of this study was to undertake an economic evaluation to compare the cost-effectiveness of recombinant (r)FSH with urinary (u)FSH for attaining clinical pregnancy with assisted reproduction. METHODS: Mathematical modelling was utilized incorporating a Markovian decision framework and a Monte Carlo simulation. Statistical representations of recurrent events over time were incorporated into a decision analysis involving fresh and frozen cycles in any sequence (after the first fresh embryo transfer cycle) over three successive assisted reproduction attempts. The mean values of transition probabilities were derived from randomized controlled clinical trials and published reports. The distributions of these transition probabilities were agreed upon by a panel of experts. Cost data for procedures and drugs were derived and validated according to the perspectives of the National Health Service and private clinics in the UK. RESULTS: The study involved 5000 Monte-Carlo simulations of treatment on a Markov cohort of 100 000 patients. The total number of pregnancies attained was significantly higher in the rFSH (40 575) compared with the uFSH (37 358) group. The cost per successful pregnancy was significantly lower for rFSH (5906 pounds sterling) compared with uFSH (6060 pounds sterling) and overall, fewer cycles of treatment were required with rFSH to achieve an ongoing pregnancy. The incremental cost-effectiveness ratio is 4148 pounds sterling for each additional clinical pregnancy with rFSH. CONCLUSIONS: In addition to the increased effectiveness of rFSH in ART, this study demonstrated that it is more cost-effective and more efficient than uFSH in attaining an ongoing pregnancy.

Use and misuse of triptans in France: data from the GRIM2000 population survey.

The extent and nature of triptan use for headache relief has been evaluated in a large epidemiological survey in the French general population. Over 25 000 individuals were screened for headache and for triptan use. Of this sample, 290 triptan users were identified from whom extensive data on headache characteristics and healthcare resource consumption were obtained. The use of triptans is relatively infrequent, 0.2% in the general population, with only 7.5% of migraine sufferers using these drugs. The majority of triptan users were female (80%) and presented headache characteristics typical of migraine (80%). The remaining 20% of subjects were thus using triptans for headache types in which the utility of these drugs has not been demonstrated. Among migraineurs, triptan consumers reported more frequent and severe headaches than non-consumers, and reported a higher incidence of nausea and vomiting. The principal determinant of triptan prescription was consultation with a general practitioner (GP), which may itself have been triggered by the severity of the headaches. GPs, rather than specialists, are the primary prescribers of triptans in France.