[Assessment of the budgetary impact of treatment guidelines in type II diabetes mellitus in France]. / Evaluation de l'impact budgétaire de l'application des recommandations de bonne pratique dans le diabète de type II en France.

BACKGROUND: Type II diabetes mellitus is associated with an increasing prevalence and incidence, and with a heavy economic burden in Western countries. As a consequence, health authorities consider that avoidance or delay of occurrence of diabetes-related micro- and macro-angiopathic complications is a public health priority, leading to the definition of treatment guidelines. The aim of the study was to assess the budgetary impact of the application of the French guidelines. METHODS: Etiologic cost ratios. RESULTS: Our results conclude that 10% decrease in body mass index (BMI) among overweight patients, smoking cessation, initiation to undertake a preventive treatment with low-dose aspirin, initiation to undertake or intensify blood pressure control, initiation to undertake or intensify lipidic control, and shift to biguanides among overweight patients are factors associated with significant benefits (avoided costs) which compensate for the increase in treatment costs. The main beneficial strategies are, in decreasing order, initiation to undertake a preventive treatment with low-dose aspirin, smoking cessation, and control of BMI. CONCLUSION: Our results support interest in reinforcing the application of current treatment guidelines for type II diabetes mellitus.

[Elements of economic problems in the field of extra-renal dialysis]. / Eléments de problématique économique dans le domaine de l'épuration extra-rénale.

The aim of this paper is to enlighten, in an economic perspective, the ongoing debate which has emerged surrounding the question of the respective place of peritoneal dialysis and haemodialysis in the treatment of terminal renal failure. In order to accomplish this, the authors used a cost effectiveness approach aiming to create a link between two kinds of data: data on the effectiveness of treatment methods on the one hand, and data on the costs associated with such treatment modalities on the other. The international literature tends to show that the two dialysis techniques are comparable in terms of effectiveness, except in the case of diabetic patients, for a significantly lower treatment cost in the case of peritoneal dialysis as opposed to haemodialysis, regardless of the geographical location and in spite of certain methodological biases existing due to the sample sizes implemented in the cost studies. All things considered, it seems that in comparison to haemodialysis methods, peritoneal dialysis results in lower cost effectiveness ratios (that is to say, lower cost of treatment to attain a certain level of effectiveness). The conclusion of this report therefore emphasizes the need to develop and promote peritoneal dialysis, in situations where this modality is clinically applicable, in countries where it is currently underused, which is the case in France.

[Consequences of obliterating arteriopathy of the legs on the professional activity of patients and external assistance]. / Conséquences de l'artériopathie oblitérante des membres inférieurs (AOMI) sur l'activité professionnelle des patients et sur les aides extérieures.

Peripheral arterial occlusive disease of the lower limbs results in increased risks of cardiovascular and cerebrovascular morbidity and mortality. However, peripheral arterial disease also has an incapacitating effect upon patients' daily lives, and indeed can have considerable consequences upon their quality of life as well as upon their professional activities. The purpose of this study was to describe patients in terms of their professional activities, the consequences of the disease upon such activities, need for external assistance, and the effects of treatment over a six-month treatment follow-up period. This was a prospective, randomised, double-blind, multicentre study comparing naftidrofuryl (three 200-mg tablets per day) versus placebo in patients presenting with stage-II peripheral arterial disease. Four study visits were scheduled for each patient: an initial selection visit, followed by a 30-day placebo wash-out period, an inclusion visit (to allow verification of inclusion and non-inclusion criteria), and follow-up visits after 3 and 6 months of treatment. 234 patients were included in the study in intention to treat (117 patients in the naftidrofuryl group and 117 patients in the placebo group). These two groups were entirely comparable for all criteria (sociodemographic criteria, risk factors, cardiovascular history, duration of disease) except for obesity and dyslipidaemia, for which prevalence was higher in the naftidrofuryl group. 12.4% of the study population were professionally active at the time of the survey (mean age: 65.9 years). However, 42.3% of patients had in fact been active at the time when arterial disease became manifest. Of these patients, 45.4% (45 patients) stated that arterial disease had affected their professional activity: 28.9% (13 patients) reported a change in their activity, 26.7% (12 patients) reported partial suspension of their activity, and 44.4% (20 patients) stated that all professional activities had ceased. Changes in professional activity comprised invalidity (36.2%), prolonged sick leave (25.5%), premature retirement (14.9%), sick leave (17%), unemployment (6.4%), reduction in long-distance travel (4.3%), change of job (8.5%) or salary reduction (2.1%). During the 6-month follow-up period, only 4 patients were on sick leave (3 in the placebo group and 1 in the naftidrofuryl group). Furthermore, less than 10% of the study population required external assistance as a result of the disease. This analysis thus highlights the repercussions of this disease upon the patients' daily and professional activities.

[Profiles of 939 patients with obstructive sleep apnea syndrome treated with continuous positive pressure]. / Typologie de 939 patients traités par pression positive continue pour syndrome d'apnées obstructives du sommeil.

The aim of this study was to analyze the characteristics of patients on long-term continuous positive pressure therapy for obstructive sleep apnea in order to determine the efficacy, observance, tolerance, degree of patient satisfaction and patient quality of life using the Nottingham scale. A questionnaire was sent to 939 patients treated for at least six months in 11 centers. Factorial analysis of multiple correspondences and two classification analyses were used to establish patient profiles. Factorial analysis evidenced a relationship between patient satisfaction, reduced symptoms, observance and tolerance. The classification analyses distinguished three groups. Group A (n = 596) included primarily men (93%) who were satisfied with the treatment (99%) and showed good observance. Group B (n = 284) was characterized by patient satisfaction, observance, improved symptoms and lower quality of life than group A. Group C was composed of older patients who were satisfied with their treatment and showed good observance but who had no notable improvement in their symptoms. In conclusion, this study pointed out the difficulty in defining which patients with obstructive sleep apnea would benefit most from continuous positive pressure therapy. Good observance is not a sufficient criterion for therapeutic efficacy.

A French survey of 3,225 patients treated with CPAP for obstructive sleep apnoea: benefits, tolerance, compliance and quality of life.

The aim of this study was to investigate in a large population of patients with obstructive sleep apnoea and on long-term treatment with continuous positive airway pressure (CPAP) the patients' perception of symptomatic improvement, side-effects and quality of life. Questionnaires were mailed via local respiratory homecare associations to 5,339 French patients who had been treated at home for at least 6 months with CPAP machines and who continued their treatment. In total, 3,225 questionnaires were analysable. More than 80% of the responding patients reported that CPAP treatment had greatly improved their symptoms. Despite discomfort related to nasal problems and excess noise from the blower, the mean rate of use for the whole population was 6 h 36 min+/-2 h 15 min. The perceived health evaluated by the Nottingham Health Profile was good (mean score <50) for at least 75% of the patients in each dimension explored. The perceived health was significantly related to the improvement in symptoms, the overall satisfaction and the objective compliance. This retrospective study indicates that patients who continued continuous positive airway pressure treatment for more than 6 months felt a great improvement in their symptoms, were satisfied with the treatment and had a relatively good perception of their health.

Accidents in obstructive sleep apnea patients treated with nasal continuous positive airway pressure: a prospective study. The Working Group ANTADIR, Paris and CRESGE, Lille, France. Association Nationale de Traitement à Domicile des Insuffisants Respiratoires.

Many studies have shown a relationship between obstructive sleep apnea (OSA) and accidents, but to our knowledge, none have investigated prospectively the effects of treatment with nasal continuous positive airway pressure (CPAP). CPAP was proposed to 973 patients, of whom 893 patients actually underwent CPAP. These patients were consecutively invited to enter a prospective follow-up study including a questionnaire before treatment and after 6 and 12 months of treatment; 547 patients completed the study (153 left the study, and only partial data were available for 193). The baseline questionnaire included questions concerning accidents in the previous 12 months, asking whether patients had had an accident and, if so, whether they felt that the accident(s) were related to sleepiness, and whether the patients felt that they had had near-miss accidents due to sleepiness. The questionnaires at 6 and 12 months included the same questions referring to the previous 6 months; the accidents reported on each follow-up questionnaire were cumulated and compared with the accidents during the 1-year period before treatment. The number of patients having an accident decreased with treatment for real accidents (from 60 to 36; p<0.01), as well as for near-miss accidents (from 151 to 32; p<0.01). The average number of accidents per patient also decreased, for real accidents (from 1.6+/-1.3 to 1.1+/-0.3; p<0.01) and for near-miss accidents (from 4.5+/-6.5 to 1.8+/-1.4; p<0.01). The cost, in terms of days in hospital related to accidents, decreased from 885 to 84 days. With caution due to the absence of a control group, it is suggested that treatment with CPAP decreases the number of accidents occurring in OSA patients. This result may have important implications in the evaluation of the cost/benefit ratio when treating OSA patients.

[Medico-economical assessment in cancerology]. / Evaluation médico-économique en cancérologie.

In recent studies, the economic criteria has begun to be integrated to the appraisal in cancerology. The question asked by the economist can be framed as follows: what incremental cost should the collectivity or the health insurance system consent, in order to improve the care of cancer patients? This involves first that the cost of the strategies, foreseen or already implemented, can be appraised, then, that indicators can be defined to capture health improvement, and finally, that this health improvement can be quantified. In this article, we present the process of integrated appraisal (cost/result approach). We specifically analyze costs in cancerology, their source and their evolution. We demonstrate the meaning of the integration of economic costs and medical results. We emphasize on the fact that part of the costs, especially those supported by the patient and his close relations, are most of the time excluded from the analysis. Two main points should be carefully analyzed, when proceeding to an appraisal in cancerology: the measurement of the patient's QoL, which represents an expression of the results of the strategy of care; the financing modalities, for the same type of care, if we consider the specificity of the structures involved and the organization of the care. We conclude by mentioning how difficult this task is and under which conditions it should be developed.

[Cost-effective approach to the screening of HIV, HBV, HCV, HTLV in blood donors in France]. / Approche coût-efficacité du dépistage des virus VIH, VHB, VHC, HTLV chez les donneurs de sang en France.

In order to provide greater safety in blood transfusions, public health authorities have imposed the use of screening tests. The purpose of this paper is to estimate the cost-effectiveness ratios of the screening test used in France. Four risks were studied: HIV, HBV, HCV and HTLV. Two efficiency measures were used: cost per positive blood donation detected and cost per case of prevented infection transmission. Moreover, for HTLV alone, the efficiency was estimated by the cost per prevented pathology. Data concerning the costs were provided by the French Blood Agency; those concerning the results of the screening campaigns were provided by the official health authorities, the other data used in the calculations were drawn either from the French Blood Agency data or from a review of international literature. Results gave information about the expenditure devoted to the screening of virologic risks associated with blood transfusion in France (250 million francs per year for the four viruses studied). They stressed the differences in screening efficiency according to the test studied (the cost by prevented seroconversion varied from 31,795 francs for HBV, 72,180 francs for HCV, 676,596 francs for HIV to 6,137,346 francs for HTLV screening test in the base case) and especially the very low efficiency of the systematic screening of the HTLV virus (from 34 to 307 million francs per prevented leukemia).

Attempt to establish a classification of patients suffering from coma and admitted to a hospital structure for short or medium term treatment: medical aspects and costs of hospital care.

We dispose of a database, constituted between 1987 and 1993, containing medical and cost information concerning 515 patients suffering from coma and admitted, after a period of resuscitation, to a French hospital establishment--Etablissement Hélio-Marin of Berck-sur-Mer (EHMB)--for short and medium term treatment, between 1974 and 1986. From this base, which contains demographic and clinical data (age, sex, condition upon admission, duration of consciousness disorders, Glasgow Outcome Scale (GOS) upon discharge) we devised a hierarchical classification analysis following a factorial analysis of multiple correspondences, on 2 sets: a sample of 515 patients (all causes of coma being merged) and a sample of 266 patients suffering from brain injuries. Four groups were determined for each typology. These groups were first described on the basis of the variables used for their construction, and later by considering other available variables: origin of coma, duration of stay at EHMB, future evolution of patients and cost of treatment (cost of specific care, average daily cost, total cost of hospitalization). Thus, typical clinical situations were identified in each classification, depending on age of patient, origin of coma and condition upon admission. These situations led to extremely different treatment costs (ratio from 1 to 5 in the general typology and 1 to 2.85 in the classification of brain injuries.

[Measuring the economic impact of ambulatory dialysis: the case of continuous ambulatory peritoneal dialysis]. / Mesure de l'intérêt économique de la dialyse hors centre: le cas de la dialyse péritonéale continue ambulatoire.

BACKGROUND: As concerns the treatment of terminal renal failure (TRF), France is characterized by a minimal use of peritoneal dialysis, even though this technique is as effective and less expensive than others and that authorities precognize to switch patients to out-of-centre techniques, like peritoneal dialysis. The purpose of the article is to estimate benefits for the Social Security induced by an incitative program leading the current structure of TRF treatment to the existing government standards defined in 1984. METHODS: We computed treatment cost differences, on the basis of an incident case of TRF followed during 7 years, between three different situations: the current French structure of TRF treatment (29.5% of patients treated by out-of-center techniques); two reference situations A and B (respectively 45% and 37% of patients treated by out-of-center techniques). We performed a sensitivity analysis on the rate of use of continuous ambulatory peritoneal dialysis (CAPD). We made assumptions on the cost of techniques, the cost of complications and the rate of CAPD treatment failure. RESULTS: Results stress the existence of benefits induced by increased use of out-of-centre techniques on the basis of a 7-year follow-up of an incident TRF patient: around 65,000 FF in situation A with a 20% rate of use of CAPD; around 5,000 FF in situation B with a 15% rate of use of CAPD. Assumptions concerning CAPD treatment lead to an underestimation of the true benefits. CONCLUSION: The study highlights the therapeutic and economic interest to transfer some patients from hemodialysis to peritoneal dialysis.

[Prognostic factors of post-traumatic vegetative states: 522 cases]. / Facteurs pronostics des états végétatifs post-traumatiques: 522 cas.

Long-term prognosis of post-traumatic vegetative state (VS) remains poorly defined. Three kinds of data have been collected for 522 patients in VS 1 month after head injury: pre-traumatic data; early data, collected during the first two weeks after trauma; late data, collected one month or more after trauma. Statistical relationships have been searched for, between these data and outcome one year after trauma, according to the Glasgow Outcome Scale. Some late data appear as essential prognostic factors of VS: threat blink; complications; ventricular dilatation; motor score (Glasgow Coma Score); spontaneous eye movements. Pretraumatic data then take place: age; previous deficiencies. Other data (especially early data) seem to have a weaker influence or outcome.

Economic aspects of the care of patients in the vegetative state.

The raising of economic issues related to the care of patients in the vegetative state (V.S.) is troublesome to both health-care practitioners and to the public opinion, given the general perception that economics and ethics are incompatible. The main purpose of this article is to show that economic considerations are not merely reconcilable with ethical concerns, they nourish, enrich, and complement them. Three areas of intersection between ethics and economics are described: economic considerations can help bring to the surface the choices involved in decision-making, whether they are explicit or not; these considerations are a natural outgrowth of a well thought-out ethical approach; an economic analysis can accommodate and take into consideration ethical criteria. The second part presents the results of a study conducted in France between 1987 and 1993 which attempted to evaluate the costs of hospital care of comatose patients hospitalized for short and medium term periods. The article concludes with an examination of the economic issues that may be raised in future debates about how much effort should be expended in the care of patients afflicted by V.S.

[Functional and occupational repercussions and seeking care services in chronic asthma]. / Les répercussions fonctionnelles, professionnelles et en termes de recours aux soins de l'asthme chronique.

This article reports on a 5-month long prospective survey carried out in 1990 on 208 patients aged 18 and over, suffering from moderate to severe asthma. The recorded data included information on the history of the illness, the respiratory problems encountered and asthma attacks, the repercussions the illness had on household and professional occupations, the perceived state of health, drug consumption and recourse to external services. The medical costs and production loss due to this pathology were also estimated.

The introduction of economic criteria into the management of arterial disease: an illustration with regard to the socioeconomic consequences of peripheral occlusive arterial disease of the lower limbs.

A survey of studies was used to investigate the economic repercussions of arterial disease; these repercussions included the cost of the disease and its management, and cost/efficacy, cost/utility, and cost/benefit studies of preventive, diagnostic, and therapeutic strategies. The study presented is an evaluation of the socio-economic consequences of peripheral occlusive arterial disease of the lower limbs (POADLL). The cost of health care was measured by means of a prospective 6-month study of 85 patients recruited in 6 centers. The average cost over the 6-month period was 15,735 FF (1991 francs) ($2,760 U.S.). The 85 patients were classified by age, sex, risk factors, concomitant disease, and how the illness was managed, notably in terms of hospitalization and vascular surgery. The four-group classification was used to calculate an annual management cost for POADLL, which ranged from 9,500 FF ($1,667 U.S.) for a stage II patient (mean age, 66 years) with no major risk factors and not presenting any complication requiring admission to hospital, to 35,000 FF ($6,140 U.S.) for patients (mean age, 62 years) who presented major risk factors and who required vascular surgery during the year.

Cost-effectiveness in patients awaiting transplantation receiving intravenous inotropic support.

Cost-effectiveness, assessed in terms of cost/survivor and cost/additional day of survival, has been evaluated in two groups of patients awaiting cardiac transplantation: in six treated by mechanical support (mechanical bridge) and in 31 treated successfully by the addition of intravenous enoximone to previous existing inotropic support (pharmacological bridge). The mean cost per patient was $45,843, ranging from $38,326 in patients receiving pharmacological support to $84,683 in patients receiving mechanical support. The cost per patient transplanted after pharmacological support was $50,745. The mean cost per survivor at 1 year was $210,000 for all patients, ranging from $192,455 with pharmacological support to $254,000 with mechanical support. At 1 month, the cost per additional day of survival was higher (by 228%) in the mechanical support group than in the pharmacological support group.

[Cost and efficacy of therapeutic strategies in candidates for heart transplantation as salvage therapy]. / Coût, efficacité des stratégies thérapeutiques chez les candidats à la transplantation cardiaque de sauvetage.

A study of the real cost, the cost-effectiveness of treatment was performed in 31 cases of cardiogenic shock referred for cardiac transplantation, treated in a flexible therapeutic protocol associating implantation of an expensive mechanical circulatory support system (mechanical bridge) or treatment by drugs alone (pharmacological bridge) depending on the efficacy of IV enoximone. The average patient cost was 238,386 French Francs, ranging from 440,353 FF in patients receiving the mechanical bridge to 199,296 FF in those receiving the pharmacological bridge. The cost-effectiveness ratio expressed either as cost per patient surviving the different stages of the disease or as cost of obtaining an additional day of survival at the same intervals was twice as favourable in the group receiving the pharmacological treatment. This study suggests that IV enoximone and strict selection procedures for candidates for the more expensive option should help bring together the interest of the individual patient and of society as a whole.

[Determination of cost-effective strategies in colorectal cancer screening]. / Détermination de stratégies coût-efficaces dans le dépistage du cancer colorectal.

The object of the article is to implement particular methodologies in order to determine which strategies are cost-effective in the mass screening of colorectal cancer after a positive Hemoccult test. The first approach to be presented consists in proposing a method which enables all the admissible diagnostic strategies to be determined. The second approach enables a minimal cost function to be estimated using an adaptation of "Data Envelopment Analysis". This method proves to be particularly successful in cost-efficiency analysis, when the performance indicators are numerous and hard to aggregate. The results show that there are two cost-effective strategies after a positive Hemoccult test: coloscopy and sigmoidoscopy; they put into question the relevance of double contrast barium enema in the diagnosis of colo-rectal lesions.

[Artificial hearts. The experience of Henri Mondor University Hospital]. / Les coeurs artificiels. L'expérience du CHU Henri Mondor.

Results obtained with 52 patients referred for urgent heart transplantation or when transplantation was impossible because no graft, mechanical assistance or circulatory support were available, are reported. These suggest that the protocol used to select the indications of assistance and transplantation, based on the response to the introduction of enoximone into the medical treatment, allows reconciling the patients' interest-their survival-with the community's interest-i.e. the control of the costs of implemented treatments.

Cost and cost effectiveness of the mechanical and pharmacologic bridge to transplantation.

A prospective study has been carried out to evaluate the cost and cost effectiveness of the mechanical bridge (MB) or pharmacologic bridge (PB) to transplantation (HTx) in patients referred in cardiogenic shock (CS), who are candidates for Htx unresponsive to sympathomimetics. Selection between MB and PB was based on immediate efficacy of i.v. enoximone (2 mg/kg/BW) therapy. From 1986 to 1989, 37 patients who should have been immediately treated by MB entered the protocol. Six were unresponsive and rapidly received a Jarvik heart or left ventricular bypass (MB). Thirty-one improved (PB), with the need for HTx reconfirmed in 22 and performed in 14. Survival of the entire group was 70% and 51% at 1 and 3 months, respectively. Cost per patient was $45,843 ranging from 38,326 in PB patients to $84,683 in MB patients. Cost per patient transplanted after PB was $50,745. Cost per survivor at 1 year was $210,000 for all, ranging from $254,000 in MB to $192,455 in PB. Cost per added day of survival was higher in MB (+ 228%) at 1 month compared to PB. The difference was reduced at 1 year.