[Methods for the analysis and treatment of cost data by micro- and gross-costing approaches]. / Méthodes d'analyse et de traitement des données de coût : approches par « micro-costing ¼ et « gross-costing ¼.

This work addresses the analysis of individual cost data in the setting of interventional or observational studies using statistical analysis software once the costs per patient have been estimated. It is in fact necessary to be able to present and describe data in an appropriate manner in each of the studied health strategies and to test whether the difference in costs observed between treatment groups is due to chance or not. Furthermore, cost analysis differs from conventional statistical analysis in that cost data have a certain number of specific properties, including their use by health decision-makers. This work also addresses the difficulties that generally arise in regard to the distribution of cost; it explains why the mathematical average constitutes the only relevant measure for economists; and it outlines which analyses are required for inter-strategy cost comparisons. It also covers the issue of missing or censored data, features that are inherent to information collected regarding costs and to sensitivity analyses.

The economic burden of urinary tract infections in women visiting general practices in France: a cross-sectional survey.

BACKGROUND: Urinary tract infections (UTIs) are among the most common bacterial infections. Despite this burden, there are few studies of the costs of UTIs. The objective of this study was to determine the costs of UTIs in women over 18 years of age who visit general practitioners in France. METHODS: The direct and indirect costs of clinical UTIs were estimated from societal, French National Health Insurance and patient perspectives. The study population was derived from a national cross-sectional survey entitled the Drug-Resistant Urinary Tract Infection (Druti). The Druti included every woman over 18 years of age who presented with symptoms of UTI and was conducted in France in 2012 and 2013 to estimate the annual incidence of UTIs due to antibiotic-resistant Enterobacteriaceae in women visiting general practitioners (GPs) for suspected UTIs. RESULTS: Of the 538 women included in Druti, 460 were followed over 8 weeks and included in the cost analysis. The mean age of the women was 46 years old. The median cost of care for one episode of a suspected UTI was €38, and the mean cost was €70. The annual societal cost was €58 million, and €29 million of this was reimbursed by the French National Health Insurance system. In 25 % of the cases, the suspected UTIs were associated with negative urine cultures. The societal cost of these suspected UTIs with negative urine cultures was €13.5 million. No significant difference was found between the costs of the UTIs due to antibiotic-resistant E. coli and those due to wild E. coli (p = 0.63). CONCLUSION: In the current context in which the care costs are continually increasing, the results of this study suggests that it is possible to decrease the cost of UTIs by reducing the costs of suspected UTIs and unnecessary treatments, as well as limiting the use of non-recommended tests.

[Hospital-based health technology assessment in France: how to proceed to evaluate innovative medical devices?]. / Évaluation des technologies de santé en milieu hospitalier : quelle organisation pour évaluer et acquérir des dispositifs médicaux innovants ?

Innovative medical devices offer solutions to medical problems and greatly improve patients' outcomes. Like National Health Technology Assessment (HTA) agencies, hospitals face numerous requests for innovative and costly medical devices. To help local decision-makers, different approaches of hospital-based HTA (HB-HTA) have been adopted worldwide. The objective of the present paper is to explore HB-HTA models for adopting innovative medical devices in France and elsewhere. Four different models have been conceptualized: "ambassador" model, "mini-HTA" model, "HTA unit" model and "internal committee". Apparently, "HTA unit" and "internal committee" (or a mixture of both models) are the prevailing HB-HTA models in France. Nevertheless, some weaknesses of these models have been pointed out in previous works. Only few examples involving hospital pharmacists have been found abroad, except in France and in Italy. Finally, the harmonization of the assessment of innovative medical devices in France needs a better understanding of HB-HTA practices.

Prevalence of residual excessive sleepiness in CPAP-treated sleep apnoea patients: the French multicentre study.

The percentage of compliant continuous positive airway pressure (CPAP)-treated apnoeic patients that continue to experience residual excessive sleepiness (RES) is unknown. RES was defined by an Epworth Sleepiness Scale (ESS) score of >or=11. In total, 502 patients from 37 French sleep centres using CPAP >3 h night(-1) attending their 1-yr follow-up visit were eligible. ESS and polysomnographic data as well as symptoms, quality of life, depression scores and objective CPAP compliance at 1 yr were collected. Overall, 60 patients remained sleepy on CPAP (ESS 14.3+/-2.5) leading to a prevalence rate of RES of 12.0% (95% confidence interval (CI) 9.1-14.8). After having excluded associated restless leg syndrome, major depressive disorder and narcolepsy as confounding causes, the final prevalence rate of RES was 6.0% (95% CI 3.9-8.01). Patients with RES were younger and more sleepy at diagnosis. The relative risk of having RES was 5.3 (95% CI 1.6-22.1), when ESS before treatment was >or=11. Scores of emotional and energy Nottingham Health Profile domains were two times worse in patients with RES. As 230,000 obstructive sleep apnoea patients are currently treated in France by continuous positive airway pressure, more than 13,800 of them might suffer from residual excessive sleepiness.

Impact of the Sofia® Influenza A+B FIA rapid diagnostic test in a pediatric emergency department.

OBJECTIVE: The objective of this study was to evaluate the impact of a rapid diagnostic test for influenza (the Sofia® Influenza A+B FIA rapid diagnostic test [RDT]) in a pediatric emergency department (PED). METHODS: A retrospective, observational, cross-sectional study was conducted in the PED of the Lille University Hospital between 2013 and 2015. All patients under 18 years of age for whom influenza RDT was administered were included. Clinical data, management, and related hospitalizations were compared between positive and negative RDT groups. The length of stay in the PED (main outcome) and the number of additional tests (biological and radiographic tests) between the two groups were compared. RESULTS: A total of 238 tests were reported: 119 positive, 110 negative, nine invalid. The mean length of stay in the PED was significantly lower in the positive RDT group: 4.0h vs. 7.4h (P<10-6). Patients with positive RDT had significantly fewer biological tests (20% vs. 56%; P<10-7) and radiographs (23% vs. 52%; P<10-5). The prevalence of hospitalizations in a short-stay unit was significantly lower in patients with positive RDT (0.8% vs. 9.1%; P=0.009). CONCLUSIONS: This study showed a significant medical impact of the use of Sofia® Influenza RDT A+B FIA in a PED regarding the length of stay and the number of additional explorations.

Additional direct medical costs associated with nosocomial infections after head and neck cancer surgery: a hospital-perspective analysis.

The clinical impact of surgical site infections (SSI) and postoperative pneumonia (PP) after head and neck cancer surgery has been assessed in the past, but little is known about their economic impact. The present study was designed to evaluate costs related to SSI and PP after head and neck cancer surgery with opening of mucosa. The incidence of SSI and PP was measured in a prospective cohort of 261 patients who had undergone head and neck cancer surgery. The additional direct medical costs related to these infections from the hospital perspective were determined based on postoperative length of stay. The mean direct hospital costs for patients with and without SSI or PP were compared. Of the 261 patients, 81 (31%), 21 (8%) and 13 (5%) developed SSI, PP or both, respectively. The additional lengths of stay attributable to SSI, PP or both were 16, 17 and 31 days, respectively, and additional direct medical costs related to these conditions were 17,000, 19,000 and 35,000 Euros. Nosocomial infections after head and neck cancer surgery significantly increase patients' length of stay and therefore generate additional direct medical costs. These results support the application of preventive interventions to reduce nosocomial infections in this setting.

[The cost of complications: implications for the measurement of the cost of type II diabetes mellitus]. / Prise en compte de l'effet propre du diabète de type II sur la mesure du coût de ses principales complications.

BACKGROUND: A well-known methodology used to compute the macroeconomic cost of risk factors is the etiologic cost ratio, leading to estimates based on data on the prevalence of the risk factor in the general population, the relative risk of complications associated to it and the cost of the complications. A major problem of this method is that it is in some extent inconsistent with recent findings showing an increase in the per capita cost of some complications in presence of type II diabetes mellitus. The aim of the paper is to reconcile the approach with most recent economic studies and to overview the consequences of such an attempt in terms of methodological framework. METHODS: We developed a methodological framework introducing heterogeneity in the cost of treating complications according to the presence of diabetes. We estimated the macroeconomic cost of type II diabetes mellitus based on selected complications (stroke, myocardial infarction, nephropathy and peripheral arterial obstructive disease) from French representative data in two situations: a situation in which the heterogeneity is not taken into account, another situation in which heterogeneity is introduced. RESULTS: Our results point out that the assumption of homogeneity in the cost of complications is associated to an underestimation of the cost of diabetes by about 30%. CONCLUSION: Our results present an attempt to reconcile the economic modeling of the cost of type II diabetes mellitus with the "real world". We conclude that the introduction of heterogeneity is necessary to capture the whole extent of the economic burden of the disease and that it places significant constraints on the data and the methodological framework to be used in such attempts.

Sensitivity of fetal anomaly detection as a function of time.

In this paper, we show that the ratio of the number of fetal anomalies detected by ultrasounds (US) to the total number of cases is not a consistent estimator of the US sensitivity. As Eddy pointed out, when the disease evolves over time, the sensitivity of a test also varies over time according to the development of the disease. To assess correctly the detection capability of a test, it is therefore necessary to estimate a time continuous function (sensitivity function) instead of a single parameter. From a methodological point of view, by considering the "detectability" time of a fetal anomaly as a random variable and parametrizing its distribution function, we estimate the probability that an anomaly is detected conditional upon the precise timing of actually performed US during pregnancy. We fit this model with Eurofetus data (about 7,300 abnormal fetuses), and we compare estimations for different kinds of anomalies (classification based on the system involved and/or severity of the handicap). To allow for heterogeneity of anomalies regarding the detectability time, we generally adopt mixture models. For instance, we select a bi-gamma distribution for major malformations and estimate that 63% of such anomalies are detectable quite early in pregnancy (conditional mean: 15.2 weeks of amenorrhea (WA) +/- 4.2 WA), the others becoming detectable later (30.3 WA +/- 6.4 WA). Such results are then integrated in a cost-effectiveness analysis.

[Determination of the sensitivity of echography in prenatal diagnosis of fetal malformations. Methodological aspects]. / Détermination de la sensibilité de l'échographie dans le diagnostic anténatal des malformations foetales. Aspects méthodologiques.

In the article, following Eddy's work we show that the ratio of the number of cases detected by echography to the total number of cases is not a consistent estimator of test sensitivity of the pathology over time. In such conditions, the sensitivity of the test function is the only correct way to evaluate the test's ability to detect pathologic cases in an asymptomatic population. From a methodological point of view, if the time of detectability of the condition is considered as a random variable, then the function of sensitivity is estimated by fitting a distribution function to the observed date. In order to illustrate the feasibility and the consistency of our methodology, we present results based on simulated data.

[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.

[Assessment of primary care physicians' adherence to the national childhood vaccination schedule]. / Évaluation de l'application du calendrier vaccinal de l'enfant en médecine libérale.

OBJECTIVE: To assess the levels of primary care physicians' adherence to the 2010 French vaccination schedule against pertussis, measles-mumps-rubella (MMR), and pneumococcal infections in northern France. METHODS: Two hundred forty-nine primary care physicians were questioned over the phone from February 15th to May 27th 2010. RESULTS: The total response rate was 61% (n=152) : 43 pediatricians and 109 general practitioners (GPs). The conjugated pneumococcal vaccination was routinely proposed by 93% of the physicians (100% of the pediatricians and 90% of the GPs, P=0.02), and the recommended immunization schedule was correctly stated by 98% of the pediatricians and 70% of the GPs, P<0.001. While the pertussis vaccination was proposed by all the physicians, the recommended immunization schedule was correctly followed in only 46% of the cases (there was no significant difference between the 2 groups of physicians). As for the MMR vaccination, 1 physician did not propose it; 27% had correct knowledge about the MMR vaccination schedule (44% of the pediatricians and 20% of the GPs, P<0.01); 39% initiated an early MMR vaccination schedule for children in day care centers. The main source of their information was medical representatives of pharmaceutical companies, medical journals, and to a lesser degree, weekly epidemiological bulletins and continuing medical education meetings. CONCLUSION: The level of physicians' knowledge about the vaccination schedule in children was insufficient in northern France, especially for pertussis and measles. This can decrease vaccination coverage levels as well as its beneficial effects for children.

[Evaluation of imported pediatric malaria management in northern France]. / Évaluation des pratiques dans la prise en charge du paludisme d'importation de l'enfant dans la région Nord--Pas-de-Calais.

OBJECTIVES: The study's objective was to evaluate the adequacy of treatment to recommendations, for the management of pediatric malaria. METHODS: A descriptive, retrospective, multicentre cohort study was conducted over a 7-year period (2000-2006) in 18 pediatric and infectious diseases units in northern France. All children, under 18 years of age, having consulted in one of these hospitals and for whom the diagnosis of malaria has been made by blood smear and/or thick drop examination, were included. RESULTS: One hundred and thirty-three cases of imported malaria were reported. Among the 120 available files, 23 documented severe malaria. Treatment documentation was available for 115 patients. This treatment was initiated orally in 47 cases and intravenously in 68 cases. Intravenous quinine was the first-line treatment in 58% of cases. Halofantrine was the first-line oral treatment. No change was observed along the 6 years. Only 32% of management was in adequacy with recommendations. Five therapeutic failures were recorded. The optimal application of recommendations would have saved 117 days in terms of hospital stay, corresponding to 54,000 €. CONCLUSIONS: The French Infectious Disease Society (SPILF) recommendations were not well observed. This inappropriate management was responsible for treatment failures and increased costs.

[Strategies for early diagnosis and prevention of prostate cancer]. / Stratégies de diagnostic précoce et de prévention du cancer de la prostate.

Prostate cancer (CaP) has become the most frequent cancer in France and represents the 4th cause of mortality by cancer. Main risk factors include age, family history, black ethnic origin and carcinogenesis results from interaction between environmental and endogen factors. This work aimed to review main data and strategic trends about evolution of prevention and early diagnosis of CaP. Research topics considered as priorities results from the main objective including definition of most efficient medico-economic strategies according to epidemiology, diagnostic and therapeutic modalities and ethno-sociologic particularities, including in the schema presently used (PSA/biopsies): 1) new markers (genetic, serum and urinary), measurable environmental risk factors and potential prevention actions; 2) functional imaging (new techniques including contrast echography, dynamic MRI, spectro-MRI) in order to avoid unnecessary biopsies (60-70% biopsies are negative); 3) optimization of biopsies technique in identifying tumor zones in order to decrease false negative biopsies (about 15% of CaP < 0,5 cm3 but of high grade are missed in the first set of biopsies) and in improving the representativity of the tumor sample biopsied (discordance of about 40% between biopsy data and complete pathological analysis of prostatectomy specimen); 4) development of predictive models in order to perform individual prediction taking into account several risk factors (clinical and molecular) and genes/environment interactions in order to offer rational help in diagnostic and primary prevention procedures.

Cost and cost-effectiveness of childhood vaccination against rotavirus in France.

OBJECTIVES: To assess the effectiveness and cost-effectiveness of routine childhood vaccination by new vaccines against rotavirus in France. METHODS: We constructed a Markov decision tree to compare two alternatives: "no vaccination" and "vaccination". A hypothetical birth cohort of 750,000 children was followed until 3 years of age. First, the disease burden without vaccine was estimated using data from French databases and medical literature. Incidence rates in unvaccinated children were modelled as a function of age and seasons. Next, using data from the medical literature, the vaccine's protective effect on rotavirus diarrhoea was considered. RESULTS: A routine universal rotavirus immunization programme was estimated capable of annually avoiding 89,000 cases of diarrhoea, 10,500 hospitalizations, and 8 deaths. At a vaccination cost of euro 150/course, assuming 75% vaccine coverage, the programme would cost euro 95 million and involve a net loss of euro 68 million to the health care system. The vaccination programme would cost euro 298,000/year of life saved, and euro 138,000/QALY saved. Key variables affecting the results were disease incidence, mortality rates and vaccine price. CONCLUSION: In France, childhood rotavirus vaccination with new anti-rotavirus vaccines would reduce the morbidity burden of rotavirus infection, but would not be cost-effective unless the price of vaccine decreased considerably.

Economic evaluation of varicella vaccination in Spain: results from a dynamic model.

Varicella is a universal childhood disease in Spain, causing approximately 400,000 cases, 1,500 hospitalizations and 15 deaths every year. The aim of this study is to determine the economic impact of childhood varicella vaccination on the burden of disease and associated costs by using a dynamic model. The analysis is based on the varicella transmission model developed by Halloran and adapted to the Spanish context. Cost data (Euro, 2004) were derived from previous studies and official tariffs. Two vaccination scenarios were analysed: (1) routine vaccination program for children aged 1-2 years, and (2) routine vaccination program for children aged 1-2 years completed by a catch-up program during the first year of vaccine marketing for children aged 2-11 years. The analysis considers that a similar coverage rate to the MMR one would be achieved (97.15%). A societal perspective, including direct and indirect costs, and a health care payor perspective were adopted. A probabilistic sensitivity analysis was performed. A routine vaccination program has a positive impact on varicella-related morbidity: the number of varicella cases is estimated to be reduced by 89%, and 1230 hospitalizations are prevented. From the societal perspective, scenario (1) is cost-saving whether or not indirect costs are considered (-51 and -4%, respectively). From the Health Care System the strategy is cost-effective, with a cost-effectiveness ratio estimated at 3,982 Euro per life-year gained, although it leads to a small increase in the costs. Considering the impact of vaccination on morbidity and costs, a routine childhood vaccination program against varicella is worth while in Spain without taking into account the potential impact on HZ.

Cost-effectiveness analysis of breast cancer adjuvant treatment: FEC 50 versus FEC 100 (FASG05 study).

BACKGROUND: The aim of the study was to assess the incremental cost-effectiveness ratio (ICER) of the FEC 100 compared with the FEC 50 in the FASG05 trial. MATERIALS AND METHODS: A cost-effectiveness analysis was performed using a multi-state Markov process model. Relevant clinical data introduced into the model were obtained from 10-year follow-up of the clinical trial FASG05. Survival curves for each health state were assessed by survival parametric model. The model allowed assessments from the start of adjuvant chemotherapy until death. The costs of adjuvant treatment and follow-up were estimated. The costs of recurrence were evaluated from the medical records of 146 patients. A prospective survey was performed on a cohort of 87 patients to quantify the resources external to the hospital (including cost of transportation). The inpatient costs were evaluated using the French diagnosis-related groups. The ambulatory costs were assessed using the French nomenclature. Costs were expressed in 2002 Euro (), according to the French societal perspective. The ICER assessed the cost of one additional life year saved. A discount rate of 5% per year was used for cost, and alternatively 0%, 3% and 5% for effectiveness. We validated the results with a probabilistic sensitivity analysis incorporating parametric and non-parametric bootstraps, and with the acceptability curves. RESULTS: The mean total discounting cost of adjuvant treatments was 11 465 for FEC 50 and 13 815 for FEC 100; the mean total discounting cost of recurrences was 14 636 and 13 503, respectively. According to the discount rate of effectiveness, the life expectancy was 16.5, 11.4 and 9.3 years for FEC 50 and 18.4, 12.5 and 10.2 years for FEC 100. The ICER (cost per life year saved) were 642, 1084 and 1460, respectively. The probability according to which FEC 50 is strictly dominated by FEC 100 was 0.15. CONCLUSION: The clinical benefit of FEC 100 generates a negligible cost increase when compared with FEC 50.

Parameters of control when facing stochastic demand: a DEA approach applied to Bangladeshi vaccination sites.

An aim of vaccination programs is near-complete coverage. One method for achieving this is for health facilities providing these services to operate frequently and for many hours during each session. However, if vaccine vials are not fully used, the remainder is often discarded, considered as waste. Without an active appointment schedule process, there is no way for facility staff to control the stochastic demand of potential patients, and hence reduce waste. And yet reducing the hours of operation or number of sessions per week could hinder access to vaccination services. In lieu of any formal system of controlling demand, we propose to model the optimal number of hours and sessions in order to maximize outputs, the number and type of vaccines provided given inputs, using Data Envelopment Analysis (DEA). Inputs are defined as the amount of vaccine wastage and the number of full-time equivalent staff, size of the facility, number of hours of operation and the number of sessions. Outputs are defined as the number and type of vaccines aimed at children and pregnant women. This analysis requires two models: one DEA model with possible reallocations between the number of hours and the number of sessions but with the total amount of time fixed and one model without this kind of reallocation in scheduling. Comparing these two scores we can identify the "gain" that would be possible were the scheduling of hours and sessions modified while controlling for all other types of inefficiency. By modeling an output-based model, we maintain the objective of increasing coverage while assisting decision-makers determining optimal operating processes.