An economic evaluation of tranexamic acid to prevent postpartum haemorrhage in women with vaginal delivery: the randomised controlled TRAAP trial.

OBJECTIVE: To estimate the cost-effectiveness of tranexamic acid (TXA) use to prevent postpartum haemorrhage. DESIGN: A trial-based economic evaluation. SETTING: Fifteen French university maternity hospitals. POPULATION: Women enrolled in the TRAAP randomised controlled trial comparing TXA versus placebo in women with vaginal delivery. TRAAP failed to show a reduction in postpartum haemorrhage of at least 500 ml in the intervention arm but evidenced significant lower rates of secondary outcomes related to blood loss. METHODS & MAIN OUTCOME MEASURES: We estimated direct medical costs from within-trial hospital resources collected prospectively from the study report form. All resources were costed at their value to the hospital. We estimated incremental cost per incremental haemorrhage averted. RESULTS: Among the 4079 women in the TRAAP trial, data necessary to calculate costs were available for 3836 (94.0%). The average total costs in the TXA and control groups were €2278 ± 388 and €2288 ± 409 per woman, respectively (P = 0.79). In women with postpartum haemorrhage of at least 500 ml (trial primary endpoint), costs were €2359 ± 354 and €2409 ± 525 (P = 0.14); for provider-assessed clinically significant postpartum haemorrhage and postpartum haemorrhage of at least 1000 ml, costs were respectively €2316 ± 347 versus €2381 ± 521 (P = 0.22) and €2321 ± 318 versus €2411 ± 590 (P = 0.35) in the tranexamic and placebo groups, respectively. The probabilistic sensitivity analysis showed that the use of TXA had a 65-73% probability of saving costs and improving outcome. CONCLUSIONS: Our findings support the use of TXA, as both bleeding events and cost may be reduced three out of four times. TWEETABLE ABSTRACT: Tranexamic acid at vaginal delivery reduces both costs and bleeding events 3 times out of 4.

[Childhood cancer in part of France: Key issues and organization of care in Corsica island]. / État des lieux des maladies onco-hématologiques pédiatriques en Corse et organisation des soins.

INTRODUCTION: In France, the management of pediatric cancers is carried out in reference hospitals that can delegate care to local health centres (LHC), forming "care networks". There is no LHC in Corsica, forcing children and their families to leave the island for all care in the reference centre. The aim of this study was to describe the situation in Corsica and to consider this organisation. METHODS: This is a descriptive preliminary study based on databases from the National Childhood Cancer Registry, "RHeOP" network and a patient questionnaire. We included over a period of 10 years all children with onco-hematological disease who resided in Corsica. RESULTS: The incidence of pediatric cancers since 2005 ranged from 5 to 12 new cases per year. The hospital centre of Timone (Marseille) was the reference centre for 73% of patients, followed by Nice University Hospital for 14%. Almost all the parents interviewed (90%) were in favour of creating an LHC and all of them highlighted many difficulties that, according to them, could be improved by the presence of a LHC in Corsica (organisation of travel, delay and distance from home…). However, there currently appears to be a lack of training for medical and paramedical staff to provide quality second-line care. CONCLUSION: The rates of pediatric onco-hematological diseases in Corsica may warrant the creation of an LHC on the island. Additional cost studies on the feasibility of an LHC in Corsica are needed to optimise the care and quality of life of these children and their families.

Cost-effectiveness of five prenatal screening strategies for trisomies and other unbalanced chromosomal abnormalities: model-based analysis.

OBJECTIVE: To evaluate the cost-effectiveness of five prenatal screening strategies for trisomies (13/18/21) and other unbalanced chromosomal abnormalities (UBCA), following the introduction of cell-free DNA (cfDNA) analysis. METHODS: A model-based cost-effectiveness analysis was performed to estimate prevalence, safety, screening-program costs and healthcare costs of five different prenatal screening strategies, using a virtual cohort of 652 653 pregnant women in France. Data were derived from the French Biomedicine Agency and published articles. Uncertainty was addressed using one-way sensitivity analysis. The five strategies compared were: (i) cfDNA testing for women with a risk following first-trimester screening of ≥ 1/250; (ii) cfDNA testing for women with a risk of ≥ 1/1000 (currently recommended); (iii) cfDNA testing in the general population (regardless of risk); (iv) invasive testing for women with a risk of ≥ 1/250 (historical strategy); and (v) invasive testing for women with a risk of ≥ 1/1000. RESULTS: In our virtual population, at similar risk thresholds, cfDNA testing compared with invasive testing was cheaper but less effective. Compared with the historical strategy, cfDNA testing at the ≥ 1/1000 risk threshold was a more expensive strategy that detected 158 additional trisomies, but also 175 fewer other UBCA. Implementation of cfDNA testing in the general population would give an incremental cost-effectiveness ratio of €9 166 689 per additional anomaly detected compared with the historical strategy. CONCLUSION: Extending cfDNA to lower risk thresholds or even to all pregnancies would detect more trisomies, but at greater expense and with lower detection rate of other UBCA, compared with the historical strategy. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd.

Relación costo-eficacia de cinco estrategias de cribado prenatal para trisomías y otras anomalías cromosómicas no equilibradas: un análisis basado en modelos OBJETIVO: Evaluar la eficacia en función de los costos de cinco estrategias de cribado prenatal para trisomías (13/18/21) y otras anomalías cromosómicas no equilibradas (UBCA, por sus siglas en inglés), tras la introducción del análisis de ADN fetal (cfDNA, por sus siglas en inglés). MÉTODOS: Se realizó un análisis de la relación costo-eficacia basado en modelos para estimar la prevalencia, la seguridad, los costos de los programas de cribado y los costos sanitarios de cinco estrategias diferentes de cribado prenatal, para lo cual se usó una cohorte virtual de 652 653 mujeres embarazadas en Francia. Los datos se obtuvieron de la Agencia Francesa de Biomedicina y de artículos publicados. La incertidumbre se abordó mediante un análisis de sensibilidad unidireccional. Las cinco estrategias comparadas fueron: (i) pruebas de cfDNA para mujeres con un riesgo ≥1/250 después del examen del primer trimestre; (ii) pruebas de cfDNA para mujeres con un riesgo ≥1/1000 (las recomendadas actualmente); (iii) pruebas de cfDNA en la población general (independientemente del riesgo); (iv) pruebas invasivas para mujeres con un riesgo ≥1/250 (estrategia histórica); y (v) pruebas invasivas para mujeres con un riesgo ≥1/1000. RESULTADOS: En esta población virtual, con umbrales de riesgo similares, la prueba de cfDNA fue más barata pero menos efectiva en comparación con la prueba invasiva. En comparación con la estrategia histórica, la prueba de cfDNA para el umbral de riesgo de ≥1/1000 fue una estrategia más costosa que detectó 158 trisomías adicionales, pero también 175 menos de otras UBCA. La aplicación de las pruebas de cfDNA en la población general daría una relación costo-eficacia incremental de 9 166 689 EUR por cada anomalía adicional detectada en comparación con la estrategia histórica. CONCLUSIÓN: Extender las pruebas de cfDNA a umbrales de riesgo más bajos o incluso a todos los embarazos detectaría más trisomías, pero a un costo mayor y con una tasa de detección más baja de otras UBCA, en comparación con la estrategia histórica.

Paris MEM: a study protocol for an effectiveness and efficiency trial on the treatment of traumatic stress in France after the 2015-16 terrorist attacks.

BACKGROUND: The Paris and Nice terrorist attacks affected a thousand of trauma victims and first-line responders. Because there were concerns that this might represent the first of several attacks, there was a need to quickly enhance the local capacities to treat a large number of individuals suffering from trauma-related disorders. Since Reconsolidation Therapy (RT) is brief, relatively easy to learn, well tolerated and effective, it appeared as the ideal first-line treatment to teach to clinicians in this context. METHODS: This study protocol is a two-arm non-randomized, multicenter controlled trial, comparing RT to treatment as usual for the treatment of trauma-related disorders. RT consists of actively recalling one's traumatic event under the influence of the ß-blocker propranolol, once a week, for 10-25 min with a therapist, over 6 consecutive weeks. This protocol evaluates the feasibility, effectiveness, and cost-utility of implementing RT as part of a large multi-center (N = 400) pragmatic trial with a one-year follow-up. DISCUSSION: Paris MEM is the largest trial to date assessing the efficiency of RT in the aftermath of a large-scale man-made disaster. RT could possibly reinforce the therapeutic arsenal for the treatment of patients suffering from trauma-related disorders, not only for communities in western countries but also worldwide for terror- or disaster-stricken communities. TRIAL REGISTRATION: Clinical Trials (ClinicalTrials.gov). June 3, 2016. NCT02789982.

Colorectal cancer (CRC) monitoring by 6-monthly 18FDG-PET/CT: an open-label multicentre randomised trial.

Background: [18F]2-fluoro-2-deoxy-d-glucose positron emission tomography/computed tomography (18FDG-PET/CT) has high sensitivity for detecting recurrences of colorectal cancer (CRC). Our objective was to determine whether adding routine 6-monthly 18FDG-PET/CT to our usual monitoring strategy improved patient outcomes and to assess the effect on costs. Patients and methods: In this open-label multicentre trial, patients in remission of CRC (stage II perforated, stage III, or stage IV) after curative surgery were randomly assigned (1 : 1) to usual monitoring alone (3-monthly physical and tumour marker assays, 6-monthly liver ultrasound and chest radiograph, and 6-monthly whole-body computed tomography) or with 6-monthly 18FDG-PET/CT, for 3 years. A multidisciplinary committee reviewed each patient's data every 3 months and classified the recurrence status as yes/no/doubtful. Recurrences were treated with curative surgery alone if feasible and with chemotherapy otherwise. The primary end point was treatment failure defined as unresectable recurrence or death. Relative risks were estimated, and survival was analysed using the Kaplan-Meier method, log-rank test, and Cox models. Direct costs were compared. Results: Of the 239 enrolled patients, 120 were in the intervention arm and 119 in the control arm. The failure rate was 29.2% (31 unresectable recurrences and 4 deaths) in the intervention group and 23.7% (27 unresectable recurrences and 1 death) in the control group (relative risk = 1.23; 95% confidence interval, 0.80-1.88; P = 0.34). The multivariate analysis also showed no significant difference (hazards ratio, 1.33; 95% confidence interval, 0.8-2.19; P = 0.27). Median time to diagnosis of unresectable recurrence (months) was significantly shorter in the intervention group [7 (3-20) versus 14.3 (7.3-27), P = 0.016]. Mean cost/patient was higher in the intervention group (18 192 ± 27 679 € versus 11 131 ± 13 €, P < 0.033). Conclusion: 18FDG-PET/CT, when added every 6 months, increased costs without decreasing treatment failure rates in patients in remission of CRC. The control group had very close follow-up, and any additional improvement (if present) would be small and hard to detect. ClinicalTrials.gov identifier: NCT00624260.

Editor's choice - thirty day outcomes and costs of fenestrated and branched stent grafts versus open repair for complex aortic aneurysms.

OBJECTIVE: To compare 30 day outcomes and costs of fenestrated and branched stent grafts (f/b EVAR) and open surgery (OSR) for the treatment of complex abdominal aortic aneurysms (AAA) and thoraco-abdominal aortic aneurysms (TAAA). METHODS: The multicenter prospective registry WINDOW was set up to evaluate f/b EVAR in high risk patients with para/juxtarenal AAA, and infradiaphragmatic and supradiaphragmatic TAAA. A control group of patients treated by OSR was extracted from the national hospital discharge database. The primary endpoint was 30 day mortality. Secondary endpoints included severe complications, length of stay, and costs. Mortality was assessed by survival analysis and uni/multivariate Cox regression analyses using pre- and post-operative characteristics. Bootstrap methods were used to estimate the cost-effectiveness of f/b EVAR versus OSR. RESULTS: Two hundred and sixty eight cases and 1,678 controls were included. There was no difference in 30 day mortality (6.7% vs. 5.4%, p = 0.40), but costs were higher with f/b EVAR (€38,212 vs. €16,497, p < .001). After group stratification, mortality was similar with both treatments for para/juxtarenal AAA (4.3% vs. 5.8%, p = .26) and supradiaphragmatic TAAA (11.9% vs. 19.7%, p = .70), and higher with f/b EVAR for infradiaphragmatic TAAA (11.9% vs. 4.0%, p = .010). Costs were higher with f/b EVAR for para/juxtarenal AAA (€34,425 vs. €14,907, p < .0001) and infradiaphragmatic TAAA (€37,927 vs. €17,530, p < .0001), but not different for supradiaphragmatic TAAA (€54,710 vs. €44,163, p = .18). CONCLUSION: f/b EVAR does not appear justified for patients with para/juxtarenal AAA and infradiaphragmatic TAAA fit for OSR but may be an attractive option for patients with para/juxtarenal AAA not eligible for surgery and patients with supradiaphragmatic TAAA. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov/ct2/show/NCT01168037; identifier: NCT01168037 (WINDOW registry).

[Economic evaluation of the treatments of non-metastatic prostate cancer]. / Évaluation médico-économique de la chirurgie et des autres primo-traitements du cancer de la prostate non métastatique.

OBJECTIVES: Prostate cancer is the most frequent cancer and the third leading cause of cancer death in men in France. The development of treatment for prostate cancer is fast and sometimes relies on costly innovations. Medico-economic studies are however rare in this area. This literature review aims to summarize available medico-economic data on the initial management of localized prostate cancer and discuss the quality and usability of existing economic studies on the subject. MATERIALS AND METHOD: Literature review was done using PubMed and Cochrane databases. Studies and articles were selected based on several criteria: population with initial treatment for localized prostate cancer (without metastasis), comparative studies with surgery as control treatment, studies in countries members of the OECD, articles in English or French published between 2004 and 2014. RESULTS: The surgical robot, one of the newest innovations, is more expensive than conventional open surgery or no robotic laparoscopy, even if it is associated with a reduction of the original period of stay. Radiation therapy seems more expensive than surgery as initial therapy of localized prostate cancer. CONCLUSION: Conclusions remain limited because of the rarity of reliable health economic studies on the subject.

Cost-effectiveness analysis of hip fracture prevention with vitamin D supplementation: a Markov micro-simulation model applied to the French population over 65 years old without previous hip fracture.

UNLABELLED: We performed a cost-effectiveness analysis of four vitamin D supplementation strategies for primary prevention of hip fracture among the elderly population and found that the most cost-effective strategy was screening for vitamin D insufficiency followed by adequate treatment to attain a minimum 25(OH) serum level. INTRODUCTION: Vitamin D supplementation has a demonstrated ability to reduce the incidence of hip fractures. The efficiency of lifetime supplementation has not yet been assessed in the population over 65 years without previous hip fracture. The objective was to analyze the efficiency of various vitamin D supplementation strategies for that population. METHODS: A Markov micro-simulation model was built with data extracted from published studies and from the French reimbursement schedule. Four vitamin D supplementation strategies were evaluated on our study population: (1) no treatment, (2) supplementation without any serum level check; (3) supplementation with a serum level check 3 months after initiation and subsequent treatment adaptation; (4) population screening for vitamin D insufficiency followed by treatment based on the vitamin D serum level. RESULTS: "Treat, then check" and "screen and treat" were two cost-effective strategies and dominated "treat without check" with incremental cost-effectiveness ratios of €5,219/quality-adjusted life-years (QALY) and €9,104/QALY, respectively. The acceptability curves showed that over €6,000/QALY, the "screen and treat" strategy had the greatest probability of being cost-effective, and the "no treatment" strategy would never be cost-effective if society were willing to spend over €8,000/QALY. The sensitivity analysis showed that among all parameters varying within realistic ranges, the cost of vitamin D treatment had the greatest effect and yet remained below the WHO cost-effectiveness thresholds. CONCLUSIONS: Population screening for vitamin D insufficiency followed by treatment based on the vitamin D serum level is the most cost-effective strategy for preventing hip fracture occurrence in the population over 65 years old.

Cost of stroke in France.

BACKGROUND AND PURPOSE: A cost of illness study was undertaken on behalf of the French Ministry of Health to estimate the annual cost of stroke in France with the goal of better understanding the current economic burden so that improved strategies for care may be developed. METHODS: Using primary data from exhaustive national databases and both top-down and bottom-up approaches, the stroke-related costs for healthcare, nursing care and lost productivity were estimated. RESULTS: The total healthcare cost of stroke patients in France in 2007 was €5.3 billion, 92% of which was borne by statutory health insurance. The average cost of incident cases was €16 686 per patient in the first year, while the annual cost of prevalent cases was a little less than half that amount (€8099). Nursing care costs were estimated at €2.4 billion. Lost productivity reached €255.9 million and that income loss for stroke patients was partially compensated by €63.3 million in social benefit payments. CONCLUSIONS: With healthcare costs representing 3% of total health expenditure in France, stroke constitutes an ongoing burden for the health system and overall economy. Nursing care added nearly half again the amount spent on healthcare, while productivity losses were more limited because nearly 80% of acute incident strokes were in patients over age 65. The high cost of illness underscores the need for improved prevention and interventions to limit the disabling effects of stroke.

[The cost of schizophrenia: a literature review]. / Le coût de la schizophrénie: revue de la littérature internationale.

INTRODUCTION: Schizophrenia represents a major burden for patients, their families, healthcare systems and societies. The objective of this literature review is to document the economic burden of schizophrenia. METHOD: The literature search was performed using the MEDLINE-PUBMED database and the following keywords: schizophrenia and cost, burden of disease, qaly or price. The grey literature search was performed using several databases (e.g. Banque de Données en Santé Publique) and the Google Scholar(®) web search engine. The studies that met the following criteria were included: published since 1998, written in English or French, studied OECD countries and presented costs data that were given in monetary terms. The costs data identified in the literature were classified into the following five main categories: cost for healthcare system, cost for social and medico-social system (medico-social system is a French specificity), cost for prison and legal systems, cost of informal care given by family, and cost associated with productivity losses. To improve comparability, costs were reported as a percentage of health care expenditures and as a per-ten-thousand of GDP (gross domestic product). RESULTS: Among the 201 articles identified as potentially relevant to the topic, nine were included in the literature review. Schizophrenia health care costs ranged from four (Ireland) to 140000 of GDP (Spain). Hospital care was the main health care cost driver but ranged from 19 (USA) to 92% (Belgium) demonstrating a great variability in treatment patterns. The costs for social and medico-social system ranged from 1.3 (Korea) to 13.80000 of GDP (USA) and the costs of informal caregivers ranged from 1.2 (Australia) to 12.70000 of GDP (Spain). The productivity losses associated with unemployment ranged from 6.2 (Australia) to 21.30000 of GDP (USA). The productivity losses associated with premature mortality ranged from less than 0.01 (Canada) to 3.850000 (Ireland). Among others factors, such as targeted population, the choice of valuation method between "Friction costs" and "Human Capital" could account for the heterogeneity of estimates. DISCUSSION: Median health care costs of schizophrenia represented 1.1% of total national health care expenditures. Productivity losses associated with morbidity constituted the major cost burden of schizophrenia. Valuation method, costs items, target populations and prevalence rates differed widely from study to study. Furthermore, the burden attributable to loss of quality of life was not estimated in the studies. CONCLUSION: Cost-of-illness studies of schizophrenia provide information about its burden on society. The external validity of such studies however is poor and justifies country-specific data collection.

[Dermatology day-care: between official rules and reality]. / Hôpital de jour de dermatologie : entre circulaire frontière et réalité

BACKGROUND: Official rules published in 2006 and 2010 concerning ambulatory care rates in France led to artificial redistribution of this activity from day-care hospitalization to consultations. In our dermatological day-care establishment, we compared the financial costs engendered for patients admitted for day-care hospitalization and those seen at consultations. PATIENTS AND METHODS: From 2011/01/10 to 2011/02/04, for each patient, we prospectively analyzed the following data: day-care hospitalization or consultation, age, sex, diagnosis, laboratory and radiological examination, non-dermatological consultations, time spent with the patient by doctors (interns, senior doctors) and nurses, with timing by a stop-watch. The hospital cost was the total for medical examinations (official nomenclature), non-dermatological consultations, physicians' and nurses' salaries and establishment overheads (216 €). The hospital revenue regarding the consultation group consisted of the sum of reimbursement for medical examination, dermatological and non-dermatological consultations, and regarding the day-care hospitalization group, the dermatology rate (670 €) or chemotherapy sessions (380 €). Results were compared using a Chi(2) test and a Student's t-test (P ≤ 0.05). RESULTS: One hundred and twenty-seven patients were included: 67 in the day-care hospitalization group and 60 in the consultation group. Patients in the day-care hospitalization group were older and had significantly more radiological examinations and non-dermatological consultations, but the number of laboratory examinations and skin biopsies did not differ between the two groups. The mean time spent by doctors was similar in both groups but the time spent by senior doctors without the help of interns was significantly greater and longer than the time for a standard consultation. Nurses spent a mean 72 minutes with each hospitalized patient and 35 minutes with consultation patients (P = 0.007). Hospital costs were identical in both groups at around 415 €. The hospital showed a profit for day-care hospitalization patients (252 €) and a loss (244 €) for consultation patients. DISCUSSION: Half of the patients studied were in day-care hospitalization and half were seen in consultations. The high number of bed-ridden patients with bullous pemphigoid accounts for the fact that day-care patients were older. The reasons for the significantly longer time spent by nurses with day-care hospitalized patients were administration and supervision of chemotherapy, skin care and nursing of bed-ridden patients. However, nurses spent 35 min with each consultation patient, justifying the need to maintain the posts of these staff in such day-care units. The availability of physicians for patients with severe dermatoses and the organization of medical examinations in the same place in the same day underscore the need for medical structures like day-care hospitalization. At present, time spent on intellectual work involving reflection is regrettably not taken into account, which is detrimental to this specialty. The hospital was in profit for day hospitalizations while consultations resulted in losses, in particular because of the absence of social security reimbursement of the establishment's overheads. CONCLUSION: Rules are in need of modification in order to allow the treatment of patients with more complicated conditions.

Appraisal of cancer drugs: a comparison of the French health technology assessment with value frameworks of two oncology societies.

OBJECTIVES: Our primary objective was to compare the grading of the value of cancer drugs ('Amélioration du Service Médical Rendu' [ASMR] level) by the French health technology assessment authority ('Haute Autorité de santé' [HAS]) with that by the American Society of Clinical Oncology Value Framework (ASCO-VF) and the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). Our secondary objective was to study the drivers of the French grading system. METHODS: We included new drugs for solid tumors assessed by the HAS between 2010 and 2016 and compared their ASMR level to scores calculated by the 2016-updated ASCO-VF and 2015 ESMO-MCBS. RESULTS: We investigated 27 new cancer drugs assessed by the French HAS between 2010 and 2016. Among the 17 drugs eligible for comparison, the correlation between ASMR levels and ASCO and ESMO scores was weak (r = 0.34 and r = 0.27, respectively). The agreement between the HAS and ESMO regarding the level of meaningful additional benefit was moderate (kappa = 0.43). We found no significant association between 12 potential variables and ASMR level of additional benefit of drugs. CONCLUSION: Our findings show inconsistencies in cancer drug appraisals among the three appraisers.

Informed consent in clinical research in France: assessment and factors associated with therapeutic misconception.

BACKGROUND: Informed consent in clinical research is mandated throughout the world. Both patient subjects and investigators are required to understand and accept the distinction between research and treatment. AIM: To document the extent and to identify factors associated with therapeutic misconception in a population of patient subjects or parent proxies recruited from a variety of multicentre trials (parent studies). PATIENTS AND METHODS: The study comprised two phases: the development of a questionnaire to assess the quality of informed consent and a survey of patient subjects based on this questionnaire. RESULTS: A total of 303 patient subjects or parent proxies were contacted and 279 questionnaires were analysed. The median age was 49.5 years, sex ratio was 1 and 61% of respondents were professionally active. Overall memorisation of the oral or written communication of informed consent was good (69-97%), and satisfaction with the process was around 70%. Therapeutic misconception was present in 70% of respondents, who expected to receive better care and ignored the consequence of randomisation and treatment comparisons. This was positively associated with the acuteness and severity of the disease. CONCLUSION: The authors suggest that the risk of therapeutic misconception be specifically addressed in consent forms as an educational tool for both patients and investigators.

[Economic and political aspects of prostate cancer prevention]. / Aspects économiques et politiques de la prévention du cancer de la prostate.

Deciding on a health policy in practice means dedicating human and financial resources and prioritising spendings. The economic evaluation of prevention strategies attempts to establish a relationship between the medical benefit of prevention and its additional cost (or in some cases cost reduction) compared to no prevention. Decisions on reimbursing drugs, interventions or funding health programmes do not usually follow efficiency criteria which define economic rationality. Politics may for example decide to make prostate cancer a public health priority if mortality in a country or in some regions of the country appears to be excessively high. Economic rationality alone is not an appropriate factor on which to base a decision which may be purely political, reflecting the actual values of the society at a given point in time.

[VIVOPTIM: Feedback of an e-Health experimental program of primary prevention of cardiovascular risk on 30 to 70 years old volunteers]. / VIVOPTIM : retour d'expérience d'un programme expérimental de e-santé et de prévention primaire du risque cardiovasculaire global chez des sujets volontaires âgés de 30 à 70 ans.

Today by the e-health and the telemedicine, many people are more and more interested by the improvement of disease knowledge on cardiovascular diseases and associated risk factors, personalized self management support follow-up and e-Health monitoring. MGEN is a not-for-profit complementary health insurance gave itself the ways to use the new digital tools in health. MGEN developed an original and personalized program VIVOPTIM for the primary prevention of the cardiovascular risks for their members. The VIVOPTIM Pilot program is based upon digital services and was experimented by November 2015 to December, 2017 with 8000 members of the MGEN, from 30 to 70 years old and resident in two French areas (Occitanie and Bourgogne Franche-Comté). The assessment of the experiment VIVOPTIM e -health program was positive for the personalized cardiovascular support and for their health. Therefore, the MGEN generalized the VIVOPTIM program of cardiovascular prevention, to the whole France on July 11th, 2018.

[Screening for Down syndrome using first-trimester combined screening followed by second trimester ultrasound examination in an unselected population]. / Dépistage de la trisomie 21 par le test combiné du premier trimestre suivi par l'échographie du second trimestre en population générale.

BACKGROUND: Recent studies have reported the efficacy of first trimester combined screening for Down Syndrome based on maternal age, serum markers (human chorionic gonadotropin, pregnancy-associated plasma protein A), and ultrasound measurement of fetal nuchal translucency. However, those do not incorporate the value of the widely accepted routine 20-22 week anomaly scan. STUDY DESIGN: We carried out a multi-centre, interventional study in the unselected population of a single health authority in order to assess the performance of first trimester combined screening, followed by routine second trimester ultrasound examination and/or screening by maternal serum markers (free beta-hCG and alpha-fetoprotein measurement or total hCG, alpha-fetoprotein and unconjugated estriol measurement) when incidentally performed. Detection and screen positive rates were estimated using a correction method for non verified issues. A cost analysis was also performed. RESULTS: During the study period, 14,934 women were included. Fifty-one cases of Down Syndrome were observed, giving a prevalence of 3.4 per 1000 pregnancies. Of these, 46 were diagnosed through first (N=41) or second (N=5) trimester screening. Among the 5 screen-negative Down syndrome cases, all were diagnosed postnatally after an uneventful pregnancy. Detection and screen positive rates of first trimester combined screening were 79.6% and 2.7%, respectively. These features reached 89.7 and 4.2%, respectively when combined with second trimester ultrasound screening. The average cost of the full screening procedure was 108 euro (120 $) per woman and the cost per diagnosed Down syndrome pregnancy was 7,118 euro (7,909 $). CONCLUSION: Our findings suggest that one pragmatic interventional two-step approach using first-trimester combined screening followed by second trimester detailed ultrasound examination is a suitable and acceptable option for Down syndrome screening in pregnancy.

[Ultrasound screening for birth defects: A medico-economic review]. / Aspects médico-économiques du dépistage échographique des malformations fœtales : revue de la littérature.

OBJECTIVES: The systematic use of ultrasound during pregnancy aims at birth defect detection. Our objective was to assess the economic efficiency of prenatal ultrasound screening for fetal malformations. METHODS: We carried out a literature review on Medline via PubMed between 1985 and 2015, from the economic perspective of the prenatal ultrasound screening for fetal malformations. RESULTS: The literature on this subject was sparse and we selected only twelve articles presenting relevant economic data, of which only eight were proper medico-economic studies. We found arguments for the economic effectiveness of ultrasound screening for fetal malformation detection, which is largely linked to the terminations of pregnancies and to the cost of the handicaps "avoided". However, none of the reviewed articles could reach medico-economic conclusions. Additionally, we highlighted various elements making economic analyses more complex in this field: the choice of the method, the uncertainty around two essential parameters (the efficiency of ultrasound and the costs of procedures) and the difficulties to compare or to generalize results. We also noticed important methodological heterogeneity among the studies and the absence of French study. CONCLUSIONS: Previously published data are insufficient to assess the economic efficiency of prenatal ultrasound screening for fetal malformations.

Randomized clinical trial of ultrasonic scissors versus conventional haemostasis to compare complications and economics after total thyroidectomy (FOThyr).

BACKGROUND: The benefits of single-use ultrasonic scissors in thyroid surgery are still debated. Although this device has been shown to reduce operating time compared with conventional haemostasis, its cost-effectiveness has never been demonstrated. The aim of this study was to evaluate the efficacy, cost-effectiveness and safety of ultrasonic scissors for total thyroidectomy. METHODS: This was a prospective, randomized, multicentre trial conducted at 13 hospital sites. The primary endpoint was the percentage of patients with hypocalcaemia (serum calcium level below 2 mmol/l) on day 2. Secondary endpoints included postoperative complications and costs, with calculation of incremental cost differences and cost-effectiveness ratios. RESULTS: In total, 1329 patients who underwent total thyroidectomy were included in the analysis: 670 were randomized to treatment with ultrasonic scissors and 659 to conventional haemostasis. There was no difference between groups in the rate of complications, including hypocalcaemia on day 2 (19.7 per cent in ultrasonic scissors group versus 20.3 per cent in conventional haemostasis group; P = 0·743). Median operating times were significantly shorter with ultrasonic scissors (90 versus 100 min with conventional haemostasis; P < 0·001). Total mean(s.d.) direct costs at 6 months were €4311(1547) and €4011(1596) respectively (P < 0·001). CONCLUSION: Ultrasonic scissors were no more clinically effective than conventional haemostasis, but use of these devices was more costly. Registration number: NCT01551914 (http://www.clinicaltrials.gov).

Economic implications of hepatic arterial infusion chemotherapy in treatment of nonresectable colorectal liver metastases. Meta-Analysis Group in Cancer.

BACKGROUND: Approximately 20% of patients with colorectal cancer die of metastases confined to the liver. A meta-analysis recently performed by our group confirmed that in these patients hepatic arterial infusion of 5-fluoro-2'-deoxyuridine, compared with intravenous chemotherapy with fluoropyrimidines or supportive care (including symptom palliation when necessary), improved tumor response. PURPOSE: Because of the high cost of hepatic arterial infusion, we undertook a cost-effectiveness analysis that related the cost of such therapy to its medical efficacy. METHODS: The patient population was drawn from the seven randomized clinical trials included in the meta-analysis and included individual data on 654 patients. Of these seven trials, five compared hepatic arterial infusion and intravenous chemotherapy and two compared hepatic arterial infusion and a control group in which some patients could be left untreated. Patients assigned to receive hepatic arterial infusion made up the hepatic arterial infusion group; the other patients constituted the control group. The measures of efficacy were survival and tumor response. Health-care costs (in 1995 U.S. dollars) were computed over the duration of patient follow-up and were derived from actual costs in two centers, one at Henri Mondor Hospital (Paris, France) and the other at Stanford University Medical Center (Palo Alto, CA). The total cost of treatment included the initial procedure, chemotherapy cycles, and main complications. RESULTS: The mean gain in life expectancy in the hepatic arterial infusion group compared with the control group was 3.2 months (standard error = 1.0 month). For patients treated by hepatic arterial infusion in Paris, the hepatic arterial infusion pump, initial hospitalization, and the entire process (including follow-up and complications) cost, on average, $8400, $15172, and $29562, respectively; in Palo Alto, these costs were $4700, $13784, and $25 208, respectively. For patients in the control groups in Paris and Palo Alto, the total treatment costs were, on average, $9926 and $5928. The additional costs of hepatic arterial infusion over control treatment were $19636 in Paris and $19280 in Palo Alto. The cost-effectiveness (i.e., the additional cost divided by the additional benefit) with respect to survival of the patients in the hepatic arterial infusion group compared with the patients in the control group was $73635 per life-year in Paris and $72300 per life-year in Palo Alto. CONCLUSIONS AND IMPLICATIONS: The cost-effectiveness of localized chemotherapy for colorectal liver metastases is within the range of accepted treatments for serious medical conditions, although it might be considered borderline by policy-makers in some countries. Prospective clinical trials should be conducted to more definitively answer this question.