Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II).
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Acute Disease↗
Biomedical subjects
Isabelle Durand-Zaleski
Publications and source records attributed to Isabelle Durand-Zaleski.
Screening for Down syndrome using first-trimester combined screening followed by second-trimester ultrasound examination in an unselected population.
OBJECTIVE: 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 weeks' anomaly scan. STUDY DESIGN: We carried out a multicenter, 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 nonverified 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 euros (120 dollars) per woman and the cost per diagnosed Down syndrome pregnancy was 7,118 euros (7909 dollars). CONCLUSION: Our findings suggest that 1 pragmatic interventional 2-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.
Adult↗
Ethanol versus radiofrequency ablation for the treatment of small hepatocellular carcinoma in patients with cirrhosis: a retrospective study of efficacy and cost.
OBJECTIVE: To compare cost effectiveness of radio-frequency (RF) ablation versus percutaneous ethanol (Pe) ablation for treatment of small hepatocellular carcinoma. METHODS: 57 patients with 72 hepatocellular carcinomas (HCC) treated with ethanol ablation were retrospectively compared with 60 new patients who had 72 HCC treated with RF ablation. All patients had Child-Pugh A cirrhosis and HCC less than 3.5 cm in diameter. Therapeutic efficacy was evaluated with tri-phase spiral computed tomography. Cost of hospital stay, supplies and follow-up including complications were calculated. Survival was estimated by Kaplan-Meier method and prognostic value of treatment methods by Log Rank test and multivariate Cox proportional hazard model. RESULTS: The two groups had similar baseline characteristics. The rate of severe complications associated with RF was 15% (9/60) vs 6,9% (9/60) with Pe (P=0,11) The two-year overall survival, disease free survival and local tumor free survival in the ethanol and radiofrequency groups were 70.8% vs. 91.2% (Odd Ratio=3.7, P=0.006), 48.6% vs. 71.1% (Odd Ratio=2.2, P=0.01), and 68.5% vs. 80.7%, (Odd Ratio=1.9; P=0.09), respectively. The treatment method was the sole significant factor related to overall and tumor free survival. Costs per patient of ethanol and radiofrequency treatments were 1534 euro and 1196 euro, respectively. CONCLUSION: This retrospective study suggests that RF is the most cost effective strategy, with higher 2-year disease free survival rate.
Adult↗
Comparison of outcome in patients with cirrhosis and ascites following treatment with albumin or a synthetic colloid: a randomised controlled pilot trail.
BACKGROUND: The question of which colloid (albumin or synthetic colloids) used for plasma expansion following paracentesis or other complications requiring fluid loading in patients with cirrhosis remains controversial. AIMS: To compare outcome and hospital-related cost in patients with cirrhosis treated with 20% human albumin with those treated with a synthetic colloid (3.5% polygeline). METHODS: The primary end point was occurrence of a first liver-related complication. RESULTS: When the trial was prematurely discontinued because of safety concerns about bovine-derived products, 30 patients were assigned to receive albumin and 38 were assigned to receive a synthetic colloid. Sixty-three patients were included for ascites removal by paracentesis and five patients for ascites removal by paracentesis and renal impairment. The median time to first liver-related complication was not significantly longer in the albumin group (20 vs. 7 days). However, the total number of liver-related complications adjusted to a 100-day period was significantly lower in the albumin group. The median hospital cost for a 30-day period was significantly lower in the albumin group (1915 euros vs. 4612 euros). CONCLUSIONS: In patients with cirrhosis and ascites, human albumin appears to be more effective in preventing liver-related complications than synthetic colloid. This may be associated with decreased hospital costs.
Adult↗
A double-blind low dose-finding phase II study of granulocyte colony-stimulating factor combined with chemotherapy for stem cell mobilization in patients with non-Hodgkin's lymphoma.
The aim of the study was to define the minimal effective dose (MED) of granulocyte colony-stimulating factor (G-CSF) among five daily doses following chemotherapy for peripheral blood stem cell (PBSC) collection. Twenty-five patients were included in this double-blind dose-finding phase II study conducted according to a two-stage Bayesian design. The estimated probabilities of success for PBSC collection for the G-CSF doses of 50, 75, 100, 125 and 150 microg/m2/day were 84%, 87.7%, 91%, 93.9 and 96.4%, respectively. Low G-CSF doses may be used with a similar probability of success as conventional doses and could allow significant savings.
Adult↗
[Economic evaluation of radiotherapy: methods and results].
The cost of radiotherapy, which concerns 150,000 new patients yearly in France has been estimated 1700 euros per patients in this country, 50% lower than the European average. Economic evaluations of radiotherapy have related the cost of either curative or palliative treatment to the medical outcome. For lung, rectal, breast cancer and bone metastases of prostate cancer, radiation therapy prolongs life by an estimated 6 to 10 months. The cost effectiveness ranges from 5,000 to 25,000 euros per life year gained.
Costs and Cost Analysis↗
The cost-effectiveness of prophylaxis with valaciclovir in the management of cytomegalovirus after renal transplantation.
Prophylaxis-based antiviral treatment and intensive monitoring followed by pre-emptive antiviral treatment are both commonly used management strategies to reduce risk of cytomegalovirus (CMV) infection following renal transplantation. This study employed a decision-model approach using published efficacy data and information from a recent survey of French clinical practice to consider the relative costs and outcomes associated with CMV prevention strategies for high-risk patient groups. The cost per case of treating tissue invasive and symptomatic CMV disease was estimated at euro 15,431 and euro 10,852, respectively. In the highest infection-risk patient group (positive donor with no previous CMV history) prophylactic oral valaciclovir was shown to avoid the greatest number of CMV disease cases (35 cases per 100 transplanted patients) and reduced the overall CMV-related costs per transplanted patient by around 14% over a'wait-and-treat' baseline strategy. In contrast, intensive monitoring and preemptive treatment resulted in a much higher cost per transplanted patient. This analysis suggests that prophylactic treatment remains the most cost-effective approach to the management of CMV in renal-transplanted patients. Further comparative studies between prophylactic and pre-emptive treatment would be a valuable addition to the current evidence based on CMV prevention.
Acyclovir↗
Surgery versus medical follow-up in patients with asymptomatic primary hyperparathyroidism: a decision analysis.
OBJECTIVES: To examine the cost-effectiveness of strategies for management of primary asymptomatic hyperparathyroidism: surgical strategies and medical follow-up versus surgery. DESIGN: We used a Markov state-transition decision-analytic model for an hypothetical cohort of 55-year-old women to compare with a lifetime horizon costs and effectiveness of bilateral neck exploration (BNE), unilateral neck exploration (UNE), video-assisted parathyroidectomy (VAP) and lifelong medical follow-up shifting for either BNE or UNE in case of disease progression. METHODS: Data on localization tests, complications and treatment efficacies were derived from a systematic review of the literature. Outcomes were expressed as quality-adjusted life years (QALY). Costs (2002 Euro) discounted at 3% yearly were estimated from the health care system perspective. RESULTS: In the base-case analysis, VAP strategy (VAPS) was the most effective and BNE strategy (BNES) was the least costly. UNE strategy (UNES) had an incremental cost-effectiveness ratio of 2688 Euro/QALY versus BNES and VAPS of 17,250 Euro/QALY in comparison with UNES. Surgical management was more effective than medical follow-up with acceptable incremental cost-effectiveness ratios. VAPS became less effective than UNES over 71 years. Differences between UNES and VAPS were sensitive to success and complication rates, quality-of-life weights and procedural costs. Medical follow-up strategies became the most effective if quality-of-life weight for this condition was higher than 0.99. CONCLUSIONS: Surgery is more effective than medical follow-up at a reasonable cost and can be preferred except in patients choosing medical follow-up. Minimally invasive surgery is cost-effective compared to the traditional surgical approach.
Cost-Benefit Analysis↗
Predicting the costs of allogeneic sibling stem-cell transplantation: results from a prospective, multicenter, French study.
BACKGROUND: Allogeneic hematopoietic stem-cell transplantation is a widely used, cost-intensive procedure. Our purpose was to estimate costs and determine cost predictors. METHODS: We used data from a prospective French study comparing four doses of immunoglobulins. Resource use of hematopoietic stem-cell transplant recipients during the first 6 months posttransplant, both inpatient and ambulatory costs, in 85 patients from five centers were collected prospectively and costed. Baseline data and clinical events were retrieved. Protocol-driven costs were excluded. Multivariable analysis evaluated the association between costs and patient's pretransplant status and transplant-related complications. Because of the absence of differences in outcome among the four randomization groups, cost data for all patients were pooled. RESULTS: Total costs per patient were the following: mean 76,237 Euros; standard deviation 32,565 Euros; median 69,516 Euros; range 183,758 to 14,761Euros. The major cost driver was hospital days. No association was found between costs and baseline status. The "predictors" of higher costs (adding an average 20,000 Euros/patient) were the occurrence of transplant-related complications: graft-versus-host disease and repeated infections that were unpredictable before transplant in this homogeneous group of patients. CONCLUSION: Our data highlight the discrepancy between the Diagnosis Related Group prospective payment system and actual costs. The actual cost of geno-identical stem-cell transplantation results from posttransplant complications that cannot be predicted prospectively and require ex post cost adjustment.
Acute Disease↗
Lack of multiplicative transitivity in person trade-off responses.
BACKGROUND: The person trade-off (PTO) is a technique for eliciting preferences for resource allocation across patient groups. In principle PTO responses should satisfy a requirement of multiplicative transitivity, i.e. that if people consider treatment of 1 in state A to be equivalent to treating 10 in state B, and 1 in state B to be equivalent to 10 in state C, then they should find 1 in state A equivalent to 100 in state C. Earlier studies addressing labelled diseases (specific diagnoses), have shown multiplicative intransitivity of the PTO responses. Our purpose was to test multiplicative transitivity in the case of health states described with the EuroQol instrument only and to find a possible framing effect such as the number of persons in the reference intervention. METHODS: Forty-four master degree students were asked to fill in a questionnaire addressing four chronic health states. Their task consisted in (1). ranking the states by severity, (2). valuing each of them by the means of the time trade-off, and (3). doing the PTO for all the 10 possible pairwise combinations of the four chronic states plus a fatal one. In a subsequent questionnaire the number of persons in the reference intervention in the PTO was increased from 10 to 100. Multiplicative transitivity was studied in subjects who demonstrated a willingness to trade off and consistency in ranking individual values. RESULTS: None of the 39 subjects included satisfied a minimum multiplicative transitivity requirement in PTO responses. Internal consistency was not improved when the PTO involved health states close to each other in terms of severity, nor when the prevention of death was not the reference intervention. For the 22 subjects having answered both types of questionnaire, increasing the number of persons in the reference intervention did not improve multiplicative transitivity. CONCLUSIONS: The PTO holds promise as a useful method for determining social preferences for priority setting, inasmuch as it captures distributive concerns that individual utility techniques such as the time trade-off do not address. But the lack of multiplicative transitivity in PTO responses is unsatisfactory, and ways to reduce this problem need to be explored.
Cost-Benefit Analysis↗
DECOPI (DEsobstruction COronaire en Post-Infarctus): a randomized multi-centre trial of occluded artery angioplasty after acute myocardial infarction.
AIM: To determine whether late recanalization of an occluded infarct artery after acute myocardial infarction is beneficial. METHODS AND RESULTS: Two hundred and twelve patients with a first Q-wave myocardial infarction (MI) and an occluded infarct vessel were enrolled. After coronary and left ventricular contrast angiography, patients were randomized to percutaneous revascularization (PTCA, n=109), carried out 2-15 days after symptom onset or medical therapy (n=103). The primary endpoint was a composite of cardiac death, non-fatal MI, or ventricular tachyarrhythmia. The majority had single-vessel disease and less than one-third had involvement of the left anterior descending artery. The use of pharmacological therapy was high in both groups. At six months, left ventricular ejection fraction was 5% higher in the invasive compared with the medical group (P=0.013) and more patients had a patent artery (82.8% vs 34.2%, P<0.0001). Restenosis was seen in 49.4% of patients in the PTCA group. At a mean of 34 months of follow-up, the occurrence of the primary endpoint was similar in the medical and PTCA groups (8.7% vs 7.3% respectively, P=0.68), but the overall costs were higher for PTCA. The secondary endpoint combining the primary endpoint with admission for heart failure was also similar between groups (12.6% vs 10.1% in the medical and PTCA groups, respectively, P=0.56). CONCLUSIONS: Systematic late PTCA of the infarct vessel was associated with a higher left ventricular ejection fraction at six months, no difference in clinical outcomes, and higher costs than medical therapy. These results must be interpreted with caution given the small size and low risk of the population.
Adult↗
The value of clopidogrel versus aspirin in reducing atherothrombotic events: the CAPRIE study.
Atherothrombotic disease is a growing health problem, and is increasingly more costly to manage. Clopidogrel is an advanced, specific adenosine diphosphate receptor antagonist, which has been shown to be a highly potent antiplatelet agent. Data from the Clopidogrel versus Aspirin in Patients at Risk of Ischaemic Events (CAPRIE) study have demonstrated the significantly superior clinical benefit of clopidogrel over aspirin for secondary prevention of atherothrombotic disease, with a relative risk reduction in myocardial infarction, stroke or vascular death of 8.7% (95% confidence interval 0.3, 16.5; P = 0.043). Moreover, clopidogrel demonstrated an amplified clinical benefit versus aspirin in patients at high risk of atherothrombotic events, such as those with a previous history of symptomatic atherothrombotic disease or with major risk factors such as diabetes mellitus or hypercholesterolaemia. On the basis of commonly accepted threshold criteria (Euros 20000 per life-year gained; LYG), clopidogrel in comparison with aspirin is cost-effective for the secondary prevention of atherothrombotic disease (cost per LYG ranging from Euros 19462 to Euros 3256). Economic analyses have demonstrated consistent cost-effectiveness results with clopidogrel in different countries. Moreover, in high-risk patient subgroups the cost-effectiveness of clopidogrel in comparison with aspirin was evenbetter (cost per LYG ranging from Euros 5900 to Euros 6310). Compared with other treatment strategies used for the prevention of ischaemic or atherothrombotic events, the cost-effectiveness of clopidogrel in comparison with aspirin based on CAPRIE is favourable, with most analyses in the intermediate range of cost-effectiveness. The available data thus support the use of clopidogrel as a clinically efficient and cost-effective option for secondary prevention of atherothrombotic disease, particularly in high-risk patients.
Arterial Occlusive Diseases↗
Geographic disparities in access to organ transplant in France.
BACKGROUND: Allocation of organs is organized on a regional basis in France. We assessed regional differences in access to organ transplant. MATERIAL AND METHODS: We used the recipient database and the waiting list database from the year 1994 onward. We estimated median waiting time by region and organ. The probability of receiving a transplant was estimated using the Kaplan-Meier method. Between-region comparisons used the log-rank test, with adjustment for blood type and disease category. RESULTS: At the end of a 4-month follow-up period, 49% of 3,553 patients had received transplants: 64% of 797 benefited from liver transplants, 52% of 549 from heart transplants, and 22% of 2,207 from kidney transplants. Death rates on the waiting lists were 10%, 14%, and 1% for patients selected for liver, heart, and kidney transplant, respectively. Transplantation percentage (all organs) decreased from 63% in the West to 43% in the Paris region and mortality increased from 2% in the West to 7% in the Southeast. All tests of inter-regional differences were statistically significant. CONCLUSION: Factors explaining geographic differences related to the background of transplant teams, activity of organ procurement, and severity of patients on the list.
Cadaver↗
The costs of septic syndromes in the intensive care unit and influence of hospital-acquired sepsis.
OBJECTIVE: To document the costs and outcomes of the various forms of the septic syndromes [systemic inflammatory response syndrome (SIRS), sepsis, severe sepsis, septic shock), particularly those associated with infection acquired in an intensive care unit (ICU). DESIGN: Prospective data collection for all septic patients admitted to a medical ICU during a 1-year period. Costs were computed from the viewpoint of the hospital. RESULTS: Mean total hospital costs were Euro 26,256, Euro 35,185, and Euro 27,083 for patients with sepsis, severe sepsis, and septic shock, respectively. Total costs varied slightly according to the site of infection and the severity of sepsis but were influenced mostly by its mode of acquisition: patients having sepsis associated with ICU-acquired infection incurred total costs about three times those of patients presenting with infection and sepsis on ICU admission (from Euro 39,908 in patients with ICU acquired sepsis to Euro 44,851 in patients with ICU-acquired septic shock). Stratifying patients by the presence of ICU-acquired infection also showed that a first episode of infection complicated by ICU-acquired sepsis incurred at least 2.5 times more costs than a single episode of sepsis. CONCLUSIONS: In this series the medical costs of sepsis were not markedly influenced by its severity but by its mode of acquisition. Due to wide variations in ICU costs cost-effectiveness analyses of treatments for sepsis should document the case-mix of patients and the contribution to this of nosocomial infections.
Costs and Cost Analysis↗
Prevalence and risk factors for carriage of methicillin-resistant Staphylococcus aureus at admission to the intensive care unit: results of a multicenter study.
BACKGROUND: Detection of methicillin-resistant Staphylococcus aureus (MRSA) carriers on admission to the intensive care unit (ICU) is an important component of strategies for controlling the spread of MRSA. METHODS: A prospective multicenter study was conducted in 14 French ICUs for 6 months. All patients were screened within 24 hours after admission, using nasal and cutaneous swabs In addition, clinical samples were obtained. Patient data collected on ICU admission included presence of immunosuppression; history of hospital stay, surgery, antimicrobial treatments, or previous colonization with MRSA; chronic health evaluation and McCabe scores; reason for admission; whether the patient was transferred from another ward; severity of illness; presence of skin lesions; and invasive procedures. Risk factors for MRSA carriage at ICU admission were estimated, and significantly associated variables were used to develop a predictive score for MRSA carriage. A cost-benefit analysis was then performed. RESULTS: Of the 2347 admissions with MRSA screening, 162 (6.9%; range, 3.7%-20.0% among ICUs) were positive for MRSA, of whom 54.3% were detected through screening specimens only. Of the 2310 first admissions (vs repeat admissions) to the ICU, 96 were newly identified MRSA carriers. Factors associated with MRSA carriage in the multivariate analysis were age older than 60 years, prolonged hospital stay in transferred patients, history of hospitalization or surgery, and presence of open skin lesions in directly admitted patients. Only universal screening detected MRSA carriage with acceptable sensitivity. A cost-benefit analysis confirmed that universal screening and preventive isolation were beneficial. CONCLUSIONS: The prevalence of MRSA carriage on admission to the ICU is high in this endemic setting. Screening for MRSA on admission is useful to identify the imported cases and should be performed in all ICU-admitted patients.
Aged↗
A break-even price calculation for the use of sirolimus-eluting stents in angioplasty.
BACKGROUND: One of the major complications of angioplasty is the early occurrence of restenosis requiring a repeat procedure. When bare-metal stents are used, clinical restenosis results in a repeat procedure in 10% to 15% of cases. Based on the results of an international, randomized clinical trial, the use of sirolimus-eluting stents reduces this risk. OBJECTIVES: The aims of this study were to calculate the theoretical break-even price for sirolimus-eluting stents in France, the Netherlands, and the United States, and to determine the additional health care cost per patient. METHODS: The break-even price was calculated by adding the savings resulting from a 15% decrease in the rate of clinical restenosis to the price of bare-metal stents. Costs were computed from the viewpoint of the health care system, exclusive of other societal costs. RESULTS: The break-even prices were 1291 Euro to 1489 Euro in France, 2028 Euro in the Netherlands, and 2708 Euroin the United States (1.00 Euro = 1.00 US dollar in purchasing power parity). These results indicate that the commercial price of sirolimuseluting stents will increase hospital spending for patients undergoing angioplasty by 17% to 55% per patient. CONCLUSION: This additional cost to the health care system should be discussed in view of possible productivity savings and improved quality of life for patients.
Angioplasty↗
Direct treatment costs for patients with lung cancer from first recurrence to death in france.
OBJECTIVE: To determine the direct treatment cost of lung cancer management from progression to death from the viewpoint of the hospital. METHODS: A retrospective descriptive study was performed. Data from 100 patients who died of lung cancer and who had received treatment from four different types of hospital were used; the hospitals were public hospitals (teaching and non-teaching), private not-for-profit cancer centres, and private hospitals. Resource utilisation/cost data collected included the cost of diagnosis of the recurrence, the cost of hospitalisations or day care treatments and ambulatory surgery. All resources were valued in 2001 euros. RESULTS: In France, the average cost per patient was euro12 518 for the whole group (78% with non-small cell lung cancer [NSCLC], and 22% with small cell lung cancer [SCLC]), euro13 969 for patients with NSCLC and euro7369 for patients with SCLC. The higher cost of treatment in patients with NSCLC is explained by longer survival and duration of chemotherapy. In patients with NSCLC, 51% of the total cost corresponded to terminal care, with up to seven lines of chemotherapy. In patients with SCLC, the costs of diagnosis and terminal care each represented 41% of the total cost. CONCLUSIONS: The cost of treatment of recurrence of lung carcinoma is high, and is related to the number of lines of chemotherapy and the use of radiotherapy and surgery.
Antineoplastic Agents↗
[Economic assessment of Caelyx versus topotecan in advanced ovarian cancer].
UNLABELLED: Ovarian cancer is the most frequent cause of death due to gynecologic malignancy in both the United States and in Europe. A phase III investigation compared second line treatment Caelyx with topotecan in patients with advanced epithelial ovarian carcinoma who failed a first-line platinum-containing regimen. A total of 474 patients were enrolled Although no significant advantage of Caelyx over topotecan with regards to overall survival and progression was found, there were fewer adverse events in the Caelyx arm and Caelyx had significantly better quality of life profile. We conducted a cost minimization analysis of both treatment arms. Costs were estimated from the viewpoint of the hospital, over the duration of the study period (12 weeks). The frequency of adverse events was derived from the trial's CRF, the treatment patterns of adverse events was estimated for each type of adverse event and each grade for a given type of adverse event. Costs included that of the drug and management of adverse events. Because of uncertainty on actual time spent in French hospitals, administration costs were not valued. Adverse events valued in the analysis were: stomatitis/ pharyngitis, PPE, nausea/vomiting diarrhea, anemia, thrombocytopenia, neutropenia, sepsis, fever. Drug costs and costs of blood products were valued using the purchase price by the hospital, costs of tests and hospital days were estimated from the hospital's accounting system. The drug cost per patient was 8,735 euros for Caelyx and 6,196 euros for topotecan, the cost of adverse events were 528 and 3,632 euros for Caelyx and topotecan respectively, due to the high rate of adverse events in patient treated with topotecan. The total costs were 9,279 and 9,938 for Caefyx and topotecan respectively. CONCLUSION: the least expensive management for second line advanced ovarian cancer is Caelyx. Although the initial cost of the drug is higher, the reduced number of adverse events results in a lower total cost. Because treatment with Caelyx is also associated with a better of quality of life, this treatment strategy could be considered dominant.
Antineoplastic Agents↗