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Biomedical subjects

M J Al

Publications and source records attributed to M J Al.

10 recordsLinked to original sources

Long term outcome and cost-effectiveness of stenting versus balloon angioplasty for acute myocardial infarction.

OBJECTIVE: To investigate the long term clinical outcome and cost-effectiveness of stenting compared with balloon angioplasty in patients with acute myocardial infarction. METHODS: Patients with acute myocardial infarction were randomly allocated to primary stenting (112) or balloon angioplasty (115). The primary end point was the cumulative first event rate of death, non-fatal reinfarction, or target vessel revascularisation. Secondary end points were restenosis at six months and the cost-effectiveness at follow up. RESULTS: After 24 months, the combined clinical end point of death/reinfarction was 4% after stenting and 11% after balloon angioplasty (p = 0.04). Subsequent target vessel revascularisation was necessary in 15 patients (13%) after stenting and in 39 (34%) after balloon angioplasty (p < 0.001). The cumulative cardiac event-free survival rate was also higher after stenting (84% v 62%, p < 0.001). The angiographic restenosis rate after stenting was less than after balloon angioplasty (12% v 34%, p < 0.001). Despite the higher initial costs of stenting (Dfl 21 484 v Dfl 18 625, p < 0.001), the cumulative costs at 24 months were comparable with those of balloon angioplasty (Dfl 31 423 v Dfl 32 933, p = 0.83). CONCLUSIONS: Compared with balloon angioplasty, primary stenting for acute myocardial infarction results in a better long term clinical outcome without increased cost.

Aged↗

Healthcare resource utilisation and costs of treating NSAID-associated gastrointestinal toxicity. A multinational perspective.

OBJECTIVE: The aim of the study was to perform an economic analysis of a new therapy in 11 countries (Australia, Belgium, Finland, France, Germany, Italy, The Netherlands, Spain, Sweden, Switzerland and the UK) to assess the cost of treating the gastrointestinal (GI) events associated with the use of nonsteroidal anti-inflammatory drugs in patients with osteoarthritis and rheumatoid arthritis. METHODS: Estimates of GI event-related costs were based on the results of resource utilisation questionnaires. Resources required for the treatment and follow-up of GI events were identified and converted into costs from society and payer perspectives. RESULTS: From the perspective of society, the total per-event cost of managing GI-related events varies from $US51 to $US772 for GI discomfort, from $US108 to $US1100 for anaemia, from $US145 to $US1200 for ulcer and from $US1923 to $US5473 for serious GI events requiring hospitalisation. From the payer perspective, the total per-event cost varies from $US47 to $US680 for GI discomfort, from $US144 to $US762 for anaemia, from $US229 to $US795 for ulcer and from $US1787 to $US6729 for serious GI events requiring hospitalisation. The total cost is driven by hospital expenses for those events requiring hospital admission. For GI discomfort, physician consultations are generally the cost driver, whereas for ulcer and anaemia, cost is primarily driven by the rate of endoscopy. CONCLUSIONS: Costs associated with nonsteroidal anti-inflammatory drug-related GI events differ significantly across countries as a result of variations in resources consumed and price/tariff policies.

Anti-Inflammatory Agents, Non-Steroidal↗

A Bayesian approach to economic analyses of clinical trials: the case of stenting versus balloon angioplasty.

New results about the costs and effects of a new therapy may be weighted with prior information. As such, classical confidence intervals surrounding the costs and effects of a therapy may not reflect the real uncertainties. Bayesian techniques may improve this by formalizing the way that prior information is taken into account in assessing the new evidence. Costs and effects can be analysed separately, but also, when considering the balance between costs and effects, they can be analysed simultaneously. Here, an example is given using data from two trials that compared costs and effectiveness of stent implantation with balloon angioplasty. The Bayesian results make it clear that different prior distributions may lead to different decisions, and it is concluded that even Bayesian analysis may not always reflect the process of capturing the remaining uncertainties.

Angioplasty, Balloon↗

Sample size calculation in economic evaluations.

A simulation method is presented for sample size calculation in economic evaluations. As input the method requires: the expected difference and variance of costs and effects, their correlation, the significance level (alpha) and the power of the testing method and the maximum acceptable ratio of incremental effectiveness to incremental costs. The method is illustrated with data from two trials. The first compares primary coronary angioplasty with streptokinase in the treatment of acute myocardial infarction, in the second trial, lansoprazole is compared with omeprazole in the treatment of reflux oesophagitis. These case studies show how the various parameters influence the sample size. Given the large number of parameters that have to be specified in advance, the lack of knowledge about costs and their standard deviation, and the difficulty of specifying the maximum acceptable ratio of incremental effectiveness to incremental costs, the conclusion of the study is that from a technical point of view it is possible to perform a sample size calculation for an economic evaluation, but one should wonder how useful it is.

2-Pyridinylmethylsulfinylbenzimidazoles↗

The relation between TISS and real paediatric ICU costs: a case study with generalizable methodology.

OBJECTIVE: To determine the quantitative relation between the Therapeutic Intervention Scoring System (TISS) in combination with other relevant clinical variables and the real costs of (paediatric) intensive care. DESIGN: A prospective, observational study. SETTING: A Ten-bed paediatric intensive care unit in a university children's hospital. PATIENTS AND PARTICIPANTS: In a 17-months registration period we collected patient- and treatment-related data for all 611 consecutive admissions. A 21-day calibration period was used to collect detailed data to calculate the real costs of 33 consecutive admissions, in addition to the same data as in the registration period. MEASUREMENTS AND RESULTS: We used the Multi Moment Measurement method to measure time spent by nurses and physicians and medication used in the 21-day calibration period. The calibration period data set with explanatory variables including TISS was used to build a regression model to estimate nurse and physician time, which were converted to personnel costs, and to estimate medication costs. The regression models built from the calibration period were subsequently used to estimate the total costs per day and per admission in different patient groups in the registration period. CONCLUSION: It was feasible to calculate total direct medical costs based on a limited number of readily available clinical variables related to patient characteristics and treatment, of which TISS was the most important determinant. The proposed methods provide further tools for assessment of (paediatric) intensive care unit performance.

Direct Service Costs↗

Technology assessment of the Dutch Lung Transplantation Program.

The costs, effects, and cost-effectiveness of the Dutch Lung Transplantation program were assessed. The results show that lung transplantation is a very costly intervention that improves survival and quality of life. Costs per life-year and per QALY gained were, respectively, US $90,000 and US $71,000.

Algorithms↗

Cost-effectiveness of lung transplantation in The Netherlands: a scenario analysis.

STUDY OBJECTIVES: To calculate cost-effectiveness of scenarios concerning lung transplantation in The Netherlands. DESIGN: Microsimulation model predicting survival, quality of life, and costs with and without transplantation program, based on data of the Dutch lung transplantation program of 1990 to 1995. SETTING: Netherlands, University Hospital Groningen. PATIENTS: Included were 425 patients referred for lung transplantation, of whom 57 underwent transplantation. INTERVENTION: Lung transplantation. RESULTS: For the baseline scenario, the costs per life-year gained are G 194,000 (G=Netherlands guilders) and the costs per quality-adjusted life-year (QALY) gained are G 167,000. Restricting patient inflow ("policy scenario") lowers the costs per life-year gained: G 172,000 (costs per QALY gained: G 144,000). The supply of more donor lungs could reduce the costs per life-year gained to G 159,000 (G 135,000 per QALY gained; G1 =US $0.6, based on exchange rate at the time of the study). CONCLUSIONS: Lung transplantation is an expensive but effective intervention: survival and quality of life improve substantially after transplantation. The costs per life-year gained are relatively high, compared with other interventions and other types of transplantation. Restricting the patient inflow and/or raising donor supply improves cost-effectiveness to some degree. Limiting the extent of inpatient screening or lower future costs of immunosuppressives may slightly improve the cost-effectiveness of the program.

Cost-Benefit Analysis↗

Economic aspects of treatment with captopril for patients with asymptomatic left ventricular dysfunction in The Netherlands.

OBJECTIVE: To estimate the costs and effects of preventive treatment with captopril compared with the current treatment policy in patients with asymptomatic left ventricular dysfunction after a myocardial infarction. METHODS: Estimates of effects are based on the results of the SAVE trial. Costs are estimated on the basis of current treatment patterns in four Dutch hospitals. All knowledge is incorporated in a mathematical model extrapolating the SAVE results to 20 years. RESULTS AND CONCLUSIONS: Captopril treatment is expected to increase survival at certain costs. The average additional costs per patient are estimated at DF1 2,491 in 4 years and at DF1 8,723 in 20 years of treatment. Costs per additional survivor after 4 years are estimated at DF1 69,126. After extrapolation of the results of the SAVE trial to 20 years, costs per life-year gained can be estimated at DF1 15,799. From univariate sensitivity analysis it appears that the results are highly sensitive for the costs of treatment with captopril and the occurrence and prevention of clinical heart failure. Varying all estimates randomly between upper and lower limits-in 5,000 simulations-an estimate of costs per life-year gained of DF1 15,729 is made for 20 years of treatment, with 95% of all estimates between DF10 and DF1 50, 000. On a national level, undiscounted costs are expected to increase up to approximately DF1 42 million annually during the first 40 years after introduction of the preventative strategy.

Angiotensin-Converting Enzyme Inhibitors↗

The cost effectiveness of diclofenac plus misoprostol compared with diclofenac monotherapy in patients with rheumatoid arthritis.

The objective of our study was to estimate the cost effectiveness of treatment with a fixed-dose combination of diclofenac and misoprostol compared with diclofenac monotherapy in the prevention of nonsteroidal anti-inflammatory drug (NSAID)-induced ulcers in rheumatoid arthritis (RA) patients. A model was used to incorporate estimates of costs, incidence of ulcers and their complications, death rates and the efficacy of misoprostol. The costs per ulcer-free period gained and costs per additional survivor were calculated. Cost effectiveness was calculated for the treatment of all RA patients, and of risk groups only. All costs were measured in 1995 Netherlands guilders (NLG; exchange rate at the time of the study: NLG1 = $US0.60). The analysis showed that if 100 RA patients receive 3 months of treatment with diclofenac plus misoprostol, instead of diclofenac alone, this will lead to overall additional costs of NLG773, while 0.82 symptomatic ulcers and 0.019 deaths will be prevented. If misoprostol is given only to patients at high risk for NSAID-induced ulcer, cost savings will occur instead of additional costs. Univariate sensitivity analysis showed that the outcomes are sensitive to changes in: (i) the percentage of ulcers treated in the ambulatory setting; (ii) the price difference between diclofenac and the fixed-dose diclofenac-misoprostol combination; (iii) the percentage of ulcers with complications; and (iv) the efficacy of misoprostol. In conclusion, it can be stated that treatment with diclofenac-misoprostol is cost saving in RA patients at high risk for NSAID-induced ulcers. For RA patients in general, the cost-effectiveness of this intervention compares favourably with that of other prophylactic treatments.

Age Factors↗

Costs, effects and C/E-ratios alongside a clinical trial.

A general approach is discussed to assess the uncertainty surrounding the cost effectiveness ratio (C/E-ratio) estimated on the basis of data from a randomised clinical trial. The approach includes the calculation of a 95% probability ellipse and introduces the concept of a so called C/E-acceptability curve. This last curve defines for each predefined C/E-ratio the probability that the C/E-ratio found in the study is acceptable. The approach is illustrated by estimates of costs per life saved and costs per patient discharged alive on the basis of data from a phase II trial addressing the value of anakinra in treating sepsis syndrome.

Cost-Benefit Analysis↗