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.
As measured one year after the procedure, coronary stenting for multivessel disease is less expensive than bypass surgery and offers the same degree of protection against death, stroke, and myocardial infarction. However, stenting is associated with a greater need for repeated revascularization.
The role of modelling in economic evaluation is explored by discussing, with examples, the uses of models. The expanded use of pragmatic clinical trials as an alternative to models is discussed. Some suggestions for good modelling practice are made.
Objective: To estimate the contribution of excessive alcohol use to socioeconomic variation in mortality among men and women in Finland. Design: Register based follow up study. Subjects: The population covered by the 1985 and 1990 censuses, aged >20 in the follow up period 1987-93. Main outcome measures: Total mortality and alcohol related mortality from all causes, from diseases, and from accidents and violence according to socioeconomic position. The excess mortality among other classes compared with upper non-manual employees and differences in life expectancy between the classes were used to measure mortality differentials. Results: Alcohol related mortality constituted 11% of all mortality among men aged >20 and 2% among women and was higher among manual workers than among other classes. It accounted for 14% of the excess all cause mortality among manual workers over upper non-manual employees among men and 4% among women and for 24% and 9% of the differences in life expectancy, respectively. Half of the excess mortality from accidents and violence among male manual workers and 38% among female manual workers was accounted for by alcohol related deaths, whereas in diseases the role of alcohol was modest. The contribution of alcohol related deaths to relative mortality differentials weakened with age. Conclusions: Class differentials in alcohol related mortality are an important factor in the socioeconomic mortality differentials in Finland, especially among men, among younger age groups, and in mortality from accidents and violence.
The benefits of a pharmacy-based, active therapeutic drug monitoring (TDM) service (ATM) on outcomes were examined in a prospective study at four hospitals. ATM involved pharmacokinetic dosage optimization at the start of treatment, subsequent Bayesian adaptive control, and frequent patient evaluation. Cost-effectiveness was calculated based on real costs. The ATM group comprised 105 patients and 127 patients with nonguided TDM who were followed up as controls. Forty-eight of the ATM and 62 of the nonguided TDM patients had an infection on admission. Peak concentrations in ATM patients were significantly higher (10.6+/-2.9 mg/L; nonguided TDM, 7.6+/-2.2 mg/L; p < 0.01). Trough levels in the ATM group were significantly lower (p < 0.01). There was a trend toward lower mortality in the ATM group (nine of 105 versus 18 of 127; p = 0.26) that was significant for patients with an infection on admission (one of the 48 ATM patients died versus nine of the 62 nonguided TDM patients; p = 0.023). ATM reduced the length of hospital stay for all patients in the study (20.0+/-1.4 days; nonguided TDM, 26.3+/-2.9 days; p = 0.045) and for patients admitted with an infection (12.6+/-0.8 days; nonguided TDM, 18.0+/-1.4; p < 0.001). The incidence of nephrotoxicity was reduced from 13.4% (nonguided TDM) to 2.9% (p < 0.01). With ATM, total costs were lower for all patients (Dutch guilders [DFL], 13,125+/-9,267; nonguided TDM, DFL 16,862+/-17,721; p < 0.05) and for patients admitted with an infection (DFL 8,883+/-3,778; nonguided TDM, DFL 11,743+/-7,437; p < 0.01). Goal-oriented, model-based dosing of aminoglycosides resulted in higher antibiotic efficacy, shorter hospitalization, and reduced incidence of nephrotoxicity. By combining efficacy with savings, ATM offered a significant alternative to usual care.
The aim of our study was to validate a hip fracture risk function, composed of age and femoral neck bone mineral density (BMD). This estimate of the 1-year cumulative risk was previously developed on the basis of Dutch hip fracture incidence data and BMD in men and women. A cohort of 7046 persons (2778 men) aged 55 years and over was followed for an average of 3.8 years. The 1-year hip fracture risk estimate was calculated for each participant according to the risk function and categorized as low (<0.1%), moderate (0.1 to <1%), or high (>1%). Observed first hip fracture incidence was then analyzed for each of these risk categories by age and gender. Additionally, we calculated the relative risk per standard deviation (SD) decrease in femoral neck BMD in this population. At baseline, 2360 individuals were categorized as low risk, 2567 as moderate risk, and 378 as high risk. During follow-up, 110 first hip fractures were observed corresponding to an incidence rate of 4.1/1000 person-years (pyrs) (95% confidence interval 3.4 -5.0). The observed incidence rate in the low risk group was 0.2/1000 pyrs (0.1-0.9), 2.7/1000 pyrs (1.8 -3.9) in the moderate risk group, and 18.4/1000 pyrs (12.4 -27.2) in the high risk group. Below the age of 70 years, incidence was low in all categories, and very few individuals were considered at high risk. Above the age of 70 years, the observed incidence was high in the high risk group, while in the low and moderate risk groups, the incidence remained low even over 80 years of age. In women, the age-adjusted relative risk for hip fractures was 2.5 per SD decrease in femoral neck BMD (1.8 -3.6), while in men this relative risk was 3.0 per SD (1.7-5.4). In conclusion, we observed a similar relation of hip fracture with femoral neck BMD in men and women and were able to predict accurately hip fracture rates over a period of almost 4 years. (J Bone Miner Res 1998; 13:1587-1593)
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