http://repub.eur.nl/res/aut/1779/ List of Publications en http://repub.eur.nl/static-eur/img/logo.png http://repub.eur.nl http://repub.eur.nl/res/pub/31102/ 2011-09-05T00:00:00Z Background: During the past decade, blood screening tests such as triplex nucleic acid amplification testing (NAT) and human T-cell lymphotropic virus type I or I (HTLV-I/II) antibody testing were added to existing serologic testing for hepatitisB virus (HBV), human immunodeficiency virus (HIV), and hepatitisC virus (HCV). In some low-prevalence regions these additional tests yielded disputable benefits that can be valuated by cost-effectiveness analyses (CEAs). CEAs are used to support decision making on implementation of medical technology. We present CEAs of selected additional screening tests that are not uniformly implemented in the EU. Study Design And Methods: Cost-effectiveness was analyzed of: 1) HBV, HCV, and HIV triplex NAT in addition to serologic testing; 2) HTLV-I/II antibody test for all donors, for first-time donors only, and for pediatric recipients only; and 3) hepatitisA virus (HAV) for all donations. Disease progression of the studied viral infections was described in five Markov models. Results: In the Netherlands, the incremental cost-effectiveness ratio (ICER) of triplex NAT is €5.20 million per quality-adjusted life-year (QALY) for testing minipools of six donation samples and €4.65 million/QALY for individual donation testing. The ICER for anti-HTLV-I/II is €45.2 million/QALY if testing all donations, €2.23 million/QALY if testing new donors only, and €27.0 million/QALY if testing blood products for pediatric patients only. The ICER of HAV NAT is €18.6 million/QALY. Conclusion: The resulting ICERs are very high, especially when compared to other health care interventions. Nevertheless, these screening tests are implemented in the Netherlands and elsewhere. Policy makers should reflect more explicit on the acceptability of costs and effects whenever additional blood screening tests are implemented. http://repub.eur.nl/res/pub/25151/ 2011-03-17T00:00:00Z BACKGROUND: Previous studies have shown that among patients undergoing multivessel revascularization, coronary-artery bypass grafting (CABG), as compared with percutaneous coronary intervention (PCI) either by means of balloon angioplasty or with the use of bare-metal stents, results in greater relief from angina and improved quality of life. The effect of PCI with the use of drug-eluting stents on these outcomes is unknown. METHODS: In a large, randomized trial, we assigned 1800 patients with three-vessel or left main coronary artery disease to undergo either CABG (897 patients) or PCI with paclitaxeleluting stents (903 patients). Health-related quality of life was assessed at baseline and at 1, 6, and 12 months with the use of the Seattle Angina Questionnaire (SAQ) and the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36). The primary end point was the score on the angina-frequency subscale of the SAQ (on which scores range from 0 to 100, with higher scores indicating better health status). RESULTS: The scores on each of the SAQ and SF-36 subscales were significantly higher at 6 and 12 months than at baseline in both groups. The score on the angina-frequency subscale of the SAQ increased to a greater extent with CABG than with PCI at both 6 and 12 months (P = 0.04 and P = 0.03, respectively), but the between-group differences were small (mean treatment effect of 1.7 points at both time points). The proportion of patients who were free from angina was similar in the two groups at 1 month and 6 months and was higher in the CABG group than in the PCI group at 12 months (76.3% vs. 71.6%, P = 0.05). Scores on all the other SAQ and SF-36 subscales were either higher in the PCI group (mainly at 1 month) or were similar in the two groups throughout the follow-up period. CONCLUSIONS: Among patients with three-vessel or left main coronary artery disease, there was greater relief from angina after CABG than after PCI at 6 and 12 months, although the extent of the benefit was small. (Funded by Boston Scientific; ClinicalTrials.gov number, NCT00114972.). Copyright http://repub.eur.nl/res/pub/22926/ 2011-02-01T00:00:00Z Background Cost-effectiveness analyses of blood safety interventions require estimates of the life expectancy after blood product transfusion. These are best derived from survival after blood transfusion, per age group and blood component type.Study design and methods In the PROTON (PROfiles of TransfusiON recipients) study transfusion recipient data was collected from a hospital sample covering 28% of the total blood use between 1996 and 2006 in the Netherlands. The dataset includes date of transfusion, blood component type transfused and recipient identification details. PROTON data were individually matched to mortality data of the Netherlands. Survival after first transfusion and after any transfusion was calculated, per blood component type and age group. PROTON mortality rates were compared to mortality rates in the general population. The results were used to estimate survival beyond the study period and to estimate life expectancy after transfusion.Results Of all 2 405 012 blood product transfusions in the PROTON dataset, 92% was matched to the national Dutch Municipal Population Register, which registers all deaths. After 1 year, survival after any transfusion was 65.4%, 70.4% and 53.9% for RBC, FFP and PLT respectively. After 5 years, this was 46.6%, 58.8% and 39.3% for RBC, FFP and PLT, respectively. Ten years after transfusion, mortality rates of recipients are still elevated in comparison with the general population.Conclusion Mortality rates of transfusion recipients are higher than those of the general population, but the increase diminishes over time. The mortality rates found for the Netherlands are lower than those found in comparable studies for other countries. http://repub.eur.nl/res/pub/27541/ 2010-07-01T00:00:00Z Background: Transfusion recipient data are needed for correct estimation of cost-effectiveness in terms of recipient outcomes after transfusion. Also, such data are essential for monitoring blood use, estimation of future blood use and benchmarking. Study Design and Methods: A sample of 20 of 93 Dutch hospitals was selected. Datasets containing all blood product transfusions between 1996 and 2006 were extracted from hospital blood bank computer systems, containing transfusion date, blood product type and recipient characteristics such as gender, address, date of birth. The datasets were appended and matched to national hospitalization datasets including primary discharge diagnoses (ICD-9). Using these data, we estimated distributions of blood recipient characteristics in the Netherlands. Results: The dataset contains information on 290 043 patients who received 2 405 012 blood products (1 720 075 RBC, 443 697 FFP, 241 240 PLT) from 1996 to 2006. This is 28% of total blood use in the Netherlands during this period. Comparable diagnosis and age distributions of all hospitalizations indicate included hospitals to be representative, per hospital category, for the Netherlands. Of all red blood cells (RBC), fresh-frozen plasma (FFP) and platelets (PLT), respectively 1·7%, 2·5% and 4·5% were transfused to neonates. Recipients of 65 years or older received 57·6% of RBC, 41·4% of FFP and 29·0% of PLT. Most of the blood products were transfused to patients with diseases of the circulary system (25·1%) or neoplasms (22·0%). Conclusion: Transfusion data from a limited sample of hospitals can be used to estimate national distributions of blood recipient characteristics. http://repub.eur.nl/res/pub/24804/ 2009-05-01T00:00:00Z Background and Objectives European legislation requires manufacturers of plasma products to report epidemiological data on human immunodeficiency virus, hepatitis B virus and hepatitis C virus in donor populations. The incidence rates of such infections are directly related to the risk of infection transmission. We propose two statistical tests to evaluate these incidence rates. Materials and Methods Infection data of the four Dutch blood collection centres from 2003 through 2006 were analysed. For transversal comparison of centres and detection of increased incidence rates, a new statistical test was developed (outlier test). For longitudinal detection of trends in incidence rates, a generic test for trend is proposed. The power and risk of non-detection are evaluated for both tests. Results Application of the outlier test did not reveal any significantly increased incidence rates among centres in The Netherlands. The test for trend showed no significant increase in incidence rates in individual centres, but on national level a statistically significant increase in hepatitis C virus incidence was observed (P-value of 0·01). Conclusion The proposed tests allow signalling of outlier centres and trends in incidence rates both at individual centre and at national levels. Graphical support and the use of as much relevant historical data as possible is recommended. The statistical tests described are generic and can be applied by any blood establishment and plasma fractionation institute. http://repub.eur.nl/res/pub/30044/ 2008-07-01T00:00:00Z Aims: To critically review the available transcatheter aortic valve implantation techniques and their results, as well as propose recommendations for their use and development. Methods and results: A committee of experts including European Association of Cardio-Thoracic Surgery and European Society of Cardiology representatives met to reach a consensus based on the analysis of the available data obtained with transcatheter aortic valve implantation and their own experience. The evidence suggests that this technique is feasible and provides haemodynamic and clinical improvement for up to 2 years in patients with severe symptomatic aortic stenosis at high risk or with contraindications for surgery. Questions remain mainly concerning safety and long-term durability, which have to be assessed. Surgeons and cardiologists working as a team should select candidates, perform the procedure, and assess the results. Today, the use of this technique should be restricted to high-risk patients or those with contraindications for surgery. However, this may be extended to lower risk patients if the initial promise holds to be true after careful evaluation. Conclusion: Transcatheter aortic valve implantation is a promising technique, which may offer an alternative to conventional surgery for high-risk patients with aortic stenosis. Today, careful evaluation is needed to avoid the risk of uncontrolled diffusion. http://repub.eur.nl/res/pub/29396/ 2008-06-01T00:00:00Z Aims: To critically review the available transcatheter aortic valve implantation techniques and their results, as well as propose recommendations for their use and development. Methods and results: A committee of experts including European Association of Cardio-Thoracic Surgery and European Society of Cardiology representatives met to reach a consensus based on the analysis of the available data obtained with transcatheter aortic valve implantation and their own experience. The evidence suggests that this technique is feasible and provides haemodynamic and clinical improvement for up to 2 years in patients with severe symptomatic aortic stenosis at high risk or with contraindications for surgery. Questions remain mainly concerning safety and long-term durability, which have to be assessed. Surgeons and cardiologists working as a team should select candidates, perform the procedure, and assess the results. Today, the use of this technique should be restricted to high-risk patients or those with contraindications for surgery. However, this may be extended to lower risk patients if the initial promise holds to be true after careful evaluation. Conclusion: Transcatheter aortic valve implantation is a promising technique, which may offer an alternative to conventional surgery for high-risk patients with aortic stenosis. Today, careful evaluation is needed to avoid the risk of uncontrolled diffusion. http://repub.eur.nl/res/pub/8358/ 2005-01-01T00:00:00Z OBJECTIVE: To assess the balance between costs and effects of the sirolimus eluting stent in the treatment of single native de novo coronary lesions in the RAVEL (randomised study with the sirolimus eluting Bx Velocity balloon expandable stent in the treatment of patients with de novo native coronary artery lesions) study. DESIGN: Multicentre, double blind, randomised trial. SETTING: Percutaneous coronary intervention for single de novo coronary lesions. PATIENTS: 238 patients with stable or unstable angina. INTERVENTIONS: Randomisation to sirolimus eluting stent or bare stent implantation. MAIN OUTCOME MEASURES: Patients were followed up to one year and the treatment effects were expressed as one year survival free of major adverse cardiac events (MACE). Costs were estimated as the product of resource utilisation and Dutch unit costs. RESULTS: At one year, the absolute difference in MACE-free survival was 23% in favour of the sirolimus eluting stent group. At the index procedure, sirolimus eluting stent implantation had an estimated additional procedural cost of 1286. At one year, however, the estimated additional cost difference had decreased to 54 because of the reduction in the need for repeat revascularisations in the sirolimus group (0.8% v 23.6%; p < 0.01). After adjustment of actual results for the consequences of angiographic follow up (correction based on data from the BENESTENT (Belgium Netherlands stent) II study), the difference in MACE-free survival was estimated at 11.1% and the additional one year costs at 166. CONCLUSIONS: The one year data from RAVEL suggest an attractive balance between costs and effects for sirolimus eluting stents in the treatment of single native de novo coronary lesions. The cost effectiveness of drug eluting stents in more complex lesion subsets remains to be determined. http://repub.eur.nl/res/pub/4671/ 2004-03-09T00:00:00Z Background— The primary results of Arterial Revascularization Therapy Study reported a greater need for repeated revascularization after percutaneous coronary intervention with stenting (PCI). However, PCI was less expensive than coronary artery bypass grafting (CABG) and offered the same degree of protection against death, stroke, and myocardial infarction. Methods and Results— Patients with multivessel disease (n=1205) were randomly assigned to either CABG or PCI and followed up for up to 3 years. Survival rates without stroke or myocardial infarction were similar in each group at 1 year and 3 years (90.5% versus 91.4% for PCI versus CABG at 1 year and 87.2% versus 88.4% for PCI versus CABG at 3 years). However, the respective repeat revascularization rates were 21.2% and 26.7% at 1 and 3 years in patients allocated to PCI, compared with 3.8% and 6.6% in patients allocated to CABG (P<0.0001). Diabetes (P<0.0009) and maximal pressure for stent deployment (P<0.002) are the strongest independent predictors of events at 3 years after PCI, whereas left anterior descending coronary artery grafting (P<0.006) is the best predictor of event-free survival at 3 years after CABG. The incremental cost of surgery compared with PCI for an event-free patient was 19 257 at 1 year but decreased to 10 492 at 3 years. It remained at 142 391 at 3 years when revascularization procedures were excluded in the efficacy end point, however. Conclusions— Three-year survival rates without stroke and myocardial infarction are identical in both groups, and the cost/benefit ratio of stenting is determined primarily by the increasing need for revascularization in the PCI group. http://repub.eur.nl/res/pub/4752/ 2003-03-01T00:00:00Z Abstract AIMS: This study examined the six-month angiographic results of direct coronary stenting, and compared the nine-month safety, efficacy and cost of this strategy versus stenting after balloon predilatation. METHODS: In phase I of VELVET, 122 patients (mean age = 62.3 +/- 10.1 years, 77% male, 11% with diabetes) with angina pectoris or myocardial ischemia resulting from a single de novo 51% to 95% coronary stenosis underwent direct stenting. The endpoints of phase I included angiographic findings and rates of major adverse cardiac events up to six months of follow-up. In phase II, 401 patients (mean age = 61.3 +/- 10.8 years, 79% male, 16% with diabetes) with angina pectoris or documented myocardial ischemia resulting from single or multiple, de novo or restenotic, coronary lesions were randomized between direct stenting and stenting after predilatation. The immediate angiographic results, and clinical outcomes and costs associated with the two treatment strategies up to nine months of follow-up were compared. RESULTS: In phase I the mean diameter stenosis immediately before and after the procedure, and at six months was 61.7+/-9.4%, 13.5+/-6.3%, and 33.6+/-16.2%, respectively. The six-month binary restenosis rate was 11%. The overall rate of major adverse cardiac events, including two non-cardiac deaths, was 9.8%. In phase II, the success rates of the intended delivery strategies were 87.9% and 97.9% for direct stenting and predilatation, respectively (p < 0.001), while the procedural success rates were similar (93.9% vs 96.5%). Over a follow-up period of nine months, major adverse cardiac events rates were 12.0% and 10.9% in patients randomized to direct stenting and predilatation, respectively (non-significant). Analyses of the costs incurred up to nine months in each treatment group revealed a mean saving of e362 per patient in favor of the direct stenting strategy (non-significant). CONCLUSIONS: Compared with a strategy of stenting preceded by balloon dilatation, direct stenting was associated with an equivalent procedural success rate, equivalent clinical results up to nine months of follow-up, and a reduction in procedural and in-hospital costs (p < 0.0001 and p < 0.001, respectively), that was no longer significant after nine months. http://repub.eur.nl/res/pub/11370/ 2002-01-01T00:00:00Z The methods that have been used to estimate the clinical and economic impact of vaccination programmes are not always uniform, which makes it difficult to compare results between economic analyses. Furthermore, the relative efficiency of vaccination programmes can be sensitive to some of the more controversial aspects covered by general guidelines for the economic evaluation of healthcare programmes, such as discounting of health gains and the treatment of future unrelated costs. In view of this, we interpret some aspects of these guidelines with respect to vaccination and offer recommendations for future analyses. These recommendations include more transparency and validation, more careful choice of models (tailored to the infection and the target groups), more extensive sensitivity analyses, and for all economic evaluations (also nonvaccine related) to be in better accordance with general guidelines. We use these recommendations to interpret the evidence provided by economic evaluation applied to viral hepatitis vaccination. We conclude that universal hepatitis B vaccination (of neonates, infants or adolescents) seems to be the most optimal strategy worldwide, except in the few areas of very low endemicity, where the evidence to enable a choice between selective and universal vaccination remains inconclusive. While targeted hepatitis A vaccination seems economically unattractive, universal hepatitis A vaccination strategies have not yet been sufficiently investigated to draw general conclusions. http://repub.eur.nl/res/pub/12943/ 2001-08-31T00:00:00Z AIMS: The EPISTENT study has demonstrated that the combined use of abciximab and stenting as an adjunct to PTCA leads to increased event-free survival compared to either using abciximab or stenting alone. However, this combined strategy may be costly and the additional costs have to be weighted against the additional effects. METHOD AND RESULTS: The 6-months efficacy data from the EPISTENT study are combined with Dutch estimates of unit costs. Adding a stent to a procedure with abciximab further decreases the number of revascularizations at an extra cost of Euros 12,000 (95% upper limit (u.l.) Euros 31,000) per additional major adverse cardiac event-free survivor. Adding abciximab to a stenting procedure decreases the incidence of myocardial infarctions at an extra cost of Euros 13,000 (95% u.l. Euros 27,000) per additional myocardial infarction-free survivor. In the subgroup of diabetics, adding abciximab improves revascularization rates as well, resulting in a cost-efficacy rate of Euros 2000 (95% u.l. Euros 25,000) per additional MACE-free survivor, with uncertainty regions indicating potential costs savings. CONCLUSION: The combination of stenting and abciximab costs about Euros 13,000 to avoid one event after PTCA. In diabetic patients the strategy may be cost-saving. http://repub.eur.nl/res/pub/5654/ 2001-07-20T00:00:00Z Aims Treatment guidelines have been developed for both ‘primary’ and ‘secondary’ prevention of coronary heart disease. These should consider both the efficacy as well as the costs of such treatment, particularly the costs of treatment with HMG co-enzyme A reductase inhibitors (statins). In the context of guideline development in The Netherlands, the cost effectiveness of treatment with statins was analysed. Methods Following a modelling approach, cost effectiveness was analysed as a function of a patient's initial risk for new coronary heart disease events, combining results from 4S, CARE, LIPID, WOSCOPS and AFCAPS with Dutch cost data. For each sex and age group, an estimate was made of the level of cardiovascular risks that might correspond to a cost-effectiveness ratio under NLG 40000 (Euro 18151) per life year gained. Results If the 10-year risk of myocardial infarction, stroke or cardiovascular death was estimated at 9% (AFCAPS/TexCAPS), 20% (WOSCOPS), 36% (CARE) 36% (LIPID) and 47% (4S), cost effectiveness was estimated at Euro 51400, Euro 26013, Euro 9970, Euro 8028 and Euro 6695. The arbitrary threshold of NLG 40000 (approximately Euro 18000) was achieved at a 10 year coronary heart disease event risk ranging from 19% to 26% for different age groups. Assuming the effectiveness of statin treatment decreased with age, a 10-year risk, corresponding to Euro 18000, varied from 11% (under age 30) to 41% (over age 80). Patients at higher risk levels should be considered for statin therapy. Conclusions Treatment costs for primary or secondary prevention are determined predominantly by the costs of statin drugs. The developed model allows comparison of cost effectiveness of statin therapy across a wide range of subjects with or without coronary heart disease. The consensus committee in the Netherlands postulated that drug therapy should be considered in subjects with or without coronary heart disease in which cost-effectiveness is similar. Such groups can be identified using the presented model. When cost effectiveness ratios up to Euro 18000 per life year gained are deemed acceptable, statin treatment should be considered in most patients with known cardiovascular disease (secondary prevention), and in a limited group of subjects who are at high risk of developing coronary heart disease (primary prevention). http://repub.eur.nl/res/pub/12927/ 2001-01-01T00:00:00Z AIMS: Treatment guidelines have been developed for both "primary" and "secondary" prevention of coronary heart disease. These should consider both the efficacy as well as the costs of such treatment, particularly the costs of treatment with HMG co-enzyme A reductase inhibitors (statins). In the context of guideline development in The Netherlands, the cost effectiveness of treatment with statins was analysed. METHODS: Following a modelling approach, cost effectiveness was analysed as a function of a patient's initial risk for new coronary heart disease events, combining results from 4S, CARE, LIPID, WOSCOPS and AFCAPS with Dutch cost data. For each sex and age group, an estimate was made of the level of cardiovascular risks that might correspond to a cost-effectiveness ratio under NLG 40 000 (Euro 18 151) per life year gained. RESULTS: If the 10-year risk of myocardial infarction, stroke or cardiovascular death was estimated at 9% (AFCAPS/TexCAPS), 20% (WOSCOPS), 36% (CARE) 36% (LIPID) and 47% (4S), cost effectiveness was estimated at Euro 51 400, Euro 26 013, Euro 9970, Euro 8028 and Euro 6695. The arbitrary threshold of NLG 40 000 (approximately Euro 18 000) was achieved at a 10 year coronary heart disease event risk ranging from 19% to 26% for different age groups. Assuming the effectiveness of statin treatment decreased with age, a 10-year risk, corresponding to Euro 18 000, varied from 11% (under age 30) to 41% (over age 80). Patients at higher risk levels should be considered for statin therapy. CONCLUSIONS: Treatment costs for primary or secondary prevention are determined predominantly by the costs of statin drugs. The developed model allows comparison of cost effectiveness of statin therapy across a wide range of subjects with or without coronary heart disease. The consensus committee in the Netherlands postulated that drug therapy should be considered in subjects with or without coronary heart disease in which cost-effectiveness is similar. Such groups can be identified using the presented model. When cost effectiveness ratios up to Euro 18 000 per life year gained are deemed acceptable, statin treatment should be considered in most patients with known cardiovascular disease (secondary prevention), and in a limited group of subjects who are at high risk of developing coronary heart disease (primary prevention). http://repub.eur.nl/res/pub/8448/ 2001-01-01T00:00:00Z BACKGROUND: The recent recognition that coronary-artery stenting has improved the short- and long-term outcomes of patients treated with angioplasty has made it necessary to reevaluate the relative benefits of bypass surgery and percutaneous interventions in patients with multivessel disease. METHODS: A total of 1205 patients were randomly assigned to undergo stent implantation or bypass surgery when a cardiac surgeon and an interventional cardiologist agreed that the same extent of revascularization could be achieved by either technique. The primary clinical end point was freedom from major adverse cardiac and cerebrovascular events at one year. The costs of hospital resources used were also determined. RESULTS: At one year, there was no significant difference between the two groups in terms of the rates of death, stroke, or myocardial infarction. Among patients who survived without a stroke or a myocardial infarction, 16.8 percent of those in the stenting group underwent a second revascularization, as compared with 3.5 percent of those in the surgery group. The rate of event-free survival at one year was 73.8 percent among the patients who received stents and 87.8 percent among those who underwent bypass surgery (P<0.001 by the log-rank test). The costs for the initial procedure were $4,212 less for patients assigned to stenting than for those assigned to bypass surgery, but this difference was reduced during follow-up because of the increased need for repeated revascularization; after one year, the net difference in favor of stenting was estimated to be $2,973 per patient. CONCLUSION: 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. http://repub.eur.nl/res/pub/9697/ 2001-01-01T00:00:00Z BACKGROUND: Our aims were to compare coronary artery bypass grafting (CABG) and stenting for the treatment of diabetic patients with multivessel coronary disease enrolled in the Arterial Revascularization Therapy Study (ARTS) trial and to determine the costs of these 2 treatment strategies. METHODS AND RESULTS: Patients (n=1205) were randomly assigned to stent implantation (n=600; diabetic, 112) or CABG (n=605; diabetic, 96). Costs per patient were calculated as the product of each patient's use of resources and the corresponding unit costs. Baseline characteristics were similar between the groups. At 1 year, diabetic patients treated with stenting had the lowest event-free survival rate (63.4%) because of a higher incidence of repeat revascularization compared with both diabetic patients treated with CABG (84.4%, P<0.001) and nondiabetic patients treated with stents (76.2%, P=0.04). Conversely, diabetic and nondiabetic patients experienced similar 1-year event-free survival rates when treated with CABG (84.4% and 88.4%). The total 1-year costs for stenting and CABG in diabetic patients were $12 855 and $16 585 (P<0.001) and in the nondiabetic groups, $10 164 for stenting and $13 082 for surgery. CONCLUSIONS: Multivessel diabetic patients treated with stenting had a worse 1-year outcome than patients assigned to CABG or nondiabetics treated with stenting. The strategy of stenting was less costly than CABG, however, regardless of diabetic status. http://repub.eur.nl/res/pub/1312/ 2000-01-01T00:00:00Z Doel. Het verkrijgen van inzicht in de balans tussen kosten en effecten van Regranex, als toevoeging aan de standaard behandeling van diabetische voetulcera van neuropatische standaardbehandeling oorsprong met adequate bloedvoorziening. Methode. Kosten en effecten worden berekend van met behulp van een Markov-model waarin - met een tijdshorizon van respectievelijk 1 en 2 jaar - Amerikaanse gegevens omtrent het natuurlijke beloop van de ziekte worden gecombineerd met 1) Nederlands/Zweedse kostenramingen en 2) gegevens omtrent de effectiviteit van Regranex ontleend aan gerandomiseerd klinisch onderzoek. Patiënten worden in 9 toestanden verdeeld naar gelang of het ulcus is genezen, of er sprake is van een infectie dan wel gangreen en of de patiënt een amputatie heeft ondergaan. De kostenramingen zijn beperkt tot de directe medische kosten. Effecten worden uitgedrukt in het aantal maanden zonder ulcera, het aantal amputaties en QALY's. Resultaten. Er wordt verwacht dat door behandeling van Regranex het aantal ulcusvrije dagen gedurende het eerste jaar na behandeling met 33 toeneemt en dat het percentage patiënten dat een amputatie nodig heeft, afneemt van 14,4% naar 12,9%. Voorts wordt verwacht dat de additionele kosten van Regranex (NLG 2.990 per patiënt) al gedurende het eerste jaar worden gecompenseerd door de besparingen in de kosten van standaardbehandeling (NLG 3.979) en in de kosten van en na amputaties (NLG 566). Na 1 jaar worden de besparingen geraamd op NLG 1.555 per patiënt, na 2 jaar op NLG 2.880 per patiënt. Gevoeligheidsanalyse geeft aan dat de verwachte besparingen vooral samenhangen met de geschatte effectiviteit van Regranex en de kosten van standaardbehandeling. Na 2 jaar worden er geen besparingen verwacht als het genezingspercentage na 20 weken met het gebruik van Regranex op 44,51% wordt geraamd in plaats van op 50% of als de kosten van standaardbehandeling op gemiddeld NLG 1.813 per 4weken worden geraamd in plaats van op NLG 3.425. Wanneer men de grens van wat acceptabel is, op NLG 25 per ulcus vrije dag legt, mag de effectiviteit van Regranex niet lager liggen dan op 43,59% en mogen de kosten van standaardbehandeling niet lager liggen dan op NLG 1.346 per 4weken. Conclusie. Ondanks de beperking van het model, waarin gegevens per patiënt noodzakelijkerwijs worden gecombineerd met gegevens per ulcus, wijzen de beschikbare gegevens erop dat Regranex een effectieve en doelmatige aanwending is van de schaarse middelen binnen de gezondheidszorg. http://repub.eur.nl/res/pub/9552/ 2000-01-01T00:00:00Z BACKGROUND: Coronary stenting improves outcomes compared with balloon angioplasty, but it is costly and may have other disadvantages. Limiting stent use to patients with a suboptimal result after angioplasty (provisional angioplasty) may be as effective and less expensive. METHODS AND RESULTS: To analyze the cost-effectiveness of provisional angioplasty, patients scheduled for single-vessel angioplasty were first randomized to receive primary stenting (97 patients) or balloon angioplasty guided by Doppler flow velocity and angiography (523 patients). Patients in the latter group were further randomized after optimization to either additional stenting or termination of the procedure to further investigate what is "optimal." An optimal result was defined as a flow reserve >2.5 and a diameter stenosis <36%. Bailout stenting was needed in 129 patients (25%) who were randomized to balloon angioplasty, and an optimal result was obtained in 184 of the 523 patients (35%). There was no significant difference in event-free survival at 1 year between primary stenting (86.6%) and provisional angioplasty (85.6%). Costs after 1 year were significantly higher for provisional angioplasty (EUR 6573 versus EUR 5885; P:=0.014). Results after the second randomization showed that stenting was also more effective after optimal balloon angioplasty (1-year event free survival, 93.5% versus 84.1%; P:=0. 066). CONCLUSIONS: After 1 year of follow-up, provisional angioplasty was more expensive and without clinical benefit. The beneficial value of stenting is not limited to patients with a suboptimal result after balloon angioplasty. http://repub.eur.nl/res/pub/5560/ 1998-04-23T00:00:00Z Cost-effectiveness analyses are routinely performed to determine whether the additional cost of a novel therapy is balanced by additional effectiveness. The definitions of costs and effects involve a variety of assumptions, both in general economic terms and with regard to the specific medical setting under consideration. Similarly, differing criteria for acceptability of cost-effectiveness estimates can be used to generate different conclusions regarding cost-effectiveness. The issues and problems inherent in economic evaluation are discussed by an analysis of findings with the platelet glycoprotein IIb/IIIa inhibitor abciximab in the EPIC (Evaluation of 7E3 for the Prevention of Ischemic Complications) study in high-risk patients undergoing percutaneous transluminal coronary angioplasty. http://repub.eur.nl/res/pub/1315/ 1996-01-01T00:00:00Z This report provides an overview of the available quantitative information about osteoporosis in the Netherlands, and of the costs associated with it. We present information relevant for this country, making as few assumptions as possible. Although the main subject is osteoporosis, the focus in this report is on fractures, as these are the most relevant outcome events of this condition. Data were collected from publicly available data sources and from international literature and information is mostly about the year 1993. The reader finds detailed information about the occurrence of osteoporosis and fractures, the utilization of health care, mortality, and the costs in the results section of this report. In the conclusions, we present a synthesis of the most important findings. Osteoporosis is, by consensus, defined as a systemic skeletal disease, characterized by low bone mass and microarchitectural deterioration of bone tissue with a consequent increase in bone fragility and susceptibility to fracture. There is an important age-related decrease in bone mass and bone strength. Osteoporosis is primarily described in post-menopausal women but men are not free from it; they also reach high fracture incidence rates at an older age. Combined with the longer survival of women, this leads to the observation that most osteoporotic fractures are encountered in females. Osteoporosis and fractures are a major source of illness and healthcare costs in the Netherlands, both today as in the foreseeable future. Especially the most serious consequence, hip fracture, is frequent and the incidence is increasing. The total number of hip fractures will inevitable rise if no serious prevention efforts are undertaken. For the prevention of osteoporotic fractures it is important to know who are at risk as well as which preventive strategy is effective for the different risk categories. The parameter that is most commonly used nowadays to determine fracture risk is bone mineral density (BMD), but also other factors are important contributors to the fracture risk, namely the previously mentioned bone quality and the propensity to fall. Prevention only focussed on bone mineral density will thus do nothing to prevent the hip fractures caused by the above mentioned factors. An additional effect of therapy on bone quality can be important and the intervention should certainly not have adverse effects on bone quality. Reducing the frequency and severity of falls, and the use of external protective devices, together with physical exercise and other lifestyle interventions, have been looked at as additional intervention possibilities. Patients with a hip fracture more often have concomitant illnesses and a poor general condition. This condition in itself can increase the risk of falling and the perioperative risk. This situation can also impair the rehabilitation after treatment and hamper mobilization. Osteoporosis and fractures are found to be an important cause of health care consumption. Hip fractures lead to long hospitalizations with a mean length of stay of 26 days. Forearm and vertebral fractures are most frequently treated in an outpatient setting. People over age 85, representing less than 2 % of the population nevertheless cause over one third of the hospitalization days for hip fractures. After the acute phase and the hospitalization, nursing home care is often needed. Using hospital data, we see that 21 % of men and 27 % of women are discharged directly into nursing homes. In this study we estimated the direct medical cost associated with fractures at older age. The cost of osteoporosis is mainly the cost of hip fractures. It is this cost we could determine most accurately. The results indicate a yearly cost between 390 and 470 million Dutch guilders. It appears that the cost of medication is minor, compared to the cost of clinical treatment of the fractures. http://repub.eur.nl/res/pub/5511/ 1995-01-01T00:00:00Z A cost effectiveness study is presented on the use of c7E3 in high risk patients undergoing percutaneous coronary angioplasty (PTCA). The results from the EPIC study have been combined with cost data from The Netherlands. The study took account of the number of survivors without ischaemic events, and the number with neither ischaemic events nor bleeding (both measured after 6 months). It is estimated that the initial costs of c7E3 and the additional costs due to the increased risk of bleeding are almost entirely counterbalanced by the savings, as a result of fewer myocardial infarctions and revascularizations. The additional costs per additional patient without ischaemic events are approximately DFL 5235. The additional costs per additional patient with neither ischaemic events nor bleeding are estimated at DFL 15,685. Both figures are less than the average for similar procedures without c7E3. Sensitivity analysis supports the conclusion that c7E3 treatment is efficient. However, cost effectiveness could be further improved if patients are carefully selected. http://repub.eur.nl/res/pub/1306/ 1994-01-01T00:00:00Z In this paper the costs and benefits associated with DNA-diagnosis of individuals who are at risk of a child with a monogenic disease and who seek genetic counselling because of their reproductive plans are predicted under various assumptions using a mathematical model. Four monogenic diseases have been considered: cystic fibrosis, Duchenne muscular dystrophy, myotonic dystrophy and fragile X syndrome. Counselling (triggered by prior information) on the basis of DNA-diagnosis is compared to the situation that only risk evaluation based on pedigree analysis is possible. The results show for each disease that with DNA-diagnosis couples can be more confident in choosing (further) offspring leading to the birth of more healthy children while the number of affected children is reduced. The costs minus savings within the health care sector depend on the prior risks and to the future burden of the monogenic illness considered. DNA-diagnosis of relative "low" prior risks of a child with CF (e.g. 1:180, 1:240 and 1:480) leads to costs in stead of savings. For higher prior risks of CF and for the three other diseases DNA-diagnosis induces considerable savings. This result remains valid when assumptions regarding behaviour regarding reproduction and receiving DNA-diagnosis under different circumstances are varied.