[Deterioration of endocrine ophthalmology after radioiodine therapy in Graves' disease?]. / Verschlechterung einer endokrinen Orbitopathie nach Radioiodtherapie bei M. Basedow?

AIM: Our goal was to show the development of EO in RITH and compare it with the outcome of surgery or thyreostatic therapy. METHODS: In this study 103 cases of an RITH at 82 patients were performed. The EO findings were measured before RITH and several times afterwards by the same experienced researcher according to the following criteria: 1. subjective complaints, 2. NOSPECS-classification, 3. exophthalmometry, 4. by photo. The observation period was at least 12 months. The measured dosage to the thyroid gland was on average 210 +/- 80 Gy. In 57 cases no EO and in 46 cases an EO of grades I to IV before therapy occurred. RESULTS: In 11 cases there was an improvement and in 8 cases a worsening of the EO. In 84 cases the EO findings remained unchanged. Our data pointed towards the fact that with an achieved dosage to the thyroid of less than 200 Gy, a pretherapeutic thyroid gland volume greater than 55 ml, or implementation of RITH with preexisting EO without accompaning cortison therapy can worsen the EO findings. CONCLUSION: In comparison to surgical or thyreostatic therapy there was no increased risk of EO during or subsequent to RITH under cortison.

[1,3,7-trimethylxanthine. Effects on circadian aqueous humor dynamics in probands]. / 1,3,7-Trimethylxanthin. Einfluss auf die zirkadiane Kammerwasserdynamik von Probanden.

Anterior chamber fluorophotometry (Fluorotron Master II, Coherent, Palo Alto, Calif.) was used to investigate the influence of 1,3,7-trimethylxanthin on the circadian rhythm of aqueous humor secretion in two age-, race- and sex-matched groups of healthy volunteers. In ten males and ten females (mean age 27 years), aqueous humor secretion was measured over 24 h at: 0800, 0900, 1000-1400, 1500, 1600-2000, 2100, 2200-0200, 0300, and 0400 hours. Flow was calculated using the Yablonsky protocol of Fluorotron Master II. In group I all volunteers received about 800 mg trimethylxanthin in the form of caffeinated coffee between 2200 and 2300 hours. In group II volunteers went to sleep at 2300 hours. Sleep was only interrupted for measurements. During the daytime the mean aqueous humor flow was the same in both groups (0800 to 2200 hours) (Student's t-test): Group I (n = 10) RA 2.27 +/- 0.70 microliters/min LA 2.25 +/- 0.74 microliters/min Group II (n = 10) RA 2.23 +/- 0.73 microliters/min LA 2.06 +/- 0.64 microliters/min During the night the mean aqueous humor flow decreased in both groups (0200 to 0400 hours): Group I: RA 1.99 +/- 0.74 microliters/min delta flow = -12% LA 1.93 +/- 0.75 microliters/min Group II: RA 0.97 +/- 0.50 microliters/min delta flow = -56% LA 0.97 +/- 0.48 microliters/min The difference between groups was statistically significant (P = 0.01, t-test for unpaired samples). There was no significant change in mean aqueous humor flow between the daytime vs night in group I (P < 0.5).(ABSTRACT TRUNCATED AT 250 WORDS)

[The future of medical technology assessment in Germany--five proposals for its development]. / Die Zukunft von Medical Technology Assessment in Deutschland. Uberlegungen zur Weiterentwicklung.

How progress in medicine will be financed in the future is an important issue internationally and in Germany. Medical Technology Assessment is an interdisciplinary concept that proposes solutions to this issue. This article deals with health political measures which should be taken to implement Medical Technology Assessment in the German health care system. Five proposals are developed: Establishing a coordinating and communication unit for Medical Technology Assessment. Intensifying the research into efficient health care. Increasing the use of Medical Technology Assessment in coverage decisions. Increasing consumer participation in coverage decisions. Establishing a competitive order for the use of expensive technology.

[Conception and conversion of medical technology assessment--an international comparison]. / Konzeption und Umsetzung des Medical Technology Assessment--ein internationaler Vergleich.

The outcome of adjusting health care spending to the overall economic performance of the country has become a major issue of health care policy of the industrialized nations. How can progress in medicine be consistently financed under the restriction of fixed contributions to mandatory sickness funds? Medical Technology Assessment is an interdisciplinary concept that proposes solutions to this issue. This article discusses the concept of Medical Technology Assessment and shows how Medical Technology Assessment should be implemented into the health care system. This article depicts how Medical Technology Assessment is implemented in the United States of America, in the United Kingdom and in the Netherlands. It also discusses which institutions take steps towards Medical Technology Assessment in Germany. The second article examines how to implement Medical Technology Assessment into the German health care system.

[Cost-benefit analysis of an evidence-based secondary prevention of coronary heart diseases by statins. An analysis for Germany from a social security perspective]. / Kosten-Nutzen-Analyse einer evidenzbasierten Sekundärprävention koronarer Herzkrankheiten durch Statine. Eine Analyse für Deutschland aus Perspektive der Sozialversicherung.

BACKGROUND: Lowering of the cholesterol level is of central importance in the prevention of coronary heart disease. Although the clinical benefits of treatment with statins have been shown in numerous studies, economic considerations are also being taken increasingly into account for the decision process about health care benefits. With this background, a cost-benefit analysis was carried out for statin treatment. METHODS: Based on a cost analysis for coronary heart disease carried out by the authors from a social security standpoint, the net prevention costs for secondary prevention in Germany were assessed. The ICD-9 codes 410-414 were assigned to coronary heart disease. In addition to the direct costs of treatment for coronary heart disease, loss of premiums for social security, savings on old age pensions, related pension claims and wage compensations over a time period of 10 years were also quantified in the cost analysis. Furthermore, prevention through medication for the 45- to 64-year-old coronary heart disease patients was considered. Costs for prevention were assessed on the basis of the mean dosages of all medications on the market according to the Rote Liste (German Formulary). A risk reduction of 30% was assumed and numerous univariate sensitivity analyses were carried out. RESULTS: Depending on which parameters were varied, there were pronounced differences in the results. The most favourable cost-benefit relation was achieved for the preventive measures in 400,000 patients with net prevention costs of 1.08 billion DM (2.16 billion DM for 800,000 patients) for a duration of medical preventive care of 5 years. The highest net prevention costs of 3.47 billion DM for 400,000 coronary heart disease patients (or 6.93 billion DM for 800,000 patients) resulted when maximum prices for statins were assumed. In the setting taken as base analysis, approximately 25% of the prevention costs are accounted for by cost saving through prevention. DISCUSSION: The transfer of clinical study results into clinical practice is associated with uncertainties which necessitate comprehensive sensitivity analyses. The costs of coronary heart disease were shown to be highly sensitive to the cost-benefit relationship. Although from an overall social security perspective, the direct costs of treatment and the loss of premiums were balanced by reduced expenditure (pension savings), coronary heart disease does lead to a financial burden on the social security. CONCLUSION: This financial burden is decreased by prevention of coronary heart disease. Part of the costs of statin therapy can be covered in every situation by cost savings through the avoidance of coronary heart disease. Even complex simulation models, that uses realistic assumptions, could only determine the costs of an evidence-based secondary prevention of coronary heart disease unprecisely, because the worst case and the best case vary with the factor 7.

The effect of isosorbide-mononitrate eye drops on the human intraocular pressure and aqueous humor dynamics.

In a randomized, double-masked, single drop study the effect of topical isosorbid-mononitrate (ISMO) 0.5% eye drops, the main metabolite of isosorbid-dinitrate, widely used in the treatment of coronary heart diseases, was studied in patients suffering from open angle glaucoma or ocular hypertension. There was no statistically significant IOP change within 8 hours posttreatment after topical administration of ISMO 0.5%. There were no side effects after application of the ophthalmic solution of ISMO 0.5%. There were no significant changes in blood pressure and pulse rate either. A 2% ophthalmic solution of ISMO was investigated with respect to a response on the aqueous humor dynamics in 10 healthy volunteers. Anterior chamber fluorophotometry revealed a mean increase in aqueous flow of 39% within 3 hours after topical application (P less than 0.01). However, in comparison to the placebo treated fellow eyes there were no statistical significant difference in aqueous humor flow during the time of investigation. There was a statistical significant reduction of IOP during the same time period (p less than 0.03) in all treated eyes.

Cost-effectiveness of primary and secondary prevention in cardiovascular diseases.

UNLABELLED: INTRODUCTION, AIMS, AND METHODS: Industrial countries' societies are challenged to counter the increasing costs of health care. The preponderance of cardiovascular diseases in middle-aged people demands new strategies to reduce the extremely high rates of early deaths and increased morbidity and thus to avert considerable costs. Prevention programmes are appropriate means to combine therapeutic needs with health economic goals. A review of techniques of economic evaluation is given, from which a critical appraisal of cost-effectiveness analyses in primary and secondary prevention with HMG-CoA reductase inhibitors in coronary heart disease follows. Our own analysis of cost-effectiveness of primary prevention based on the clinical results of the WOSCOP study is also presented. RESULTS AND CONCLUSIONS: Long-term treatment with HMG-CoA reductase inhibitors is effective (30% mortality reduction), safe and tolerable. With a cost-effectiveness ratio of DM15,000-25,000/life-year saved ($9000-15,000) it can be recommended for secondary prevention. The application of statins in primary prevention has also proved to be clinically effective. But with a cost-effectiveness ratio of DM330,000/life-year saved ($195,000) they cannot be generally advocated in patients with hypercholesterolaemia. However, the treatment has to be considered for high risk patients. Aspirin prevention seems to be an alternative in patients without additional risk factors.

[Costs of coronary heart diseases over the remaining life time in coronary heart disease cases--an analysis of the current status of coronary heart disease cases in Germany from the social perspective]. / Kosten koronarer Herzkrankheiten über die verbleibende Lebenszeit von KHK-Fällen--Eine Analyse des aktuellen Bestandes an KHK-Fällen in Deutschland aus gesellschaftlicher Perspektive.

UNLABELLED: Cardiovascular diseases are the major cause of death not only in Germany. Coronary heart diseases result in substantial disability and loss of productivity and contribute to escalating costs of health care. OBJECTIVE: It was our objective to estimate the costs of CHD for the German population from the perspective of the society. The characteristic of this approach is the calculating of costs until the approximated end of life. METHODS: In the study, all health care costs concerning CHD in Germany were allocated to age, sex, health care sector and primary diagnosis on the basis of comprehensive data on morbidity, mortality, direct and indirect costs. For the estimate of indirect costs the human capital approach was taken. Considered as cases were all patients hospitalized in the reference year (1996). The costs of this cohort in 1996 and up to their protected end of life were estimated. It was taken into account that, in comparison to the general population, life expectancy of cases with risk factors or CHD would have been reduced. In calculating indirect costs, gender and age specific unemployment rates were considered. All future costs were discounted by 4% from the reference year onward. RESULTS: Direct costs are approximately 39 billion DM discounted at 4%, indirect costs total 73 billion DM. The average cost per case (including morbidity and mortality) until the approximated end of life is nearly 125,000 DM. CONCLUSION: In our cost analysis, the indirect costs are higher than the direct costs. For the future, it will be important to estimate the costs of prevalent cases until the end of life and to compare the influence of different interventions on these parameters and on the whole budget of the social security system.

[Coronary disease and social security. A simulation model on cost analysis]. / Die koronare Herzkrankheit und die Sozialversicherung. Ein Simulationsmodell zur Kostenanalyse.

A Monte Carlo simulation model is presented which allows an assessment of the costs for coronary heart disease (CHD) (from a social security perspective) to be made over a time interval of 10 years. The difference between a CHD population and a normal population is calculated whereby the CHD population corresponds in terms of age and gender distribution to a German population with existing hypercholesteremia. The data were generated from the results of the German Cardiovascular Prevention Trial (DHP), a population was determined which represents the age group of the 45- to 65-year-old German population. Both direct as well as indirect costs were taken into account. The model simulates 2 submodels: 1. CHD is already present in the observed population. 2. A proportion of the observed cases of hypercholesteremia develop CHD over a time interval of 10 years, whereby normal distribution of the events is assumed. From the social security perspective, the cumulative costs of CHD for the observed age group who already have CHD amount to approximately 59 billion DM in 10 years (see Table 4). On the assumption that CHD develops during the course of these 10 years and that the population does not already present with CHD at the start of the simulation model, the costs are calculated to be about 41 billion DM (see Table 3). Numerous sensitivity analyses were carried out which showed that the assumption of the direct costs per case/year were highly sensitive (see Figure 1). The special advantage of the model is the perspective chosen, since social security is considered as a whole and interactions between individual branches of social security become transparent.

[Coronary intervention and occupational rehabilitation--a prospective, randomized intervention study]. / Koronarintervention und berufliche Reintegration--Eine prospektive, randomisierte Interventionsstudie (KIRL).

Coronary catheter revascularisation is less costly than bypass surgery due to lower direct (medical) and indirect costs (loss of work). Many studies show that the time patients stay out of work following coronary intervention is much longer than necessary. This leads to a considerable increase of indirect costs, which can far exceed the medical costs of the treatment. This prospective randomised study was done to determine whether specific information to patient and family doctor results in an earlier return to work. After catheter revascularisation 100 working patients (mean age 52.4 years) were randomised either to the intervention group (information to patient and family doctor) or to the control group (no specific information about return to work). Four months later 81 patients had returned to their previous jobs (mean sick leave 18.9 +/- 24.8 days) while 19 were still out of work. In the control group, the rate was 79% and the mean sick leave was 16.4 +/- 22.0 days (median 7); in the intervention group 83% had returned to work after a mean of 21.5 +/- 27.4 days (median 10). There was no significant difference between the two groups, neither according to the rate of returned workers nor to the duration of sick leave. In the subgroup of patients with a private insurance (23% of all) 96% started to work again (mean sick leave 5.7 +/- 5.1 days median 3.5), while the rate was 77% in the group of panel patients (mean sick leave 23.7 +/- 27.4 days, median 11). The difference in sick leave between these two groups was highly significant (p = 0.0003). Specific information to the patient and family doctor has no effect on the time patients stay out of work following catheter revascularisation. It seems that the observed delay depends on social and psychological factors that cannot be influenced directly.