[Quo vadis quality assurance?].
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Biomedical subjects
Publications and source records attributed to H K Selbmann.
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The efforts to measure the quality of medical activities have been described in the literature a great many times. In this respect, high blood pressure, urinary tract infections and cholecystectomy are great health problems which are most frequently the objects of the investigations. This is also to be seen in the choice of the qualitative measurements used. Whereas adaptable procedures to measure the quality of processes seem to be available, the search for suitable process-specific result measures is far from being concluded. But approximations can be made use of. Finally the quality of medical activities need not be measured exactly in order to be able to assure quality.
Patients treated for gynaecological cancer by combined external irradiation and intravaginal radium application participated in two randomized, controlled, and prospective trials. In the first trial the incidence of deep vein thrombosis (DVT) diagnosed by the 125I-fibrinogen test was 43% in the control group. The injection of 7,500 i.u. of subcutaneous calcium heparin twice daily prevented DVT in the test group. An increase of soluble fibrin monomer complexes (SFMC) and fibrinogen in the plasma of patients with DVT suggested that the patients were hypercoagulable. No correlation between AT III values and DVT was observed. In the second trial, the effect of the same dose of heparin was compared with a twice daily s.c. injection of 5,000 U of a semi-synthetic heparin analogue (SSHA). The incidence of DVT was reduced to 15% by heparin; in the patients given SSHA the incidence was 25%, which was not significantly different from the heparin-treated group.
Endotoxemia in dogs was induced by a slow intravenous infusion of E. coli endotoxin for 2 h. Thereby, a significant decrease was observed in the plasma levels of several clotting, fibrinolysis and complement factors. The changes were studied over an experimental period of 14 h and checked for statistical significance by three-way analysis of variance. Application of the broad-spectrum proteinase inhibitor aprotinin (Trasylol) from bovine organs clearly lowered the endotoxin-induced decline of the plasma proteins studied. By intravenous application of a specific granulocytic proteinase inhibitor (Bowman-Birk inhibitor from soybeans), the endotoxin-induced reduction of the plasma proteins was prevented in a similar manner. It can be concluded that at least some of the pathobiochemical mechanisms observed in clotting, fibrinolysis and complement systems during endotoxemia are not only caused by a severe consumption reaction but also by unspecific proteolytic degradation due to neutral granulocytic proteinases.
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Histological grading from I--III was carried out for 22 osteosarcomas. There was a positive correlation between higher histological grade of differentiation and higher rate of 2-years-survival. The death rate was 3,7 times higher for osteosarcomas of grade III than for grade I and II tumors. However, no significant differences as to prognosis and age of the patients, localization of tumor metastases, various stages and kind of therapy became evident. In spite of distinct regional differences, as subclassification according to 6 subtypes proposed by Scranton et al. (1975) was possible in all our cases. Statistically significant correlations between these subtypes of osteosarcoma and differences in survival time could not be found, neither for our own limited material, nor for the combined material, including the cases of Scranton et al.
In the Munich area from 1975 to 1977 37.3% of 55089 women came to birth without any risk, 7.4% with anamnestic risks (i.e. existing before pregnancy), 12.1% with gestational risks acquired during pregnancy, 4,0% with anamnestic and gestational risks. In 17,0% risks were developed at first during delivery. 4.0% of the pregnant women had anamnestic and birth risks, 12.6% gestational and birth risks, and 5.5% anamnestic and gestational and birth risks. There were remarkable interrelationships between the combination of risks, obstetrical management and outcome (perinatal mortality and infant transferral rate as a crude measure of neonatal morbidity). Anamnestic risks are followed by gestational risks with a chance of 50%. If pregnancy began without risks the probability of gestational risks is approximately 33%. Some distinct anamnestic risks considerably contribute to cesarean section rate. Risks solely occurring during pregnancy have a rather low perinatal mortality (6%o compared to 2%o of riskfree pregnancies). The combination of gestational and birth risks increases perinatal mortality and neonatal morbidity by a factor of 10. This increase is due to some "mortgage-risks", i.e. impairments which are still present at birth. Among those risks conditions most often associated with threatening preterm delivery predominate. Pregnant women who develop such persisting risks should be transferred to a perinatal center.
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Statistically evaluating the influence of a histological grading, respectively of morphological differences on prognosis of nephroblastomas and neuroblastomas, better chances for survival become evident not only for earlier clinical stages, but also for nephroblastomas with high differentiation, or neuroblastomas with signs for differentiation. Only for neuroblastomas a relevant predeliction of tumors with signs of differentiation for the early clinical stage I is present. Combined subclassification according to clinical stages and histological grades results in 3 risk groups with different chances for survival. These 3 groups may play a role for specific therapeutic considerations.
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Quality control has four component parts: standardized observation, a procedure to measure the quality of individual production, a technique for aggregating and comparing measurements, and a means by which the behaviour of the subjects can be influenced by these comparisons. The greatest problems, which often remain unsolved, can be traced to the definition and measurement of the quality of medical care. Some problems and the feasibility of quality control are demonstrated using perinatalogy and the Munich Perinatal Study as models. This trial of self control shows that voluntary participation of the hospitals, assured anonymity, self-responsibility, and a statistical evaluation that can be used for educational purposes play an important part.
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Multicenter or cooperative trials should be initially evaluated for efficacy using criteria that in some way measure the degree to which the various centers are coordinated. The fundamental limitations of these studies can be traced to the inadequacy of coordination among the centers taking part in the trial. Whereas the structural homogeneity of the patient groups can be achieved by stratification and randomization within the centers, the organisational effort to prevent observer variation between centers is often underestimated. In this case the selection of the centers has a great bearing. More specifically their representativeness plays an important part in the interpretation of the apparent differences between the centers.
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From 1970 to 1972, there were 216 perinatal deaths among 5595 newborns at the I. Frauenklinik der Universität München. 54 of these deaths were children of foreign workers (so-called "Gastarbeiter"). The data have been processed on punch cards and analysed by a computer. The differences noted underwent significance testing by the CHI-Quadrat test. Only statistical significant results are published. The perinatal mortality in the above period shows no difference between foreign and German ward patients. There is, however, a significant lower perinatal mortality in private patients. We feel that this difference is due to a significant lower rate of prematures in the private patient group. The cocial status as well as higher interest and motivation in health resulting in better prenatal care are discussed as causal reasons for this fact.