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Biomedical subjects

W Gaus

Publications and source records attributed to W Gaus.

At least 19 recordsLinked to original sources

Structured reporting of medical findings: evaluation of a system in gastroenterology.

A system using structured reporting of findings was developed for the preparation of medical reports and for clinical documentation purposes in upper abdominal sonography, and evaluated in the course of routine use. The evaluation focussed on the following parameters: completeness and correctness of the entered data, the proportion of free text, the validity and objectivity of the documentation, user acceptance, and time required. The completeness in the case of two clinically relevant parameters could be compared with an already existing database containing freely dictated reports. The results confirmed the hypothesis that, for the description of results of a technical examination, structured data reporting is a viable alternative to free-text dictation. For the application evaluated, there is even evidence of the superiority of a structured approach. The system can be put to use in related areas of application.

Attitude to Computers

Recommendations of the German Association for Medical Informatics, Biometry and Epidemiology for education and training in medical informatics.

In the fields of health care and medicine there is an immense demand for a systematic application of methods of information processing and for the use of computers. Obviously, to that end well-trained scientists and qualified personnel must be available. With the present recommendations on education and training in medical informatics the German Association for Medical Informatics, Biometry and Epidemiology (GMDS) proposes structure and contents of medical informatics curricula and courses. The recommendations describe a 2-dimensional educational framework with different education levels in one dimension and various types of educational needs and orientation in the other one. The recommendations comprise at the university level education as well specialized curricula covering the total spectrum of medical informatics as well as informatics curricula with medical informatics as integrated applied subject or subsidiary subject, respectively. Besides these informatics-oriented approaches medical-oriented programs of education in medical informatics are recommended, e.g., post-graduate education in medical informatics for physicians based on foundations in medical informatics as part of their initial training in medicine. At the level of polytechnical schools curricula of medical documentation and informatics and at the level of professional schools training in medical documentation are recommended. This report is a translation of its German original. Although considered by the GMDS as recommendations for the Federal Republic of Germany, the text may also contribute to the development of an international, especially European framework of training in medical informatics.

Germany

Balanced designs for multiple crossover studies.

Experimental situations are considered, in which t different treatments are administered to n cases (volunteers, patients, animals etc.) during p periods (p less than or equal to t) in a way that each of these cases receives p different treatments in sequence (crossover designs). In order to minimize the influence of carry-over effects the designs of the trials are constructed with regard to three conditions of balance: (a) Each case receives the same number of treatments, (b) each treatment is applied the same number of times in each period, and (c) each possible transition between two consecutive periods appears the same number of times during the experiment. The minimal numbers of cases are given for complete (p = t) and incomplete (p less than t) designs balanced according to all the above mentioned conditions. Furthermore, the designs themselves (plans of the experiments) are also listed for the minimal number of cases for 2 less than or equal to p less than or equal to t less than or equal to 10.

Clinical Trials as Topic

[HIV study of German Red Cross blood banks in Germany and Berlin].

In the HIV study of the German Red Cross blood banks the overall rate has remained constantly low, with less than two Western blot positive donors in 100,000 donors since 1987. However, the rate of HIV positivity tends to increase in male first time and in male repeat blood donors. Despite this fact, the overall rate stays constant since the number of young first time donors has decreased with increasing donations by women. Therefore the blood banks once again have to take newly intensified but also sophisticated measures to guarantee further as well a sufficient number of blood products as their HIV safety.

Berlin

Prevention of infection in acute leukemia.

In a randomized study comparing cotrimoxazole plus colistin with ciprofloxacin, each in combination with nonabsorbable antimycotics, the incidence of major infections in terms of septicemias and pneumonias as well as of minor infections and episodes of unexplained fever (FUO) was higher in patients treated with ciprofloxacin. In cases of microbiologically documented infections, gram-positive cocci dominated by far. In surveillance cultures of oral washings and of feces, gram-negative enterobacteria were only rarely detected; however, large numbers of cultures were positive for Acinetobacter species. There were four cases of documented Pneumocystis carinii pneumonia in patients not receiving cotrimoxazole. The incidence of documented mycotic infections as well as the detection of fungi in surveillance cultures was similar in both treatment groups. A decrease in the number of adverse events, especially of allergic reactions, could not be achieved by the administration of ciprofloxacin. In conclusion, cotrimoxazole plus colistin in combination with nonabsorbable antimycotics remains the standard regimen for prevention of infection in patients with acute leukemia undergoing aggressive remission induction therapy. A detailed analysis of study II will be prepared for publication.

Acute Disease

[Current data on the prevalence and epidemiology of HIV from the HIV study by the German Red Cross of West Germany].

From the multicenter study of the Red Cross Blood Banks in the FRG HIV-antibody prevalences and incidences are documented since July 1985. Constantly low prevalences and incidences since 1987 of less than 2 Western blot (Wb)-positive donors and less than 1 Wb-positive donor per 100,000 donors respectively confirm our estimate of the rest risk of an HIV-infection by blood products of 1:500,000 to 1:3 million donations. In the epidemiologic details there seems to be a trend to an increase of the incidence in male repeat blood donors. The modes of HIV-infection in blood donors have changed to an increasing number of infections acquired in heterosexual contacts to persons at risk.

AIDS Serodiagnosis

[Regional chemotherapy of liver metastases in colorectal carcinoma. Intra-arterial vs intravenous plus intra-arterial therapy].

Regional chemotherapy with floxuridine was undertaken in 50 patients (32 men and 18 women, mean age 57 years) with colorectal carcinoma with metastases only to the liver. In 25 patients (group I) the drug (0.2 mg/kg) was administered exclusively intraarterially into the hepatic artery, while in the remaining 25 (group II) it was given both intraarterially (0.21 mg/kg) and intravenously (0.09 mg/kg) via the inferior vena cava. The remission rate in group I was 56% (14 of 25), in group II it was 64% (16 of 25). It was subsequently discovered that 4 of the 25 in group II already had extrahepatic metastases at the time of implantation of the infusion catheter. The difference in remission rate between the two groups is not significant. Extrahepatic tumour recurrence occurred after a median period of 16 months in 17 patients of group I (68%) and six of 21 of group II (29%, P less than 0.01). Over an observation period of 34 months the survival rates of the two groups were not significantly different. However, these results suggest that over a longer period a higher survival rate is to be expected for the intraarterially plus intravenously treated group.

Adult

Regional chemotherapy for hepatic metastases of colorectal carcinoma (continuous intraarterial versus continuous intraarterial/intravenous therapy). Results of a controlled clinical trial.

Sixty-four patients with a biopsy diagnosis of colorectal cancer with liver metastases were treated with 5-fluorodeoxyuridine (FUDR) infusions. In a pilot study, the first 20 patients were given hepatic artery infusions of FUDR by implanted pumps. The remaining 44 patients were then randomized prospectively to compare the effectiveness of continuous hepatic artery and intravenous infusion of FUDR (IA/IV group; 21 patients) with hepatic artery infusion alone (IA group; 23 patients). A continuous 14-day infusion regimen of FUDR was applied each month. The dosage was 0.2 mg/kg/d of FUDR for the IA group and 0.3 mg/kg/d for the IA/IV group. The complete and partial response rates were each 50% in the pilot study and 52% and 48% in the IA and IA/IV randomized groups, respectively. Drug toxicities in the 64 patients included gastroenteritis (21%), chemical hepatitis (57%), and biliary sclerosis (25%). There was no difference in the toxicity of FUDR in the two randomized groups (P greater than 0.1). Extrahepatic spread of cancer during therapy was found in 61% (n = 14) of the IA group and 33% (n = 7) of the IA/IV group. There was no difference in survival between the randomized groups. The 64 patients were categorized into the following two groups according to their response to therapy: (1) responders (patients with complete or partial remission [n = 32]) or nonresponders (patients with stable disease or progression of metastases [n = 32]). The median survival time was 31 months for responders and 16 months for nonresponders (P less than 0.0001). Intraarterial FUDR infusion provided control of liver metastases. The combination of intraarterial and intravenous therapy seemed to prevent extrahepatic spread during therapy in most of the patients. Survival appeared to be significantly prolonged in patients with a regression of metastases.

Adenocarcinoma

[Reversible germ cell toxicity following aggressive chemotherapy in patients with testicular tumors: results of a prospective study].

The impact of aggressive chemotherapy on reproductive and endocrine gonadal function was prospectively studied in 44 patients with germ cell tumors. Diagnostic procedures to determine gonadal toxicity consisted of hormone determinations, semen analyses, interviews with a standardized questionnaire, and gonadal histology. After chemotherapy all patients showed elevated serum levels of follicle-stimulating hormone (FSH) and azoospermia due to germ cell and stem cell loss. Recovery of spermatogenesis, as indicated by normalization of serum FSH levels and sperm density, occurred in 77% of the patients 25-60 months after cessation of chemotherapy. In all patients serum testosterone and luteinizing hormone (LH) values remained within normal limits after therapy indicating resistance of Leydig cells to cytotoxic drugs. Three patients fathered four healthy children after completion of chemotherapy. These data suggest significant reproductive dysfunction in all men treated for germ cell tumors. However, most patients showed late and complete recovery of spermatogenesis. In contrast, endocrine gonadal function was unaffected after chemotherapy in all patients. FSH and LH are feasible markers to assess drug-induced gonadal toxicity.

Adolescent

[Efficiency of homeopathic preparation combinations in sinusitis. Results of a randomized double blind study with general practitioners].

In a controlled randomized double-blind trial carried out by 47 physicians in private practice with totally 152 patients with sinusitis the therapeutic success of the following homeopathic drug preparations was investigated: Group A: combination of luffa operculata D4, kalium bicromicum D4 and cinnabaris D3. Group B: combination of kalium bicromicum D4 and cinnabaris D3. Group C: luffa operculata D4. Group D: placebo. Criteria for the therapeutic result were headache, blocked nasal breathing, trigeminal tenderness, reddening and swelling of nasal mucosa and postnasal secretion. There was no remarkable difference in the therapeutic success among the investigated homeopathic drug combinations nor between the active drugs and placebo. Averaged over all four groups 81% of the patients with acute sinusitis and 67% of the patients with chronic sinusitis recovered. In the literature comparable therapeutic results are reported for antibiotic therapy, decongestant nose drops and for the drainage of nasal cavities.

Adult

[Prevention of cystoid macular edema with diclofenac eyedrops in intracapsular cataract extraction using the Choyce Mark IX anterior chamber lens].

Diclofenac is superior to other nonsteroid anti-inflammatory drugs (NAD) with respect to its antiphlogistic properties, as demonstrated in laboratory animal experiments. The antiphlogistic action of diclofenac eyedrops versus placebo eyedrops in the prophylaxis of cystoid macular edema (CME) and postoperative inflammatory symptoms was therefore tested in a prospective randomized double-blind study. A total of 179 patients with intracapsular cataract operations and Choyce Mark IX anterior chamber lens implantation received 2 drops 5 times preoperatively and 1 drop 5 times postoperatively until they were discharged, and then subsequently for 6 months they used 1 drop of diclofenac or placebo eyedrops 3 times. To evaluate the CME, fluorescence angiography was carried out on all patients on the day of discharge, 6 weeks later, and after 6 months following the operation. The patients who completed the study according to plan numbered 112. With diclofenac eyedrops, significantly less CME occurred in comparison with treatment with placebo eyedrops (p = 0.03). Visual acuity improved faster and the postoperative inflammatory symptoms receded more quickly in the diclofenac group.

Aged

[Operation documentation. A program for the detection and statistical documentary evaluation of surgery reports].

A computer program specifically designed for surgical data retrieval was tested for longer than one year. By using the information contained in operation reports, with this program statistical analysis may be achieved. The reports are generated and printed using a personal computer running MS-DOS. Entering data does not cause any additional effort for the secretary. The selection of requested data is possible with any combination of criteria, and the resultant information is displayed on the computer terminal screen or printed on the computer printer. A combination of terms is used instead of a numeric code for data entry allowing far greater selectivity, with a reduced risk of data loss due to wrong numeric code entry.

Data Display

[Transfusion hepatitis. Occurrence and comparison of risks of blood transfusion and surgery].

The incidence of hepatitis (B and non-A, non-B) was determined in a prospective multicentre study of 1100 hospital patients during 12 months without or after surgery and with or without transfusion. The incidence was 3.6% (4 of 111 patients) after surgery and transfusion, and 0.5% (5 of 989) without transfusion - with or without surgery. The incidence of hepatitis B was significantly higher in the transfused group, while non-A, non-B hepatitis had the same incidence in all three groups. Hepatitis was clinically manifest in only three of the nine patients. The remaining six silent ones were uncovered by a careful prospective follow-up plan. Thus the incidence of hepatitis in this study was higher than has been reported in retrospective series. However, the absolute number of cases is small and the confidence limits thus rather wide: the incidence of non-A, non-B hepatitis must be interpreted with caution.

Adolescent

[Epidemiology of HIV in blood donors in West Germany].

Of a total of 5.6 million blood donations by 1.6 million German Red Cross donors between July, 1985 and December, 1987 tested for HIV antibodies 210 were found to be positive in at least one Western blot. Calculated per quarter, the prevalence (for first-time donors) of 10 per 100,000 in 1985 decreased to 4 per 100,000 in 1986, while the incidence (for multiple donors) was a constant 2 per 100,000 for each quarter in 1987. This indicates that new HIV infections were rare in blood donors and there was no exponential increase. Further analysis revealed that over 90% of those with confirmed Western blot positive results were members of risk groups or their direct contacts. The age and sex distribution conformed to the known pattern for AIDS cases in the Federal Republic of Germany. The data demonstrate that there is at present no indication of a rapid spread of HIV infections transmitted heterosexually among blood donors.

Acquired Immunodeficiency Syndrome

Results of a multicenter placebo-controlled double-blind randomized phase III clinical study of treatment of rheumatoid arthritis with recombinant interferon-gamma.

In a multicenter placebo-controlled double-blind randomized clinical study, 91 patients with rheumatoid arthritis were given 28 days' treatment with recombinant interferon-gamma (50 micrograms daily for 20 days, then 50 micrograms each second day up to day 28, given by subcutaneous injection). The aim of the study was to provide a methodologically clear demonstration of the efficacy of treatment with interferon-gamma, using criteria that could be handled by statistical tests. Evaluatable documentation was available for 79 patients, of whom 40 were treated with the active compound. The principal criterion for the statistical evaluation of the therapeutic success was improvement of the Ritchie "joint pain index" or Lansbury "joint pain index" by at least 30% within 28 days. The chi-square test showed superiority of the interferon arm over the placebo arm with an error probability of alpha less than 1%. In addition, efficacy of interferon-gamma was demonstrated in respect of practically all parameters investigated. The frequency of side-effects, including febrile reactions, was the same for the active compound and the placebo. During interferon treatment the daily maximum body temperature was raised by 0.3 degrees C on average, but was below 37.2 degrees C at all times.

Adolescent

[Ulrich and Ulrich oculo-oscillodynamography: results in patients with healthy eyes].

Ulrich and Ulrich's method of oculo-oscillodynamography (OODG) is a relatively new method which enables the systolic retinal, systolic ciliary, and systolic ocular perfusion pressure or respectively blood pressure to be measured. The results obtained by the present authors are in good agreement with those of Ulrich and Ulrich (n = 30). The intraocular pressure values obtained with this method correlate somewhat less well with the systemic blood pressure than is the case with suction cup ophthalmodynamometry. However, the correlation coefficients are sufficiently high to permit their application in ophthalmological diagnosis. The results presented here indicate that the diastolic ocular pressure should be determined by applying the formoscillatory criterion. The positive intercept in the regression equations can be explained by the assumption that the regression is curvilinear at systemic blood pressure values which are generally not encountered in humans in whom OODG is of diagnostic importance. It is suggested that the linear regression is a sufficiently exact model at the systemic blood pressures most frequently measured. Normal OODG values can be read off easily from the diagrams published here.

Adult

[Quantitative assessment of the clinical electroretinogram].

The clinical application of electroretinography has been limited until now by the lack of standardisation, especially of stimulus conditions. Normal values for the electroretinographic response parameters can only be used if patients are examined under the conditions which were given for the examination of healthy subjects. It is shown in this paper that the inexpensive apparatus designed by Kooijman and Damhof (1981) can be calibrated by any user simply and at justifiable expense. Normal values for the amplitudes and peak times for the a- and b-wave are presented. The normal range of the values has been defined with regard to the frequency distribution. According to the authors' results, methods of descriptive statistics in skewed distributions are mainly necessary at low stimulus intensities. The descriptive methods for normal distributions were regularly applied at higher stimulus intensities. In general, however, ERG parameters are normally distributed as shown by the distribution of the residuals between the linear regression of the parameter to the logarithm of the corneal illuminance and the measured values. The influence of age on the amplitude was calculated according to the results of Lehnert and Wünsche (1966) and the lower limits of the normal range are given for four age groups. The data presented here may be used as normal values provided that the simple calibration methods are applied. Thus electroretinography is no longer a method merely for the laboratory, but can be used in clinics and offices as well. However, a prerequisite is that the physician has sufficient experience in ophthalmological electrophysiology.

Adult