[Placebo-surgery between "efficacy" and "evidence"].
Explore the source record for details and available documents.
Clinical Trials as Topic↗
Biomedical subjects
F Porzsolt
Publications and source records attributed to F Porzsolt.
[Guidelines from the viewpoint of clinical economics].
In an experiment that compared the quality of medical guidelines in German cancer centers we were able to demonstrate that the selection of guidelines was not based on common criteria. These decisions were frequently based on personal preferences rather than on scientific evidence. We should consider that the scientific quality of clinical publications is easily assessed by simple methods in two dimensions, effectiveness and efficiency. This subsequently led to three conclusions: Clinical epidemiology/evidence-based medicine should be integrated into medical education. Interdisciplinary co-operation to create "common criteria for guidelines" should be supported. Politicians have the responsibility to provide the legal framework in order to ensure self administration in health care.
Cancer Care Facilities↗
[Implementing evidence-based medicine: what effects are measurable?].
Evidence-based medicine (EBM) was proposed as a possible method of solving two of health care's present problems: the increasing flood of information and rising expenditures. Although this concept appears to be plausible, the measurable improvements in health care brought about by possible implementation of EBM should be explicitly described. After having demonstrated the present problems as well as the necessity to solve them, we described the goals intended to be achieved by the implementation of EBM. Furthermore, the impact of EBM on medical education was described. The possible influence of EBM on the effectiveness and efficiency of health care was also considered. The conflicts caused by the introduction of EBM were demonstrated using the example of the "German Guideline Discussion". Finally, three proposals were made; the integration of EBM into education, the avoiding of conflicts similar to the German Guideline Discussion and the need to alter the political framework accompanying these processes.
Cost Control↗
[Differences between evidence based-medicine and best conventional medicine].
The practical application of rational concepts will be possible in the health care system if two conditions will be met. The legal framework has to fit these goals and new strategies are to establish. The new strategies will be needed to identify from the huge amount of data "evidence" which will support the medical progress. Evidence-Based Medicine (EBM) offers these strategies. Modifications of our conventional procedures are necessary to establish EBM: the conditions of clinical actions, the definitions of goals of medical training, the rational of clinical decisions and the continued medical education.
Cost-Benefit Analysis↗
[Physicians' attitude in the treatment of incompetent patients. Comparison between East and West Germany].
BACKGROUND: Health care decision-making in incompetent severely ill patients presents a number of difficult medical, ethical and legal problems for the physician. The factors and the degree to which various factors contribute to such decisions have rarely been investigated. SUBJECTS AND METHODS: 310 physicians from the state of Baden-Württernberg (Western Germany) and the state of Mecklenburg (eastern Germany) were asked by means of a questionnaire to rate the importance of eight factors in their health care decisions in the elderly. RESULTS: Both, ethical concerns and patients' wishes emerged as the most important factors for decisions in both subsamples. However, significant differences in the degree to which the factors hospital costs, patients' and family wishes, the level of dementia and the patients' age contribute to their decisions could be found between the answers of the doctors of the two lands. CONCLUSIONS: The socialization of the physicians in different health care and social systems seems to be one of the most important reasons for different health care decisions in old and incompetent patients.
Adult↗
[Evidence-based medicine].
New instruments are required to allocate the available resources to services which are not only effective but also beneficial to the patients. These instruments are needed to manage the huge amount of new information in medicine and to appraise its quality. Evidence-based medicine (EBM) provides these instruments to find the relevant literature, to appraise its quality and to merge it with the user's clinical experience. EBM is different from "conventionally best medicine (CMB)" of four levels; conditions of clinical action, teaching goals, medicine at the patient, and goals of continued medical education. We can increase our chances to benefit from medical progress if we use these new instruments.
Cost-Benefit Analysis↗
Treatment decisions in palliative cancer care: patients' preferences for involvement and doctors' knowledge about it.
The aim of this study was to evaluate the extent to which hospitalised patients with advanced cancer and a palliative treatment goal wanted to be involved in the process of making treatment decisions and how well their physicians actually knew their preferences for participation. 59 hospitalised patients with non-curable cancer, 86 hospitalised patients with chronic non-neoplastic disease, and 115 non-hospitalised persons were surveyed with a standardised questionnaire. In addition, the physicians of the hospitalised patients were asked to complete a similar questionnaire. The majority of patients with advanced cancer wanted to decide either by themselves/mainly by themselves (9%) or to collaborate and decide together with their physician (73%), compared with 17% and 49%, respectively, of patients with chronic non-neoplastic disease, and 40% and 56%, respectively, of the non-hospitalised persons (difference between groups: P = 0.001). Younger age, higher education, employment and higher Karnofsky index were significantly associated with active involvement. The agreement of patients' preference with their physicians' assessment did not exceed chance. In conclusion, most patients wanted to participate in a decision regarding their treatment, although physicians were unaware of their patients' preferences.
Adult↗
Quality of life in oncology practice: prognostic value of EORTC QLQ-C30 scores in patients with advanced malignancy.
Quality of life (QL) scores may be used to assess the impact of disease and treatment, and to predict survival of cancer patients in prospective clinical trials. The aim of this study was to evaluate the prognostic association of QL scores among patients with advanced malignancies in routine practice. Adult patients with advanced malignancy from 12 institutions in 10 countries completed the EORTC QLQ-C30 questionnaire, in their native language, once at study entry. Baseline patient and disease characteristics were recorded. We used a proportional hazards model stratified on diagnostic category to test whether QL scores from the QLQ-C30 were significantly and independently predictive of overall survival duration from the time of QL measurement. In all, 735 eligible patients were entered between November 1989 and September 1995. On 1 October 1995, follow-up information was obtained on 656 patients, of whom 411 had died. Patient and disease factors predictive of worse survival were age and performance status. The global scale and the scales of physical, role, emotional, cognitive and social function were each significantly predictive of subsequent survival duration in univariate analyses. Single-item QL scores for overall physical condition (question 29), overall quality of life (question 30), and the global and social functioning scales remained independently prognostic after allowing for performance status and age, and, among solid tumour patients, metastatic site. QL can be measured in an international setting based on routine oncology practice. QL scores carry prognostic information independent of other recorded factors.
Age Factors↗
Polymorphism of the tumour necrosis factor-alpha and lymphotoxin-alpha genes in hairy cell leukaemia.
Hairy cell leukaemia (HCL) is a rare chronic B lymphoproliferative disorder which can lead to severe pancytopenia and several immunologic abnormalities. The pathogenetic role of tumour necrosis factor (TNF)-alpha in HCL prompted us to study the potential contribution of functionally important genetic polymorphisms of the TNF gene cluster in a large group of patients with HCL. The TNF-alpha (-308 bp) promoter/enhancer point mutation and two polymorphisms located within the first intron of the lymphotoxin (LT)-alpha gene showed neither significant allelic deviation for the patient group nor, after analysis of clinical characteristics such as blood counts, stable or progressive disease or response to therapy.
Adult↗
Polymorphism of the tumour necrosis factor-alpha and lymphotoxin-alpha genes in chronic lymphocytic leukaemia.
The neoplastic cells of CLL are able to produce TNF which is known to stimulate the proliferation of CLL cells in an autocrine and paracrine manner. Genetic polymorphism of molecules of the TNF ligand superfamily has been described and certain alleles were suspected to predispose to variant biological responses. Previously, the rare allele TNFB*1 of the TNF-beta/lymphotoxin (LT)-alpha gene (NcoI, asparagine at amino acid position 26) was found to be associated with a stronger LT-alpha response of PBMC in vitro. We now report on a significant increase of the allele TNF1 (TNFA -308 G) of the TNF-alpha promoter/enhancer polymorphism in a group of 73 CLL patients when compared to healthy individuals (RR = 3.18, 95% confidence interval 1.57-8.3; P = 0.006). The allelic distribution of the TNF-beta/LT-alpha NcoI polymorphism did not differ significantly from randomized healthy controls. On the other hand, the frequency of the allele TNFB*2 was increased in CLL patients with advanced clinical stage (P = 0.004). These findings indicate immunogenetic associations involving polymorphisms of cytokine genes serving as paracrine and autocrine growth factors, which thus can contribute to the pathogenesis of the TNF/LT-sensitive haematological malignancy CLL.
Adult↗
[Clinical economics--a guideline for economic management in the clinic and general practice].
Explore the source record for details and available documents.
Cost-Benefit Analysis↗
Quality assurance by specification and achievement of goals in palliative cancer treatment.
As the goals of palliative cancer treatments have not always been clearly specified, this paper describes how frequently the goals of palliative cancer treatment can be specified according to a given definition and how frequently those specified goals can be achieved. The clinical problems of 171 cancer patients were discussed in the Interdisciplinary Oncologic Conference (IOC) of the Cancer Centre University of Ulm (CCUU) and recommendations concerning further diagnostic treatments and/or therapy were provided. These recommendations had been documented and analysed retrospectively. The goals were classified as either cure or palliation or further investigation. If the goal was palliation, it was investigated whether or not the goal was specified as either alleviation of existing problems or prevention of impending problems. The achievement of the specified goals was assessed. Palliation was the goal of treatment in 119 (71%) of the 168 evaluable recommendations. In 83 of the 119 cases (70%), immediate treatment was recommended. The goal was specified in 57 (69%) of the 83 recommendations and could be realized in 24 of 57 specified cases (42%). Patients in this group survived longer (p < 0.01) than patients in whom the goals could not be achieved. Impending problems could be prevented more often (p = 0.001) in 14 out of 18 cases, while existing problems could be alleviated in only 10 out of 34 cases. It is concluded that specification of the goals of palliation is necessary because it is impossible to decide if a goal of treatment could be achieved or not unless the goal of treatment has been defined (as existing/impending problem). The prevention of impending problems could be investigated in prospectively controlled clinical trials.
Adult↗
Practical aspects of quality-of-life measurement: design and feasibility study of the quality-of-life recorder and the standardized measurement of quality of life in an outpatient clinic.
Explore the source record for details and available documents.
Ambulatory Care Facilities↗
High-titer interferon-alpha antibodies in a patient with pemphigus foliaceus.
Among 13 patients with pemphigus or bullous pemphigoid, high titers of anti-interferon-alpha (IFN-alpha) antibodies were present in all serum samples of one patient suffering from pemphigus foliaceus. This patient was characterized by a relatively benign course of the disease. The IFN antibodies were of oligoclonal or polyclonal origin, predominantly of the IgG subtype, and displayed a broad spectrum of specificity including various natural and recombinant IFN-alpha subtypes as well as recombinant IFN-omega 1. In vitro, these antibodies neutralized both the antiviral and antiproliferative activities of the respective IFN types. Recognition of the patient's endogenous IFN-alpha demonstrated their autoantibody nature. The IFN antibodies were present at diagnosis and resistant to continued immunosuppressive treatment. Despite clinical remission, the IFN antibodies persisted, suggesting that they were not pathogenically related to the skin manifestations of the pemphigus. There were no sings of immune complex-mediated organ damage. IFN antibodies constitute a new class of autoantibodies that may occur in conjunction with pemphigus and likely interfere with the endogenous IFN system.
Adult↗
Endocrine effects of recombinant interleukin 6 in man.
In a phase II study, 5 male patients with a good performance status, who had metastatic renal cell carcinoma, received interleukin 6 (IL-6) to evaluate a possible antitumor effect of the cytokine. This offered the opportunity to investigate endocrine effects of IL-6 in man. The patients were studied the day before (day-1), and on days +1 and +21 of the IL-6 therapy (150 micrograms administered subcutaneously every day at 09.00 h). Blood was sampled at 09.00, 11.00, 13.00, 16.00, and 20.00 h. Compared with day -1, on days +1 and +21 serum levels of IL-6 were substantially elevated between 11.00 and 20.00 h. IL-6 significantly decreased serum thyrotropin (TSH) levels on day +1 (p < 0.05). The decrease was even more pronounced on day +21 when TSH concentrations were persistently below the respective values of day +1, suggesting, in addition to the acute action of IL-6, an effect developing with repeated IL-6 administrations. Total serum T3 and T4 levels were significantly lower on day +21 than on days -1 and +1. In contrast, free T3 and free T4 values did not differ among days -1, +1 and +21. Acutely, IL-6 had no effect on serum luteinizing hormone (LH) concentrations. However, on day +21, averaged serum LH levels (between 11.00 and 20.00 h) were significantly higher (8.4 +/- 1.1 IU/l) than on days -1 (6.5 +/- 0.2 IU/l) and +1 (6.4 +/- 0.4 IU/l). Average serum testosterone levels were slightly but not significantly enhanced on day +21. IL-6 did not influence follicle-stimulating hormone, growth hormone, or prolactin levels, neither acutely nor after 3 weeks of daily administration. The data indicate a modulating effect of IL-6 on secretory activity of different endocrine axes in man.
Carcinoma, Renal Cell↗
Antibodies to interferon-alpha: a novel type of autoantibody occurring after allogeneic bone marrow transplantation.
Antibodies to IFN-alpha have been recognized as a novel type of autoantibody developing after allogeneic BMT. Ninety-six patients undergoing BMT for various hematologic disorders were followed for the presence of spontaneous IFN-alpha antibodies until 12 years after transplantation. Seven of them (7.3%) developed IFN-alpha antibodies occurred late after BMT (> or = 15 months), rose to very high titers in some patients, and persisted for years despite combined immunosuppressive treatment. They were oligo- or polyclonal in nature, predominantly IgG with a broad IgG subclass distribution, and neutralized the antiviral and antiproliferative activity of various natural and recombinant IFN-alpha types including the patients' endogenous IFN-alpha in vitro. All antibody-positive recipients suffered from chronic GVHD (n = 5) or chronic viral hepatitis (n = 2), but the only significant association was with prior severe aplastic anemia (3/9, 33%; P = 0.022). There was no discernible HLA association of IFN antibody development. Although the clinical relevance of the IFN-alpha antibodies is uncertain they may interfere with cellular defence mechanisms and immune regulation after BMT.
Adolescent↗
Polymorphism within the second intron of the IL-1 receptor antagonist gene in patients with hematopoietic malignancies.
Alleles of the IL-1 genes are associated with several autoimmune and inflammatory diseases, where they tend to have a role in the severity of the disease rather than in susceptibility to the disease itself. Allele 2 of the variable number tandem repeat (VNTR) polymorphism in the IL-1 receptor antagonist (IL-1ra) gene was the first marker of the IL-1 cluster to be associated in this way with severity of chronic, systemic and local inflammatory diseases. Because of the role that IL-1 also plays in the pathobiology of certain hematopoietic disorders, we aimed at examining the allelic distribution of the IL-1ra VNTR in leukemias, lymphomas and related malignancies. While in patients with chronic lymphocytic leukemia (CLL), hairy cell leukemia (HCL), multiple myeloma (MM) and related disorders, primary acute myeloid leukemia (AML), chronic myeloid leukemia (CML), and Hodgkin's disease (HD), the allelic distribution of IL-1RN was comparable to that seen in healthy control subjects, in a small group of patients with secondary AML the frequency of the IL-1RN*4 allele appeared to be significantly increased.
Alleles↗
Observations regarding hairy cell leukemia and chronic lymphocytic leukemia within the proposed new classification of lymphoid neoplasms.
Explore the source record for details and available documents.
Antineoplastic Agents↗