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  • 1
    Electronic Resource
    Electronic Resource
    European postmarketing surveillance of ramipril in hypertension (1995)
    Springer
    European journal of clinical pharmacology 49 (1995), S. 73-79 
    Details
    ISSN: 1432-1041
    Keywords: Postmarketing surveillance ; Ramipril ; Hypertension
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract A prospective observational cohort study of the angiotensin inhibitor, ramipril, was undertaken in four countries within the European Community-Netherlands, United Kingdom, Germany and Belgium. A total of 10,377 consecutive patients with essential hypertension were recruited to the study with the aim of follow-up for one year. Overall 37% of doctors who agreed to participate in the study actually enrolled at least one patient. One third of the doctors who enrolled patients in the study entered two thirds of patients studied. Some 15% of participating males and 27% of females were aged over 70 years. Newly diagnosed hypertensives comprised 22% of the study cohort, the proportion being highest in UK and Netherlands, whereas 53% were established hypertensives of two or more years' duration, the proportion being highest in Germany and Belgium. There were substantial differences among the participating countries in the concurrent treatment these patients were receiving for hypertension, with two or more co-therapies being most frequent in Germany and Belgium. There were also substantial differences in co-therapies for concurrent diseases among the participating countries, reflecting both standard therapeutic practices in local areas and differences in marketing of drugs in the different countries. This report describes the initial findings of this multinational study and emphasises the need to consider several major potentially confounding variables in the analysis of the outcome events both in this study and in other collaborative observational international monitoring schemes for adverse drug reactions.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00192362
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  • 2
    Electronic Resource
    Electronic Resource
    Systematische Studienübersichten in der Kardiologie: Ansätze einer evidenzbasierten Medizin und die Cochrane-Collaboration (1997)
    Springer
    Zeitschrift für Kardiologie 86 (1997), S. 313-319 
    Details
    ISSN: 1435-1285
    Keywords: Key words Systematic reviews — evidence-based medicine — meta-analysis — clinical epidemiology ; Schlüsselwörter Systematische Reviews — evidenz-basierte Medizin — Meta-Analyse — klinische Epidemiologie
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Description / Table of Contents: Summary The ever growing tide of results from great numbers of clinical studies clearly outweighs the abilities of the individual clinician to keep abreast of the actual state of scientific evidence and to apply it in his clinical decision-making in a timely and valid manner. Evidence-based medicine, with its central demand to link best individual clinical knowledge with best available external, scientific evidence to achieve optimal patient care, has clearly identified the urgent need for scientific techniques which allow the synthesis of scientific evidence, as collected in numerous singular studies, in an explicit, reproducible, and critically appraisable report format, and to up-date these reports regularly. The methods of Systematic Reviews, encompassing the techniques of meta-analysis, were developed for this purpose. They are explained and presented here in detail as they relate to the field of cardiology. Various problematic aspects have recently dominated cardiologists' discussion of meta-analyses. We point out that the techniques of Systematic Reviews hold promising solutions for many of them and that work on technical improvements is ongoing. The International Cochrane Collaboration is introduced as a global network of scientists and experts from varying fields of medicine with the aim of producing highest quality Systematic Reviews on a wide scope of topics. However, to date only few cardiologists have joined the rapidly rising numbers of Cochrane collaborators.
    Notes: Zusammenfassung Die stetig wachsende Flut von klinischen Studienergebnissen überfordert die Fähigkeit des einzelnen Arztes, die aktuell vorhandene biomedizinisch-wissenschaftliche Evidenz frühzeitig und in valider Weise für die ärztliche Entscheidungsfindung zu nutzen. Die evidenz-basierte Medizin stellt die zentrale Forderung, daß die individuelle, klinische Expertise des Arztes stets mit der besten, aktuell verfügbaren Evidenz aus der Wissenschaft zu einer optimalen Patientenversorgung verknüpft werden soll. Sie hat die Entwicklung wissenschaftlicher Techniken forciert, welche es gestatten, die mit großem Aufwand in Einzelprojekten gesammelten wissenschaftlichen Evidenzen in einer klaren, nachvollziehbaren und der kritischen Bewertung zugänglichen Form zusammenzufassen und auf einem aktuellen Stand zu halten. Diese formalisierten Zusammenfassungen werden als Systematische Studienübersichten oder Systematischer Review bezeichnet und schließen in der Regel auch meta-analytische Techniken mit ein. Für viele Probleme, die in der kardiologischen Diskussion in letzter Zeit das Thema ,"Meta-Analysen" dominiert haben, bieten die Techniken der Systematischen Reviews hoffnungsvolle Lösungsansätze. Die Arbeit an ihrer Verbesserung befindet sich in einem stetigen Entwicklungsprozeß. Die Internationale Cochrane Collaboration wird vorgestellt als ein globales Netzwerk von Wissenschaftlern und Medizinern, das sich allein der Aufgabe qualitativ hochstehender Systematischer Reviews widmet, und ihre Struktur wird beschrieben. Leider finden sich bisher kaum Kardiologen bereit, in dieser Kollaboration mitzuwirken.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s003920050063
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  • 3
    Electronic Resource
    Electronic Resource
    Disturbed calcium metabolism in subjects with elevated diastolic blood pressure (1992)
    Springer
    Journal of molecular medicine 70 (1992), S. 748-751 
    Details
    ISSN: 1432-1440
    Keywords: Hypertension ; Calcium ; Parathyroid hormone ; 1,25-Dihydroxyvitamin D3
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary Essential hypertension has been associated with disturbed calcium metabolism, but the available data are controversial. We measured parameters of calcium metabolism in groups of untreated male subjects (n = 78) with elevated diastolic blood pressure (101 ± 6 mmHg, mean ± SD) and age-matched male subjects (n=79) with low diastolic blood pressure (62 ± 4 mmHg). The participants of the study were drawn from a random population sample. Subjects with high diastolic blood pressure had significantly higher carboxy-terminal parathyroid hormone (PTH) plasma concentrations than controls with low diastolic blood pressure (median 114 vs. 43 pmol/l, P 〈 0.01). The 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D concentrations were comparable in both groups. Individuals with high diastolic blood pressure had significantly lower total serum calcium (2.41 ± 0.10 vs. 2.47 ± 0.10 mmol/l, mean ± SD; P 〈 0.01). PTH concentrations were correlated with diastolic pressure (r = −0.39, P 〈 0.001). The data are compatible with increased parathyroid activity despite unchanged concentrations of vitamin D metabolites in human hypertension.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00180741
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  • 4
    Electronic Resource
    Electronic Resource
    Meta-Analysen: Zugewinn an Information oder Irrweg? (1998)
    Springer
    Herzschrittmachertherapie & Elektrophysiologie 9 (1998), S. S61 
    Details
    ISSN: 1435-1544
    Keywords: Schlüsselwörter Meta-Analyse ; Systematische Reviews ; Evidenz-basierte Medizin ; Randomisierte Klinische Studien ; Cochrane Collaboration
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Description / Table of Contents: Key words Meta-analysis – systematic reviews – evidence-based medicine – randomized clinical trials – Cochrane Collaboration
    Abstract: Zusammenfassung Der Begriff Meta-Analyse wird im allgemeinen für die Ergebnissynthese aus verschiedenen Studien verwendet. Dabei wird nicht beachtet, daß Meta-Analysen eigentlich nur den letzten statistischen Schritt eines Systematischen Reviews darstellen. Letzterer ist eine wissenschaftliche Methode, die „beste gegenwärtig verfügbare“ Evidenz aus allen veröffentlichten randomisierten, kontrollierten Studien (RCTs) zu extrahieren. Die Auswahl von RCTs, die in eine Meta-Analyse aufgenommen werden dürfen, unterliegt dabei expliziten Regeln. Diese betreffen vor allem Kriterien der Studienqualität wie Datenerhebung, Patientenauswahl und Auswertungsverfahren. Meta-Analysen von gepoolten Individualdaten sind zwar sehr aufwendig, sie erlauben aber z. B. eine vorsichtige Untersuchung von Subgruppen und produzieren so Resultate, die über die Einzelstudien hinaus neue Erkenntnisse und Hypothesen ermöglichen. Meta-Analysen, die alleine auf Literaturinformationen beruhen und nicht unter Einbindung der Studienleiter zustande gekommen sind, sollten kritisch beurteilt werden. Meta-Analysen von nicht-randomisierten Beobachtungsstudien sollten weitgehend vermieden werden.
    Notes: Summary Meta-analysis is often used as a synonym for result synthesis of single studies. This disregards the important fact that meta-analysis is only the last statistical step in a systematic review. The latter is a scientific method which extracts the best actually available evidence from randomized controlled trials (RCTs). Systematic reviews use explicit rules for the inclusion of studies. These refer to criteria of study quality such as patient selection, conduct or methods of analyses. Meta-analyses of pooled individual study data facilitate a cautious analysis of patient subgroups impossible with single study results. They may produce new evidence and generate new hypotheses. Meta-analyses which are merely restricted to information obtained from the literature require critical scrutiny. Summarizing non-randomized observational studies with meta-analytical techniques should be avoided in most situations.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s003990050093
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  • 5
    Electronic Resource
    Electronic Resource
    Factors associated with tumor volume and primary metastases in Ewing tumors: Results from the (EI)CESS studies (1999)
    Springer
    Annals of oncology 10 (1999), S. 1073-1077 
    Details
    ISSN: 1569-8041
    Keywords: EICESS ; Ewing's sarcoma ; Ewing tumors ; PNET ; primary metastasis ; tumor volume
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Background: Tumor volumes of more than 100 ml and the presence of primary metastases have been identified as determinants of poor prognosis in patients with Ewing tumors. We sought to assess the prevalence of critical tumor size and primary metastases in a large national sample of patients at the time of first diagnosis and to identify factors that are associated with their occurrence. Patients: The present report is based on data of 945 German patients who were enrolled into the (EI)CESS therapy studies between 1980 and 1997. It is assumed that registration of German patients with Ewing tumors under the age of 15 years was almost complete since around 1985. Diagnoses of primary tumors were ascertained exclusively by biopsies. Analyses were restricted to patients with Ewing tumors of bone due to the few occurrences in soft tissues. Methods: Tumor volume data as assessed by radiography, computed tomography or nuclear magnetic imaging were available for 821 patients. The diagnosis of primary metastases was based on thoracic computed tomography or on whole body bone scans in 936 patients. Suspicious lesions had to be confirmed by bone marrow biopsies. We explored how year of first diagnosis, age at first diagnosis, sex, histological subtype and site of the primary tumor related to tumor size and presence of metastases by univariate and multivariate statistical techniques. Results: Sixty-eight percent of the patients (n = 559) had a volume above 100 ml with smaller tumors being more common in childhood than in late adolescence and early adulthood. Extensive volumes were observed in almost 90% of the tumors located in femur and pelvis while they were less common in other sites (P 〈 0.001). On average, 26% of all patients presented with clinically apparent primary metastases. The detection rate of metastases was markedly higher in patients diagnosed after 1991 (P 〈 0.001). Primary metastases were also significantly more common for tumors originating in the pelvis and for peripheral neuroectodermal tumors (PNET; P 〈 0.01). Tumors greater than 100 ml were positively associated with metastatic disease (P 〈 0.001). Multivariate analyses, which included simultaneously all univariate predictors in a logistic regression model, indicated that most of the observed associations were essentially unconfounded. The adjusted odds ratios (OR) for the presence of tumor volumes ≥100 ml were OR = 1.5 per age rise of 10 years, and OR = 5.8 for pelvis and OR = 7.1 for femur as primary tumor site (all P 〈 0.001). The presence of metastases was significantly associated with the year of diagnosis (OR = 1.9, after 1991 vs. before 1986), pelvis as site of the primary tumor (OR = 1.8), a PNET (OR = 1.5), and tumor size ≥100 ml (OR = 1.6). Conclusions: In conclusion, we find that the prevalence of established factors for an unfavorable prognosis is disturbingly high among patients diagnosed with Ewing tumors. Recent progress in imaging techniques seems to account for much of the rise in the detection rate of metastases after 1991. We identify age and, in particular, pelvic and femoral site as the major determinants of local tumor extension. Occurrence of primary metastases is independently related to tumor size, pelvic site, and PNET.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1008357018737
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