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  • 1
    Electronic Resource
    Electronic Resource
    Springer
    European journal of clinical pharmacology 49 (1995), S. 73-79 
    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
    Library Location Call Number Volume/Issue/Year Availability
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  • 2
    Electronic Resource
    Electronic Resource
    Springer
    Herzschrittmachertherapie & Elektrophysiologie 9 (1998), S. S61 
    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
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