Zusammenfassung
Interventionsstudien sind grundsätzlich gemeinde- oder klinisch orientiert. Während der heute klassische Studientyp der randomisierten kontrollierten Studie (RKS) die individuelle Randomisierung von (meistens) freiwilligen Probanden in eine Studien- und eine Vergleichsgruppe beinhaltet, setzen sich bei gemeindeorientierten Interventionsstudien Studien- und Vergleichsgruppen aus ganzen Bevölkerungsgruppen (z. B. Städte, Fabriken) zusammen.
Nach einem überblick über die historische Entwicklung der Epidemiologie ←s Grundlagenmethode für beide Studientypen werden Vor- und Nachteile der RKS anhand der «diet-heart»-Hypothese und der gemeindeorientierten Interventionsstudien anhand des NFP 1A dargelegt. Während die genannten Studientypen als Endpunkte Veränderungen der Risikofaktorenverteilung, der Morbidität und/ oder Mortalität einbeziehen, versprechen Fortschritte der Angiographie die direkte Messung einer Regression der Atheromatose als zusätzliche Alternative. Diese Studientypen stellen nicht Gegensätze dar, sondern ergänzen sich zu einem sinnvollen Ganzen.
Résumé
Il existe deux types fondamentalement différents d'études d'intervention. Le type classique de l'étude contrÔlée randomisée comprend l'attribution aléatoire des individus, en général volontaires, à un groupe d'intervention et un groupe témoin. Dans les études d'intervention d'approche communautaire par contre, le collectif d'intervention et le collectif témoin sont formés par des populations entières (villes, usines p. ex.).
Après un rappel historique de l'évolution de l'épidémiologie comme méthode de base, les principaux avantages et désavantages de ces deux types d'études sont présentées respectivement par l'exemple de l'hypothèse «diet-heart» et celui du programme national de recherche 1A.
Comme critères d'évaluation, ces études utilisent les modifications de la distribution des facteurs de risque, de la morbidité et/ou de la mortalité. En outre, les progrès de l'angiographie permettent une nouvelle approche: la mesure directe de la régression des athéromes. Ces différents types d'études sont complémentaires pour essayer de comprendre les mécanismes d'une maladie d'étiologie multifactorielle.
Summary
Intervention trials can principally be classified into community or clinically oriented designs. The clinical approach of the randomized controlled trial (RCT) implies the individual randomization of a volunteer population into a study and a control group. In community-oriented trials, however, the study and control group are not composed of individuals, but rather of total population groups (e.g. communities, factories).
The paper gives first an overview over the historial development of epidemiological methods as the basis for both study types. Shortcomings and advantages both of RCT's and of community trials are discussed, using the examples of the “diet-heart” hypothesis and of the National Research Program 1A design, respectively. The two study types use as primary endpoints for the analysis changes in risk factor distribution, morbidity and/or mortality. A recent alternative is presented, too: advances in angiography allow direct measurements of changes in vessels with atherosclerotic disease.
The different study types available complement one another in trying to understand the mechanisms involved in disease of multifactorial origin.
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Kredit-Nr. 4.077.0.76.01, Schweizerischer Nationalfonds.
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Gutzwiller, F. Das Nationale Forschungsprogramm 1A: Eine gemeindeorientierte Interventionsstudie. Methodische überlegungen zu verschiedenen Studientypen. Soz Präventivmed 25, 244–249 (1980). https://doi.org/10.1007/BF02078489
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DOI: https://doi.org/10.1007/BF02078489