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| Pragmatische randomisierte klinische Studie× | Prospektive Kohortenstudie× | |
|---|---|---|
| Fachgebiet | Epidemiologie | Epidemiologie |
| Familie | Process / pipeline | Process / pipeline |
| Entstehungsjahr≠ | 1967 | 1950s (systematic application); conceptual roots earlier |
| Urheber≠ | Daniel Schwartz & Joseph Lellouch | Richard Doll and Austin Bradford Hill (landmark application, 1951-1954); cohort methodology formalised by modern epidemiology textbooks |
| Typ≠ | Interventional study design | Observational longitudinal study design |
| Wegweisende Quelle≠ | Schwartz, D., & Lellouch, J. (1967). Explanatory and pragmatic attitudes in therapeutical trials. Journal of Chronic Diseases, 20(8), 637–648. DOI ↗ | Rothman, K. J., Greenland, S., & Lash, T. L. (2008). Modern Epidemiology (3rd ed.). Lippincott Williams & Wilkins. ISBN: 978-0781755641 |
| Aliasnamen | pragmatic RCT, effectiveness trial, real-world RCT, practical clinical trial | longitudinal cohort study, prospective follow-up study, incidence study, prospective observational cohort |
| Verwandt | 6 | 6 |
| Zusammenfassung≠ | A pragmatic randomized clinical trial (pragmatic RCT) is an interventional study that tests whether a treatment works under routine clinical conditions, as opposed to the tightly controlled setting of an explanatory trial. It prioritizes broad eligibility, flexible delivery, and patient-relevant outcomes to answer the question 'Does this treatment work in everyday practice?' rather than 'Can this treatment work under ideal circumstances?' The distinction between pragmatic and explanatory trials was formally articulated by Schwartz and Lellouch in 1967 and operationalized by the PRECIS tool in 2009. | A prospective cohort study assembles a group of participants who are free of the outcome of interest at baseline, measures their exposures, and then follows them forward in time to record who develops the outcome. By collecting exposure data before outcomes occur, it establishes a clear temporal sequence that supports causal inference — a major advantage over retrospective designs. It is the cornerstone observational method in epidemiology and clinical research. |
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