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| Pragmatische ökologische Studie× | Pragmatische randomisierte klinische Studie× | |
|---|---|---|
| Fachgebiet | Epidemiologie | Epidemiologie |
| Familie | Process / pipeline | Process / pipeline |
| Entstehungsjahr≠ | 1967–1982 (pragmatic concept 1967; ecological study formalized ~1982) | 1967 |
| Urheber≠ | Morgenstern (ecological study framework); Schwartz & Lellouch (pragmatic design concept) | Daniel Schwartz & Joseph Lellouch |
| Typ≠ | Observational ecological study with pragmatic framing | Interventional study design |
| Wegweisende Quelle≠ | Morgenstern, H. (1982). Uses of ecologic analysis in epidemiologic research. American Journal of Public Health, 72(12), 1336–1344. DOI ↗ | Schwartz, D., & Lellouch, J. (1967). Explanatory and pragmatic attitudes in therapeutical trials. Journal of Chronic Diseases, 20(8), 637–648. DOI ↗ |
| Aliasnamen | real-world ecological study, effectiveness ecological study, population-level pragmatic study, pragmatic ecologic design | pragmatic RCT, effectiveness trial, real-world RCT, practical clinical trial |
| Verwandt≠ | 5 | 6 |
| Zusammenfassung≠ | A pragmatic ecological study is an observational epidemiological design that examines associations between exposures and outcomes at the population or group level — using routinely collected, real-world data — with the explicit goal of informing practical public health decisions under everyday conditions. Rather than controlling every variable in a laboratory-like manner, it embraces the complexity and heterogeneity of natural settings to answer effectiveness questions relevant to policy. | 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. |
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