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| Pragmatic Survival Analysis× | Pragmatikus randomizált klinikai vizsgálat× | |
|---|---|---|
| Tudományterület | Epidemiológia | Epidemiológia |
| Módszercsalád | Process / pipeline | Process / pipeline |
| Keletkezés éve≠ | Conceptual framework: 1967; widespread application: 1990s–2000s | 1967 |
| Megalkotó≠ | Schwartz & Lellouch (explanatory vs. pragmatic distinction, 1967); extended in survival analysis literature from the 1970s onward | Daniel Schwartz & Joseph Lellouch |
| Típus≠ | Observational / experimental hybrid — time-to-event analysis in real-world or pragmatic-trial settings | Interventional study design |
| Alapmű≠ | Ford, I., & Norrie, J. (2016). Pragmatic Trials. New England Journal of Medicine, 375(5), 454–463. DOI ↗ | Schwartz, D., & Lellouch, J. (1967). Explanatory and pragmatic attitudes in therapeutical trials. Journal of Chronic Diseases, 20(8), 637–648. DOI ↗ |
| Alternatív nevek | real-world survival analysis, pragmatic time-to-event analysis, effectiveness survival analysis, PSA | pragmatic RCT, effectiveness trial, real-world RCT, practical clinical trial |
| Kapcsolódó≠ | 5 | 6 |
| Összefoglaló≠ | Pragmatic survival analysis applies time-to-event statistical methods within pragmatic or real-world settings, estimating how long patients survive, remain event-free, or retain treatment benefit under conditions of routine clinical practice. Unlike explanatory survival analyses conducted under tightly controlled trial conditions, the pragmatic variant embraces the heterogeneity, treatment switching, non-adherence, and competing events that characterise real-world patient populations, prioritising external validity over internal precision. | 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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