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| Pragmatisk dosis-respons-analyse× | Pragmatisk randomiseret klinisk forsøg× | |
|---|---|---|
| Fagområde | Epidemiologi | Epidemiologi |
| Familie | Process / pipeline | Process / pipeline |
| Oprindelsesår≠ | 1990s–2000s (formalized in pragmatic trial context) | 1967 |
| Ophavsperson≠ | Rooted in pharmacoepidemiology and pragmatic trial methodology; PRECIS framework by Thorpe et al. (2009) | Daniel Schwartz & Joseph Lellouch |
| Type≠ | Observational or experimental quantitative method | Interventional study design |
| Oprindelig kilde≠ | Greenland, S., & Longnecker, M. P. (1992). Methods for trend estimation from summarized dose-response data, with applications to meta-analysis. American Journal of Epidemiology, 135(11), 1301–1309. DOI ↗ | Schwartz, D., & Lellouch, J. (1967). Explanatory and pragmatic attitudes in therapeutical trials. Journal of Chronic Diseases, 20(8), 637–648. DOI ↗ |
| Aliasser | real-world dose-response analysis, pragmatic exposure-response study, dose-response in pragmatic trials, effectiveness dose-response analysis | pragmatic RCT, effectiveness trial, real-world RCT, practical clinical trial |
| Relaterede≠ | 4 | 6 |
| Resumé≠ | Pragmatic dose-response analysis quantifies how varying levels of an exposure or treatment relate to clinical outcomes under real-world conditions. By embedding dose-response questions within pragmatic study designs — broad eligibility criteria, routine care settings, and heterogeneous populations — it bridges the gap between controlled pharmacological dose-finding and the messy variability of everyday clinical practice. The approach is especially valued when the goal is to establish or refine optimal dosing guidance from evidence that reflects actual patient populations. | 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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