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| Pragmatisk fas IV-studie× | Pragmatisk randomiserad klinisk prövning× | |
|---|---|---|
| Ämnesområde | Epidemiologi | Epidemiologi |
| Familj | Process / pipeline | Process / pipeline |
| Ursprungsår≠ | 1967 (pragmatic concept); 2000s (pragmatic Phase IV formalized) | 1967 |
| Upphovsperson≠ | Schwartz & Lellouch (explanatory vs. pragmatic distinction, 1967); PRECIS framework by Thorpe et al. (2009) | Daniel Schwartz & Joseph Lellouch |
| Typ≠ | Observational / interventional hybrid study design | Interventional study design |
| Ursprungskälla≠ | Thorpe, K. E., Zwarenstein, M., Oxman, A. D., Treweek, S., Furberg, C. D., Altman, D. G., ... & Chalkidou, K. (2009). A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. Journal of Clinical Epidemiology, 62(5), 464-475. DOI ↗ | Schwartz, D., & Lellouch, J. (1967). Explanatory and pragmatic attitudes in therapeutical trials. Journal of Chronic Diseases, 20(8), 637–648. DOI ↗ |
| Alias | pragmatic post-marketing study, real-world phase IV trial, pragmatic pharmacovigilance study, pragmatic post-approval study | pragmatic RCT, effectiveness trial, real-world RCT, practical clinical trial |
| Närliggande≠ | 5 | 6 |
| Sammanfattning≠ | A pragmatic Phase IV study is a post-marketing investigation conducted under routine clinical conditions to evaluate a drug or device's real-world effectiveness, long-term safety, and comparative performance. Unlike the controlled Phase III environment, it intentionally minimizes protocol restrictions — broad eligibility criteria, standard-of-care comparators, and naturalistic follow-up — to generate evidence directly applicable to everyday clinical practice. | 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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