Porovnat metody
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| Pragmatická studie fáze IV× | Analýza dávka-odezva× | |
|---|---|---|
| Obor | Epidemiologie | Epidemiologie |
| Rodina | Process / pipeline | Process / pipeline |
| Rok vzniku≠ | 1967 (pragmatic concept); 2000s (pragmatic Phase IV formalized) | Conceptual roots 16th century; modern epidemiological application mid-20th century |
| Tvůrce≠ | Schwartz & Lellouch (explanatory vs. pragmatic distinction, 1967); PRECIS framework by Thorpe et al. (2009) | Paracelsus (conceptual foundation); formalized by John Snow and later Bradford Hill |
| Typ≠ | Observational / interventional hybrid study design | Quantitative analytical method |
| Původní zdroj≠ | 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 ↗ | Rothman, K. J., Greenland, S., & Lash, T. L. (2008). Modern Epidemiology (3rd ed.). Lippincott Williams & Wilkins. ISBN: 978-0781755641 |
| Další názvy | pragmatic post-marketing study, real-world phase IV trial, pragmatic pharmacovigilance study, pragmatic post-approval study | exposure-response analysis, concentration-response modeling, dose-response modeling, DRA |
| Příbuzné≠ | 5 | 4 |
| Shrnutí≠ | 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. | Dose-response analysis quantifies the relationship between the magnitude of an exposure (the dose) and the probability or rate of an outcome (the response). It is a core analytical strategy in epidemiology and toxicology, providing evidence that increasing exposure systematically increases — or decreases — the risk of disease. A demonstrated dose-response gradient is one of Bradford Hill's classic criteria supporting causal inference. |
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