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| Pragmatikus III. fázisú klinikai vizsgálat× | Randomizált kontrollált vizsgálat (RCT)× | |
|---|---|---|
| Tudományterület≠ | Epidemiológia | Kísérlettervezés |
| Módszercsalád≠ | Process / pipeline | Hypothesis test |
| Keletkezés éve≠ | 1967 (Schwartz & Lellouch); formalized further in 2000s–2010s | 1948 |
| Megalkotó≠ | Schwartz & Lellouch (distinction between pragmatic and explanatory trials) | James Lind (early precursor, 1747); modern formulation: Austin Bradford Hill & Medical Research Council (1948) |
| Típus≠ | Randomized controlled trial design | Interventional comparative study |
| Alapmű≠ | 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 ↗ | Schulz, K.F., Altman, D.G., Moher, D., for the CONSORT Group (2010). CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomised Trials. BMJ, 340, c332. DOI ↗ |
| Alternatív nevek | pragmatic RCT, effectiveness trial, real-world RCT, pragmatic trial | RCT, randomised controlled trial, clinical trial, Randomize Kontrollü Çalışma (RCT) Tasarımı |
| Kapcsolódó≠ | 2 | 7 |
| Összefoglaló≠ | A pragmatic phase III clinical trial is a large-scale randomized study designed to evaluate whether an intervention works under the conditions of everyday clinical practice rather than the tightly controlled environment of an explanatory efficacy trial. It recruits a broad, representative patient population, allows flexibility in treatment delivery, and measures outcomes that matter to patients and health systems, generating evidence directly applicable to real-world treatment decisions. | A randomized controlled trial (RCT) is the gold standard experimental design in clinical and health research, in which participants are randomly allocated to a treatment group or a control group so that the effect of an intervention can be measured with the highest possible degree of internal validity. The modern parallel-group RCT was formalized by Austin Bradford Hill and the Medical Research Council in their landmark streptomycin trial of 1948, and its reporting is governed today by the CONSORT 2010 guidelines (Schulz et al., 2010). |
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