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| Pragmatisches adaptives Experiment× | Randomisierte kontrollierte Studie (RCT)× | |
|---|---|---|
| Fachgebiet | Versuchsplanung | Versuchsplanung |
| Familie≠ | Process / pipeline | Hypothesis test |
| Entstehungsjahr≠ | 2000s–2010s (convergence period) | 1948 |
| Urheber≠ | Synthesized from pragmatic trial tradition (Schwartz & Lellouch, 1967) and adaptive design methodology; formalized convergence in 2000s–2010s | James Lind (early precursor, 1747); modern formulation: Austin Bradford Hill & Medical Research Council (1948) |
| Typ≠ | Hybrid experimental design | Interventional comparative study |
| Wegweisende Quelle≠ | Pallmann, P., Bedding, A. W., Choodari-Oskooei, B., Dimairo, M., Flight, L., Hampson, L. V., ... & Sydes, M. R. (2018). Adaptive designs in clinical trials: why use them, and how to run and report them. BMC Medicine, 16(1), 29. 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 ↗ |
| Aliasnamen | pragmatic adaptive trial, real-world adaptive trial, PAT, adaptive pragmatic RCT | RCT, randomised controlled trial, clinical trial, Randomize Kontrollü Çalışma (RCT) Tasarımı |
| Verwandt≠ | 3 | 7 |
| Zusammenfassung≠ | A pragmatic adaptive experiment is a hybrid clinical trial design that combines the real-world generalizability of pragmatic trials with the statistical flexibility of adaptive designs. It enrolls a broad, representative patient population under routine care conditions, while using pre-specified interim analyses to modify trial parameters — such as sample size, allocation ratios, or arm selection — as outcome data accumulate. The result is a design that is both externally valid and resource-efficient. | 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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