方法对比
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| 实用性III期临床试验× | 簇随机试验× | |
|---|---|---|
| 领域≠ | 流行病学 | 临床研究 |
| 方法族 | Process / pipeline | Process / pipeline |
| 起源年份≠ | 1967 (Schwartz & Lellouch); formalized further in 2000s–2010s | 1999-2000 |
| 提出者≠ | Schwartz & Lellouch (distinction between pragmatic and explanatory trials) | Campbell, Grimshaw, Elbourne et al. |
| 类型≠ | Randomized controlled trial design | Research Design |
| 开创性文献≠ | 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 ↗ | Campbell, M. K., Grimshaw, J. M., & Elbourne, D. R. (2000). Intracluster correlation coefficients in cluster randomized trials: empirical insights into how should they be reported. BMC Medical Research Methodology, 4, 30. link ↗ |
| 别名 | pragmatic RCT, effectiveness trial, real-world RCT, pragmatic trial | CRT, cluster RCT, cluster trial, group randomization |
| 相关≠ | 2 | 3 |
| 摘要≠ | 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 cluster randomized trial (CRT) randomizes intact groups—schools, clinics, villages, or hospital wards—rather than individuals. Developed by Campbell, Grimshaw, and colleagues in the late 1990s to address real-world settings where intervention delivery or contamination occurs at the group level, CRTs are now standard for evaluating population-level, community-based, and policy interventions. |
| ScholarGate数据集 ↗ |
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