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| Badanie pragmatyczne fazy IV× | Ocena testów przesiewowych× | |
|---|---|---|
| Dziedzina | Epidemiologia | Epidemiologia |
| Rodzina | Process / pipeline | Process / pipeline |
| Rok powstania≠ | 1967 (pragmatic concept); 2000s (pragmatic Phase IV formalized) | 1968 (Wilson-Jungner principles); statistical framework developed 1970s–2000s |
| Twórca≠ | Schwartz & Lellouch (explanatory vs. pragmatic distinction, 1967); PRECIS framework by Thorpe et al. (2009) | Wilson & Jungner (WHO criteria, 1968); foundational work by Pepe, Altman, and others in statistical test evaluation |
| Typ≠ | Observational / interventional hybrid study design | Observational diagnostic / epidemiological evaluation design |
| Źródło pierwotne≠ | 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 ↗ | Wilson, J. M. G., & Jungner, G. (1968). Principles and Practice of Screening for Disease. World Health Organization. Public Health Papers No. 34. link ↗ |
| Inne nazwy | pragmatic post-marketing study, real-world phase IV trial, pragmatic pharmacovigilance study, pragmatic post-approval study | screening study, screening performance evaluation, screening accuracy assessment, STE |
| Pokrewne≠ | 5 | 6 |
| Podsumowanie≠ | 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. | Screening test evaluation is a systematic epidemiological approach for assessing whether a test or program can accurately and cost-effectively identify individuals with a condition before symptoms appear. It quantifies diagnostic performance metrics — sensitivity, specificity, predictive values, and the ROC curve — and evaluates whether a screening program meets established public health criteria for adoption and harm-benefit balance. |
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