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| Adaptive Diagnostic Accuracy Study× | Adaptive Kohortenstudie× | |
|---|---|---|
| Fachgebiet | Epidemiologie | Epidemiologie |
| Familie | Process / pipeline | Process / pipeline |
| Entstehungsjahr≠ | 2000s–2010s (adaptive designs codified for diagnostics ~2010s) | 2000s–2010s (systematic formalisation) |
| Urheber≠ | Adaptation of STARD framework (Bossuyt et al.) combined with adaptive design principles (Jennison & Turnbull; FDA guidance) | Extension of classic cohort methods; adaptive design principles formalised by regulatory and epidemiology communities in the 2000s–2010s |
| Typ≠ | Adaptive observational/experimental study design | Observational / adaptive epidemiological design |
| Wegweisende Quelle≠ | Bossuyt, P. M., Reitsma, J. B., Bruns, D. E., Gatsonis, C. A., Glasziou, P. P., Irwig, L., ... & Cohen, J. F. (2015). STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies. BMJ, 351, h5527. DOI ↗ | VanderWeele, T. J., & Hernan, M. A. (2012). Results on differential and dependent measurement error of the exposure and the outcome using signed directed acyclic graphs. American Journal of Epidemiology, 175(12), 1303–1310. DOI ↗ |
| Aliasnamen | adaptive DTA study, adaptive diagnostic test evaluation, adaptive test accuracy trial, adaptive STARD study | adaptive longitudinal study, flexible cohort design, adaptive prospective cohort, ACS |
| Verwandt≠ | 6 | 4 |
| Zusammenfassung≠ | An adaptive diagnostic accuracy study evaluates how well an index test distinguishes between patients with and without a target condition, while incorporating pre-specified interim analyses that allow modifications — such as sample size re-estimation, threshold adjustment, or subgroup enrichment — based on accumulating data. This design improves efficiency and ethical conduct compared to fixed-sample diagnostic studies, particularly when prior prevalence or test performance data are uncertain. | An adaptive cohort study is a longitudinal observational design that follows a defined group of individuals over time to assess exposure-outcome relationships, while incorporating pre-specified adaptation rules that allow protocol modifications — such as sample-size re-estimation, subgroup enrichment, or measurement schedule adjustments — based on accumulating interim data. Adaptations are made without compromising validity, guided by a statistical analysis plan agreed upon before data collection begins. |
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