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| 適応型診断精度研究× | 診断精度の研究デザイン× | |
|---|---|---|
| 分野≠ | 疫学 | 臨床研究 |
| 系統 | Process / pipeline | Process / pipeline |
| 提唱年≠ | 2000s–2010s (adaptive designs codified for diagnostics ~2010s) | 2003-2015 |
| 提唱者≠ | Adaptation of STARD framework (Bossuyt et al.) combined with adaptive design principles (Jennison & Turnbull; FDA guidance) | Bossuyt, Reitsma, and STARD group (2003); clinical epidemiology pioneers |
| 種類≠ | Adaptive observational/experimental study design | Research Design |
| 原典≠ | 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 ↗ | Bossuyt, P. M., Reitsma, J. B., Bruns, D. E., Gatsonis, C. A., Glasziou, P. P., Irwig, L. M., ... & de Vet, H. C. (2003). Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. Annals of Internal Medicine, 138(1), 40–44. DOI ↗ |
| 別名 | adaptive DTA study, adaptive diagnostic test evaluation, adaptive test accuracy trial, adaptive STARD study | diagnostic accuracy study, test accuracy, STARD, diagnostic evaluation |
| 関連≠ | 6 | 2 |
| 概要≠ | 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. | A diagnostic accuracy study evaluates how well a new diagnostic test (or biomarker, imaging modality, clinical assessment) detects the presence or absence of disease compared to a reference standard (gold standard). Standardized since 2003 by the STARD (Standards for Reporting of Diagnostic Accuracy Studies) initiative, diagnostic accuracy studies are fundamental to clinical medicine, determining whether and how new tests can improve patient diagnosis and treatment. |
| ScholarGateデータセット ↗ |
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