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| 遡及的診断精査研究× | 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≠ | Formalized 2000s; STARD 2003, revised 2015 | 2003-2015 |
| 提唱者≠ | Formalized through the STARD initiative led by Patrick Bossuyt and colleagues | Bossuyt, Reitsma, and STARD group (2003); clinical epidemiology pioneers |
| 種類≠ | Observational, retrospective study design | Research Design |
| 原典≠ | Bossuyt, P. M., Reitsma, J. B., Bruns, D. E., et al. (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 | retrospective DAS, retrospective test accuracy study, retrospective index test evaluation, historical diagnostic accuracy study | diagnostic accuracy study, test accuracy, STARD, diagnostic evaluation |
| 関連≠ | 5 | 2 |
| 概要≠ | A retrospective diagnostic accuracy study evaluates how well a diagnostic test (the index test) correctly identifies a target condition by applying it to previously collected data or archived specimens alongside a reference standard. Because both index test results and reference standard results are drawn from existing records or stored material rather than generated prospectively, this design is faster and less costly than a prospective counterpart — but carries specific methodological risks that must be controlled to produce valid estimates of sensitivity, specificity, and related measures. | 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. |
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