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| 적응형 진단 정확도 연구× | 전향적 진단 정확도 연구× | |
|---|---|---|
| 분야 | 역학 | 역학 |
| 계열 | Process / pipeline | Process / pipeline |
| 기원 연도≠ | 2000s–2010s (adaptive designs codified for diagnostics ~2010s) | Formalized 2000s; practice dates to mid-20th century |
| 창시자≠ | Adaptation of STARD framework (Bossuyt et al.) combined with adaptive design principles (Jennison & Turnbull; FDA guidance) | Established through STARD initiative (Bossuyt, Reitsma et al., 2000s) |
| 유형≠ | Adaptive observational/experimental study design | Observational / evaluative study design |
| 원전 | 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., ... & Cohen, J. F. (2015). STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies. BMJ, 351, h5527. DOI ↗ |
| 별칭 | adaptive DTA study, adaptive diagnostic test evaluation, adaptive test accuracy trial, adaptive STARD study | prospective DTA study, prospective test accuracy study, forward-looking diagnostic study, prospective index test evaluation |
| 관련 | 6 | 6 |
| 요약≠ | 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 prospective diagnostic accuracy study enrolls participants before any test results are known and follows them forward in time to evaluate how well an index test (the test under evaluation) distinguishes individuals with and without a target condition, using a reference standard applied independently. Key accuracy metrics include sensitivity, specificity, positive and negative predictive values, and the area under the ROC curve. The prospective design reduces many biases inherent in retrospective test evaluations. |
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