方法对比

	前瞻性病例系列研究	诊断准确性研究设计
领域	流行病学	临床研究
方法族	Process / pipeline	Process / pipeline
起源年份	Late 19th century onward; formalized in modern clinical epidemiology by the 1970s–1980s	2003-2015
提出者	Evolved from clinical case reporting traditions in 19th–20th century medicine	Bossuyt, Reitsma, and STARD group (2003); clinical epidemiology pioneers
类型	Observational study design	Research Design
开创性文献	Meinert, C. L. (1996). Clinical Trials: Design, Conduct, and Analysis. Oxford University Press. ISBN: 978-0195035681	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.
别名	prospective case series study, forward-looking case series, prospective uncontrolled study, prospective observational case series	diagnostic accuracy study, test accuracy, STARD, diagnostic evaluation
相关	5	2
摘要	A prospective case series is an observational study design in which a group of patients with a particular condition, exposure, or intervention is identified in advance and followed forward in time according to a pre-specified protocol. Data on outcomes, adverse events, and clinical course are collected as they occur, yielding higher data quality and temporal clarity than retrospective designs. No control group is included, so causal inference is limited, but the design is valuable for characterizing natural disease history, early safety signals, and feasibility of new interventions.	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.