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诊断准确性研究设计×队列研究设计×随机对照试验 (RCT)×
领域临床研究临床研究实验设计
方法族Process / pipelineProcess / pipelineHypothesis test
起源年份2003-20151970s-1980s1948
提出者Bossuyt, Reitsma, and STARD group (2003); clinical epidemiology pioneersDonald Acheson, Olli Miettinen, and others in modern epidemiologyJames Lind (early precursor, 1747); modern formulation: Austin Bradford Hill & Medical Research Council (1948)
类型Research DesignResearch DesignInterventional comparative study
开创性文献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 ↗Miettinen, O. S. (1976). Estimability and estimation in case-referent studies. American Journal of Epidemiology, 103(2), 226–235. DOI ↗Schulz, K.F., Altman, D.G., Moher, D., for the CONSORT Group (2010). CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomised Trials. BMJ, 340, c332. DOI ↗
别名diagnostic accuracy study, test accuracy, STARD, diagnostic evaluationprospective study, follow-up study, longitudinal study, cohort studyRCT, randomised controlled trial, clinical trial, Randomize Kontrollü Çalışma (RCT) Tasarımı
相关227
摘要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.A cohort study follows a group of individuals forward in time from exposure to outcome. Exposed and unexposed participants (or participants with differing exposure levels) are enrolled at baseline, characterized, and observed prospectively until the outcome occurs or the study ends. Cohort studies are fundamental to epidemiology and are the design of choice for establishing causal associations when randomized trials are infeasible or unethical.A randomized controlled trial (RCT) is the gold standard experimental design in clinical and health research, in which participants are randomly allocated to a treatment group or a control group so that the effect of an intervention can be measured with the highest possible degree of internal validity. The modern parallel-group RCT was formalized by Austin Bradford Hill and the Medical Research Council in their landmark streptomycin trial of 1948, and its reporting is governed today by the CONSORT 2010 guidelines (Schulz et al., 2010).
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ScholarGate方法对比: Diagnostic Accuracy Study Design · Cohort Study Design · Randomized Controlled Trial. 于 2026-06-18 检索自 https://scholargate.app/zh/compare