Fletcher James W., Adams Elizabeth, Flynn Karen, Papatheofanis Frank J.
Saint Louis University School of Medicine, Department of Medicine, Division of Nuclear Medicine and St. Louis VA Medical Center, Diagnostic Service Line, St. Louis, Missouri, USA
Clin Positron Imaging. 1998 Jun;1(3):201-211. doi: 10.1016/s1095-0397(98)00016-8.
This article will briefly review measures of accuracy for diagnostic tests. We will present valid, methodologically rigorous prospective clinical trial design features that avoid bias and that can generate high-quality evidence on the diagnostic accuracy of PET and its impact on diagnostic decision-making and therapeutic efficacy. Knowledge of the principles of Evidence-based Medicine, and an understanding of the key elements of designing a methodologically rigorous, prospective clinical trial will permit avoidance of the previous study design limitations and weaknesses of the existing literature on diagnostic imaging modalities. Published results of studies that are valid, obtained rapidly, and generalizable, will provide important support for the paradigm shift away from informal, opinion-driven decision-making in health care, toward a process that is evidence-based, rationale and considerate of our available resources and their most effective use in patient care.
本文将简要回顾诊断试验准确性的测量方法。我们将介绍有效、方法严谨的前瞻性临床试验设计特点，这些特点可避免偏差，并能产生关于PET诊断准确性及其对诊断决策和治疗效果影响的高质量证据。了解循证医学原理，并理解设计方法严谨的前瞻性临床试验的关键要素，将有助于避免先前研究设计的局限性以及现有诊断成像模式文献的弱点。有效、快速获得且具有可推广性的研究发表结果，将为医疗保健从非正式的、基于意见的决策向基于证据、合理且考虑可用资源及其在患者护理中最有效利用的过程转变提供重要支持。
