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新型诊断成像技术的评估

Evaluation of new diagnostic imaging technologies.

作者信息

Lerner M A

出版信息

Isr J Med Sci. 1986 Mar-Apr;22(3-4):203-6.

PMID:3528043
Abstract

New imaging technologies have to be evaluated for safety and for utility taking into account the uniqueness of the biological feature examined, the quality of the anatomical visualization, and accuracy of diagnosis. Comparative studies establish whether the new technology complements or replaces older methods, and what contribution it makes to therapeutic strategies. Historically, there were three phases: that of the great lone innovators, from whose efforts new techniques diffused; that of the large cooperative studies by academic clinicians and, recently, with the advent of MRI (magnetic resonance imaging), the phase of publicly appointed assessors, such as the FDA (Food and Drug Administration, USA). The methods of the latter two are detailed and critically compared. Evaluation in the clinical setting is more comprehensive. Therapeutic benefit, and not just image quality, has to be the ultimate consideration.

摘要

新的成像技术必须从安全性和实用性方面进行评估,要考虑到所检查生物特征的独特性、解剖结构可视化的质量以及诊断的准确性。对比研究确定新技术是补充还是取代旧方法,以及它对治疗策略有何贡献。从历史上看,有三个阶段:伟大的独立创新者阶段,新技术通过他们的努力得以传播;学术临床医生进行大型合作研究的阶段,以及最近随着MRI(磁共振成像)的出现,由公众指定的评估机构(如美国食品药品监督管理局)进行评估的阶段。后两个阶段的方法将进行详细且批判性的比较。临床环境中的评估更为全面。最终必须考虑治疗效果,而不仅仅是图像质量。

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