Wells Wendy A, Barker Peter E, MacAulay Calum, Novelli Marco, Levenson Richard M, Crawford James M
Dartmouth Medical School, Department of Pathology, 1 Rope Ferry Road, Hanover, New Hampshire 03755, USA.
J Biomed Opt. 2007 Sep-Oct;12(5):051801. doi: 10.1117/1.2795569.
Noninvasive optical imaging technology has the potential to improve the accuracy of disease detection and predict treatment response. Pathology provides the critical link between the biological basis of an image or spectral signature and clinical outcomes obtained through optical imaging. The validation of optical images and spectra requires both morphologic diagnosis from histopathology and parametric analysis of tissue features above and beyond the declared pathologic "diagnosis." Enhancement of optical imaging modalities with exogenously applied biomarkers also requires validation of the biological basis for molecular contrast. For an optical diagnostic or prognostic technology to be useful, it must be clinically important, independently informative, and of demonstrated beneficial value to patient care. Its usage must be standardized with regard to methods, interpretation, reproducibility, and reporting, in which the pathologist plays a key role. By providing insight into disease pathobiology, interpretive or quantitative analysis of tissue material, and expertise in molecular diagnosis, the pathologist should be an integral part of any team that is validating novel optical imaging modalities. This review will consider (1) the selection of validation biomarkers; (2) standardization in tissue processing, diagnosis, reporting, and quantitative analysis; (3) the role of the pathologist in study design; and (4) reference standards, controls, and interobserver variability.
非侵入性光学成像技术有潜力提高疾病检测的准确性并预测治疗反应。病理学在图像或光谱特征的生物学基础与通过光学成像获得的临床结果之间提供了关键联系。光学图像和光谱的验证既需要组织病理学的形态学诊断，也需要对已声明的病理“诊断”之外的组织特征进行参数分析。用外源性应用的生物标志物增强光学成像模式也需要验证分子对比度的生物学基础。要使一种光学诊断或预后技术有用，它必须在临床上具有重要意义、具有独立的信息价值，并对患者护理具有已证明的有益价值。其使用必须在方法、解释、可重复性和报告方面进行标准化，病理学家在其中起着关键作用。通过深入了解疾病病理生物学、对组织材料进行解释性或定量分析以及提供分子诊断专业知识，病理学家应成为验证新型光学成像模式的任何团队中不可或缺的一部分。本综述将考虑：（1）验证生物标志物的选择；（2）组织处理、诊断、报告和定量分析中的标准化；（3）病理学家在研究设计中的作用；以及（4）参考标准、对照和观察者间变异性。
