Standardization of Central Off-Line Quantitative Image Analysis: Implications from Experiences with Quantitative Coronary Angiography

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Abstract
Developments in both medical equipment and software provide the opportunity to obtain more detailed, and in many instances direct digital images, i.e. not using film or video, that can be used for off-line quantitative analysis. As a result, the use of imaging data besides clinical data as a primary end point in clinical trials has nowadays become more acceptable. However, whereas clinical laboratories have been standardized worldwide according to prespecified criteria, standardization of core laboratories conducting centralized off-line quantitative analysis is still lacking. Here, we describe the procedures and guidelines to be followed to standardize off-line analysis in quantitative coronary arteriography. By using a set of standard images and phantoms, the compliance of a core laboratory with respect to these requirements and the acceptable range of interobserver variability can be verified on a regular basis. This will improve the overall quality of a study and, even more importantly, the patient outcome.