A scale of methodological quality for clinical studies of radiologic examinations.

Abstract

To develop and evaluate a scale for assessment of the methodological quality for clinical investigations of radiologic studies. A scale was developed that included methodological standards compiled from established sources for assessing the methodological quality of study designs in clinical research and characteristics related to biases commonly observed in clinical radiologic research. The scale was composed of 15 standards and was tested with the results of 96 studies on imaging of liver hemangioma. Interrater reliability was measured between two observers by using percentage agreement and kappa statistics. Interrater reliability between two observers for a composite quality index that encompassed the 15 standards was measured with the intraclass correlation coefficient. Agreement between the two observers was almost perfect (kappa value, 0.8-1.0) for 11 standards and substantial (kappa value, 0.74-0.78) for four standards. Agreement between the observers with regard to the composite quality index also was high (intraclass correlation coefficient r, 0.91 [95% CI: 0.87, 0.94]). The scale appears to be reliable for the assessment of methodological quality of clinical investigations of radiologic studies.