A scale of methodological quality for clinical studies of radiologic examinations

PURPOSE: To develop and evaluate a scale for assessment of the methodologic al quality for clinical investigations of radiologic studies. MATERIALS AND METHODS: A scale was developed that included methodological s tandards 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 i maging of liver hemangioma. Interrater reliability was measured between two observers by using percentage agreement and kappa statistics. Interrater r eliability between two observers for a composite quality index that encompa ssed the 15 standards was measured wit the intraclass correlation coefficie nt. RESULTS: Agreement between the two observers was almost perfect (kappa valu e, 0.8-1.0) for 11 standards and substantial (kappa value, 0.74-0.78) for f our standards. Agreement between the observers with regard to the composite quality index also was high (intraclass correlation coefficient r, 0.91 [9 5% CI: 0.87, 0.94]). CONCLUSION: The scale appears to be reliable for the assessment of methodol ogical quality of clinical investigations of radiologic studies.