Vertebral fracture diagnosis in the multinational BONE study of oral ibandronate: quality management in radiology.

A multicenter trial has established the antifracture efficacy of oral daily (2.5mg) as well as intermittent (20mg every other day for 12 doses every 3 mo) ibandronate in women with postmenopausal osteoporosis. As diagnostic spinal radiographs for this trial were read at 2 centers, the study protocol included rigorous procedures for diagnosis of morphometric vertebral fractures. These included standardized qualitative and morphometric assessment methods for diagnosing vertebral osteoporotic fractures and consensus cross-validation procedures for maximizing fracture diagnostic accuracy and consistency between the 2 radiographic reading centers. Using these stringent measures, the between-center discrepancy in the diagnosis of prevalent fractures was only 8%. Furthermore, after cross-validation, discrepancy in the final diagnosis of incident fractures between centers was found for only 4 patients, resulting in a net gain of only 2 fractures in the trial. This meticulous methodology provided a highly effective means of identifying vertebral fractures and recruiting the trial population in which to assess the efficacy of ibandronate in postmenopausal osteoporosis.

Computer based methods for measurement of joint space width: update of an ongoing OMERACT project.

Computer-based methods of measuring joint space width (JSW) could potentially have advantages over scoring joint space narrowing, with regard to increased standardization, sensitivity, and reproducibility. In an early exercise, 4 different methods showed good agreement on measured change in JSW over time in the small joints of the hands and feet. Despite differences in measurement values between methods, measurement of within-joint change over time showed no systematic differences. The within-method variation was small, with intra-operator variation being smaller than inter-operator variation. Although this initial study was limited in terms of the number of patients and timepoints (total 10), the number of joints was relatively high (340 joints), so the results were considered strong evidence supporting the validity of computer-based JSW measurements to continue the study of the potential value of JSW by comparison of measurements to manual scoring of joint space narrowing using the COBRA trial images.

Fixed-flexion radiography of the knee provides reproducible joint space width measurements in osteoarthritis.

The validity of a non-fluoroscopic fixed-flexion radiographic acquisition and analysis protocol for measurement of joint space width (JSW) in knee osteoarthritis is determined. A cross-sectional study of 165 patients with documented knee osteoarthritis participating in a multicenter, prospective study of chondroprotective agents was performed. All patients had posteroanterior, weight-bearing, fixed-flexion radiography with 10 degrees caudal beam angulation. A specially designed frame (SynaFlexer) was used to standardize the positioning. Minimum medial and lateral JSW were measured manually and twice by an automated analysis system to determine inter-technique and intra-reader concordance and reliability. A random subsample of 30 patients had repeat knee radiographs 2 weeks apart to estimate short-term reproducibility using automated analysis. Concordance between manual and automated medial JSW measurements was high (ICC=0.90); lateral compartment measurements showed somewhat less concordance (ICC=0.72). There was excellent concordance between repeated automated JSW measurements performed 6 months apart for the medial (ICC=0.94) and lateral (ICC=0.86) compartments. Short-term reproducibility for the subsample of 30 cases with repeat acquisitions demonstrated an average SD of 0.14 mm for medial JSW (CV=4.3%) and 0.23 mm for lateral JSW (CV=4.0%). Fixed-flexion radiography of the knee using a positioning device provides consistent, reliable and reproducible measurement of minimum JSW in knee osteoarthritis without the need for concurrent fluoroscopic guidance.