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Study Design for Concurrent Development, Assessment, and Implementation of New Diagnostic Imaging Technology¹

¹ From the Program for the Assessment of Radiological Technology (ART Program), Departments of Radiology (M.G.M.H., G.K.) and Epidemiology and Biostatistics (M.G.M.H.), Erasmus University Medical Center Rotterdam, Dr Molewaterplein 50, Room EE2140, 3015 GE Rotterdam, the Netherlands; and the Department of Health Policy and Management, Harvard School of Public Health, Boston, Mass (M.G.M.H.). From the 2000 RSNA scientific assembly. Received January 18, 2001; revision requested February 26; revision received July 3; accepted July 16. Address correspondence to M.G.M.H. (e-mail: hunink@epib.fgg.eur.nl).

View larger version (44K): [in a new window]   Figure 1. Schematic shows the hierarchical approach to development, assessment, and implementation of new diagnostic imaging technology. Dx = diagnosis, Px = prognosis, Rx = therapy.

View larger version (46K): [in a new window]   Figure 2. Diagram illustrates the conflict between performing a hierarchical assessment versus subjective evaluation of new diagnostic imaging technology.

View larger version (37K): [in a new window]   Figure 3. Schematic shows study design for an empirical RCT to compare CT angiography (CTA) with intraarterial DSA (Angio) for pretreatment diagnostic imaging work-up of peripheral arterial disease. After randomization, either CT angiography or intraarterial angiography (in a few cases followed immediately by percutaneous transluminal angioplasty or stent placement [+/-PTA/stent]) is performed. The imaging findings are discussed at the vascular conference. The imaging work-up is required to help determine the optimal treatment: percutaneous transluminal angioplasty, stent placement, bypass surgery, or exercise therapy. The dotted arrows indicate where subjective experience is expected to influence the clinical process. duplex = duplex ultrasonography, +/- = with or without.

View larger version (15K): [in a new window]   Figure 4. Graph shows expected trends in costs of diagnostic work-up and treatment. Patients undergoing the experimental strategy, in this example CT angiography (CTA), may still need additional work-up with the control strategy, intraarterial DSA (Angio). As physicians gain more experience with the new technology over time, additional examinations will probably be required less often, and the costs of the work-up with the experimental strategy will decrease. Patients undergoing the control strategy may require additional work-up, which may, over time, be performed more and more with the experimental strategy.

View larger version (17K): [in a new window]   Figure 5. Graph shows expected trends in confidence in decision making. The physicians’ confidence may be measured by using a rating scale or visual analogue scale. One would expect that their confidence is constant over time for the control strategy (intraarterial DSA [Angio] in this example). For the experimental strategy of CT angiography (CTA), one would expect their confidence initially to be lower than that for the control strategy and to increase over time as they become more familiar with the new technology.

View larger version (18K): [in a new window]   Figure 6. Graph shows the recruitment rate as a function of time since the start of the study. As long as the two strategies are considered equivalent, physicians will be comfortable with patients being randomly assigned to treatment. If, over time, it becomes clear from clinical experience that use of one of the diagnostic imaging strategies is preferable, physicians will be reluctant to recruit patients for the trial. Despite strict inclusion and exclusion criteria, a subtle change in those considered eligible for the trial may take place. A criterion for stopping the study (arrow) could be based on the percentage of potentially eligible patients recruited for the study.

View larger version (28K): [in a new window]   Figure 7. Diagram illustrates the concept of an interwoven, circular, self-organizing approach to development, assessment, and implementation of new diagnostic imaging technology.