Study design for concurrent development, assessment, and implementation of new diagnostic imaging technology.

With current constraints on health care resources and emphasis on value for money, new diagnostic imaging technologies must be assessed and their value demonstrated. The state of the art in the field of diagnostic imaging technology assessment advocates a hierarchical step-by-step approach. Although rigorous, such a hierarchical assessment is time-consuming, and, given the current rapid advances in technology, results are often too late to influence management and policy decisions. The purpose of this article is to discuss a study design in which development, assessment, and implementation of new diagnostic imaging technology take place concurrently in one integrated process. An empirically based pragmatic study design is proposed for imaging technology assessment. To minimize bias and enable comparison with current technology, a randomized controlled design is used whenever feasible and ethical. Outcome measures should reflect the clinical decision-making process based on imaging information and acceptance of the new test. Outcome measures can include additional imaging studies requested, costs of diagnostic work-up and treatment, physicians' confidence in therapeutic decision making, recruitment rate, and patient outcome measures related to the clinical problem. The key feature of the proposed study design is analysis of trends in outcome measures over time.