Abstract
The purpose of this paper is to outline some of the key methodologic issues in designing clinical trials to assess the cost-effectiveness of clinical magnetic resonance imaging (MRI). Because the possible objectives of such trials are so diverse, and the appropriate methodologies correspondingly numerous, no attempt is made to identify a single objective or methodology as appropriate. Rather, this paper should be read as an “options paper,” in which alternative formulations of objectives, outcome measures, study design, and protocol instrumentation are reviewed, with critical discussion of their theoretical strengths and weaknesses, as well as their practical implementability.