Operationalization of the UFuRT methodology for usability analysis in the clinical research data management domain

Data management software applications specifically designed for the clinical research environment are increasingly available from commercial vendors and open-source communities, however, general-purpose spreadsheets remain widely employed in clinical research data management (CRDM). The suitability of spreadsheets for this use is controversial, and no formal comparative usability evaluations have been performed. We report on an application of the UFuRT (user, function, representation, and task (analyses) methodology to create a domain-specific process for usability evaluation. We demonstrate this process in an evaluation of differences in usability between a spreadsheet program (Microsoft® Excel) and a commercially available clinical research data management system (Phase Forward Clintrial™). Through this domain-specific operationalization of UFuRT methodology, we successfully identified usability differences and quantified task and cost differences, while differentiating these from socio-technical aspects. UFuRT can be generalized to other domains.