Temporal query of attribute-value patient data: utilizing the constraints of clinical studies

We describe an interface and architecture for ad hoc temporal query of TrialDB, a clinical study data management system (CSDMS). A clinical study focuses primarily on the effect of therapy on a group of patients, who have individually enrolled in a study at different times. Relative times (chronological offsets from the time of enrollment) are therefore more useful than absolute times when collectively describing therapeutic or adverse events. For logistic reasons, study parameter values are typically recorded at fixed relative times (‘study events’), which serve as time-stamps and can be used by CSDMS temporal query algorithms to simplify temporal computations. The entity-attribute-value model of clinical data storage, used by both CSDMSs and clinical patient record systems, complicates temporal query. To apply temporal operators, data for parameters of interest must first be transiently converted into conventional relational form, with one column per parameter.