Metadata-driven ad hoc query of patient data: meeting the needs of clinical studies.

Clinical study data management systems (CSDMSs) have many similarities to clinical patient record systems (CPRSs) in their focus on recording clinical parameters. Requirements for ad hoc query interfaces for both systems would therefore appear to be highly similar. However, a clinical study is concerned primarily with collective responses of groups of subjects to standardized therapeutic interventions for the same underlying clinical condition. The parameters that are recorded in CSDMSs tend to be more diverse than those required for patient management in non-research settings, because of the greater emphasis on questionnaires for which responses to each question are recorded separately. The differences between CSDMSs and CPRSs are reflected in the metadata that support the respective systems' operation, and need to be reflected in the query interfaces. The authors describe major revisions of their previously described CSDMS ad hoc query interface to meet CSDMS needs more fully, as well as its porting to a Web-based platform.