Executive Summary
A clinical research information model (CRIM) is presented for the integration of clinical research covering randomized clinical trials (RCT), case-control studies and database searches into the TRANSFoRm application development. TRANSFoRm clinical research is based on primary care data, clinical data and genetic data stored in databases and electronic health records and employs the principle of reusing primary care data, adapting data collection by patient reported outcomes (PRO) and eSource based Case Report Forms. CRIM was developed using the TRANSFoRm clinical use cases of GORD and Diabetes [1]. Our use case driven approach [2] consisted of three levels of modelling drawing heavily on the clinical research workflow of the use cases. Different available information models were evaluated for their usefulness to represent TRANSFoRm clinical research, including for example CTOM of caBIG, Primary Care Research Object Model (PRCOM) [3] of ePCRN and BRIDG of CDISC. The PCROM model turned out to be the most suitable and it was possible to extend and modify this model with only 12 new information objects, 3 episode of care related objects and 2 areas to satisfy all requirements of the TRANSFoRm research use cases. Now the information model covers GCP compliant research, as well as case control studies and database search studies, including the interaction between patient and GP (family doctor) during patient consultation, appointment, screening, patient recruitment and adverse event reporting.
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The extension of PCROM was achieved by introducing two high-ranking concepts (areas) into the information model: a care and an ENTRY area. Because some of the research operations take place in the overlapping area of care and non-care activities (e.g. patient consultation and recruitment), a new area for care-related research activities was introduced including episode of care and encounter as basic elements. In the ENTRY area different aspects of data collection are addressed and combined, like the data semantics for observations, assessment activities, intervention activities and patient reporting.
Because the querying of databases plays an important part in the TRANSFoRm research infrastructure and is a prerequisite of patient recruitment and case-control studies, the information model was extended to cover the information requirements for the development of the query tool. The eligibility concept of the model was expanded by an integrated Eligibility Criteria Model (ECM) that specifies the information constraints on the formulation of inclusion / exclusion criteria. A novel combination of Filter and Comparator was introduced for the design of queries for inclusion and exclusion criteria enabling the expression of complex temporal relationships.
The developed CRIM informs the TRANSFoRm provenance, security and interoperability frameworks. It will directly impact the Reference Terminologies and the development of study protocols. In conjunction with the Clinical Data Integration Model (CDIM), CRIM will be used within the TRANSFoRm workbench, for the Query tool and the eCRF tool.
Report Details
Authors: W. Kuchinke, T. Karakoyun, C. Ohmann, (UDUS)
