Title |
Design of case report forms based on a public metadata registry: re-use of data elements to improve compatibility of data
|
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Published in |
Trials, November 2016
|
DOI | 10.1186/s13063-016-1691-8 |
Pubmed ID | |
Authors |
Martin Dugas |
Abstract |
Clinical trials use many case report forms (CRFs) per patient. Because of the astronomical number of potential CRFs, data element re-use at the design stage is attractive to foster compatibility of data from different trials. The objective of this work is to assess the technical feasibility of a CRF editor with connection to a public metadata registry (MDR) to support data element re-use. Based on the Medical Data Models portal, an ISO/IEC 11179-compliant MDR was implemented and connected to a web-based CRF editor. Three use cases were implemented: re-use at the form, item group and data element levels. CRF design with data element re-use from a public MDR is feasible. A prototypic system is available. The main limitation of the system is the amount of available MDR content. |
X Demographics
Geographical breakdown
Country | Count | As % |
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Spain | 1 | 25% |
Portugal | 1 | 25% |
Unknown | 2 | 50% |
Demographic breakdown
Type | Count | As % |
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Members of the public | 3 | 75% |
Practitioners (doctors, other healthcare professionals) | 1 | 25% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 26 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
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Researcher | 9 | 35% |
Other | 3 | 12% |
Student > Ph. D. Student | 2 | 8% |
Student > Bachelor | 1 | 4% |
Librarian | 1 | 4% |
Other | 1 | 4% |
Unknown | 9 | 35% |
Readers by discipline | Count | As % |
---|---|---|
Computer Science | 5 | 19% |
Medicine and Dentistry | 5 | 19% |
Pharmacology, Toxicology and Pharmaceutical Science | 2 | 8% |
Nursing and Health Professions | 2 | 8% |
Social Sciences | 2 | 8% |
Other | 3 | 12% |
Unknown | 7 | 27% |