Data standards for clinical research data collection forms: Current status and challenges

Department of Pediatrics, University of South Florida College of Medicine, Tampa, Florida, USA.
Journal of the American Medical Informatics Association (Impact Factor: 3.5). 05/2011; 18(3):341-6. DOI: 10.1136/amiajnl-2011-000107
Source: PubMed

ABSTRACT Case report forms (CRFs) are used for structured-data collection in clinical research studies. Existing CRF-related standards encompass structural features of forms and data items, content standards, and specifications for using terminologies. This paper reviews existing standards and discusses their current limitations. Because clinical research is highly protocol-specific, forms-development processes are more easily standardized than is CRF content. Tools that support retrieval and reuse of existing items will enable standards adoption in clinical research applications. Such tools will depend upon formal relationships between items and terminological standards. Future standards adoption will depend upon standardized approaches for bridging generic structural standards and domain-specific content standards. Clinical research informatics can help define tools requirements in terms of workflow support for research activities, reconcile the perspectives of varied clinical research stakeholders, and coordinate standards efforts toward interoperability across healthcare and research data collection.

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    • "Recently, several studies have shown semantic and structural limitations of ISO/IEC 11179 [10] [11] [12] [13]. The limitations of ISO/IEC 11179 can be categorized as the following. "
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    ABSTRACT: Achieving semantic interoperability is critical for biomedical data sharing between individuals, organizations and systems. The ISO/IEC 11179 MetaData Registry (MDR) standard has been recognized as one of the solutions for this purpose. The standard model, however, is limited. Representing concepts consist of two or more values, for instance, are not allowed including blood pressure with systolic and diastolic values. We addressed the structural limitations of ISO/IEC 11179 by an integrated metadata object model in our previous research. In the present study, we introduce semantic extensions for the model by defining three new types of semantic relationships; dependency, composite and variable relationships. To evaluate our extensions in a real world setting, we measured the efficiency of metadata reduction by means of mapping to existing others. We extracted metadata from the College of American Pathologist Cancer Protocols and then evaluated our extensions. With no semantic loss, one third of the extracted metadata could be successfully eliminated, suggesting better strategy for implementing clinical MDRs with improved efficiency and utility.
    Studies in health technology and informatics 08/2013; 192:618-21. DOI:10.3233/978-1-61499-289-9-618
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    • "Other reporting systems frequently provide the means of facilitating the form design process by providing ‘form builders’: some of these are simplistic [39]; others treat each form as an indivisible whole [33, 40], preventing comparison and re-use at a data-element or question level. As different conditions, different questions, and even different individuals may be presented with different forms [41], the ability to compare designs at a question level is essential for data re-use and integration. The ability to re-use designs at this level is equally essential for the harmonization of reporting standards and procedures. "
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    ABSTRACT: The European PARTNER project developed a prototypical system for sharing hadron therapy data. This system allows doctors and patients to record and report treatment-related events during and after hadron therapy. It presents doctors and statisticians with an integrated view of adverse events across institutions, using open-source components for data federation, semantics, and analysis. There is a particular emphasis upon semantic consistency, achieved through intelligent, annotated form designs. The system as presented is ready for use in a clinical setting, and amenable to further customization. The essential contribution of the work reported here lies in the novel data integration and reporting methods, as well as the approach to software sustainability achieved through the use of community-supported open-source components.
    Journal of Radiation Research 03/2013; 54. DOI:10.1093/jrr/rrt037 · 1.80 Impact Factor
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    • "Paralleling the growth in CRI prominence, JAMIA has received an increasing number of CRI submissions. In 2010, five published articles were completely focused on CRI,10–14 while in 2011 this number rose to 23,15–37 accounting for 11.5% of all JAMIA articles for that year. There was a special section focused on CRI papers in the December 2011 supplement issue. "
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    ABSTRACT: Clinical research informatics is the rapidly evolving sub-discipline within biomedical informatics that focuses on developing new informatics theories, tools, and solutions to accelerate the full translational continuum: basic research to clinical trials (T1), clinical trials to academic health center practice (T2), diffusion and implementation to community practice (T3), and 'real world' outcomes (T4). We present a conceptual model based on an informatics-enabled clinical research workflow, integration across heterogeneous data sources, and core informatics tools and platforms. We use this conceptual model to highlight 18 new articles in the JAMIA special issue on clinical research informatics.
    Journal of the American Medical Informatics Association 04/2012; 19(e1):e36-e42. DOI:10.1136/amiajnl-2012-000968 · 3.50 Impact Factor
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