Improving the value of clinical research through the use of Common Data Elements.

The use of Common Data Elements can facilitate cross-study comparisons, data aggregation, and meta-analyses; simplify training and operations; improve overall efficiency; promote interoperability between different systems; and improve the quality of data collection. A Common Data Element is a combination of a precisely defined question (variable) paired with a specified set of responses to the question that is common to multiple datasets or used across different studies. Common Data Elements, especially when they conform to accepted standards, are identified by research communities from variable sets currently in use or are newly developed to address a designated data need. There are no formal international specifications governing the construction or use of Common Data Elements. Consequently, Common Data Elements tend to be made available by research communities on an empiric basis. Some limitations of Common Data Elements are that there may still be differences across studies in the interpretation and implementation of the Common Data Elements, variable validity in different populations, and inhibition by some existing research practices and the use of legacy data systems. Current National Institutes of Health efforts to support Common Data Element use are linked to the strengthening of National Institutes of Health Data Sharing policies and the investments in data repositories. Initiatives include cross-domain and domain-specific resources, construction of a Common Data Element Portal, and establishment of trans-National Institutes of Health working groups to address technical and implementation topics. The National Institutes of Health is seeking to lower the barriers to Common Data Element use through greater awareness and encourage the culture change necessary for their uptake and use. As National Institutes of Health, other agencies, professional societies, patient registries, and advocacy groups continue efforts to develop and promote the responsible use of Common Data Elements, particularly if linked to accepted data standards and terminologies, continued engagement with and feedback from the research community will remain important.

Sharing behavioral data through a grid infrastructure using data standards.

OBJECTIVE: In an effort to standardize behavioral measures and their data representation, the present study develops a methodology for incorporating measures found in the National Cancer Institute's (NCI) grid-enabled measures (GEM) portal, a repository for behavioral and social measures, into the cancer data standards registry and repository (caDSR). METHODS: The methodology consists of four parts for curating GEM measures into the caDSR: (1) develop unified modeling language (UML) models for behavioral measures; (2) create common data elements (CDE) for UML components; (3) bind CDE with concepts from the NCI thesaurus; and (4) register CDE in the caDSR. RESULTS: UML models have been developed for four GEM measures, which have been registered in the caDSR as CDE. New behavioral concepts related to these measures have been created and incorporated into the NCI thesaurus. Best practices for representing measures using UML models have been utilized in the practice (eg, caDSR). One dataset based on a GEM-curated measure is available for use by other systems and users connected to the grid. CONCLUSIONS: Behavioral and population science data can be standardized by using and extending current standards. A new branch of CDE for behavioral science was developed for the caDSR. It expands the caDSR domain coverage beyond the clinical and biological areas. In addition, missing terms and concepts specific to the behavioral measures addressed in this paper were added to the NCI thesaurus. A methodology was developed and refined for curation of behavioral and population science data.

Overview of electronic data sharing: why, how, and impact.

Electronic data sharing is a critical, but underappreciated, requirement for modern medical informatics systems. This capability is facilitated by acquisition of structured clinical data, but optimized only if this data is stored and transmitted using standardized representations. Most electronic medical record and clinical trials management systems are poorly suited for data sharing. In the near future, sharing clinical outcome data is likely to become very important, so these capabilities must be improved. In this article, basic concepts of electronic data sharing are reviewed and their use illustrated in a data-sharing project developed to support Hematopoietic Cell Transplantation reporting to a national database.

Bluebottle envenomation-induced crystalline keratopathy.

PURPOSE: To report a patient who developed a crystalline keratopathy after bluebottle envenomation of the cornea. METHOD: Case report with histopathological correlation and literature review. RESULTS: A 61-year-old man presented to the Ophthalmology clinic after he was stung in the left eye by a bluebottle while swimming in the sea. He complained of ocular and facial pain, facial swelling, and transient blurred vision. First aid by the beach included a hot shower and methoxyflurane for the pain. Crystalline deposits and pseudodendritiform epithelial defects were noted on slit-lamp examination. Topical chloramphenicol was prescribed, and 2 days after the injury, the cornea was debrided of persisting crystalline material. The cornea healed quickly after debridement with visual acuity improving from 6/9 to 6/6 in the affected eye. Microscopic examination demonstrated the corneal crystals to be irregularly shaped and nonrefractile with squared off edges. Raman spectroscopy partially identified the crystals as calcium based. CONCLUSIONS: Although bluebottle stings of the cornea are infrequent, they may be challenging to manage. In addition to inactivation of the nematocysts and pain management, early debridement of the foreign matter may aid in the rapid resolution of the symptoms.

A rare unilateral case of ocular mucous membrane pemphigoid.

PURPOSE: Ocular mucous membrane pemphigoid (MMP) is known to be rapidly progressive in younger patients and affects both eyes. We are aware of only one other reported case of unilateral ocular MMP. The case presented in this study is unique in that it demonstrates genuinely unilateral ocular MMP in a younger patient. METHODS: We report a case of a 50-year-old man who presented with a 3-month history of left eye redness, irritation, and mild discharge. He also suffered from mouth ulcers, skin lesions, and recurrent nose bleeds secondary to nasal mucosal lesions. RESULTS: Examination revealed unilateral lid granulomas and cicatricial conjunctivitis in his left eye. There were no abnormal findings in his right eye. Biopsy of the lesions showed nonspecific inflammation with positive immunofluorescence for immunoglobulin G and C3 on epithelial basement membranes of conjunctiva, buccal mucosa, and skin, which were consistent with MMP. He was treated with immunosuppression and had no disease progression at 12-month follow-up. CONCLUSIONS: This represents a rare case of unilateral nonprogressive ocular MMP in a younger patient. Histological analysis and immunofluorescence testing excluded a neoplastic process and confirmed the diagnosis. This case demonstrates that the presentation of unilateral eyelid pyogenic granulomas should include ocular MMP in the differential diagnosis once a neoplastic process has been excluded.

Synchronous radiation-induced orbital meningioma and multiple cavernomas.

Synchronous radiation-induced tumours are extremely rare. We present the first reported case of synchronous radiation-induced orbital meningioma and cavernomas of the cerebellum and bilateral basal ganglia, presenting 16 years after ionizing radiation therapy for parietal anaplastic ependymoma, at the age of five. This case again underscores the risks of radiotherapy to children.

caCORE version 3: Implementation of a model driven, service-oriented architecture for semantic interoperability.

One of the requirements for a federated information system is interoperability, the ability of one computer system to access and use the resources of another system. This feature is particularly important in biomedical research systems, which need to coordinate a variety of disparate types of data. In order to meet this need, the National Cancer Institute Center for Bioinformatics (NCICB) has created the cancer Common Ontologic Representation Environment (caCORE), an interoperability infrastructure based on Model Driven Architecture. The caCORE infrastructure provides a mechanism to create interoperable biomedical information systems. Systems built using the caCORE paradigm address both aspects of interoperability: the ability to access data (syntactic interoperability) and understand the data once retrieved (semantic interoperability). This infrastructure consists of an integrated set of three major components: a controlled terminology service (Enterprise Vocabulary Services), a standards-based metadata repository (the cancer Data Standards Repository) and an information system with an Application Programming Interface (API) based on Domain Model Driven Architecture. This infrastructure is being leveraged to create a Semantic Service-Oriented Architecture (SSOA) for cancer research by the National Cancer Institute's cancer Biomedical Informatics Grid (caBIG).