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Integrated web-based viewing and secure remote access to a clinical data repository and diverse clinical systems.

The advent of the World-Wide-Web protocols and client-server technology has made it easy to build low-cost, user-friendly, platform-independent graphical user interfaces to health information systems and to integrate the presentation of data from multiple systems. The authors describe a Web interface for a clinical data repository (CDR) that was moved from concept to production status in less than six months using a rapid prototyping approach, multi-disciplinary development team, and off-the-shelf hardware and software. The system has since been expanded to provide an integrated display of clinical data from nearly 20 disparate information systems.

Computer Graphics↗

Purdue ionomics information management system. An integrated functional genomics platform.

The advent of high-throughput phenotyping technologies has created a deluge of information that is difficult to deal with without the appropriate data management tools. These data management tools should integrate defined workflow controls for genomic-scale data acquisition and validation, data storage and retrieval, and data analysis, indexed around the genomic information of the organism of interest. To maximize the impact of these large datasets, it is critical that they are rapidly disseminated to the broader research community, allowing open access for data mining and discovery. We describe here a system that incorporates such functionalities developed around the Purdue University high-throughput ionomics phenotyping platform. The Purdue Ionomics Information Management System (PiiMS) provides integrated workflow control, data storage, and analysis to facilitate high-throughput data acquisition, along with integrated tools for data search, retrieval, and visualization for hypothesis development. PiiMS is deployed as a World Wide Web-enabled system, allowing for integration of distributed workflow processes and open access to raw data for analysis by numerous laboratories. PiiMS currently contains data on shoot concentrations of P, Ca, K, Mg, Cu, Fe, Zn, Mn, Co, Ni, B, Se, Mo, Na, As, and Cd in over 60,000 shoot tissue samples of Arabidopsis (Arabidopsis thaliana), including ethyl methanesulfonate, fast-neutron and defined T-DNA mutants, and natural accession and populations of recombinant inbred lines from over 800 separate experiments, representing over 1,000,000 fully quantitative elemental concentrations. PiiMS is accessible at www.purdue.edu/dp/ionomics.

Arabidopsis↗

Policies for study monitoring and interim reporting of results.

Interim analyses of comparative trials are necessary in order to monitor for extreme therapeutic results. However, closing studies and reporting results whenever "trends" appear increases the probability of a false conclusion to well over the desired .05 level. Guidelines for early stopping of comparative trials must be carefully defined to avoid this problem. In addition, to avoid inappropriate early closure of studies due to declining accrual (as investigators draw their own conclusions from early unreliable data), it is recommended that access to interim data be limited to a multidisciplinary monitoring committee responsible for (1) performing and reviewing interim analyses, and (2) deciding when early termination should be considered. Accrual and reporting of studies from two clinical trials groups, one with a policy of limited access to interim data and one without, are compared. The group without monitoring committees had a higher incidence of accrual and reporting problems than the group with monitoring committees.

Clinical Trials as Topic↗

caCORE: a common infrastructure for cancer informatics.

MOTIVATION: Sites with substantive bioinformatics operations are challenged to build data processing and delivery infrastructure that provides reliable access and enables data integration. Locally generated data must be processed and stored such that relationships to external data sources can be presented. Consistency and comparability across data sets requires annotation with controlled vocabularies and, further, metadata standards for data representation. Programmatic access to the processed data should be supported to ensure the maximum possible value is extracted. Confronted with these challenges at the National Cancer Institute Center for Bioinformatics, we decided to develop a robust infrastructure for data management and integration that supports advanced biomedical applications. RESULTS: We have developed an interconnected set of software and services called caCORE. Enterprise Vocabulary Services (EVS) provide controlled vocabulary, dictionary and thesaurus services. The Cancer Data Standards Repository (caDSR) provides a metadata registry for common data elements. Cancer Bioinformatics Infrastructure Objects (caBIO) implements an object-oriented model of the biomedical domain and provides Java, Simple Object Access Protocol and HTTP-XML application programming interfaces. caCORE has been used to develop scientific applications that bring together data from distinct genomic and clinical science sources. AVAILABILITY: caCORE downloads and web interfaces can be accessed from links on the caCORE web site (http://ncicb.nci.nih.gov/core). caBIO software is distributed under an open source license that permits unrestricted academic and commercial use. Vocabulary and metadata content in the EVS and caDSR, respectively, is similarly unrestricted, and is available through web applications and FTP downloads. SUPPLEMENTARY INFORMATION: http://ncicb.nci.nih.gov/core/publications contains links to the caBIO 1.0 class diagram and the caCORE 1.0 Technical Guide, which provide detailed information on the present caCORE architecture, data sources and APIs. Updated information appears on a regular basis on the caCORE web site (http://ncicb.nci.nih.gov/core).

Animals↗

Unifying heterogeneous distributed clinical data in a relational database.

Access to clinical data which are distributed among multiple satellite information systems is crucial to delivering better care and reducing costs in many hospitals and medical centers. An integrated view of these data is needed to reduce the effort of users requiring data from multiple systems. We have addressed the issue of distributed data integration while developing both production and research decision-support applications. We describe an ideal integration solution, obstacles to realizing this solution, and our integration requirements and architecture. Our focus is a description of our specific schema and data integration techniques. We conclude with an analysis of our approach.

Computer Communication Networks↗

Using HL7 and the World Wide Web for unifying patient data from remote databases.

W3-EMRS is an architecture designed to access clinical data from remote heterogeneous electronic medical record system (EMRS) databases. We describe the technologies used in an experimental implementation of W3-EMRS that concurrently collects data from several sources and presents them in an integrated set of views. After describing some of the organizational constraints, the architectural decision, implementation methodology, and operation of the completed project are discussed.

Computer Communication Networks↗

Confidentiality, 'no blame culture' and whistleblowing, non-physician practice and accountability.

Confidentiality is a core tenet of medical professionalism, which enables the maintenance of trust in a doctor-patient relationship. However, both the amount of personal data stored and the number of third parties who might access this data have increased dramatically in the digital age, necessitating the introduction of various national data protection acts. Paradoxically, the Freedom of Information Act 2000 allows United Kingdom citizens to access information held by public bodies, including hospitals. Furthermore, the Public Interest Disclosure Act 1998 actively protects physicians who breach their duty of confidentiality in the name of public interest ('whistleblowing'). This article explores the evolution of the law and ethics in this area, and draws attention to the difficulties in balancing confidentiality against freedom of information. In addition, the role and responsibilities of the non-physician anaesthetist are examined.

Anesthesiology↗

[Sensor-based detection of skull positioning for image-guided cranial navigation under free head mobility].

PURPOSE: Although computer- and image-guided surgical procedures are an improvement of frame-guided stereotaxy, many navigation systems still require rigid fixation of the patient's head throughout the operation. This study describes the clinical application of a technical modification that enables cranial navigation with "free head mobility" using CT and MR images as well as the calculated 3-D reconstruction models. MATERIAL AND METHODS: A sensor-based electromagnetic neuronavigation system was expanded to allow the localization and position monitoring of several sensors within an electromagnetic field. One of these sensors was attached to a dental splint as an additional reference (DRF = dynamic reference frame). Thus, it was possible to determine the position of the sensor-guiding surgical instruments and to record the slightest movement of the cranium as well. This information was then used to continuously adapt the position of the imaging plane and the resultant calculated 3-D reconstructions to the actual position of the cranium. RESULTS: The clinical application of the DRF was tested for different neurosurgical procedures. They included image-guided biopsies and endoscopic interventions using MRI data, transnasal accesses to the base of the skull using CT data and surgical removal of multilocular metastases using data from both imaging modalities. Intracranial target reference points as well as those on the skull were found with a high accuracy to the initial measurement position after arbitrary movement of the patient's head. Thus, navigation was also possible without rigid fixation of the head because of the continuous adaptation of the imaging data on the change in position of the patient's head. CONCLUSION: Based on these first test results, a high clinical potential for DRF application in cranial navigation is to be expected. The aim of DRF is to dispense with the rigid fixation of the patient's head. This increases the application scope of image-guided navigation procedures to include, for example, any bioptic or endoscopic intervention, in which rigid pin fixation of the cranium is not required or desired. For all other procedures, continuous position monitoring by DRF ensures automatic correction of imaging data with mechanical alteration of the head position.

Brain Diseases↗

Distal revascularization-interval ligation: a durable and effective treatment for ischemic steal syndrome after hemodialysis access.

PURPOSE: The treatment of hemodialysis access-induced ischemic steal syndrome is challenging. Despite promising early results with the distal revascularization-interval ligation (DRIL) procedure, the operation has not been widely adopted because of concerns about its complexity and long-term efficacy. The purpose of this report was to determine the efficacy and durability of the DRIL procedure in relieving hand ischemia and in maintaining access patency in the setting of hemodialysis access-induced ischemia. METHODS: A retrospective review was performed of all patients who underwent the DRIL procedure for access-induced ischemia. Demographic information was compiled, as were data regarding access and bypass patency, limb salvage, and patient survival. Arteriovenous access and brachial artery bypass patency rates were determined with life-table methods. RESULTS: Between 1995 and 2001, we performed 55 DRIL procedures in 52 patients (35 women and 17 men; mean age, 60.8 years; range, 30 to 86 years). The indications for surgery were ischemic pain in 27 patients, tissue loss in 20 patients, loss of neurologic function in four patients, and pain on hemodialysis in one patient. Most patients (92%) had diabetes. The mean interval from access placement to DRIL was 7.4 months (range, 1 to 84 months). The mean follow-up interval was 16 months (range, 1 to 67 months). The brachial artery bypass primary patency rate was 80% at 4 years, and the arteriovenous access primary patency rate was 83% at 1 year. Forty-seven of 52 patients (90%) had substantial or complete relief of ischemic hand symptoms, and 15 of 20 patients with digital ischemic lesions have healed completely. CONCLUSION: DRIL is a durable and effective procedure that reliably accomplishes the twin goals in the treatment of angioaccess-induced ischemia: persistent relief of hand ischemia and continued access patency.

Adult↗