Long-term experience with setup and implementation of an IHE-based image management and distribution system in intersectoral clinical routine.

PURPOSE: Sharing of medical data is crucial for the proper treatment of patients as it could reduce the risk of duplicated medical tests and speed up the care process if all documents are readily available. Despite great technical progress, sharing patient data while maintaining full control over the process in an intersectoral (in Germany, this describes the different actors in the healthcare system consisting of clinic, ambulatory care, etc.) setting remains a particular challenge. This paper focuses on the successful implementation of a privacy compliant, standards-based image-management component of a personal electronic health record. METHODS: Over a 5-year period, a sharing system based on readily available IHE profiles constructed around XDS has been built. It was necessary to create interfaces for the existing hospital sub-systems to become part of the network. Specifically, the imaging workflow had to be adapted to allow for fast and easy access to DICOM images utilizing a flexible web-based image viewer. In addition to the standard XDS workflow, an Imaging Cache was established which combines the Imaging Document Source and Consumer to guarantee fast and streaming-based access to all images in the network observing the high security standards of the hospital network. RESULTS: The authors of this paper have proven that it is possible to build a fast and reliable sharing system based on IHE profiles using most of the transactions of XDS-I with some adaptions to the clinical workflow. Primary hospital systems were enabled by building adapters to overcome lack of IHE compatibility. The established system embraces the existing security mechanisms in hospital networks while connecting patients and referring physicians from outside in a secure and convenient manner. CONCLUSIONS: A state-of-the-art sharing system that is used in a productive clinical environment has been established and is ready to grow with more partners. The system is the basis for an elaborated interdisciplinary collaboration where data, and in particular images, can now be shared between medical professionals.

Modeling Interoperable Information Systems with 3LGM² and IHE.

BACKGROUND: Strategic planning of information systems (IS) in healthcare requires descriptions of the current and the future IS state. Enterprise architecture planning (EAP) tools like the 3LGM² tool help to build up and to analyze IS models. A model of the planned architecture can be derived from an analysis of current state IS models. Building an interoperable IS, i. e. an IS consisting of interoperable components, can be considered a relevant strategic information management goal for many IS in healthcare. Integrating the healthcare enterprise (IHE) is an initiative which targets interoperability by using established standards. OBJECTIVES: To link IHE concepts to 3LGM² concepts within the 3LGM² tool. To describe how an information manager can be supported in handling the complex IHE world and planning interoperable IS using 3LGM² models. To describe how developers or maintainers of IHE profiles can be supported by the representation of IHE concepts in 3LGM². METHODS: Conceptualization and concept mapping methods are used to assign IHE concepts such as domains, integration profiles actors and transactions to the concepts of the three-layer graph-based meta-model (3LGM²). RESULTS: IHE concepts were successfully linked to 3LGM² concepts. An IHE-master-model, i. e. an abstract model for IHE concepts, was modeled with the help of 3LGM² tool. Two IHE domains were modeled in detail (ITI, QRPH). We describe two use cases for the representation of IHE concepts and IHE domains as 3LGM² models. Information managers can use the IHE-master-model as reference model for modeling interoperable IS based on IHE profiles during EAP activities. IHE developers are supported in analyzing consistency of IHE concepts with the help of the IHE-master-model and functions of the 3LGM² tool CONCLUSION: The complex relations between IHE concepts can be modeled by using the EAP method 3LGM². 3LGM² tool offers visualization and analysis features which are now available for the IHE-master-model. Thus information managers and IHE developers can use or develop IHE profiles systematically. In order to improve the usability and handling of the IHE-master-model and its usage as a reference model, some further refinements have to be done. Evaluating the use of the IHE-master-model by information managers and IHE developers is subject to further research.

Electronically signed documents in health care--analysis and assessment of data formats and transformation.

OBJECTIVES: Our objectives were to analyze and assess data formats for their suitability for conclusive and secure long-term archiving and to develop a concept for legally secure transformation of electronically signed documents that are not available in data formats appropriate for long-term archiving. METHODS: On the basis of literature review and Internet searches we developed general evaluation criteria to assess data formats with regard to their suitability for conclusive and secure long-term archiving. The assessment of data formats refers to format specifications and available literature. For the analyses of the transformation of signed documents we analyzed legal requirements on the basis of laws and ordinances as well as technical requirements by means of literature reviews, Internet searches and technical specifications. RESULTS: The following evaluation criteria are suited for this kind of assessment of data formats: transparency and standardization, stability, presentation and security. According to our assessment the following data formats are most suitable for conclusive and secure long-term archiving: PDF for formatted and unstructured text documents, XML for markup languages, TIFF for images in general, DICOM for medical images and S/MIME for the storage of e-mail. To transform electronically signed documents we propose an elementary procedure and universal basic model in form of an XML schema definition that includes the necessary legal and technical information. CONCLUSIONS: If electronic documents are to replace paper-based documents in patient records, they have to conform to the criteria for secure long-term archiving. The analyzed data formats are to be extended by mechanisms to guarantee the long-term security of electronic signatures. To transform large quantities of documents in a legally secure way, our basic model has to be extended for automated procedures.

Towards clinical bioinformatics: advancing genomic medicine with informatics methods and tools.

OBJECTIVES: To summarize the challenges facing clinical applications in the light of growing research results in genomic medicine and bioinformatics. METHODS: Analysis of the contents of the Yearbook of Medical Informatics 2004 of the International Medical Informatics Association (IMIA). RESULTS: The Yearbook of Medical Informatics 2004 includes 32 articles selected from 22 peer-reviewed scientific journals. A special section on clinical bioinformatics highlights recent developments in this field. Several guest editors review the promises and limitations of available methods and resources from biomedical informatics that are relevant to clinical medicine. Integrated data and knowledge resources are generally regarded to be central and key issues for clinical bioinformatics. Further review papers deal with public health implications of bioinformatics, knowledge management and trends in health care education. The Yearbook includes for the first time a section on the history of medical informatics, where the significant impact of the Reisensburg protocol 1973 on international health and medical informatics education is examined. CONCLUSIONS: Close collaboration between bioinformatics and medical informatics researchers can contribute to new insights in genomic medicine and contribute towards the more efficient and effective use of genomic data to advance clinical care.

Data security and protection in cross-institutional electronic patient records.

This paper aims at identifying the specific legal requirements concerning data security and data protection of patient health data that apply to a cross-institutional electronic patient record (EPR) and describes possible solutions for meeting these requirements. In Germany, the legal framework for such records provide that disclosure of patient health information to physicians of third-party institutions is only allowed in case that it is necessary for the joint treatment of the patient, i.e. in case of a "treatment connection". As a first step, the functionality of a remote-access architecture was proven allowing a one-way connection between the EPR systems of two health institutions in Germany, which jointly treat tumor patients. Besides, a signature system model for ensuring the integrity and authenticity of medical documents was developed and implemented in the existing information system architecture of the University Medical Center of Heidelberg. Especially in Germany, the legal framework for cross-institutional EPRs is very complex and has a considerable influence on the development and implementation of cross-institutional EPRs. However, its introduction is thought to be valuable, since a cross-institutional EPR will improve communication within shared care processes, and thus improve the quality of patient care.

Medical informatics and the quality of health: new approaches to support patient care - findings from the IMIA Yearbook of Medical Informatics 2003.

OBJECTIVES: The Yearbook of Medical Informatics is published annually by the International Medical Informatics Association (IMIA) and contains a selection of excellent papers on medical informatics research which have been recently published (http://www. yearbook.uni-hd.de). The 2003 Yearbook of Medical Informatics took as its theme the role of medical informatics for the quality of health care. In this paper, we will discuss challenges for health care, and the lessons learned from editing IMIA Yearbook 2003. RESULTS AND CONCLUSIONS: Modern information processing methodology and information and communication technology have strongly influenced our societies and health care. As a consequence of this, medical informatics as a discipline has taken a leading role in the further development of health care. This involves developing information systems that enhance opportunities for global access to health services and medical knowledge. Informatics methodology and technology will facilitate high quality of care in aging societies, and will decrease the possibilities of health care errors. It will also enable the dissemination of the latest medical and health information on the web to consumers and health care providers alike. The selected papers of the IMIA Yearbook 2003 present clear examples and future challenges, and they highlight how various sub-disciplines of medical informatics can contribute to this.

Electronic signature for medical documents--integration and evaluation of a public key infrastructure in hospitals.

OBJECTIVES: Our objectives were to determine the user-oriented and legal requirements for a Public Key Infrastructure (PKI) for electronic signatures for medical documents, and to translate these requirements into a general model for a signature system. A prototype of this model was then implemented and evaluated in clinical routine use. METHODS: Analyses of documents, processes, interviews, observations, and of the available literature supplied the foundations for the development of the signature system model. Eight participants of the Department of Dermatology of the Heidelberg University Medical Center evaluated the implemented prototype from December 2000 to January 2001, during the course of an intervention study. By means of questionnaires, interviews, observations and database analyses, the usefulness and user acceptance of the electronic signature and its integration into electronic discharge letters were established. RESULTS: Since the major part of medical documents generated in a hospital are signature-relevant, they will require electronic signatures in the future. A PKI must meet the multitude of responsibilities and security needs required in a hospital. Also, the signature functionality must be integrated directly into the workflow surrounding document creation. A developed signature model, fulfilling user-oriented and legal requirements, was implemented using hard and software components that conform to the German Signature Law. It was integrated into the existing hospital information system of the Heidelberg University Medical Center. At the end of the intervention study, the average acceptance scores achieved were mean = 3.90; SD = 0.42 on a scale of 1 (very negative attitude) to 5 (very positive attitude) for the electronic signature procedure. Acceptance of the integration into computer-supported discharge letter writing reached mean = 3.91; SD = 0.47. On average, the discharge letters were completed 7.18 days earlier. CONCLUSION: The electronic signature is indispensable for the further development of electronic patient records. Application-independent hard and software components, in accordance with the signature law, must be integrated into electronic patient records, and provided to certification services using standardized interfaces. Signature-oriented workflow and document management components are essential for user acceptance in routine clinical use.

[First continuous nerve monitoring in thyroid gland surgery]. / Erstes kontinuierliches Nerven-Monitoring in der Schilddrüsenchirurgie.

UNLABELLED: A new "all in one" sensing device was developed for continuous transtracheal intraoperative monitoring and in situ detection of the recurrent laryngeal nerve (RLN) during thyroid surgery. PATIENTS AND METHODS: The new system is based on a double-balloon endotracheal tube with integrated atraumatic stimulating and tracing electrodes. The recurrent laryngeal nerve is stimulated transtracheally and compound action potentials are recorded from the laryngeal muscles. Fifty-five patients were introduced into a phase-one clinical trial. Thirty-five patients with primary thyroid operations, 20 patients with reoperations, 10 of whom had neck dissections. All patients were evaluated laryngoscopically and phoniatrically by an ENT specialist before and after surgery. RESULTS: Compound muscle action potentials were recorded continuously during the whole operation and responded sensitively to tension and pressure to the nerve. There were no accidental permanent RLN palsies. CONCLUSION: The new system offers five advantages: (1) it is atraumatic; (2) it is easy to use; (3) it can monitor continuously with an audio feedback to the surgeon; (4) it works outside the operation field; and (5) it is highly sensitive, even indicating reversible irritation to the nerve.

[Continuous monitoring of the recurrent laryngeal nerve]. / Kontinuierliches Monitoring des Nervus laryngeus recurrens.

A new "all in one" sensing device for tracing and continuous intraoperative monitoring of the recurrent laryngeal nerve during thyroid surgery is described. The system, based on a double ballooned endotracheal tube, is atraumatic, easy to use and sensitive even to imminent trauma to the nerves. The most striking feature of this instrument is that it operates outside the sterile operating field and truly monitors continuously throughout the operation.

Properties and ontogenic development of membrane-bound histidine decarboxylase from rat brain.

Histidine decarboxylase (HD) activity was determined in high-speed fractions (100,000 g for 60 min) obtained from whole rat brain homogenates. Twenty-eight percent of the HD activity was associated with membranes, and the remaining was soluble. Several properties of the soluble and membrane-bound HD were compared. No significant differences in the values of Km for histidine and pyridoxal 5'-phosphate were observed. The solubilization of membrane-bound HD with Triton X-100 resulted in an increase of 60% over the nonsolubilized activity with no changes in the Km for substrate and cofactor. The proportion of free pyridoxal 5'-phosphate-independent activity was identical in both fractions. The soluble and membrane-bound forms of the enzyme differ slightly in their pH-activity profiles, although both enzymes showed an optimum pH near 6.5. The HD activities present in soluble and membrane fractions were determined at different postnatal ages. The soluble activity increased until day 90, whereas the membrane-bound activity became stabilized from day 20.

Histamine stimulated synaptosomal Ca2+ uptake through activation of calcium channels.

Histamine stimulated Ca2+ uptake in synaptosomes was completely inhibited by the slow Ca2+ channel antagonists verapamil, cinnarizine and flunarizine, and slightly inhibited by nifedipine and diltiazem. Ca2+ uptake in synaptosomes depolarized or predepolarized with varying K+ concentrations was increased by histamine, in both conditions, until 30mM K+. At higher K+ concentrations histamine was not able to alter K+ effects in either conditions. 30mM K+ stimulated uptake of Ca2+ in the absence or presence of histamine was not inhibited by verapamil and diltiazem. However nifedipine slightly inhibited K+ and K+ +histamine effects. 3-Isobutyl-1-methyl-xanthine and dibutyryl cyclicAMP potentiated (10%) the uptake of Ca2+ in synaptosomes induced by histamine. Dibutyryl cyclicAMP alone however decreased the basal Ca2+ uptake in a concentration-dependent manner. Verapamil, but not diltiazem, antagonized the effects elicited by 3-isobutyl-1-methyl-xanthine and dibutyryl cyclicAMP in the presence of histamine. The data suggest that the increase in synaptosomal Ca2+ uptake induced by histamine is mediated by the activation of the voltage sensitive calcium channels, and possibly a cyclicAMP-dependent protein kinase phosphorylation can modulate the opening of Ca2+ channels.

Histamine H2-receptor mediated activation of neonatal rat brain ornithine decarboxylase in vivo.

The effect of histamine (HA) administered via intracerebroventricular injection on ornithine decarboxylase (ODC) activity was studied in neonatal rat brain. The HA effect was dose and time dependent. Maximal increase in ODC activity was achieved 2 hr after administration of 10 micrograms HA (38% over control levels). Impromidine (HA H2-agonist) mimicked the effect of HA on ODC and ranitidine (HA H2-antagonist) inhibited the response to HA. Neither 2-thiazolylethylamine (HA H1-agonist) nor mepyramine (HA H1-antagonist) modified control ODC activity. The HA-releasers, compound 48/80 and polymixin B sulfate, elicited an increase in brain ODC activity of 35% and 32%, respectively, over the control value.

Subcellular localization of brain mast cell histamine in developing rat.

The intracerebroventricular administration of compound 48/80 or polymixin B to rats 0 to 60 days old, produced a decrease both in the histamine which sediments in the crude nuclear fraction, as well as in the number of mast cells in the brain. In contrast, the histamine-releasers did not affect histamine levels in subcellular fractions where neuronal histamine is found. Once released, histamine disappeared rapidly (t 1/2 = 3.8 min). In untreated animals and in those treated with histamine releasers, the number of mast cells/g in the whole brains of developing rats and in the cerebral regions of adult rats showed a close correlation with the histamine levels in the crude nuclear fraction. The content of histamine per mast cell in adult rat brain was estimated to be about 13 pg/cell. Histologic examination of the subcellular fractions revealed the presence of intact mast cells in the crude nuclear fraction obtained from untreated animals, and of degranulated mast cells in the same fraction obtained from animals treated with histamine releasers. The mast cell contribution to adult rat brain histamine levels was about 22%. Our results strongly support that most of the histamine which sediments in the crude nuclear fraction of the rat brain is located in mast cells. Determination of histamine in the crude nuclear fraction and in the supernatant of this fraction is proposed as an easy way for identifying the cellular pool altered by any treatment affecting brain histamine levels.