Clinical Data Reuse or Secondary Use: Current Status and Potential Future Progress.

Objective: To perform a review of recent research in clinical data reuse or secondary use, and envision future advances in this field. Methods: The review is based on a large literature search in MEDLINE (through PubMed), conference proceedings, and the ACM Digital Library, focusing only on research published between 2005 and early 2016. Each selected publication was reviewed by the authors, and a structured analysis and summarization of its content was developed. Results: The initial search produced 359 publications, reduced after a manual examination of abstracts and full publications. The following aspects of clinical data reuse are discussed: motivations and challenges, privacy and ethical concerns, data integration and interoperability, data models and terminologies, unstructured data reuse, structured data mining, clinical practice and research integration, and examples of clinical data reuse (quality measurement and learning healthcare systems). Conclusion: Reuse of clinical data is a fast-growing field recognized as essential to realize the potentials for high quality healthcare, improved healthcare management, reduced healthcare costs, population health management, and effective clinical research.

Inconsistencies and misleading information in officially approved prescribing information from three major drug markets.

The summary of product characteristics (SPC) should provide information for the safe prescription and use of a drug. We evaluated the consistency of critical interaction warnings, the quality of presentation of undesirable effects as well as concordance of critical information of representative drugs marketed in the United States, the UK, and Germany. Reciprocal warnings regarding drug-drug interactions that constitute contraindications were frequently missing in the SPCs of the drugs concerned (all countries >40%). Most SPCs did not explicitly exclude adverse reactions considered not reasonably attributable to the use of the drug. Comparing SPCs of different generic brands of the same drug, only 60, 10, and 20% of the US, UK, and German SPCs, respectively, provided identical contraindications. Current SPCs contain inconsistencies and misleading data that are not compatible with the purpose of SPCs, which is to provide a basis for the safe prescription and use of drugs.

Memorandum on the use of information technology to improve medication safety.

BACKGROUND: Information technology in health care has a clear potential to improve the quality and efficiency of health care, especially in the area of medication processes. On the other hand, existing studies show possible adverse effects on patient safety when IT for medication-related processes is developed, introduced or used inappropriately. OBJECTIVES: To summarize definitions and observations on IT usage in pharmacotherapy and to derive recommendations and future research priorities for decision makers and domain experts. METHODS: This memorandum was developed in a consensus-based iterative process that included workshops and e-mail discussions among 21 experts coordinated by the Drug Information Systems Working Group of the German Society for Medical Informatics, Biometry and Epidemiology (GMDS). RESULTS: The recommendations address, among other things, a stepwise and comprehensive strategy for IT usage in medication processes, the integration of contextual information for alert generation, the involvement of patients, the semantic integration of information resources, usability and adaptability of IT solutions, and the need for their continuous evaluation. CONCLUSION: Information technology can help to improve medication safety. However, challenges remain regarding access to information, quality of information, and measurable benefits.

[Implementation of a patient data management system. Effects on intensive care documentation]. / Einführung eines Patientendatenmanagementsystems. Auswirkungen auf die intensivmedizinische Dokumentation.

BACKGROUND: Patient data management systems (PDMS) enable digital documentation on intensive care units (ICU). A commercial PDMS was implemented in a 25-bed ICU replacing paper-based patient charting. The ICU electronic patient record is completely managed inside the PDMS. It compiles data from vital signs monitors, ventilators and further medical devices and facilitates some drug dose and fluid balance calculations as well as data reuse for administrative purposes. Ventilation time and patient severity scoring as well as coding of diagnoses and procedures is supported. Billing data transferred via interface to the central billing system of the hospital. Such benefits should show in measurable parameters, such as documented ventilator time, number of coded diagnoses and procedures and others. These parameters influence reimbursement in the German DRG system. Therefore, measurable changes in cost and reimbursement data of the ICU were expected. MATERIAL AND METHODS: A retrospective analysis of documentation quality parameters, cost data and mortality rate of a 25-bed surgical ICU within a German university hospital 3 years before (2004-2006) and 5 years after (2007-2011) PDMS implementation. Selected parameters were documented electronically, consistently and reproducibly for the complete time span of 8 years including those years where no electronic patient recording was available. The following parameters were included: number of cleared DRG, cleared ventilator time, case mix (CM), case mix index (CMI), length of stay, number of coded diagnoses and procedures, detailed overview of a specific procedure code based on daily Apache II and TISS Core 10 scores, mortality, total ICU costs and revenues and partial profits for specific ICU procedures, such as renal replacement therapy and blood products. RESULTS: Systematic shifts were detected over the study period, such as increasing case numbers and decreasing length of stay as well as annual fluctuations in severity of disease seen in the CM and CMI. After PDMS introduction, the total number of coded diagnoses increased but the proportion of DRG relevant diagnoses dropped significantly. The number of procedures increased (not significantly) and the number of procedures per case did not rise significantly. The procedure 8-980 showed a significant increase after PDMS introduction whereas the DRG-relevant proportion of those procedures dropped insignificantly. The number of ventilator-associated DRG cases as well as the total ventilator time increased but not significantly. Costs and revenues increased slightly but profit varied considerably from year to year in the 5 years after system implementation. A small increase was observed per case, per nursing day and per case mix point. Additional revenues for specific ICU procedures increased in the years before and dropped after PDMS implementation. There was an insignificant increase in ICU mortality rate from 7.4 % in the year 2006 (before) to 8.5 % in 2007 (after PDMS implementation). In the following years mortality dropped below the base level. CONCLUSION: The implementation of the PDMS showed only small effects on documentation of reimbursement-relevant parameters which were too small to set off against the total investment. The method itself, a long-term follow-up of different parameters proved successful and can be adapted by other organizations. The quality of results depends on the availability of long-term parameters in good quality. No significant influence of PDMS on mortality was found.

Computerized Physician Order Entry (CPOE) in pediatric and neonatal intensive care: Recommendations how to meet clinical requirements.

OBJECTIVE: To identify and summarize the requirements of an optimized CPOE application for pediatric intensive care. METHODS: We analyzed the medication process and its documentation in the pediatric and neonatal intensive care units (PICU/NICU) of two university hospitals using workflow analysis techniques, with the aim of implementing computer-supported physician order entry (CPOE). RESULTS: In both PICU/NICU, we identified similar processes that differed considerably from adult medication routine. For example, both PICU/NICU prepare IV pump syringes on the ward, but receive individualized ready-to-use mixed IV bags for each patient from the hospital pharmacy on the basis of a daily order. For drug dose calculation, both PICU/NICU employ electronic calculation tools that are either incorporated within the CPOE system, or are external modules invoked via interface. CONCLUSION: On the basis of this analysis, we provide suggestions to optimize CPOE applications for use in the pediatric and neonatal intensive care unit in the form of three catalogues of desiderata for drug order entry support.

Contribution of consonant versus vowel information to sentence intelligibility for young normal-hearing and elderly hearing-impaired listeners.

The purpose of this study was to examine the contribution of information provided by vowels versus consonants to sentence intelligibility in young normal-hearing (YNH) and typical elderly hearing-impaired (EHI) listeners. Sentences were presented in three conditions, unaltered or with either the vowels or the consonants replaced with speech shaped noise. Sentences from male and female talkers in the TIMIT database were selected. Baseline performance was established at a 70 dB SPL level using YNH listeners. Subsequently EHI and YNH participants listened at 95 dB SPL. Participants listened to each sentence twice and were asked to repeat the entire sentence after each presentation. Words were scored correct if identified exactly. Average performance for unaltered sentences was greater than 94%. Overall, EHI listeners performed more poorly than YNH listeners. However, vowel-only sentences were always significantly more intelligible than consonant-only sentences, usually by a ratio of 2:1 across groups. In contrast to written English or words spoken in isolation, these results demonstrated that for spoken sentences, vowels carry more information about sentence intelligibility than consonants for both young normal-hearing and elderly hearing-impaired listeners.

[A multidisciplinary mModule for oncological documentation within a hospital information system]. / Ein interdisziplinäres Modul zur onkologischen Dokumentation in einem Klinikinformationssystem.

The follow-up documentation of oncological patients in Germany is inadequate in many cases: it is usually limited to a minimal dataset mandated by the epidemiological tumor registers; it is carried out in a paper-based fashion and rarely in a multi-disciplinary context. Parallel documentation efforts can result in redundant or erroneous data and excess work. The introduction of hospital information systems (HIS) allows the implementation of digital oncological documentation systems integrated in surrounding clinical workflows that can provide access to existing data sources as well as data entry and presentation across departmental boundaries. This concept enables the integration of tumor documentation, quality assurance and process optimization within HIS. Feasibility requirements include a high flexibility and adaptability of the underlying HIS to reach a seamless integration of oncological documentation forms within routine clinical workflows. This paper presents the conceptual design and implementation of a modular oncological documentation system at the Muenster University Hospital that is capable of integrating the documentation requirements of multiple departments within the hospital.

Integrated decision support in a hospital cancer registry.

In this paper we present (a) a shell for integrated knowledge-based functions that is destined to support decision processes of the users of the Giessener Tumordokumentationssystem (GTDS) and (b) some results we obtained during a 6-month observation period at one of the customers of the GTDS. A special characteristic of the provided decision support is the high degree of integration in the underlying information system GTDS, i.e. the functions are triggered by events in the patient database, existing patient data is reused as input for the reasoning process and generated alerts are presented instantly to the end-user. The first routine field of application was supporting registrars to adhere to integrity constraints as defined by the International Agency of Research on Cancer (IARC) during the documentation process. This information is important for the registrars since the checks of the IARC are an accepted standard for data quality in cancer registries. The expected benefit of this application area is less effort in achieving adherence to the specification of the IARC by preventing the costly rectification at a later time. During the last 5 months of the observation period 164 alerts were displayed. About 65% of the assessed alerts were considered to be correct. Especially, the analysis of the incorrect alerts revealed some shortcomings in the knowledge behind some of the integrity constraints of the IARC. The general feedback from the end-users indicate positive user satisfaction. Currently, the shell is in use in six hospital cancer registries.

Optimizing coding quality: the role of the electronic medical record in the context of diagnosis related groups.

In 2003, a new prospective payment system will be introduced in Germany, which is based on the Australian Refined Diagnosis related Groups (AR-DRGs). Physicians must code diagnoses and procedures themselves. Inaccurately or incompletely coded patient records can result in considerable underpayment, so enhancing physicians' coding compliance and competence seems crucial. Coding shall be well integrated in the electronic patient record, providing a simple interface with background information, which is invoked out of the clinical documentation. This paper describes an existing implementation and possible further development.

Evaluation of clinical information systems. What can be evaluated and what cannot?

The evaluation of clinical information systems is essential as they are increasingly used in clinical routine and may even influence patient outcome on the basis of reminder functions and decision support. Therefore we try to answer three questions in this paper: what to evaluate; how to evaluate; how to interpret the results. Those key questions lead to the discussion of goals, methods and results of evaluation studies in a common context. We will compare the objectivist and the subjectivist evaluation approach and illustrate the evaluation process itself in some detail, discussing different phases of software development and potential evaluation techniques in each phase. We use four different practical examples of evaluation studies that were conducted in various settings to demonstrate how defined evaluation goals may be achieved with a limited amount of resources. This also illustrates advantages, limitations and costs of the different evaluation methods and techniques that may be used when evaluating clinical information systems.

Bioinformatics in medical practice: what is necessary for a hospital?

Building bioinformatic facilities for a university hospital is pretty similar to using standardized building blocks to construct a house. Starting with the intention to built a dwelling house, a factory or just a shelter the architect draws a construction plan and determines the material to be used. In general, the building is then constructed by the workmen following exactly the plan. However, for particular reasons, minor alterations may be needed to improve the construction of the building. Here we use the metaphor of constructing a "bio-informatics building" to describe the steps needed to support the daily tasks of a university hospital medical microbiology department which uses genomic methods quite extensively for pathogen identification. Today the Giessen "bioinformatics building" is not yet complete but we have been able to lay solid foundations and erect the ground floor which is functional already. Using a combination of standard tools, internet accessible genomic databases and some own software tools we can support genome sequencing from the raw sequence to pathogen identification.

A dictionary server for supplying context sensitive medical knowledge.

The Giessen Data Dictionary Server (GDDS), developed at Giessen University Hospital, integrates clinical systems with on-line, context sensitive medical knowledge to help with making medical decisions. By "context" we mean the clinical information that is being presented at the moment the information need is occurring. The dictionary server makes use of a semantic network supported by a medical data dictionary to link terms from clinical applications to their proper information sources. It has been designed to analyze the network structure itself instead of knowing the layout of the semantic net in advance. This enables us to map appropriate information sources to various clinical applications, such as nursing documentation, drug prescription and cancer follow up systems. This paper describes the function of the dictionary server and shows how the knowledge stored in the semantic network is used in the dictionary service.

Two years of German summer school of nursing informatics: Did we reach the goals?

This paper describes a continuous effort to improve the knowledge of nursing informatics among German nurses. The authors have co-operated in the nursing informatics working group of the German Medical Informatics Association GMDS. Besides, one of the authors has been active in the European summer school of nursing informatics (Essoni) for several years. The authors have now established a national counterpart to the Essoni program, the German summer school of nursing informatics. This event in German language is centred around nursing informatics topics. Students may opt for one of the several study tracks to gain insight in topics such as nursing classifications and nursing terminologies, clinical information systems and their implementation or teaching requirements in nursing informatics. They go through a 5-day curriculum consisting of plenary sessions, lectures and opportunities for self learning and self teaching. At the end they demonstrate to the fellow students from the other tracks what they have achieved in their own field of study. The German Summer School is open to interested nurses, nurse executives and nurse teachers. In this paper, we will describe the curriculum, talk about the participants and show results of the questionnaire-based evaluation for the first two events in 1998 and 1999.

Can we classify medical data dictionaries?

Medical Data Dictionaries enable a clinical information system to maintain a controlled vocabulary, to store descriptive knowledge about terms, to map between those terms and from those terms to external classifications. They support a variety of functions in the information system, ranging from structured documentation to knowledgebased functions. This paper derives a multi-axial classification for medical data dictionaries. Dictionaries are classified along 4 axes, a vocabulary axis defining vocabulary properties, an application axis which characterises the degree of linkage between dictionary and information system, a semantic axis defining the quality of inter-term relationships and finally a language axis which classifies rules for inter-term relationships in semiotic theory. As an example two existing dictionaries are classified in the model and reference is taken to the design of future dictionaries.

Decision support for infectious diseases--a working prototype.

This paper presents a decision support system for nosocomial infections and its integration in the large HIS of the University Hospital of Giessen. The model comprises five different engines and a data dictionary. It is designed to detect hospital acquired infections even in a situation where only a restricted amount of clinical data is available (the data is split up in different information systems). Furthermore the model prevents time consuming manual data entry. The five engines split the main task into 1) a preselection, which sort out patients who definitely do not have a nosocomial infection; 2) a rule based reasoning process which detects patients likely to have such an infection; 3) an alarm process which is responsible for the presentation of the alert; 4) an explanation process to follow up the reasoning and 5) statistic tools to answer specific hygienic questions. A data dictionary supplies the controlled vocabulary, but it is also required to understand datastructures used in the different clinical subsystems.

XML structured clinical information: a practical example.

At Giessen university, a drug formulary comprising drug data and treatment guidelines is supplied to clinical users who can access the drug information by an index of drug substances and drug substance groups. The guideline itself is a textual description with related information such as drug substances and drug brand names. Since clinical users also want to access the information by drug names, we had to extract this information from the textual descriptions. The extraction however caused some effort. In order to not repeat this effort in the future, we used the eXtensible Markup Language (XML) to restructure the information sources. This paper describes our experiences with this kind of legacy to XML conversion and outlines a possible migration path towards the XML technology.

An object-oriented design for automated navigation of semantic networks inside a medical data dictionary.

In this paper we present a data dictionary server for the automated navigation of information sources. The underlying knowledge is represented within a medical data dictionary. The mapping between medical terms and information sources is based on a semantic network. The key aspect of implementing the dictionary server is how to represent the semantic network in a way that is easier to navigate and to operate, i.e. how to abstract the semantic network and to represent it in memory for various operations. This paper describes an object-oriented design based on Java that represents the semantic network in terms of a group of objects. A node and its relationships to its neighbors are encapsulated in one object. Based on such a representation model, several operations have been implemented. They comprise the extraction of parts of the semantic network which can be reached from a given node as well as finding all paths between a start node and a predefined destination node. This solution is independent of any given layout of the semantic structure. Therefore the module, called Giessen Data Dictionary Server can act independent of a specific clinical information system. The dictionary server will be used to present clinical information, e.g. treatment guidelines or drug information sources to the clinician in an appropriate working context. The server is invoked from clinical documentation applications which contain an infobutton. Automated navigation will guide the user to all the information relevant to her/his topic, which is currently available inside our closed clinical network.

Stepwise evaluation of information systems in an university hospital.

A prospective intervention study with historical control has been performed at Giessen University Hospital, Germany, to investigate the influence of electronic data processing systems on nurses' working environment. Two wards of the medical department were selected for this study, using the combined approach of work-sampling methods and questionnaires. In the first intervention a central information system with restricted functions was introduced. For the second intervention an additional nursing information system was installed. The distribution of nurses' worktime into the fields of general nursing care, specific nursing care and administrative activities was not influenced by electronic data processing. No time saving could be measured. Results of the questionnaires did, however, indicate a positive influence of the hospital information system on nurses' working environment.

Transferring data from one EPR to another: content--syntax--semantic.

When data are transmitted between electronic patient record (EPR) systems, we can distinguish several tasks. One task is the definition of structure and semantic content of the data in a message structure. Another task is the mapping of the sending EPR's structure to this message structure. A third task is the mapping of the message structure to the receiving EPR's structure. We describe an approach, which distinguishes clearly between these different tasks and activities. Using this approach we have implemented a data transfer procedure between a cancer registry application and a middleware for healthcare information systems. Our experience showed that the proposed systematic approach helped identify problems for data transfer in an early design phase. It also allowed us to limit modifications of the data exchange procedure to certain tasks or activities when one of the EPR applications was updated. In the end, we could even exchange the underlying message format without having to reimplement the complete interface.