DQAgui: a graphical user interface for the MIRACUM data quality assessment tool.

BACKGROUND: With the growing impact of observational research studies, there is also a growing focus on data quality (DQ). As opposed to experimental study designs, observational research studies are performed using data mostly collected in a non-research context (secondary use). Depending on the number of data elements to be analyzed, DQ reports of data stored within research networks can grow very large. They might be cumbersome to read and important information could be overseen quickly. To address this issue, a DQ assessment (DQA) tool with a graphical user interface (GUI) was developed and provided as a web application. METHODS: The aim was to provide an easy-to-use interface for users without prior programming knowledge to carry out DQ checks and to present the results in a clearly structured way. This interface serves as a starting point for a more detailed investigation of possible DQ irregularities. A user-centered development process ensured the practical feasibility of the interactive GUI. The interface was implemented in the R programming language and aligned to Kahn et al.'s DQ categories conformance, completeness and plausibility. RESULTS: With DQAgui, an R package with a web-app frontend for DQ assessment was developed. The GUI allows users to perform DQ analyses of tabular data sets and to systematically evaluate the results. During the development of the GUI, additional features were implemented, such as analyzing a subset of the data by defining time periods and restricting the analyses to certain data elements. CONCLUSIONS: As part of the MIRACUM project, DQAgui is now being used at ten German university hospitals for DQ assessment and to provide a central overview of the availability of important data elements in a datamap over 2 years. Future development efforts should focus on design optimization and include a usability evaluation.

Linking a Consortium-Wide Data Quality Assessment Tool with the MIRACUM Metadata Repository.

BACKGROUND: Many research initiatives aim at using data from electronic health records (EHRs) in observational studies. Participating sites of the German Medical Informatics Initiative (MII) established data integration centers to integrate EHR data within research data repositories to support local and federated analyses. To address concerns regarding possible data quality (DQ) issues of hospital routine data compared with data specifically collected for scientific purposes, we have previously presented a data quality assessment (DQA) tool providing a standardized approach to assess DQ of the research data repositories at the MIRACUM consortium's partner sites. OBJECTIVES: Major limitations of the former approach included manual interpretation of the results and hard coding of analyses, making their expansion to new data elements and databases time-consuming and error prone. We here present an enhanced version of the DQA tool by linking it to common data element definitions stored in a metadata repository (MDR), adopting the harmonized DQA framework from Kahn et al and its application within the MIRACUM consortium. METHODS: Data quality checks were consequently aligned to a harmonized DQA terminology. Database-specific information were systematically identified and represented in an MDR. Furthermore, a structured representation of logical relations between data elements was developed to model plausibility-statements in the MDR. RESULTS: The MIRACUM DQA tool was linked to data element definitions stored in a consortium-wide MDR. Additional databases used within MIRACUM were linked to the DQ checks by extending the respective data elements in the MDR with the required information. The evaluation of DQ checks was automated. An adaptable software implementation is provided with the R package DQAstats. CONCLUSION: The enhancements of the DQA tool facilitate the future integration of new data elements and make the tool scalable to other databases and data models. It has been provided to all ten MIRACUM partners and was successfully deployed and integrated into their respective data integration center infrastructure.

An Analysis of Erlangen University Hospital's Billing Data on Utility-Based De-Identification.

BACKGROUND: To make patient care data more accessible for research, German university hospitals join forces in the course of the Medical Informatics Initiative. In a first step, the administrative data of university hospitals is made available for federated utilization. Project-specific de-identification of this data is necessary to satisfy privacy laws. OBJECTIVE: We want to make a statement about the population uniqueness of the data. By generalizing the data, we try to reduce uniqueness and improve k-anonymity. METHODS: We analyze quasi-identifying attributes of the Erlangen University Hospital's billing data regarding population uniqueness and re-identification risk. We count individuals per equality class (k) to measure uniqueness. RESULTS: Because of the diagnoses and procedures being particularly unique in combination with sex and age of the patients, the data set is not anonymized in matters of k-anonymity with k > 1 . We are able to reduce population uniqueness with generalization and suppression of unique domains. CONCLUSION: To create k-anonymity with k > 1 while still maintaining a particular utility of the data, we need to apply further established strategies of de-identification.

Evaluation of a Patient-Facing Digital Prototype for Perioperative Risk Assessment.

Preparations for anesthesiological management of patients build on preoperative patient self-reports concerning risk factors and comorbidities. In this setting, electronic documentation could facilitate innovative computerized functions, although patient-facing digital questionnaires require appropriate tools that patients can access effectively. To explore the feasibility of an electronic application for preoperative data acquisition directly from patients, a digital, tablet-based prototypical application has been developed within a user-centered design process in order to replace a previously used paper-based anamnesis sheet for perioperative risk evaluation. The implemented prototype has been extensively tested and iteratively improved to progressively provide an easy-to-use data entry function. To assess the suitability of this tool for everyday data acquisition by patients and physicians and to identify usability problems, the stepwise development process was accompanied by a heuristic evaluation as well as a think-aloud evaluation, while another 56 participating patients completed a feedback sheet according to ISO 9241/10. The latter method detected additional usability problems that occurred during the use of the application, which contributed to iterative improvements of the prototype. Throughout the development process, 81 issues were identified and largely resolved. After these revisions of the prototype, the number of problems found per tester decreased from 4.75 to 0.96, while the overall rating increased to 6.14 out of 7 points (SD = 1.2). These improvements demonstrate the value and efficiency of such a user-centered design process and illustrate that a user-friendly patient-facing digital data entry can replace preoperative paper questionnaires for anesthesiological management.

User-centered design of a mobile medication management.

BACKGROUND: The use of a nationwide medication plan has been promoted as an effective strategy to improve patient safety in Germany. However, the medication plan only exists as a paper-based version, which is related to several problems, that could be circumvented by an electronic alternative. OBJECTIVE: The main objective of this study was to report on the development of a mobile interface concept to support the management of medication information. METHODS: The human-centered design (UCD) process was chosen. First the context of use was analyzed, and personas and an interaction concept were designed. Next, a paper prototype was developed and evaluated by experts. Based on those results, a medium-fidelity prototype was created and assessed by seven end-users who performed a thinking-aloud test in combination with a questionnaire based on the System Usability Scale (SUS). RESULTS: Initially for one persona/user type, an interface design concept was developed, which received an average SUS-Score of 92.1 in the user test. Usability problems have been solved so that the design concept could be fixed for a future implementation. Contribution: The approach of the UCD process and the methods involved can be applied by other researchers as a framework for the development of similar applications.

Quality Requirements for Electronic Health Record Systems*. A Japanese-German Information Management Perspective.

BACKGROUND: For more than 30 years, there has been close cooperation between Japanese and German scientists with regard to information systems in health care. Collaboration has been formalized by an agreement between the respective scientific associations. Following this agreement, two joint workshops took place to explore the similarities and differences of electronic health record systems (EHRS) against the background of the two national healthcare systems that share many commonalities. OBJECTIVES: To establish a framework and requirements for the quality of EHRS that may also serve as a basis for comparing different EHRS. METHODS: Donabedian's three dimensions of quality of medical care were adapted to the outcome, process, and structural quality of EHRS and their management. These quality dimensions were proposed before the first workshop of EHRS experts and enriched during the discussions. RESULTS: The Quality Requirements Framework of EHRS (QRF-EHRS) was defined and complemented by requirements for high quality EHRS. The framework integrates three quality dimensions (outcome, process, and structural quality), three layers of information systems (processes and data, applications, and physical tools) and three dimensions of information management (strategic, tactical, and operational information management). CONCLUSIONS: Describing and comparing the quality of EHRS is in fact a multidimensional problem as given by the QRF-EHRS framework. This framework will be utilized to compare Japanese and German EHRS, notably those that were presented at the second workshop.

Evaluation of an Interactive Visualization Tool for the Interpretation of Pediatric Laboratory Test Results.

The physiological age-related development of pediatric laboratory results interferes with pathological derangements, which can complicate the interpretation of test results. Recently proposed continuous reference intervals (RIs) promise to be beneficial, although their clinical use may depend on graphical presentations. To estimate the clinical utility of continuous RIs, we developed and evaluated an interactive visualization tool, and examined the differentiation of hemoglobinopathies that is attainable based on the underlying innovative RI model. The implemented web application allows users to easily enter laboratory test results, and displays various visualizations in conjunction with the corresponding RIs, such as charts and personalized Z-scores. To evaluate the usability of the visualization tool, we conducted concurrent think-aloud sessions with four physicians, who were prompted to solve a set of typical interpretation tasks, and acquired additional information through a questionnaire including the System Usability Scale (SUS). We used 85 de-identified clinical cases for an exemplified assessment of how well model-based interpretations of blood count parameters reproduced previously diagnosed hemoglobinopathies. Usability tests as well as questionnaire responses indicated that the developed tool was well received by the physicians. Results from the think-aloud evaluation revealed only minor problems and the tool reached an average SUS score of 86.9, suggesting good usability. Hemoglobinopathy discrimination depended on the considered subtype, although the overall performance of the novel method rivaled the one of the conventional approach. The interactive visualization of innovative continuous reference intervals demonstrated promising results, which justifies further testing on the path towards clinical routine.

Acceptance by laypersons and medical professionals of the personalized eHealth platform, eHealthMonitor.

INTRODUCTION AND BACKGROUND: Often, eHealth services are not accepted because of factors such as eHealth literacy or trust. Within this study, eHealthMonitor was evaluated in three European countries (Germany, Greece, and Poland) by medical professionals and laypersons with respect to numerous acceptance factors. METHODS: Questionnaires were created on the basis of factors from literature and with the help of scales which have already been validated. A qualitative survey was conducted in Germany, Poland, and Greece. RESULTS: The eHealth literacy of all participants was medium/high. Laypersons mostly agreed that they could easily become skillful with eHealthMonitor and that other people thought that they should use eHealthMonitor. Amongst medical professionals, a large number were afraid that eHealthMonitor could violate their privacy or the privacy of their patients. Overall, the participants thought that eHealthMonitor was a good concept and that they would use it. DISCUSSION AND CONCLUSION: The main hindrances to the use of eHealthMonitor were found in trust issues including data privacy. In the future, more research on the linkage of all measured factors is needed, for example, to address the question of whether highly educated people tend to mistrust eHealth information more than people with lower levels of education.

Evaluation of Acceptance of Nursing Information System in a German and American Hospital.

Nursing Information Systems (NIS) are not well-adopted and accepted in Germany. The evaluation of a NIS deployment in a German University Hospital supports this assumption. A second side study in the US should point out the differences regarding the technical and organizational differences. We use a questionnaire including standardized instruments like the Unified Theory of Acceptance (UTAUT). Results indicated that nurses in Germany compared to in the US do not use nursing process documentation to the same extent. The main reasons behind the low usage in comparison with the US are deficits in ease-of-use, system performance and the high expenditure of time and paper work for charting nursing plans.

Prospective Assessment of an innovative test for prostate cancer screening using the VITA process model framework.

Healthcare innovations are crucial for enhancing patient treatment and a high-quality healthcare system. However, bringing new technologies, methods and procedures into the healthcare market is challenging. Enormous amounts of financial, personnel and organizational resources are required with no upfront certainty for the medical and economic benefit. A new and innovative approach uses interdisciplinary medical, technical and economic expertise to forecast effects of healthcare innovations already at the early research and concept phase of an idea and before major investments are made. A process model framework was developed to operationalize this structured assessment of healthcare innovations. The Visionary Iterative Tailored Approach (VITA) is based on conceptual modeling, simulation and health economics evaluation. Its application for the prospective assessment of an innovative prostate cancer screening is presented.

Does introduction of a Patient Data Management System (PDMS) improve the financial situation of an intensive care unit?

BACKGROUND: Patient Data Management Systems (PDMS) support clinical documentation at the bedside and have demonstrated effects on completeness of patient charting and the time spent on documentation. These systems are costly and raise the question if such a major investment pays off. We tried to answer the following questions: How do costs and revenues of an intensive care unit develop before and after introduction of a PDMS? Can higher revenues be obtained with improved PDMS documentation? Can we present cost savings attributable to the PDMS? METHODS: Retrospective analysis of cost and reimbursement data of a 25 bed Intensive Care Unit at a German University Hospital, three years before (2004-2006) and three years after (2007-2009) PDMS implementation. RESULTS: Costs and revenues increased continuously over the years. The profit of the investigated ICU was fluctuating over the years and seemingly depending on other factors as well. We found a small increase in profit in the year after the introduction of the PDMS, but not in the following years. Profit per case peaked at 1039 € in 2007, but dropped subsequently to 639 € per case. We found no clear evidence for cost savings after the PDMS introduction. Our cautious calculation did not consider additional labour costs for IT staff needed for system maintenance. CONCLUSIONS: The introduction of a PDMS has probably minimal or no effect on reimbursement. In our case the observed increase in profit was too small to amortize the total investment for PDMS implementation.This may add some counterweight to the literature, where expectations for tools such as the PDMS can be quite unreasonable.

Comparative evaluation of different medication safety measures for the emergency department: physicians' usage and acceptance of training, poster, checklist and computerized decision support.

BACKGROUND: Although usage and acceptance are important factors for a successful implementation of clinical decision support systems for medication, most studies only concentrate on their design and outcome. Our objective was to comparatively investigate a set of traditional medication safety measures such as medication safety training for physicians, paper-based posters and checklists concerning potential medication problems versus the additional benefit of a computer-assisted medication check. We concentrated on usage, acceptance and suitability of such interventions in a busy emergency department (ED) of a 749 bed acute tertiary care hospital. METHODS: A retrospective, qualitative evaluation study was conducted using a field observation and a questionnaire-based survey. Six physicians were observed while treating 20 patient cases; the questionnaire, based on the Technology Acceptance Model 2 (TAM2), has been answered by nine ED physicians. RESULTS: During field observations, we did not observe direct use of any of the implemented interventions for medication safety (paper-based and electronic). Questionnaire results indicated that the electronic medication safety check was the most frequently used intervention, followed by checklist and posters. However, despite their positive attitude, physicians most often stated that they use the interventions in only up to ten percent for subjectively "critical" orders. Main reasons behind the low usage were deficits in ease-of-use and fit to the workflow. The intention to use the interventions was rather high after overcoming these barriers. CONCLUSIONS: Methodologically, the study contributes to Technology Acceptance Model (TAM) research in an ED setting and confirms TAM2 as a helpful diagnostic tool in identifying barriers for a successful implementation of medication safety interventions. In our case, identified barriers explaining the low utilization of the implemented medication safety interventions - despite their positive reception - include deficits in accessibility, briefing for the physicians about the interventions, ease-of-use and compatibility to the working environment.

Conceptual modeling for Prospective Health Technology Assessment.

Prospective Health Technology Assessment (ProHTA) is a new and innovative approach to analyze and assess new technologies, methods and procedures in health care. Simulation processes are used to model innovations before the cost-intensive design and development phase. Thus effects on patient care, the health care system as well as health economics aspects can be estimated. To generate simulation models a valid information base is necessary and therefore conceptual modeling is most suitable. Project-specifically improved methods and characteristics of simulation modeling are combined in the ProHTA Conceptual Modeling Process and initially implemented for acute ischemic stroke treatment in Germany. Additionally the project aims at simulation of other diseases and health care systems as well. ProHTA is an interdisciplinary research project within the Cluster of Excellence for Medical Technology - Medical Valley European Metropolitan Region Nuremberg (EMN), which is funded by the German Federal Ministry of Education and Research (BMBF), project grant No. 01EX1013B.

Relations between Internet use, socio-economic status (SES), social support and subjective health.

This study aimed to explore relations between Internet use, socio-economic status (SES), social support and subjective health. Participants were from representative samples between 15 and 80 years of age from seven different European countries. Two different survey datasets were used: (i) eHealth trends (eHT; N = 7934) and (ii) the European social survey (ESS2; N = 11248). Internet users who had used the Internet for health purposes were compared with Internet users who had not used it for health purposes. Structural equation modelling was used to assess the relationships between SES, Internet use, social support and subjective health. Use of other media was compared to Internet use in relation to social support and subjective health. Internet use was found to be more closely related to social support and subjective health than use of other media. Internet use was also found to be a plausible mediator between SES and subjective health, especially through interacting with social support.

Computed Quality Assessment of MPEG4-compressed DICOM Video Data.

Digital Imaging and Communication in Medicine (DICOM) has become one of the most popular standards in medicine. This standard specifies the exact procedures in which digital images are exchanged between devices, either using a network or storage medium. Sources for images vary; therefore there exist definitions for the exchange for CR, CT, NMR, angiography, sonography and so on. With its spreading, with the increasing amount of sources included, data volume is increasing, too. This affects storage and traffic. While for long-time storage data compression is generally not accepted at the moment, there are many situations where data compression is possible: Telemedicine for educational purposes (e.g. students at home using low speed internet connections), presentations with standard-resolution video projectors, or even the supply on wards combined receiving written findings. DICOM comprises compression: for still image there is JPEG, for video MPEG-2 is adopted. Within the last years MPEG-2 has been evolved to MPEG-4, which squeezes data even better, but the risk of significant errors increases, too. Within the last years effects of compression have been analyzed for entertainment movies, but these are not comparable to videos of physical examinations (e.g. echocardiography). In medical videos an individual image plays a more important role. Erroneous single images affect total quality even more. Additionally, the effect of compression can not be generalized from one test series to all videos. The result depends strongly on the source. Some investigations have been presented, where different MPEG-4 algorithms compressed videos have been compared and rated manually. But they describe only the results in an elected testbed. In this paper some methods derived from video rating are presented and discussed for an automatically created quality control for the compression of medical videos, primary stored in DICOM containers.

The diagnosis related groups enhanced electronic medical record.

PROBLEM: The introduction of Diagnosis Related Groups as a basis for hospital payment in Germany announced essential changes in the hospital reimbursement practice. A hospital's economical survival will depend vitally on the accuracy and completeness of the documentation of DRG relevant data like diagnosis and procedure codes. In order to enhance physicians' coding compliance, an easy-to-use interface integrating coding tasks seamlessly into clinical routine had to be developed. A generic approach should access coding and clinical guidelines from different information sources. METHODS: Within the Electronic Medical Record (EMR) a user interface ('DRG Control Center') for all DRG relevant clinical and administrative data has been built. A comprehensive DRG-related web site gives online access to DRG grouping software and an electronic coding expert. Both components are linked together using an application supporting bi-directional communication. Other web based services like a guideline search engine can be integrated as well. RESULTS: With the proposed method, the clinician gains quick access to context sensitive clinical guidelines for appropriate treatment of his/her patient and administrative guidelines for the adequate coding of the diagnoses and procedures. This paper describes the design and current implementation and discusses our experiences.