Models and Data Sources Used in Systems Medicine. A Systematic Literature Review.

BACKGROUND: Systems medicine is a new approach for the development and selection of treatment strategies for patients with complex diseases. It is often referred to as the application of systems biology methods for decision making in patient care. For systems medicine computer applications, many different data sources have to be integrated and included into models. This is a challenging task for Medical Informatics since the approach exceeds traditional systems like Electronic Health Records. To prioritize research activities for systems medicine applications, it is necessary to get an overview over modelling methods and data sources already used in this field. OBJECTIVES: We performed a systematic literature review with the objective to capture current use of 1) modelling methods and 2) data sources in systems medicine related research projects. METHODS: We queried the MEDLINE and ScienceDirect databases for papers associated with the search term systems medicine and related terms. Papers were screened and assessed in full text in a two-step process according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement guidelines. RESULTS: The queries returned 698 articles of which 34 papers were finally included into the study. A multitude of modelling approaches such as machine learning and network analysis was identified and classified. Since these approaches are also used in other domains, no methods specific for systems medicine could be identified. Omics data are the most widely used data types followed by clinical data. Most studies only include a rather limited number of data sources. CONCLUSIONS: Currently, many different modelling approaches are used in systems medicine. Thus, highly flexible modular solutions are necessary for systems medicine clinical applications. However, the number of data sources included into the models is limited and most projects currently focus on prognosis. To leverage the potential of systems medicine further, it will be necessary to focus on treatment strategies for patients and consider a broader range of data.

A Generic Data Harmonization Process for Cross-linked Research and Network Interaction. Construction and Application for the Lung Cancer Phenotype Database of the German Center for Lung Research.

OBJECTIVE: Joint data analysis is a key requirement in medical research networks. Data are available in heterogeneous formats at each network partner and their harmonization is often rather complex. The objective of our paper is to provide a generic approach for the harmonization process in research networks. We applied the process when harmonizing data from three sites for the Lung Cancer Phenotype Database within the German Center for Lung Research. METHODS: We developed a spreadsheet-based solution as tool to support the harmonization process for lung cancer data and a data integration procedure based on Talend Open Studio. RESULTS: The harmonization process consists of eight steps describing a systematic approach for defining and reviewing source data elements and standardizing common data elements. The steps for defining common data elements and harmonizing them with local data definitions are repeated until consensus is reached. Application of this process for building the phenotype database led to a common basic data set on lung cancer with 285 structured parameters. The Lung Cancer Phenotype Database was realized as an i2b2 research data warehouse. CONCLUSION: Data harmonization is a challenging task requiring informatics skills as well as domain knowledge. Our approach facilitates data harmonization by providing guidance through a uniform process that can be applied in a wide range of projects.

Using data from ambient assisted living and smart homes in electronic health records.

INTRODUCTION: This editorial is part of the Focus Theme of Methods of Information in Medicine on "Using Data from Ambient Assisted Living and Smart Homes in Electronic Health Records". BACKGROUND: To increase efficiency in the health care of the future, data from innovative technology like it is used for ambient assisted living (AAL) or smart homes should be available for individual health decisions. Integrating and aggregating data from different medical devices and health records enables a comprehensive view on health data. OBJECTIVES: The objective of this paper is to present examples of the state of the art in research on information management that leads to a sustainable use and long-term storage of health data provided by innovative assistive technologies in daily living. RESULTS: Current research deals with the perceived usefulness of sensor data, the participatory design of visual displays for presenting monitoring data, and communication architectures for integrating sensor data from home health care environments with health care providers either via a regional health record bank or via a telemedical center. CONCLUSIONS: Integrating data from AAL systems and smart homes with data from electronic patient or health records is still in an early stage. Several projects are in an advanced conceptual phase, some of them exploring feasibility with the help of prototypes. General comprehensive solutions are hardly available and should become a major issue of medical informatics research in the near future.

Potential and requirements of IT for ambient assisted living technologies. Results of a Delphi study.

OBJECTIVES: Ambient Assisted Living (AAL) technologies are developed to enable elderly to live independently and safely. Innovative information technology (IT) can interconnect personal devices and offer suitable user interfaces. Often dedicated solutions are developed for particular projects. The aim of our research was to identify major IT challenges for AAL to enable generic and sustainable solutions. METHODS: Delphi Survey. An online questionnaire was sent to 1800 members of the German Innovation Partnership AAL. The first round was qualitative to collect statements. Statements were reduced to items by qualitative content analysis. Items were assessed in the following two rounds by a 5-point Likert-scale. Quantitative analyses for second and third round: descriptive statistics, factor analysis and ANOVA. RESPONDENTS: 81 in first, 173 in second and 70 in third round. All items got a rather high assessment. Medical issues were rated as having a very high potential. Items related to user-friendliness were regarded as most important requirements. Common requirements to all AAL-solutions are reliability, robustness, availability, data security, data privacy, legal issues, ethical requirements, easy configuration. The complete list of requirements can be used as framework for customizing future AAL projects. CONCLUSIONS: A wide variety of IT issues have been assessed important for AAL. The extensive list of requirements makes obvious that it is not efficient to develop dedicated solutions for individual projects but to provide generic methods and reusable components. Experiences and results from medical informatics research can be used to advance AAL solutions (e.g. eHealth and knowledge-based approaches).

Biomedical informatics--a confluence of disciplines?

BACKGROUND: Biomedical informatics is a broad discipline that borrows many methods and techniques from other disciplines. OBJECTIVE: To reflect a) on the character of biomedical informatics and to determine whether it is multi-disciplinary or inter-disciplinary; b) on the question whether biomedical informatics is more than the sum of its supporting disciplines and c) on the position of biomedical informatics with respect to related disciplines. METHOD: Inviting an international group of experts in biomedical informatics and related disciplines on the occasion of the 50th anniversary of Methods of Information in Medicine to present their viewpoints. RESULTS AND CONCLUSIONS: This paper contains the reflections of a number of the invited experts on the character of biomedical informatics. Most of the authors agree that biomedical informatics is an interdisciplinary field of study where researchers with different scientific backgrounds alone or in combination carry out research. Biomedical informatics is a very broad scientific field and still expanding, yet comprised of a constructive aspect (designing and building systems). One author expressed that the essence of biomedical informatics, as opposed to related disciplines, lies in the modelling of the biomedical content. Interdisciplinarity also has consequences for education. Maintaining rigid disciplinary structures does not allow for sufficient adaptability to capitalize on important trends nor to leverage the influences these trends may have on biomedical informatics. It is therefore important for students to become aware of research findings in related disciplines. In this respect, it was also noted that the fact that many scientific fields use different languages and that the research findings are stored in separate bibliographic databases makes it possible that potentially connected findings will never be linked, despite the fact that these findings were published. Bridges between the sciences are needed for the success of biomedical informatics.

Challenges in the evolution of the medical informatics program at heidelberg/heilbronn (Germany).

OBJECTIVE: Health and medical informatics (HMI) is an evolving discipline. Therefore, evolving educational programs in HMI have to take a variety of requirements into account. The aim of this paper is to analyze these requirements and to compare them with the medical informatics program Heidelberg/Heilbronn, Germany. METHODS: Systematic analysis of the IMIA recommendations on educating HMI, the Bologna declaration, current technological and health care developments and the results of graduates surveys. RESULTS: The latest revision of the Heidelberg/Heilbronn medical informatics program not only takes current developments into account but also realizes the IMIA recommendations, the Bologna declaration and graduates' data and feedback obtained in structured surveys. The topics bioinformatics, IT security and telemedicine were strengthened, taking major research and application trends into account. The program has been transformed into a consecutive bachelor/master program. It qualifies its graduates to work in the field of medical informatics as well as in informatics. CONCLUSIONS: Medical informatics is a very broad field. Programs have to make concessions to scope: It is not possible to provide profound knowledge and skills in computer science and also teach a variety of application areas like bioinformatics, public health informatics and clinical informatics in depth within one medical informatics program. Many graduate programs in various nations concentrate on providing HMI skills to health care professionals.

Usage and usability of standard operating procedures (SOPs) among the coordination centers for clinical trials (KKS).

OBJECTIVES: With Standard Operating Procedures (SOPs) the conduction of clinical trials should be standardized so that the results are comparable and traceable. This aim can only be reached if the staff of clinical trials really uses the SOPs. Therefore, we conducted a survey to explore the use and usability of SOPs in clinical trials and to identify problems for their handling. METHOD: Standardized, validated questionnaire among the staff of all 12 coordination centers for clinical trials in Germany (n = 238), anonymous, descriptive analyses RESULTS: A return rate of 58.8% was reached. When having questions about the daily work 18.4% more likely ask a colleague than read the corresponding SOP (13.8%). For the relevance of SOPs 16.9% of the staff regard less than 10% of SOPs as relevant for them. Exclusively working with electronic SOPs are 4%. CONCLUSIONS: The results of the survey indicate that improvements for the handling of SOPs are necessary. They could be used to design a computer-based information retrieval system for SOPs to increase the ease-of-use and usefulness of SOPs in clinical trials.

On educating about medical data management - the other side of the electronic health record.

OBJECTIVES: To summarize background, challenges, objectives, and methods for the usability of patient data, in particular with respect to their multiple use, and to point out how to lecture medical data management. METHODS: Analyzing the literature, providing an example based on Simpson's paradox and summarizing research and education in the field of medical data management, respectively health information management (in German: Medizinische Dokumentation). RESULTS: For the multiple use of patient data, three main categories of use can be identified: patient-oriented (or casuistic) analysis, patient-group reporting, and analysis for clinical studies. A so-called documentation protocol, related to study plans in clinical trials, supports the multiple use of data from the electronic health record in order to obtain valid, interpretable results. Lectures on medical data management may contain modules on introduction, basic concepts of clinical data management and coding systems, important medical coding systems (e.g. ICD, SNOMED, TNM, UMLS), typical medical documentation systems (e.g. on patient records, clinical and epidemiological registers), utilization of clinical data management systems, planning of medical coding systems and of clinical data management systems, hospital information systems and the electronic patient record, and on data management in clinical studies. CONCLUSION: Usability, the ultimate goal of recording and managing patient data, requires, besides technical considerations, in addition appropriate methodology on medical data management, especially if data is intended to be used for multiple purposes, e.g. for patient care and quality management and clinical research. Medical data management should be taught in health and biomedical informatics programs.

The computerized patient record: where do we stand ?

OBJECTIVES: To provide an overview of trends in research, developments and implementations of the computerized patient record (CPR) of the last two years. METHODS: We surveyed the medical informatics literature, spanning the years 2004-2005, focusing on publications on CPRs. RESULTS: The main trends revealed were: 1) the development of technologies to realize privacy and security goals or remote data entry and access to CPRs; 2) investigations into how to enhance the quality and reuse of CPR data; 3) the development and evaluation of decision support functions to be integrated with CPRs; 4) evaluations of the impact of CPRs on clinicians, patients, clinical work settings and patient outcomes; and 5) the further development and use of standards to move towards shared electronic health records (EHRs). CONCLUSION: The CPR is playing a growing part in medical informatics research and evaluation studies, but the goal of establishing a comprehensive lifelong EHR is still a long way off. In moving forward to EHRs, convergence of EHR standards seems required to realize true interoperability of health care applications. User acceptance of present-day CPRs (for all categories of users) and compatibility with work patterns has not been achieved yet, and can only be realized by giving these goals high priority. This will require substantial resources for in-depth work flow analysis, development and evaluation of CPRs. Besides this, the implementation of effective CPRs asks for health care organizations that are willing to invest in new developments and to contribute to evaluation studies, to further improve CPRs' functionalities and enhance their use in practice.

Electronic patient records and their benefit for patient care. Findings from the Section on Patient Records.

OBJECTIVES: To summarize current excellent research in the field of patient records. METHOD: Synopsis of the articles selected for the IMIA Yearbook 2006. RESULTS: Current research in the field of patient records analyses users' needs and attitudes as well as the potential and limitations of electronic patient record systems. Particular topics are the questions physicians have when assessing patients during ward rounds, the timeliness of results when ordered electronically, the quality of documenting haemophilia home therapy, attitudes towards patient access to health records and adequate strategies for record linkage in dependence on the intended purpose. CONCLUSIONS: The best paper selection of articles on patient records shows examples of excellent research on methods used for the management of patient records and for processing their content as well as assessing the potential, limitations of and user attitudes towards electronic patient record systems. Computerized patient records are mature, so that they can contribute to high quality patient care and efficient patient management.

Standardized documentation of drug recommendations in discharge letters--a contribution to quality management in cooperative care.

OBJECTIVES: To analyze the necessity and potential usefulness of a computerized physician order entry (CPOE) system in supporting the writing of pharmacotherapeutic recommendations in discharge letters. METHODS: Systematic analysis of drug recommendations in discharge letters of a hospital providing tertiary care, structured interviews with in-hospital prescribers, and focus groups with general practitioners who admit patients to this hospital. RESULTS: We analyzed 1800 randomly selected discharge letters, 1205 of which contained pharmacotherapeutic recommendations. The frequencies, structure, and quality of these recommendations varied considerably between departments. Nearly 16% of the recommendations contained both proprietary (brand) and non-proprietary names (active ingredient). Interviewed clinicians expressed interest in CPOE systems that check for contraindications and interactions between drugs, suggest cheaper products, and automatically insert active ingredients when omitted. The focus group sessions confirmed that the pharmacotherapeutic recommendations in current discharge letters do not effectively support daily clinical practice. CONCLUSIONS: Documenting active ingredients as well as brand names in drug therapy recommendations is currently not part of clinical practice. Computerized decision support can help to optimise the structure and communication of therapeutic information across interfaces and can be a quality factor with considerable influence on process quality, outcome quality, and costs of cooperative patient care.

CSI-ISC--Concepts for smooth integration of health care information system components into established processes of patient care.

OBJECTIVES: The introduction of information system components (ISCs) usually leads to a change in existing processes, e.g. processes of patient care. These processes might become even more complex and variable than before. An early participation of end users and a better understanding of human factors during design and introduction of ISCs are key factors for a successful introduction of ISCs in health care. Nonetheless no specialized methods have been developed until now to systematically support the integration of ISCs in existing processes of patient care while taking into account these requirements. In this paper, therefore, we introduce a procedure model to implement Concepts for Smooth Integration of ISCs (CSI-ISC). METHODS: Established theories from economics and social sciences have been applied in our model, among them the stress-strain-concept, the contrastive task analysis (KABA), and the phase model for the management of information systems. RESULTS: CSI-ISC is based on the fact that while introducing new information system components, users experience additional workload. One essential aim during the introduction process therefore should be to systematically identify, prioritize and ameliorate workloads that are being imposed on human beings by information technology in health care. To support this, CSI-ISC consists of a static part (workload framework) and a dynamic part (guideline for the introduction of information system components into existing processes of patient care). CONCLUSIONS: The application of CSI-ISC offers the potential to minimize additional workload caused by information system components systematically. CSI-ISC rationalizes decisions and supports the integration of the information system component into existing processes of patient care.

The challenge of ubiquitous computing in health care: technology, concepts and solutions. Findings from the IMIA Yearbook of Medical Informatics 2005.

OBJECTIVES: To review recent research efforts in the field of ubiquitous computing in health care. To identify current research trends and further challenges for medical informatics. METHODS: Analysis of the contents of the Yearbook on Medical Informatics 2005 of the International Medical Informatics Association (IMIA). RESULTS: The Yearbook of Medical Informatics 2005 includes 34 original papers selected from 22 peer-reviewed scientific journals related to several distinct research areas: health and clinical management, patient records, health information systems, medical signal processing and biomedical imaging, decision support, knowledge representation and management, education and consumer informatics as well as bioinformatics. A special section on ubiquitous health care systems is devoted to recent developments in the application of ubiquitous computing in health care. Besides additional synoptical reviews of each of the sections the Yearbook includes invited reviews concerning E-Health strategies, primary care informatics and wearable healthcare. CONCLUSIONS: Several publications demonstrate the potential of ubiquitous computing to enhance effectiveness of health services delivery and organization. But ubiquitous computing is also a societal challenge, caused by the surrounding but unobtrusive character of this technology. Contributions from nearly all of the established sub-disciplines of medical informatics are demanded to turn the visions of this promising new research field into reality.

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.

A meta-model of chemotherapy planning in the multi-hospital/multi-trial-center-environment of pediatric oncology.

OBJECTIVE: Chemotherapy planning in pediatric oncology is complex and time-consuming. The correctness of the calculation according to state-of-the-art research is crucial for curing the child. Computer-assistance can be of great value. The objective of our research was to work out a meta-model of chemotherapy planning based on the Unified Modeling Language (UML). The meta-model is used for the development of an application system which serves as a knowledge-acquisition tool for chemotherapy protocols in pediatric oncology as well as for providing protocol-based care. METHODS: We applied evolutionary prototyping, software reengineering techniques and grounded theory, a qualitative method in social research. We repeated the following steps several times over the years: Based on a requirements analysis (i) a meta-model was developed or adapted, respectively (ii). The meta-model served as a basis for implementing evolutionary prototypes (iii). Further requirements were identified (i) from clinical use of the systems. RESULTS: We developed a comprehensive UML-based meta-model for chemotherapy planning in pediatric oncology (chemoMM). We implemented it and introduced evolutionary prototypes (CATIPO and DOSPO) in several medical centers. Systematic validation of the prototypes enabled us to derive a final meta-model which covers the requirements that have turned out to be necessary in clinical routine. CONCLUSIONS: We have developed an application system that fits well into clinical routine of pediatric oncology in Germany. Validation results have shown that the implementation of the meta-model chemoMM can adequately support the knowledge acquisition process for protocol-based care.

Medical informatics at Heidelberg/Heilbronn: status-evaluation-new challenges in a specialised curriculum for medical informatics after thirty years of evolution.

After reporting on characteristics, structure and contents of the specialised informatics-based curriculum for medical informatics (MI) at the University of Heidelberg/University of Applied Sciences Heilbronn, the paper describes the development during the last 5 years, and in particular a complementary health care oriented postgraduate program in 'Health Information Management' (IM). Furthermore, it outlines results of a study among the MI graduates, which aims to assess their job situation and to evaluate the curriculum from their viewpoint and so establishes a summary of 30 years of experience with the program. Finally, the paper discusses new challenges of the program, considering the results of the study, perspectives of health care provision in the next decade, content changes to be focused on and the growing competition in the field of programs for medical informatics.

Medical informatics specialists: what are their job profiles? Results of a study on the first 1024 medical informatics graduates of the Universities of Heidelberg and Heilbronn.

OBJECTIVES: Since 1972, the University of Heidelberg and the University of Applied Sciences Heilbronn have jointly been running a medical informatics program. To continuously provide high quality education, the curriculum is regularly evaluated among its graduates. The objectives of this study were to assess the job situation of the graduates and to evaluate the curriculum from their viewpoint. METHOD: Anonymous inquiry of all medical informatics graduates, having finished their studies before March 31, 2001 (n=1024) using a structured questionnaire. RESULTS: The questionnaire was answered by 446 (compliance: 45.5%) graduates. About one third (146 of 444 valid cases) are working in software/hardware companies. 179 (43.0% of 416 valid cases) graduates are working within medical informatics, 214 (51.4%) are working outside of medical informatics, but within other informatics. 23 (5.5%) graduates are working neither in medical nor in other informatics. 15 percent of the responding graduates have received a doctor's degree. Software engineering, database and information systems are regarded as most important parts of the education. The majority of the graduates are satisfied with their education as well as with their personal career. CONCLUSIONS: The variety of jobs, the job profiles, and the high level of our graduates' satisfaction with their education indicate the relevance of specialized medical informatics programs with a curricular profile like the one in Heidelberg/Heilbronn. Investigations like this can help to adjust the contents of the curriculum to professional needs.

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.

[Standardizing terminology in pediatric oncology--the basic data set]. / Terminologiestandardisierung in der Pädiatrischen Onkologie - der Basisdatensatz.

BACKGROUND: In the context of more than 20 therapy optimizing clinical trials in pediatric oncology an extensive documentation with a big number of case report forms was developed in the last 20 to 25 years. Across these trials same information is partially captured in different terminological ways, by which documentation about patients in the clinics is made more difficult. METHOD: Terminology of therapy optimizing clinical trials of German Society for Pediatric Oncology and Hematology (GPOH) is standardized by a central "standards committee". RESULT: As a first result the basic data set of GPOH could be revised and made available in internet via http://www.dospo.uni-hd.de. CONCLUSION: A basis of a unique documentation language in pediatric oncology is available for German speaking regions.