Early thrombosis prophylaxis with enoxaparin is not associated with hematoma expansion in patients with spontaneous intracerebral hemorrhage.

BACKGROUND AND PURPOSE: Early pharmacological deep vein thrombosis (DVT) prophylaxis is recommended by guidelines, but rarely started within 48 h. We aimed to analyze the effect of early (within 48 h) versus late (>48 h) DVT prophylaxis on hematoma expansion (HE) and outcome in patients with spontaneous intracerebral hemorrhage (ICH). METHODS: We analyzed 134 consecutive patients admitted to a tertiary neurointensive care unit with diagnosed spontaneous ICH, without previous anticoagulation, severe coagulopathy, hematoma evacuation, early withdrawal of therapy or ineligibility for DVT prophylaxis according to our institutional protocol. Significant late HE was defined as ≥6 mL increase of hematoma volume between neuroimaging within 48 h and day 3-6. Multivariate analysis was performed to identify risk factors for late HE, poor 3-month outcome (modified Rankin Scale score ≥ 4) and mortality. RESULTS: Patients had a median Glasgow Coma Scale score of 14 [interquartile range (IQR), 10-15], ICH volume of 11 (IQR, 5-24) mL and were 71 (IQR, 61-76) years old. A total of 56% (n = 76) received early DVT prophylaxis, 37% (n = 50) received late DVT prophylaxis and 8 (6%) had unknown bleeding onset. Patients with early DVT prophylaxis had smaller ICH volume [9.5 (IQR, 4-18.5) vs. 17.5 (IQR, 8-29) mL, P = 0.038] and were more often comatose (26% vs. 10%, P = 0.025). Significant late HE [n = 5/134 (3.7%)] was associated with larger initial ICH volume (P = 0.02) and lower thrombocyte count (P = 0.03) but not with early DVT prophylaxis (P = 0.36). Early DVT prophylaxis was not associated with worse outcome. CONCLUSION: Significant late HE is uncommon and DVT prophylaxis within 48 h of symptom onset may be safe in selected patients with ICH.

Feasibility and effectiveness of a multidimensional post-discharge disease management programme for heart failure patients in clinical practice: the HerzMobil Tirol programme.

AIMS: It remains unclear whether transitional care management outside of a clinical trial setting provides benefits for patients with acute heart failure (AHF) after hospitalization. We evaluated the feasibility and effectiveness of a multidimensional post-discharge disease management programme using a telemedical monitoring system incorporated in a comprehensive network of heart failure nurses, resident physicians, and secondary and tertiary referral centres (HerzMobil Tirol, HMT), METHODS AND RESULTS: The non-randomized study included 508 AHF patients that were managed in HMT (n = 251) or contemporaneously in usual care (UC, n = 257) after discharge from hospital from 2016 to 2019. Groups were retrospectively matched for age and sex. The primary endpoint was time to HF readmission and all-cause mortality within 6 months. Multivariable Cox proportional hazard models were used to assess the effectiveness. The primary endpoint occurred in 48 patients (19.1%) in HMT and 89 (34.6%) in UC. Compared with UC, management by HMT was associated with a 46%-reduction in the primary endpoint (adjusted HR 0.54; 95% CI 0.37-0.77; P < 0.001). Subgroup analyses revealed consistent effectiveness. The composite of recurrent HF hospitalization and death within 6 months per 100 patient-years was 64.2 in HMT and 108.2 in UC (adjusted HR 0.41; 95% CI 0.29-0.55; P < 0.001 with death considered as a competing risk). After 1 year, 25 (10%) patients died in HMT compared with 66 (25.7%) in UC (HR 0.38; 95% CI 0.23-0.61, P < 0.001). CONCLUSIONS: A multidimensional post-discharge disease management programme, comprising a telemedical monitoring system incorporated in a comprehensive network of specialized heart failure nurses and resident physicians, is feasible and effective in clinical practice.

The time needed for clinical documentation versus direct patient care. A work-sampling analysis of physicians' activities.

OBJECTIVES: Health care professionals seem to be confronted with an increasing need for high-quality, timely, patient-oriented documentation. However, a steady increase in documentation tasks has been shown to be associated with increased time pressure and low physician job satisfaction. Our objective was to examine the time physicians spend on clinical and administrative documentation tasks. We analyzed the time needed for clinical and administrative documentation, and compared it to other tasks, such as direct patient care. METHODS: During a 2-month period (December 2006 to January 2007) a trained investigator completed 40 hours of 2-minute work-sampling analysis from eight participating physicians on two internal medicine wards of a 200-bed hospital in Austria. A 37-item classification system was applied to categorize tasks into five categories (direct patient care, communication, clinical documentation, administrative documentation, other). RESULTS: From the 5555 observation points, physicians spent 26.6% of their daily working time for documentation tasks, 27.5% for direct patient care, 36.2% for communication tasks, and 9.7% for other tasks. The documentation that is typically seen as administrative takes only approx. 16% of the total documentation time. CONCLUSIONS: Nearly as much time is being spent for documentation as is spent on direct patient care. Computer-based tools and, in some areas, documentation assistants may help to reduce the clinical and administrative documentation efforts.

The quality of evidence in health informatics: how did the quality of healthcare IT evaluation publications develop from 1982 to 2005?

OBJECTIVE: To obtain an overview of study designs and study methods used in research evaluating IT in health care, to present a list of quality criteria by which all kinds of reported evaluation studies on IT systems in health care can be assessed, and to assess the quality of reported evaluation studies on IT in health care and its development over time (1982-2005). METHODS: A generic 10-item list of quality indicators was developed based on existing literature on quality of medical and medical informatics publications. It is applicable to all kind of IT evaluation papers and not restricted to randomized controlled trials. One hundred and twenty explanatory papers evaluating the effects of an IT system in health care published between 1982 and 2005 were randomly selected from PubMed, the study designs and study methods were extracted, and the quality indicators were used to assess the quality of each paper by two independent raters. RESULTS: The inter-rater variability of scoring the 10 quality indicators as assessed by a pre-test with nine papers was good (K=0.87). There was a trend towards more multi-centre studies and authors coming more frequently from various departments. About 70% of the studies used a design other than a randomized controlled trial (RCT). Forty percent of the studies combined at least two different data acquisition methods. The quality of IT evaluation papers, as defined by the quality indicators, was only slightly improving in time (Spearman correlation coefficient [rs]=0.19). The quality of RCTs publications was significantly higher than the quality of non-RCT studies (p<0.001). CONCLUSION: The continuous and dominant number of non-RCT studies reflects the various approaches applicable to evaluate IT systems in health care. Despite the increasing discussion on evidence-based health informatics, the quality of published evaluation studies on IT interventions in health care is still insufficient in some aspects. Journal editors and referees should take care that reports of evaluation on IT systems contain all aspects needed for a sufficient understanding and reproducibility of a paper. Publication guidelines should be developed to support more complete and better publications of IT evaluation papers.

Supporting the systematic assessment of clinical processes: the MedFlow method.

OBJECTIVES: Healthcare is characterized by complex cooperation between highly specialized healthcare departments. This often leads to inefficient clinical processes. In order to improve these processes, a systematic assessment method is needed. Such methods are still missing. The objective of this paper is to propose and evaluate a method to support the systematic and semi-automatic assessment of clinical processes, with special focus on the quality of information logistics. METHODS: Criteria for the quality of information logistics were collected based on literature research and system analysis. Appropriate quality checks for these criteria were developed. An extended process modelling notation was developed. The method was evaluated in a pilot study. RESULTS: An own model integrates four sub-models with each concentrating on distinct process aspects (i.e., control flow, data flow, tool usage, organizational information). In order to assess the quality of a process, selected process details are combined in "views". Weak points are then detected by applying specific rule-sets on these views. Each rule-set represents a pattern of critical cross-points which are searched for in the appropriate view-matrix. The MedFlow method was evaluated in a first pilot study in radiological departments--applying quality checks for the detection of e.g. media cracks or testing the transcription of information objects. CONCLUSION: The MedFlow method is best used to assess clinical processes regarding their control flow and information handling. The latter directly influences the quality of communication and thus the quality of whole processes. However, this must be evaluated in further studies.

Evaluation Considerations for Secondary Uses of Clinical Data: Principles for an Evidence-based Approach to Policy and Implementation of Secondary Analysis.

Objectives: To set the scientific context and then suggest principles for an evidence-based approach to secondary uses of clinical data, covering both evaluation of the secondary uses of data and evaluation of health systems and services based upon secondary uses of data. Method: Working Group review of selected literature and policy approaches. Results: We present important considerations in the evaluation of secondary uses of clinical data from the angles of governance and trust, theory, semantics, and policy. We make the case for a multi-level and multi-factorial approach to the evaluation of secondary uses of clinical data and describe a methodological framework for best practice. We emphasise the importance of evaluating the governance of secondary uses of health data in maintaining trust, which is essential for such uses. We also offer examples of the re-use of routine health data to demonstrate how it can support evaluation of clinical performance and optimize health IT system design. Conclusions: Great expectations are resting upon "Big Data" and innovative analytics. However, to build and maintain public trust, improve data reliability, and assure the validity of analytic inferences, there must be independent and transparent evaluation. A mature and evidence-based approach needs not merely data science, but must be guided by the broader concerns of applied health informatics.

Process potential screening - an instrument to improve business processes in hospitals.

OBJECTIVES: Hospitals are increasingly under pressure to optimize their processes. So far, an instrument to systematically identify the potentials for improvement of a given business process is missing. The aim of this project is to develop such an instrument. METHODS: Initially, central aspects of the quality of a hospital process were identified on the basis of a systematic literature review. Secondary to that, criteria to measure quality aspects were defined: More than 300 criteria from medical and business informatics, economics and quality management publications were gathered and systematically aggregated. RESULTS: As a result, the Process Potential Screening (PPS) instrument was developed. The PPS is a matrix containing two axes: Axis I comprises 30 quality aspects referring to results, execution and control of hospital processes. Axis II comprises 16 quality criteria (e.g., customer satisfaction, time). The PPS displays approximately 400 relevant combinations of those quality aspects and quality criteria that help to identify potentials for improvement of a given hospital process. It utilizes different methods for the measurement of the criteria and for application by way of individuals or groups. CONCLUSIONS: In using the PPS, relevant potentials for improvement were identified in ten typical hospital processes. The instrument's practicability must now be examined in further studies by the final target group (e.g., quality or project managers, and the staff responsible for processes).

Evaluation of the electronic transmission of medical findings from hospitals to practitioners by triangulation.

OBJECTIVES: The need for regional, cross-institutional electronic networks in health care is steadily growing to support seamless, cooperative health care. The aim of this study is to evaluate the impact of electronic transmission between hospitals and practitioners in a Tyrolean health care network, and to derive technical and organizational points for improvement. METHODS: Between March and August 2004 we carried out a triangulation-based cross-sectional study, combining a qualitative study based on semi-structured, problem-centric interviews with selected practitioners, with a quantitative study based on a standardized questionnaire survey of all the Tyrolean practitioners that receive electronic messages. The survey was designed to confirm the hypotheses which have been systematically derived from the interviews. RESULTS AND CONCLUSIONS: The results show high satisfaction and positive impact of electronic communication. The triangulation of quantitative and qualitative methods was found to be useful in order to make the definition and confirmation of the hypotheses more transparent.

Factors influencing success and failure of health informatics systems--a pilot Delphi study.

OBJECTIVES: The aim is to gain information on factors influencing success and failure for Health Informatics applications from a group of medical informaticians. METHODS: Based on the presentations at a special topic conference on success and failure in Health ICT and analysis of the proceedings, we conducted a Delphi study on success and failure aspects. RESULTS: A total of 110 success factors and 27 failure criteria were identified, distributed on categories like functional, organizational, behavioral, technical, managerial, political, cultural, legal, strategy, economy, education and user acceptance. These factors and criteria were rated for six different system types. Unanimously it was agreed that "collaboration and co-operation" and "setting goals and courses" are "essential for the success" of clinical systems, and "user acceptance" for educational systems. Similarly, the score "essential in order to avoid a failure" were given unanimously on clinical systems for "response rate and other performance measures" and on administrative systems for "not understanding the organizational context" with "not understanding or foreseeing the extent to which the new IT-system affects the organization, its structure and/or work procedures" as the highest scoring sub-item. CONCLUSIONS: All success factors and failure criteria were considered relevant by the Delphi expert panel. There is no small set of relevant factors or indicators, but success or failure of a Health ICT depends on a large set of issues. Further, clinical systems and decision support systems depend on more factors than other systems.

Impact of CPOE on mortality rates--contradictory findings, important messages.

OBJECTIVE: To analyze the seemingly contradictory results of the Han study (Pediatrics 2005) and the Del Beccaro study (Pediatrics 2006), both analyzing the effect of CPOE systems on mortality rates in pediatric intensive care settings. METHODS: Seven CPOE system experts from the United States and Europe comment on these papers. RESULTS: The two studies are not contradictory, but almost non-comparable due to differences in design and implementation. They demonstrate the range of outcomes that can be obtained from introducing informatics applications in complex health care settings. Implementing informatics applications is a sociotechnical activity, which often depends more on the organizational context than on a specific technology. As health informaticians, we must not only learn from failures, but also avoid both uncritical scepticism that may arise from drawing overly general conclusions from one negative trial, as much as uncritical optimism from limited successful ones. CONCLUSION: The commentaries emphasize the need to promote systematic studies for assessing the socio-technical factors that influence the introduction of increasingly sophisticated informatics applications within complex organizations. The emergence of evidence-based health informatics will be based both on evaluation guidelines and implementation guidelines, both of which increase the chances of successful implementation. In addition, well-educated health informaticians are needed to manage and guide the implementation processes.

Medical informatics education needs information system practicums in health care settings--experiences and lessons learned from 32 practicums at four universities in two countries.

OBJECTIVES: To report about the themes and about experiences with practicums in the management of information systems in health care settings (health information management) for medical informatics students. METHODS: We first summarize the topics of the health information management practicums/projects that the authors organized between 1990 and 2003 for the medical informatics programs at Heidelberg/Heilbronn, Germany, UMIT, Austria, as well as for the informatics program at the University of Leipzig, Germany. Experiences and lessons learned, obtained from the faculty that organized the practicums in the past 14 years, are reported. RESULTS: Thirty (of 32) health information management practicums focused on the analysis of health information systems. These took place inside university medical centers. Although the practicums were time-intensive and required intensively tutoring students with regard to health information management and project management, feedback from the students and graduates was mainly positive. DISCUSSION: It is clearly recommended that students specializing in medical informatics need to be confronted with real-world problems of health information systems during their studies.

SPIRIT: Systematic Planning of Intelligent Reuse of Integrated Clinical Routine Data. A Conceptual Best-practice Framework and Procedure Model.

BACKGROUND: Secondary use of clinical routine data is receiving an increasing amount of attention in biomedicine and healthcare. However, building and analysing integrated clinical routine data repositories are nontrivial, challenging tasks. As in most evolving fields, recognized standards, well-proven methodological frameworks, or accurately described best-practice approaches for the systematic planning of solutions for secondary use of routine medical record data are missing. OBJECTIVE: We propose a conceptual best-practice framework and procedure model for the systematic planning of intelligent reuse of integrated clinical routine data (SPIRIT). METHODS: SPIRIT was developed based on a broad literature overview and further refined in two case studies with different kinds of clinical routine data, including process-oriented nursing data from a large hospital group and high-volume multimodal clinical data from a neurologic intensive care unit. RESULTS: SPIRIT aims at tailoring secondary use solutions to specific needs of single departments without losing sight of the institution as a whole. It provides a general conceptual best-practice framework consisting of three parts: First, a secondary use strategy for the whole organization is determined. Second, comprehensive analyses are conducted from two different viewpoints to define the requirements regarding a clinical routine data reuse solution at the system level from the data perspective (BOTTOM UP) and at the strategic level from the future users perspective (TOP DOWN). An obligatory clinical context analysis (IN BETWEEN) facilitates refinement, combination, and integration of the different requirements. The third part of SPIRIT is dedicated to implementation, which comprises design and realization of clinical data integration and management as well as data analysis solutions. CONCLUSIONS: The SPIRIT framework is intended to be used to systematically plan the intelligent reuse of clinical routine data for multiple purposes, which often was not intended when the primary clinical documentation systems were implemented. SPIRIT helps to overcome this gap. It can be applied in healthcare institutions of any size or specialization and allows a stepwise setup and evolution of holistic clinical routine data reuse solutions.

Improving Evaluation to Address the Unintended Consequences of Health Information Technology:. a Position Paper from the Working Group on Technology Assessment & Quality Development.

BACKGROUND AND OBJECTIVES: With growing use of IT by healthcare professionals and patients, the opportunity for any unintended effects of technology to disrupt care health processes and outcomes is intensified. The objectives of this position paper by the IMIA Working Group (WG) on Technology Assessment and Quality Development are to highlight how our ongoing initiatives to enhance evaluation are also addressing the unintended consequences of health IT. METHODS: Review of WG initiatives Results: We argue that an evidence-based approach underpinned by rigorous evaluation is fundamental to the safe and effective use of IT, and for detecting and addressing its unintended consequences in a timely manner. We provide an overview of our ongoing initiatives to strengthen study design, execution and reporting by using evaluation frameworks and guidelines which can enable better characterization and monitoring of unintended consequences, including the Good Evaluation Practice Guideline in Health Informatics (GEP-HI) and the Statement on Reporting of Evaluation Studies in Health Informatics (STARE-HI). Indicators to benchmark the adoption and impact of IT can similarly be used to monitor unintended effects on healthcare structures, processes and outcome. We have also developed EvalDB, a web-based database of evaluation studies to promulgate evidence about unintended effects and are developing the content for courses to improve training in health IT evaluation. CONCLUSION: Evaluation is an essential ingredient for the effective use of IT to improve healthcare quality and patient safety. WG resources and skills development initiatives can facilitate a proactive and evidence-based approach to detecting and addressing the unintended effects of health IT.

Bad health informatics can kill--is evaluation the answer?

OBJECTIVE: Health care is entering the age of information society. It is evident that the use of modern information and communication technology (ICT) offers tremendous opportunities to improve health care. However, there are also hazards associated with ICT in health care. We want to present an overview of typical hazards associated with ICT in health care, and to discuss how ICT evaluation can be a solution. METHODS: We analyze examples of failures and problems associated with ICT in health care. This collection is also made available on a website. RESULTS AND CONCLUSION: Systematic, continuous evaluation of quality and effects of ICT during the whole life cycle of ICT components seems to be one important approach to detect and prevent possible ICT hazards and failures, supporting a higher quality of patient care. However, empirical studies proving this assumption are needed.

An inventory of evaluation studies of information technology in health care trends in evaluation research 1982-2002.

OBJECTIVES: During the last years the significance of evaluation studies as well as the interest in adequate methods and approaches for evaluation has grown in medical informatics. In order to put this discussion into historical perspective of evaluation research, we conducted a systematic review on trends in evaluation research of information technology in health care from 1982 to 2002. METHODS: The inventory is based on a systematic literature search in PubMed. Abstracts were included when they described an evaluation study of a computer-based component in health care. We identified 1035 papers from 1982 to 2002 and indexed them based on a multi-axial classification describing type of information system, study location, evaluation strategy, evaluation methods, evaluation setting, and evaluation focus. RESULTS AND CONCLUSIONS: We found interesting developments in evaluation research in the last 20 years. For example, there has been a strong shift from medical journals to medical informatics journals. With regard to methods, explanatory research and quantitative methods have dominated evaluation studies in the last 20 years. Since 1982, the number of lab studies and technical evaluation studies has declined, while the number of studies focusing on the influence of information technology on quality of care processes or outcome of patient care has increased. We interpret this shift as a sign of maturation of evaluation research in medical informatics.

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.

Preparing strategic information management plans for hospitals: a practical guideline SIM plans for hospitals: a guideline.

OBJECTIVES: Systematic information management in hospitals demands for a strategic information management plan (SIM plan). As preparing a SIM plan is a considerable challenge we provide a practical guideline that is directly applicable when a SIM plan is going to be prepared. METHODS: The guideline recommends a detailed structure of a SIM plan and gives advice about its content and the preparation process. It may be used as template, which can be adapted to the individual demands of any hospital. RESULTS: The guideline was used in several hospitals preparing a SIM plan. Experiences showed that the SIM plans could be prepared very efficiently and timely using the guideline, that the proposed SIM plan structure suited well, that the guideline offers enough flexibility to meet the requirements of the individual hospitals and that the specific recommendations of the guideline were very helpful. CONCLUSIONS: Nevertheless, we must strive for a more comprehensive theory of strategic information management planning which -- in the sense of enterprise architecture planning -- represents the intrinsic correlations of the different parts of a SIM plan to a greater extent.

Evidence-based Health Informatics: How Do We Know What We Know?

BACKGROUND: Health IT is expected to have a positive impact on the quality and efficiency of health care. But reports on negative impact and patient harm continue to emerge. The obligation of health informatics is to make sure that health IT solutions provide as much benefit with as few negative side effects as possible. To achieve this, health informatics as a discipline must be able to learn, both from its successes as well as from its failures. OBJECTIVES: To present motivation, vision, and history of evidence-based health informatics, and to discuss achievements, challenges, and needs for action. METHODS: Reflections on scientific literature and on own experiences. RESULTS: Eight challenges on the way towards evidence-based health informatics are identified and discussed: quality of studies; publication bias; reporting quality; availability of publications; systematic reviews and meta-analysis; training of health IT evaluation experts; translation of evidence into health practice; and post-market surveillance. Identified needs for action comprise: establish health IT study registers; increase the quality of publications; develop a taxonomy for health IT systems; improve indexing of published health IT evaluation papers; move from meta-analysis to meta-summaries; include health IT evaluation competencies in curricula; develop evidence-based implementation frameworks; and establish post-marketing surveillance for health IT. CONCLUSIONS: There has been some progress, but evidence-based health informatics is still in its infancy. Building evidence in health informatics is our obligation if we consider medical informatics a scientific discipline.

Job Profiles of Biomedical Informatics Graduates. Results of a Graduate Survey.

BACKGROUND: Biomedical informatics programs exist in many countries. Some analyses of the skills needed and of recommendations for curricular content for such programs have been published. However, not much is known of the job profiles and job careers of their graduates. OBJECTIVES: To analyse the job profiles and job careers of 175 graduates of the biomedical informatics bachelor and master program of the Tyrolean university UMIT. METHODS: Survey of all biomedical informatics students who graduated from UMIT between 2001 and 2013. RESULTS: Information is available for 170 graduates. Eight percent of graduates are male. Of all bachelor graduates, 86% started a master program. Of all master graduates, 36% started a PhD. The job profiles are quite diverse: at the time of the survey, 35% of all master graduates worked in the health IT industry, 24% at research institutions, 9% in hospitals, 9% as medical doctors, 17% as informaticians outside the health care sector, and 6% in other areas. Overall, 68% of the graduates are working as biomedical informaticians. The results of the survey indicate a good job situation for the graduates. CONCLUSIONS: The job opportunities for biomedical informaticians who graduated with a bachelor or master degree from UMIT seem to be quite good. The majority of graduates are working as biomedical informaticians. A larger number of comparable surveys of graduates from other biomedical informatics programs would help to enhance our knowledge about careers in biomedical informatics.