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.

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.

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.

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.

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.

Evaluation of an Integrated Telemonitoring Surveillance System in Patients with Coronary Heart Disease.

OBJECTIVES: Cardiovascular diseases are the most frequent cause of death in industrialized countries. Non-adherence with prescribed medication and recommended lifestyle changes significantly increases the risk of major cardiovascular events. The telemonitoring programme MyCor (Myokardinfarkt und Koronarstent Programm in Tirol) is a multi-modal intervention programme to improve lifestyle and medication management of patients with coronary heart disease (CHD). It includes patient education, self-monitoring with goal-setting and feedback, and regular clinical visits. We evaluated the MyCor telemonitoring programme regarding technical feasibility, user acceptance, patient adherence, change in health status, and change in quality of life. METHODS: A 4½-month study was conducted with two telemonitoring phases and one interim phase. The study comprised patient surveys, standardized assessment of quality of life using the MacNew questionnaire at study entry and after 4 and 18 weeks, analysis of adherence to medication and physical activity during the two telemonitoring phases, and analysis of reached goals regarding health conditions during the telemonitoring phases. RESULTS: Twenty-five patients (mean age: 63 years) participated in the study. Patients showed a high acceptance of the MyCor telemonitoring programme. Patients reported feelings of self-control, motivation for lifestyle changes, and improved quality of life. Adherence to daily measurements was high with 86% and 77% in the two telemonitoring phases. Adherence to medication was also high with up to 87% and 80%. Pre-defined goals for physical activity were reached in up to 86% and 73% of days, respectively. Quality of life improved from 5.5 at study entry to 6.3 at the end (p< 0.01; MacNew questionnaire). Reductions in blood pressure and heart rate or an improvement in reaching defined goals could not be observed. CONCLUSIONS: The MyCor telemonitoring programme Tirol for CHD patients has a high rate of acceptance among included patients. Critical evaluation revealed subjective benefits regarding quality of life and health status as well as high adherence rates to medication and lifestyle changes. Achieving long-term adherence and verifying clinical outcomes, however, remains an open issue. Our findings will promote further studies, addressing different strategies for an optimal mix of patient education, telemonitoring, feedback, and clinical follow-ups.

Usability Flaws in Medication Alerting Systems: Impact on Usage and Work System.

OBJECTIVES: Previous research has shown that medication alerting systems face usability issues. There has been no previous attempt to systematically explore the consequences of usability flaws in such systems on users (i.e. usage problems) and work systems (i.e. negative outcomes). This paper aims at exploring and synthesizing the consequences of usability flaws in terms of usage problems and negative outcomes on the work system. METHODS: A secondary analysis of 26 papers included in a prior systematic review of the usability flaws in medication alerting was performed. Usage problems and negative outcomes were extracted and sorted. Links between usability flaws, usage problems, and negative outcomes were also analyzed. RESULTS: Poor usability generates a large variety of consequences. It impacts the user from a cognitive, behavioral, emotional, and attitudinal perspective. Ultimately, usability flaws have negative consequences on the workflow, the effectiveness of the technology, the medication management process, and, more importantly, patient safety. Only few complete pathways leading from usability flaws to negative outcomes were identified. CONCLUSION: Usability flaws in medication alerting systems impede users, and ultimately their work system, and negatively impact patient safety. Therefore, the usability dimension may act as a hidden explanatory variable that could explain, at least partly, the (absence of) intended outcomes of new technology.

Patient Portals as a Means of Information and Communication Technology Support to Patient- Centric Care Coordination - the Missing Evidence and the Challenges of Evaluation. A joint contribution of IMIA WG EVAL and EFMI WG EVAL.

OBJECTIVES: To review the potential contribution of Information and Communication Technology (ICT) to enable patient-centric and coordinated care, and in particular to explore the role of patient portals as a developing ICT tool, to assess the available evidence, and to describe the evaluation challenges. METHODS: Reviews of IMIA, EFMI, and other initiatives, together with literature reviews. RESULTS: We present the progression from care coordination to care integration, and from patient-centric to person-centric approaches. We describe the different roles of ICT as an enabler of the effective presentation of information as and when needed. We focus on the patient's role as a co-producer of health as well as the focus and purpose of care. We discuss the need for changing organisational processes as well as the current mixed evidence regarding patient portals as a logical tool, and the reasons for this dichotomy, together with the evaluation principles supported by theoretical frameworks so as to yield robust evidence. CONCLUSIONS: There is expressed commitment to coordinated care and to putting the patient in the centre. However to achieve this, new interactive patient portals will be needed to enable peer communication by all stakeholders including patients and professionals. Few portals capable of this exist to date. The evaluation of these portals as enablers of system change, rather than as simple windows into electronic records, is at an early stage and novel evaluation approaches are needed.

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.

A Nursing Intelligence System to Support Secondary Use of Nursing Routine Data.

BACKGROUND: Nursing care is facing exponential growth of information from nursing documentation. This amount of electronically available data collected routinely opens up new opportunities for secondary use. OBJECTIVES: To present a case study of a nursing intelligence system for reusing routinely collected nursing documentation data for multiple purposes, including quality management of nursing care. METHODS: The SPIRIT framework for systematically planning the reuse of clinical routine data was leveraged to design a nursing intelligence system which then was implemented using open source tools in a large university hospital group following the spiral model of software engineering. RESULTS: The nursing intelligence system is in routine use now and updated regularly, and includes over 40 million data sets. It allows the outcome and quality analysis of data related to the nursing process. CONCLUSIONS: Following a systematic approach for planning and designing a solution for reusing routine care data appeared to be successful. The resulting nursing intelligence system is useful in practice now, but remains malleable for future changes.

Memorandum "Open Metadata". Open Access to Documentation Forms and Item Catalogs in Healthcare.

At present, most documentation forms and item catalogs in healthcare are not accessible to the public. This applies to assessment forms of routine patient care as well as case report forms (CRFs) of clinical and epidemiological studies. On behalf of the German chairs for Medical Informatics, Biometry and Epidemiology six recommendations to developers and users of documentation forms in healthcare were developed. Open access to medical documentation forms could substantially improve information systems in healthcare and medical research networks. Therefore these forms should be made available to the scientific community, their use should not be unduly restricted, they should be published in a sustainable way using international standards and sources of documentation forms should be referenced in scientific publications.

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.

From adverse drug event detection to prevention. A novel clinical decision support framework for medication safety.

BACKGROUND: Errors related to medication seriously affect patient safety and the quality of healthcare. It has been widely argued that various types of such errors may be prevented by introducing Clinical Decision Support Systems (CDSSs) at the point of care. OBJECTIVES: Although significant research has been conducted in the field, still medication safety is a crucial issue, while few research outcomes are mature enough to be considered for use in actual clinical settings. In this paper, we present a clinical decision support framework targeting medication safety with major focus on adverse drug event (ADE) prevention. METHODS: The novelty of the framework lies in its design that approaches the problem holistically, i.e., starting from knowledge discovery to provide reliable numbers about ADEs per hospital or medical unit to describe their consequences and probable causes, and next employing the acquired knowledge for decision support services development and deployment. Major design features of the framework's services are: a) their adaptation to the context of care (i.e. patient characteristics, place of care, and significance of ADEs), and b) their straightforward integration in the healthcare information technologies (IT) infrastructure thanks to the adoption of a service-oriented architecture (SOA) and relevant standards. RESULTS: Our results illustrate the successful interoperability of the framework with two commercially available IT products, i.e., a Computerized Physician Order Entry (CPOE) and an Electronic Health Record (EHR) system, respectively, along with a Web prototype that is independent of existing healthcare IT products. The conducted clinical validation with domain experts and test cases illustrates that the impact of the framework is expected to be major, with respect to patient safety, and towards introducing the CDSS functionality in practical use. CONCLUSIONS: This study illustrates an important potential for the applicability of the presented framework in delivering contextualized decision support services at the point of care and for making a substantial contribution towards ADE prevention. Nonetheless, further research is required in order to quantitatively and thoroughly assess its impact in medication safety.

Crucial factors for the acceptance of a computerized national medication list: insights into findings from the evaluation of the Austrian e-Medikation pilot.

OBJECTIVE: The objective of this paper is to present crucial factors among registered doctors and pharmacists for acceptance of the Austrian 'e-Medikation' system which is aimed at providing, on a national level, complete and recent information on all the medication that were prescribed or dispensed to a patient. METHODS: As the accompanying formative evaluation study of the pilot project showed different overall acceptance rates among participating physicians and pharmacists, a decision tree analysis of 30 standardized survey items was performed to identify crucial acceptance factors. RESULTS: For the physicians' group, only two items (fear of improper data use and satisfaction with software support) were crucial for overall e-Medikation acceptance. The analysis of the pharmacists' data resulted in five crucial factors primarily focusing on functional aspects and the perceived benefits of e-Medikation. CONCLUSION: The results indicate that the acceptance among physicians and pharmacists depends on quite different factors. This must be taken into account during the planned rollout of e-Medikation or of comparable products.

A proposal for an Austrian Nursing Minimum Data Set (NMDS): a Delphi study.

OBJECTIVE: Nursing Minimum Data Sets can be used to compare nursing care across clinical populations, settings, geographical areas, and time. NMDS can support nursing research, nursing management, and nursing politics. However, in contrast to other countries, Austria does not have a unified NMDS. The objective of this study is to identify possible data elements for an Austrian NMDS. METHODS: A two-round Delphi survey was conducted, based on a review of available NMDS, 22 expert interviews, and a focus group discussion. RESULTS: After reaching consensus, the experts proposed the following 56 data elements for an NMDS: six data elements concerning patient demographics, four data elements concerning data of the healthcare institution, four data elements concerning patient's medical condition, 20 data elements concerning patient problems (nursing assessment, nursing diagnoses, risk assessment), eight data elements concerning nursing outcomes, 14 data elements concerning nursing interventions, and no additional data elements concerning nursing intensity. CONCLUSION: The proposed NMDS focuses on the long-term and acute care setting. It must now be implemented and tested in the nursing practice.

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.

STARE-HI - Statement on Reporting of Evaluation Studies in Health Informatics: explanation and elaboration.

BACKGROUND: Improving the quality of reporting of evaluation studies in health informatics is an important requirement towards the vision of evidence-based health informatics. The STARE-HI - Statement on Reporting of Evaluation Studies in health informatics, published in 2009, provides guidelines on the elements to be contained in an evaluation study report. OBJECTIVES: To elaborate on and provide a rationale for the principles of STARE-HI and to guide authors and readers of evaluation studies in health informatics by providing explanatory examples of reporting. METHODS: A group of methodologists, researchers and editors prepared the present elaboration of the STARE-HI statement and selected examples from the literature. RESULTS: The 35 STARE-HI items to be addressed in evaluation papers describing health informatics interventions are discussed one by one and each is extended with examples and elaborations. CONCLUSION: The STARE-HI statement and this elaboration document should be helpful resources to improve reporting of both quantitative and qualitative evaluation studies. Evaluation manuscripts adhering to the principles will enable readers of such papers to better place the studies in a proper context and judge their validity and generalizability, and thus in turn optimize the exploitation of the evidence contained therein. LIMITATIONS: This paper is based on experiences of a group of editors, reviewers, authors of systematic reviews and readers of the scientific literature. The applicability of the details of these principles has to evolve as a function of their use in practice.

Evidence Based Health Informatics: 10 Years of Efforts to Promote the Principle. Joint Contribution of IMIA WG EVAL and EFMI WG EVAL.

OBJECTIVES: To present the importance of Evidence-based Health Informatics (EBHI) and the ethical imperative of this approach; to highlight the work of the IMIA Working Group on Technology Assessment and Quality Improvement and the EFMI Working Group on Assessment of Health Information Systems; and to introduce the further important evaluation and evidence aspects being addressed. METHODS: Reviews of IMIA, EFMA and other initiatives, together with literature reviews on evaluation methods and on published systematic reviews. RESULTS: Presentation of the rationale for the health informatics domain to adopt a scientific approach by assessing impact, avoiding harm, and empirically demonstrating benefit and best use; reporting of the origins and rationale of the IMIA- and EQUATOR-endorsed Statement on Reporting of Evaluation Studies in Health Informatics (STARE-HI) and of the IMIA WG's Guideline for Good Evaluation Practice in Health Informatics (GEP-HI); presentation of other initiatives for objective evaluation; and outlining of further work in hand on usability and indicators; together with the case for development of relevant evaluation methods in newer applications such as telemedicine. The focus is on scientific evaluation as a reliable source of evidence, and on structured presentation of results to enable easy retrieval of evidence. CONCLUSIONS: EBHI is feasible, necessary for efficiency and safety, and ethically essential. Given the significant impact of health informatics on health systems, care delivery and personal health, it is vital that cultures change to insist on evidence-based policies and investment, and that emergent global moves for this are supported.