[Value of hospital electronic health records for clinical research: contribution of the European project EHR4CR]. / Intérêt des dossiers de santé électroniques hospitaliers pour la recherche clinique - Le projet européen EHR4CR.

Electronic health records in hospitals contribute to improving the quality of care by enabling better management of clinical information. The databases thus constituted facilitate the exchange of health information with healthcare providers and optimize multidisciplinary coordination for better therapeutic results. The EHR4CR (Electronic Health Records for Clinical Research) European project has developed an innovative pilot platform enabling the reuse of this digital information for clinical research. By enhancing and speeding up clinical research procedures, this innovative approach makes it possible to conduct clinical trials more efficiently, faster, and more economically.

Business analysis for a sustainable, multi-stakeholder ecosystem for leveraging the Electronic Health Records for Clinical Research (EHR4CR) platform in Europe.

INTRODUCTION: The Electronic Health Records for Clinical Research (EHR4CR) technological platform has been developed to enable the trustworthy reuse of hospital electronic health records data for clinical research. The EHR4CR platform can enhance and speed up clinical research scenarios: protocol feasibility assessment, patient identification for recruitment in clinical trials, and clinical data exchange, including for reporting serious adverse events. Our objective was to seed a multi-stakeholder ecosystem to enable the scalable exploitation of the EHR4CR platform in Europe, and to assess its economic sustainability. MATERIALS AND METHODS: Market analyses were conducted by a multidisciplinary task force to define an EHR4CR emerging ecosystem and multi-stakeholder value chain. This involved mapping stakeholder groups and defining their unmet needs, incentives, potential barriers for adopting innovative solutions, roles and interdependencies. A comprehensive business model, value propositions, and sustainability strategies were developed accordingly. Using simulation modelling (including Monte Carlo simulations) and a 5-year horizon, the potential financial outcomes of the business model were forecasted from the perspective of an EHR4CR service provider. RESULTS: A business ecosystem was defined to leverage the EHR4CR multi-stakeholder value chain. Value propositions were developed describing the expected benefits of EHR4CR solutions for all stakeholders. From an EHR4CR service provider's viewpoint, the business model simulation estimated that a profitability ratio of up to 1.8 could be achieved at year 1, with potential for growth in subsequent years depending on projected market uptake. CONCLUSIONS: By enhancing and speeding up existing processes, EHR4CR solutions promise to transform the clinical research landscape. The ecosystem defined provides the organisational framework for optimising the value and benefits for all stakeholders involved, in a sustainable manner. Our study suggests that the exploitation of EHR4CR solutions appears profitable and sustainable in Europe, with a growth potential depending on the rates of market and hospital adoption.

Cost-benefit assessment of using electronic health records data for clinical research versus current practices: Contribution of the Electronic Health Records for Clinical Research (EHR4CR) European Project.

INTRODUCTION: The widespread adoption of electronic health records (EHR) provides a new opportunity to improve the efficiency of clinical research. The European EHR4CR (Electronic Health Records for Clinical Research) 4-year project has developed an innovative technological platform to enable the re-use of EHR data for clinical research. The objective of this cost-benefit assessment (CBA) is to assess the value of EHR4CR solutions compared to current practices, from the perspective of sponsors of clinical trials. MATERIALS AND METHODS: A CBA model was developed using an advanced modeling approach. The costs of performing three clinical research scenarios (S) applied to a hypothetical Phase II or III oncology clinical trial workflow (reference case) were estimated under current and EHR4CR conditions, namely protocol feasibility assessment (S1), patient identification for recruitment (S2), and clinical study execution (S3). The potential benefits were calculated considering that the estimated reduction in actual person-time and costs for performing EHR4CR S1, S2, and S3 would accelerate time to market (TTM). Probabilistic sensitivity analyses using Monte Carlo simulations were conducted to manage uncertainty. RESULTS: Should the estimated efficiency gains achieved with the EHR4CR platform translate into faster TTM, the expected benefits for the global pharmaceutical oncology sector were estimated at €161.5m (S1), €45.7m (S2), €204.5m (S1+S2), €1906m (S3), and up to €2121.8m (S1+S2+S3) when the scenarios were used sequentially. CONCLUSIONS: The results suggest that optimizing clinical trial design and execution with the EHR4CR platform would generate substantial added value for pharmaceutical industry, as main sponsors of clinical trials in Europe, and beyond.

Using electronic health records for clinical research: the case of the EHR4CR project.

OBJECTIVES: To describe the IMI EHR4CR project which is designing and developing, and aims to demonstrate, a scalable, widely acceptable and efficient approach to interoperability between EHR systems and clinical research systems. METHODS: The IMI EHR4CR project is combining and extending several previously isolated state-of-the-art technical components through a new approach to develop a platform for reusing EHR data to support medical research. This will be achieved through multiple but unified initiatives across different major disease areas (e.g. cardiovascular, cancer) and clinical research use cases (protocol feasibility, patient identification and recruitment, clinical trial execution and serious adverse event reporting), with various local and national stakeholders across several countries and therefore under various legal frameworks. RESULTS: An initial instance of the platform has been built, providing communication, security and terminology services to the eleven participating hospitals and ten pharmaceutical companies located in seven European countries. Proof-of-concept demonstrators have been built and evaluated for the protocol feasibility and patient recruitment scenarios. The specifications of the clinical trial execution and the adverse event reporting scenarios have been documented and reviewed. CONCLUSIONS: Through a combination of a consortium that brings collectively many years of experience from previous relevant EU projects and of the global conduct of clinical trials, of an approach to ethics that engages many important stakeholders across Europe to ensure acceptability, of a robust iterative design methodology for the platform services that is anchored on requirements of an underlying Service Oriented Architecture that has been designed to be scalable and adaptable, EHR4CR could be well placed to deliver a sound, useful and well accepted pan-European solution for the reuse of hospital EHR data to support clinical research studies.

Introducing a telemonitoring platform for diabetic patients in primary care: will it increase the socio-digital divide?

AIMS: This study investigates whether diabetes patients visiting a primary care setting are interested in using a telemonitoring platform and if so, whether characteristics of interested users could be distinguished. METHODS: Three questionnaires were administered by 92 diabetes persons recruited between May and September 2011. Descriptive statistics and logistic regression analysis were performed. Special attention was drawn to include patients with low educational levels. RESULTS: Patients with middle or high educational levels show quite some interest in the use of a telemonitoring platform, especially for the transmission of glycaemic data or for asking questions. Patients with low educational levels only show a minor interest in using such a platform. CONCLUSIONS: It is possibly worthwhile to implement a telemonitoring platform in a primary care setting; however this study did not show immediate profit for implementation in a CHC that organises diabetes clinics on regular basis. In primary care settings where it will be implemented, even if there is a social-digital divide today, the use of a telemonitoring platform could possibly reduce inequity in health care as time could become available for those most in need for face-to-face contact with their physician.

Quality requirements for EHR archetypes.

The realisation of semantic interoperability, in which any EHR data may be communicated between heterogeneous systems and fully understood by computers as well as people on receipt, is a challenging goal. Despite the use of standardised generic models for the EHR and standard terminology systems, too much optionality and variability exists in how particular clinical entries may be represented. Clinical archetypes provide a means of defining how generic models should be shaped and bound to terminology for specific kinds of clinical data. However, these will only contribute to semantic interoperability if libraries of archetypes can be built up consistently. This requires the establishment of design principles, editorial and governance policies, and further research to develop ways for archetype authors to structure clinical data and to use terminology consistently. Drawing on several years of work within communities of practice developing archetypes and implementing systems from them, this paper presents quality requirements for the development of archetypes. Clinical engagement on a wide scale is also needed to help grow libraries of good quality archetypes that can be certified. Vendor and eHealth programme engagement is needed to validate such archetypes and achieve safe, meaningful exchange of EHR data between systems.

ARGOS policy brief on semantic interoperability.

Semantic interoperability is one of the priority themes of the ARGOS Trans-Atlantic Observatory. This topic represents a globally recognised challenge that must be addressed if electronic health records are to be shared among heterogeneous systems, and the information in them exploited to the maximum benefit of patients, professionals, health services, research, and industry. Progress in this multi-faceted challenge has been piecemeal, and valuable lessons have been learned, and approaches discovered, in Europe and in the US that can be shared and combined. Experts from both continents have met at three ARGOS workshops during 2010 and 2011 to share understanding of these issues and how they might be tackled collectively from both sides of the Atlantic. This policy brief summarises the problems and the reasons why they are important to tackle, and also why they are so difficult. It outlines the major areas of semantic innovation that exist and that are available to help address this challenge. It proposes a series of next steps that need to be championed on both sides of the Atlantic if further progress is to be made in sharing and analysing electronic health records meaningfully. Semantic interoperability requires the use of standards, not only for EHR data to be transferred and structurally mapped into a receiving repository, but also for the clinical content of the EHR to be interpreted in conformity with the original meanings intended by its authors. Wide-scale engagement with professional bodies, globally, is needed to develop these clinical information standards. Accurate and complete clinical documentation, faithful to the patient's situation, and interoperability between systems, require widespread and dependable access to published and maintained collections of coherent and quality-assured semantic resources, including models such as archetypes and templates that would (1) provide clinical context, (2) be mapped to interoperability standards for EHR data, (3) be linked to well specified multi-lingual terminology value sets, and (4) be derived from high quality ontologies. There is need to gain greater experience in how semantic resources should be defined, validated, and disseminated, how users (who increasingly will include patients) should be educated to improve the quality and consistency of EHR documentation and to make full use of it. There are urgent needs to scale up the authorship, acceptance, and adoption of clinical information standards, to leverage and harmonise the islands of standardisation optimally, to assure the quality of the artefacts produced, and to organise end-to-end governance of the development and adoption of solutions.

Policy brief on the current status of certification of electronic Health Records in the US and Europe.

If Electronic Health Record systems are to provide an effective contribution to healthcare, a set of benchmarks need to be set to ensure quality control and interoperability of systems. This paper outlines the prevailing status of EHR certification in the US and the EU, compares and contrasts established schemes and poses opportunities for convergence of activity in the domain designed to advance certification endeavours generally. Several EU Member States have in the past proceeded with EHR systems quality labeling and/or certification, but these differ in scope, in legal framework under which they operate, in policies (legislation and financial incentives), in organization, and perhaps most importantly in the quality criteria used for benchmarking. Harmonization, therefore, became a must. Now, through EuroRec (with approaches ranging from self-assessment to third party certification depending on the level of confidence needed) and its Seals, the possibility to achieve this for EHR systems has started in the whole of Europe. The US HITECH Act also attempts to create incentives for all hospitals and eligible providers to adopt and use electronic information. A centerpiece of the Act is to put in place strong financial incentives to adopt and meaningfully use EHRs. The HHS/EHR Certification Programme makes use of ISO/IEC 170XX standards for accreditation, testing and certification. The approved test method addresses the functional and the interoperability requirements defined in the Final Rule criteria and standards. To date six Authorized Testing and Certification Bodies (ATCBs) are testing and certifying products in the US.

A proposed vision: the transatlantic observatory for meeting global health policy challenges through information and communications technology-enabled solutions (ARGOS).

In 2010 the ARGOS project was funded by the EC (DG RELEX) to contribute to the establishement of a "Transatlantic Observatory for meeting Global Health Policy Challenges through Information and Communication Technology-enabled solutions" to develop and promote common methods for responding to global eHealth challenges in the EU and the US. The European Institute for Health Records (EuroRec) was coordinating the project. The vision is that the Transatlantic Observatory will act as an international platform for dialogue and collaboration on health policy issues and will 1. build international consensus about how to improve the access, efficiency and quality of health services through ICT, 2. promote the importance of interoperability in eHealth, 3. help to define approaches to ensure that health data are easily available where it is needed, 4. identify optimal development paths.

Introducing telemonitoring for diabetic patients: development of a telemonitoring 'Health Effect and Readiness' Questionnaire.

PURPOSE: Till now no validated instrument exists to measure the readiness and attitude of diabetic patients towards the use of telemonitoring. The purpose of the described study was to develop a Telemonitoring Attitude and Readiness Questionnaire and to check its validity and reliability. METHODS: After performing in-depth interviews in two separate sessions, the Telemonitoring Attitude and Readiness Questionnaire was completed by a convenience sample of 138 patients with type 1 and type 2 diabetes to determine internal consistency. Test-retest reliability was further evaluated with a subsample of 21 patients. RESULTS: Analysis supports the validity and reliability of the 13-item Telemonitoring Health Effect and Readiness Questionnaire (THERQ) with three subscales: Communication with peers or during holidays with a professional (Cronbach's alpha=0.84), telemonitoring health effect (Cronbach's alpha=0.87), and communication with a professional from home (Cronbach's alpha=0.88). Test-retest reliability is satisfactory (intraclass correlation coefficients between 0.58 and 0.92). CONCLUSIONS: The results of this study provide preliminary evidence that the Telemonitoring Health Effect and Readiness Questionnaire is a valid and reliable instrument to measure the readiness and subjective feelings of health effect towards the use of telemonitoring. The THERQ could be used before the implementation of telemonitoring to check if diabetic patients are interested in the use of it but it could also be used in (randomized) controlled trials as the questions are put in such a way that also patients not (yet) using telemonitoring can answer the questions.

An evolutionary approach to the representation of adverse events.

One way to detect, monitor and prevent adverse events with the help of Information Technology is by using ontologies capable of representing three levels of reality: what is the case, what is believed about reality, and what is represented. We report on how Basic Formal Ontology and Referent Tracking exhibit this capability and how they are used to develop an adverse event ontology and related data annotation scheme for the European ReMINE project.

Trans-eCare: creating a transparent data exchange platform.

Home health care (HHC) organizations as well as hospitals encounter information-tracking problems regarding their patients. When a patient is admitted to the hospital, it is not always possible/easy to find out if this person already had HHC and if so, by which organization it was provided. HHC organizations also not always know to which hospital a person is admitted. At discharge, although discharge documents exist, HHC organizations not always receive the necessary information. However, sharing information between the different care-partners involved is important, among others for the continuity of care. Hospitals will gain better insight in the provided home care before admission, and HHC organizations will get a more complete and direct insight in the course of care at the hospital. In doing so, they are better prepared to provide the necessary care for the patient admitted to the hospital or returning at home. Discussion with the partners involved in the IBBT-Trans-eCare project resulted in tracking the current problems, defining goals and presenting a solution to meet the defined problems.

A data protection framework for trans-European genetic research projects.

The paper proposes a data protection framework for trans-European medical research projects, which is based on a technical security infrastructure as well as on organizational measures and contractual obligations. It mainly relies on pseudonymization, an internal Data Protection Authority and on a Trusted Third Party. The outcome is an environment that combines both good research conditions and an extensive protection of patients' privacy.

Certification of Electronic Health Record systems and the importance of the validation of clinical archetypes.

If Electronic Health Record (EHR) systems are to provide an effective contribution to healthcare across Europe, a set of benchmarks need to be set to ensure the quality of such systems. This article describes the results of the EU funded QRec- project and emphasizes the need for validation of clinical archetypes to support the semantic interoperability between EHR systems and other interacting eHealth applications.

Health data exchange, health data sharing and decentralised clinical data collections--recommendations from a Belgian expert group.

The Belgian Federal Health Authorities are willing to redefine their eHealth vision and to reformulate their strategy in consensus with healthcare professionals and other domain experts. The National Health Insurance Institute ordered end 2007 a study to a group of experts, representing the majority of the eHealth stakeholders. The aim of the study was to define the strategy to be followed regarding health data exchange, data sharing, decentralised clinical data collections and Electronic Health Records. The experts issued, June 2008, a description of the current standing regarding nationally available (or to be made available) services as well as a set of priorities (structural and technological ones) for the coming years. This paper presents the experts' recommendations and some translated excerpts of their report.

Test-retest reliability of wavelet - and Fourier based EMG (instantaneous) median frequencies in the evaluation of back and hip muscle fatigue during isometric back extensions.

The present study aimed at assessing the test-retest reliability of wavelet - and Fourier derived (instantaneous) median frequencies of surface electromyographic (EMG) measurements of back and hip muscles during isometric back extensions. Twenty healthy subjects (10 males and 10 females) performed a modified Biering-Sørensen test on two separate days, with a 1-week interval between the two tests. Surface EMG measurements were bilaterally performed from the latissimus dorsi, the thoracic and lumbar parts of the longissimus thoracis, the thoracic and lumbar parts of the iliocostalis lumborum, the multifidus, the gluteus maximus and the biceps femoris. In addition, three-dimensional kinematic data were recorded of the subjects' lumbar vertebrae. The (instantaneous) median frequencies were calculated from the EMG signals using continuous wavelet (IMDF) - and short-time Fourier transforms (MDF). Linear regressions performed on the IMDF and MDF data as a function of time yielded slopes (IMDF(slope) and MDF(slope)) and intercepts (IMDF(init) and MDF(init)) of the regression lines. Test-retest reliability was assessed on the normalized slopes and intercept parameters by means of intraclass correlation coefficients (ICC) and standard errors of measurements expressed as percentages of the mean values (% SEM). The results of IMDF(slope) and MDF(slope) parameters indicated ICCs for back and hip muscles between .443 and .727 for IMDF(slope), values between .273 and .734 for MDF(slope), % SEM between 7.6% and 58.9% for IMDF(slope) and % SEM between 8.2% and 25.3% for MDF(slope), respectively. The ICCs for IMDF(init) and MDF(init) parameters varied between .376 and .907 for IMDF(init) and between .383 and .883 for MDF(init), and % SEM ranged from 2.7% to 6.3% for IMDF(init) and from 2.6% to 4.7% for MDF(init), respectively. These results indicate that both wavelet - and Fourier based (instantaneous) median frequency parameters generally are reliable in the analysis of back and hip muscle fatigue during a modified Biering-Sørensen test.

Cost-effectiveness of telemonitoring for high-risk pregnant women.

PURPOSE: Cost-minimization is a main topic in present-day health care. Clinicians are urged to keep hospital stays as short as possible, also in Obstetrics and Gynaecology Departments. At present stabilized high-risk pregnant women stay in hospital for the sole purpose of being monitored. METHOD: In this retrospective study the cost-effectiveness of telemonitoring of such high-risk pregnant women was calculated by analyzing the data of 456 episodes originating from 415 patients of the Ghent University Hospital. RESULTS AND CONCLUSIONS: It was determined that telemonitoring made a cost-reduction of euro 145,822 per year possible. However, variables such as educational level, psychosocial situation, time-travel distance from home to the hospital, reimbursement system and actual clinical status were not included. Furthermore, the Belgian health authorities does not provide for a specific code to allow the billing of teleinterpretation of transmitted results.

Co-operation, interaction and information-sharing: from a paper-based Diabetes Pass to an electronic alternative.

Diabetes is one of the most challenging problems in the 21st century, whereby research showed that reducing the concentration of blood glucose is thought to prevent or reduce the long-term complications. To do so, a multidisciplinary approach is favourable. In Belgium, a revalidation programme for the diabetic patients concerning self-regulation was introduced followed by the introduction of the Diabetes Pass in March 2003 whereby some goals were stipulated. In IBBT-COPLINTHO, a still ongoing project, an eHomeCare platform is implemented whereby the patient is the central actor. The analysis of the current paper-based Diabetes Pass revealed that the data can be easily extracted from the EHR. An electronic alternative for the Diabetes pass is proposed whereby the added values for the patient are underlined. Before implementing the electronic alternative, some research should still be done, but it is thought that all the actors involved--including the patient, could easily benefit from the electronic alternative.

Privacy enhancing techniques in E-health: an overview.

This overview highlights the relevance of Privacy Enhancing Techniques (PETs) in the context of e-Health. A number of validated privacy protecting techniques is briefly presented. The implementation of such PETs could provoke, for a number of applications, a shift in paradigm, namely from "Privacy through Security" to "Security through Privacy".