Georges De Moor

Using electronic health records for clinical research

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.

Correlations between short-time Fourier- and continuous wavelet transforms in the analysis of localized back and hip muscle fatigue during isometric contractions

The aims of the current study were to examine the stationarities of surface electromyographic (EMG) signals obtained from eight bilateral back and hip muscles during a modified Biering-Sørensen test, and to investigate whether short-time Fourier (STFT) and continuous wavelet transforms (CWT) provided similar information with regard to EMG spectral parameters in the analysis of localized muscle fatigue. Twenty healthy subjects participated in the study after giving their informed consent. Reverse arrangement tests showed that 91.6% of the EMG signal epochs demonstrated no significant trends (all p>0.05), meaning 91.6% of the EMG signal epochs could be considered as stationary signals. Pearson correlation coefficients showed that STFT and CWT in general provide similar information with respect to the EMG spectral variables during isometric back extensions, and as a consequence STFT can still be used.

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.

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 (Cronbachs alpha=0.84), telemonitoring health effect (Cronbachs alpha=0.87), and communication with a professional from home (Cronbachs 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.

Privacy Protection through pseudonymisation in eHealth.

The ISO TC215 WG4 pseudonymisation task group has produced in 2008 a first version of a technical specification for the application of pseudonymisation in Healthcare Informatics 0. This paper investigates the principles set out in the technical specification as well as its implications in eHealth. The technical specification starts out with a conceptual model and evolves from a theoretical model to a real life model by adding assumptions on the observability of personal data.

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.

A Dutch medical language processor.

This paper describes the current state of a medical language processor for Dutch. The goal is to implement a language specific front-end compatible with some existing applications that aim at the intelligent extraction and processing of information from patient discharge summaries. A complete chain for processing and understanding Dutch medical documents will be the ultimate result. The text focuses mainly on the language specific aspects of the language processing chain. Evaluation results of the already functioning components are given as well as an outline for future developments and enhancements. A short theoretical background is provided (cf. also [1-3]: Rossi Mori et al., Proc. SCAMC 90, 1990, pp. 185-189; Wingert, in: Informatics and Medicine, an advanced course, Springer-Verlag. 1977, pp. 579-646; Wingert, Proc. MEDINFO 80, 1980, pp. 1321-1331) before the description of each component in order to familiarise the non-experienced reader with the basic notions of computational linguistics.

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.

The research in semantics behind the OpenLabs coding system

The OpenLabs coding system is an established, comprehensive, dynamic, flexible, open, multilingual European system which is tailored to meet the electronic data interchange (EDI) needs of medical laboratory users. The OpenLabs coding system, having many specific, independent classes and considerable flexibility, serves two different objectives: (i) unambiguous coding of entities present in messages used for EDI in clinical pathology; and (ii) interfacing with other nomenclatures and coding schemes to map concepts between different systems.

European standards development in healthcare informatics: actual and future challenges

Abstract This paper focuses on the current and future standardisation activities in CEN TC251 (European Standardisation Committee, Technical Committee on Medical Informatics). The progress of the Committees standards development is summarized per working group 1 1For a complete overview of the workplan of CEN TC251 the author refers to the Directory of the European Standardisation Requirements for Healthcare Informatics and Programme for the development of Standards, version 1.8.. The main challenges of the next years are enumerated: coordination across working groups and project teams, quality management, and international harmonisation (especially with the USA).