Policy Context and Legal Framework

The problem of antimicrobial resistance is recognised as important and requiring action on the European level. The European Commission presented a European vision and “Community strategy against Antimicrobial Resistance” in 2001. It was recognized that, in previous years, the problem of antimicrobial resistance was addressed through an increasing number of isolated measures, with little results. In this strategic positioning, the Commission outlined a comprehensive European Community approach across all sectors consisting of fifteen actions in four key areas: surveillance, prevention, research and product development, and international cooperation. In addition to these strategic points, the European Commission provided a set of detailed health actions to be taken, focusing on biological, compartmental and public health policies and programmes.

An important European project to be mentioned in this context is the European Centre for Disease Prevention and Control (ECDC) project on antimicrobial resistance (AMR) and nosocomial infections. Similar initiatives have been launched at all levels, from hospitals and communities to countries, such as Sweden. In this country, a “Strategic Programme for the Rational use of Antimicrobial Agents and
Surveillance of Resistance” (STRAMA) was launched in 1995 as a result of discussions between the Swedish Reference Group for Antibiotics (SRGA), the Medical Products Agency, the National Board of Health and Welfare, the Swedish Institute for Infectious Disease Control (SMI) and others.

Implementation and Management Approach

The management structure has five main components:
- The responsibility for the project as a whole, including any significant changes in the work plan, lies within the Project Coordination Committee (PCC);
- Technical and operational management is carried out by the Project Executive Committee (PEC), whose permanent members are the Project Coordinator and the workpackage Leaders. Compliance with ethical standards and data protection regulation, as well as the quality of the results is given special attention in the management structure of the project.
- The PCC secretariat is responsible for coordination and administrative matters, and works closely with the PEC
- Liaison with the European Commission (EC) is ensured through regular communication by the Project Coordinator and, where necessary, invitation of the Project Officer (EC) to PCC meetings;
- Critical external views and specialist knowledge will be taken into account via the exchange and work with two Advisory Boards, one clinical and one scientific. The Boards assemble leading experts in the field of eHealth, patient safety and data mining issues.

Technology solution

The DebugIT project uses large existing and heterogeneous clinical datasets of patients from several clinical information systems in different European countries. DebugIt proposes to build an interoperability platform to populate a pertinent dataset about the infectious domain to achieve a very large common shared virtualized clinical repository that enables knowledge-driven data mining. A knowledge repository drives the data mining and serves as storehouse for the results. Finally, a decision support engine exploits the aggregated knowledge to loop-back to the real world. DebugIT adopts an incremental approach as operational results for clinical information systems must be available after the end of the project.

In order to meet these requirements, the project has been organized according to architectural component-based considerations:
- Interoperability Platform (IOP);
- Clinical Data Repository (CDR);
- Multimodal Data Mining (MDM);
- Medical Knowledge Repository and associated Knowledge Authoring Tool (MDR)
- Decision Support and Monitoring engine (DSM);
- Clinical applications.

The clinical data structures used within the logical repository, the EHR archetype approach of openEHR and EN13606 are the best candidates. The coupling of formal ontologies and information models does support the goal of semantic interoperability, and makes clinical information subject to formal, classification-based reasoning.

Impact

Besides improving the quality of care and patient safety, the DebugIT project will also fundamentally contribute towards fewer interventions needed, fewer crises, shorter stays in hospital, lower costs of drugs, thus contributing to improved productivity, facilitating better patient care at the point of need. The overall feedback loops of the system and the integrated mining engine will allow for faster health information processing and quicker transfer of the new knowledge generated into clinical practice.

In addition, the new system will provide user-friendly decision support at the point of care, thus optimising medical interventions and preventing errors when treating infectious diseases and prescribing antibiotics.

Few studies have examined the costs of antibiotic resistance. One has noted that antibioticresistant infections double the duration of hospital stay, double mortality and probably double morbidity (and presumably the costs) as compared with drug-susceptible infections. A cost comparison of treating methicillin-resistant (MRSA) versus methicillin-susceptible (MSSA) S. aureus in New York City found almost a threefold increase in mortality (21% versus 8%) and an economic cost increase of 22% associated with MRSA. For all hospitalized individuals with MRSA in New York City, such costs would translate into millions of dollars.

Another study has estimated the economic costs at US $150 million to $30 billion a year, depending on the number of deaths. It noted that the antimicrobial resistance selected in one year will persist, and subsequent years will bear the burden of the resistance problem of previous years. The US Office of Technology Assessment advisory committee estimated a cost of several billion dollars when evaluating the effects of major resistant nosocomial agents. If community infections are considered, the costs are even greater, particularly for combination therapies of multiple drugs such as those used to treat MDR tuberculosis and for treatments that substitute the parenteral route for the oral route.

Track record of sharing

The results, goals and approach of the DebugIT project have been shared with a large audience of healthcare and health IT professionals. Christian Lovis of the University hospitals Geneva presented the DebugIT project to the eHealth community in Geneva. The project coordinator represented by Dr. Dirk Colaert presented the project at the 2nd EU-Korea Cooperation Forum on ICT Research in Brussels. Henning Müller (PhD) of project partner University Hospitals Geneva delivered a project presentation at this year’s 21st annual conference of the Swiss society for medical informatics (05-06 june 2008) in Sierre, Switzerland. This year’s medical informatics Europe conference was held in Gothenburg, Sweden with the objective to cover the most urgent topics occupying the eHealth (research) community today. The DebugIT conference paper passed the critical review of a total of 250 reviewers and was selected as one of 230 presentations deemed of high quality. It is published in the MIE 2008 conference proceedings by IOS Press.

The Geneva Health Forum brings together on an equal basis all actors involved in access to health – including international, national and local organizations; government agencies; the private sector; hospitals; universities; civil society; and most importantly those who need care. It provides an interactive and dynamic platform for critical reflexion on the complexity of global access to health. As part of the so-called “Open Communications”, which are presentations followed by debates,

Further sharing and dissemination work has concentrated on information workshops at Swedish hospitals and specific stakeholder workshops such as the EUROREC group. A detailed presentation of the conceptual approach of the DebugIT project, goals, objectives and expected impacts has been developed in a four-page flyer format. This flyer is designed and distributed to reach the most relevant audiences in the field of data mining, patient safety and antibiotics resistance.

Lessons learnt

Lesson 1 - Advanced ICT tools are suited to provide new knowledge about and help fight antimicrobial resistance.

Lesson 2 - Large research projects involving partners from academia and industry need a clear project management structure and careful guidance and support to be successful.

Lesson 3 - The awareness for the problem of antimicrobial resistance is increasing rapidly among healthcare decision-makers. This will help similar projects get access to funding.