Electrocardiography is one of the most important non-invasive diagnostic examinations that can be performed at a low cost for the early recognition of coronary artery disease. However, it is often not easy to accomplish in elderly or non-ambulant patients, specially in mountain area with difficult roads. The National project "Territorial Tele-Cardiology" aimed to make the ECG diagnosis easily available in the ambulance or the patients' home by supporting the diagnostic phase through telephonic consultation with an expert cardiologist.

The standard communication protocol (SCP) developed by the European project OEDIPE was chosen as a standard for ECG data filing and transmission [1]. Standard ECG requirements [2] are satisfied by the data storage format chosen, involving digital data conversion with a 500 Hz sampling rate and 5 microvolts precision. Moreover, ECG data are filed in a multimedia record and transmitted along with anamnesis, personal data and notes on cause of ECG diagnosis request. General practitioners (GP) were equipped with a standard 12-lead electrocardiograph (excel 106 scp, Cardiette) with internal modem and user friendly software for network link. Connection to the consultant station was achieved through a common wired telephone line or by mobile phone (GSM), according to the different working conditions (home, ambulance, emergency). Central stations were located at the nearest Coronary Care Unit, thus permitting a direct access for emergency and continuous management of incoming ECG.

The connection between GP and specialist cardiologist was organized in an asynchronous way, with an incoming list of in-process ECGs and a sending list automatically handled by the work station placed at the Coronary Care Units, according to a time-scheduled data base. The network, which has been in operation since May 1997, served 15000 patients with a use rate of 54+/-8 ECG per week. The average response time was 1.5 days and always less than 3 days.

In conclusion, the project demonstrated the feasibility and utility of a Tele-Cardiology network, offering improved access to a specialist for GP and their patients in a mountain region [3]. In the early efficacy-assessment study of a sample of 313 cases, use of the consultation network reduced the hospitalisation and admission to the emergency room by more than 50%.

Today

The project ended in 2000 and each Coronary Care Unit was entrusted with the management of its respective consulting network. The network was then flanked by a new system for teleconsultation in emergency, based on proprietary technology (Marquette Medical Systems, Milwaukee, WI). Since the Marquette systems were present both in the CCU and in rural peripheral hospitals and first aid centers, it was easy to set up an operational network between physicians. Any attempt at integrating the two systems failed early on, since information on filing protocol was not provided and the company did not adhere to any standard protocol. The SCP-based system was finally superseded due to the difficulty of managing two independent consultation networks. However, the fact that this solution uses a closed proprietary system that does not allow multivendor interoperability brought a number of important limits. ECG data, anamnesis, anagraphic data and diagnosis can be managed by Marquette's own medical record but not transferred. Enlargement of the network is restricted only to Marquette systems, thus making it, in actual fact, no longer available for connecting general practitioners equipped with electrocardiographs of different brands.

Therefore, although the closed system solution is currently efficient on the established network, it does not allow any integration with external sources or with existing or future multimedia hospital medical records.

Health Technology Assessment

Health technology assessment (HTA) is a relative young scientific discipline [4] that aims to answer to the growing need for appraisal of effectiveness of health services. HTA as a formal process was initiated in the mid-1970s by a specific program of the US congress. During the 25 years of its existence HTA has expanded enormously, widening its scope and improving its arsenal of analytic techniques for pursuing the best practice in health care.

Therefore, nowadays any definition of validation criteria for existing or new procedures, or promotion of the correct utilization of technologies is likely to be related to HTA [5].

Decision makers should use scientific evidence supplied by the HTA process for making judgments on the most appropriate use of a certain technology in the specific context.

According to the recent deliverables of the international agency for HTA, compliance with international standards, specification of production, ease of use, maintenance, security - in other words interoperability - should be the fundamental requisite for the introduction of any new technology.

Concluding Remarks

Transparency and openness of process are the fundamental requirements for the introduction of new technologies in medical practice. Although manufacturers put up some resistance, in health care decision making this concept is now spreading rapidly. The rate of development of technologies is faster than ever before. Whereas at one time it might have taken years to progress from concept to prototype, today this is achieved in just a year or two, in some cases just months. This aspect is particularly relevant to telecommunication systems. As a consequence, health technologies developed for telemedicine and home care threaten to become obsolete in a very short time, making investments difficult. International standards should guarantee the adequacy of any instruments for the best practice as well as interoperability between systems, thus helping decision makers in their judgments and assuring the suitability of upgrading. In the Italian project for a Telecardiology network in a mountain region the SCP standard was chosen as the elective communication protocol for ECG exchange between General Practitioner and specialists. Although the network worked successfully, delays in the acknowledgement of SCP as a true international standard, as well as the presence on the market of different implementations of the protocol, made it difficult for the SCP to be retained as the first choice for tele-cardiology.

References

1. European Committee for Standardisation Standard Communications Protocol for Computer-Assisted Electrocardiography.PrENV1064.CEN pubblications, 1993.
2. Bailey JJ, Berson AS, Garson A Jr, Horan LG, Macfarlane PW, Mortara DW, Zywietz C. Recommendations for standardization and specifications in automated electrocardiography: bandwidth and digital signal processing. Circulation 1990;81(2): 730-9.
3. Nollo G, Nones M, Malossi C, Conforti F, Batocletti B: "Standard communication protocol for ECG exchange in tele-cardiology network on rural area". Comp in Cardiol 2000; 27:663-666.
4. E. Jonsson, Development of health technology assessment in Europe. International Journal of Technology Assessment in Health Care 2002; 18:2 (): 171-183.
5. Goodman CS, Ahn R. Methodological approaches of health technology assessment. Int J Med Inf 1999;56(1-3):97-105.

Acknowledgements: The project Teleconsulto oncologico e telecardiologia sul territorio was funded by Italian Ministry of Health and Provincia Autonoma of Trento Health Councillorship and developed with the collaboration of the trial participants.