| Health Technology Assessment (HTA), despite the fact that in certain contexts it may take on a more particular meaning, is generally considered to be the discipline which sets itself up to evaluate, systematically and with a certain severity, biomedical technologies and the impact of their use.
In the early years HTA was carried out under a technologico-methodological profile; later on, in the 90s, it broadened to encompass clinical and economic factors. Today the inseparable nature of the three aspects is generally accepted in the majority of HTA applications.
HTA has recently been given a primary role in the process of continuous up-dating of technologies to be introduced into various operative sectors of the Health Services.
There are at present a wide variety of HTA programmes being used in various parts of the world.
Internet research uncovers approximately 7,000 websites relating to HTA in a strict sense, most of which are oriented towards one sector or another, depending on internal or external stimuli. HTA is highly developed in the U.S., while the situation in Europe is more varied. A further breakdown of the above-mentioned sites reveals that there are 1,464 in England, 481 in German, 183 in Spain, 110 in Denmark, 66 in Holland, but a meagre 35 in Italy, 15 in France, and a mere 20 in all the Eastern European countries together.
Of greatest note are the well-established points of reference such as ECRI in the United States or the international centre INAHTA, set up by the University of York, in England.
A certain amount of attention is being paid to new technological sectors (such as telemedicine) and to personal management of health (home care), clear signs of sensitivity towards these matters, despite an evident need for more concerted and co-ordinated action in the field.
What are missing are exhaustive references to the placing of HTA studies relating to a particular sector in one centre or another operating in the world. Observing site after site of the 7,000 available on the web, the repetition of similar experiences, on large or small scale, can be noted, without any real possibility being made available of gleaning the information necessary for the implementation of an adequate and tailormade HTA programme in any one health service.
Moreover, there is a need for proposals for general HTA programmes which could be tailored to various regional and national requirements, as there is no standard proposal at all on a worldwide basis.
The widespread and continuous development of HTA centres, programmes and resources in the United States is emblematic, all of them being independent from each other, and located in the country which houses the largest HTA centre in the world, ECRI, which, moreover, can boast unique experience over a number of decades in managing and codifying biomedical technologies for the entire American continent. A point for reflection is the fact that in this sector growth and use are still, in effect, often localised and unco-ordinated phenomena, leading necessarily to a waste of both human and financial resources.
Furthermore, there is a lack of any particular attention to the development of HTA programmes specifically set up for those countries undergoing transition. This problem is particularly evident in Europe in the eastern countries and in those of the southern Mediterranean basin.
In general, therefore, we have clear evidence of a need, both in Europe and farther afield, for policy regarding the use of HTA as a means of planning the overall development of health systems in terms of both quality and quantity, respecting diversity of requirements, customs, financial and human resources and the history of individual peoples. We also have clear evidence of a need for HTA policy intended to guarantee general standards of health on a global scale, considering the levels of mobility for reasons of employment opportunities or tourism of today's citizens.
We are considering a problem to which a definitive solution can be found only through well co-ordinated action decided upon at top level, in particular with strong support from the World Health organisation along with widespread general collaboration in order to organise, adapt, synergise and make available the already existing HTA material, in its myriad rivulets, rather than setting up further initiatives once more limited to a particular context.
Such a programme would undoubtedly be of use to the Italian health system which, despite the high standards of certain centres, suffers from a general lack of HTA in comparison with other industrialised nations.
In general terms the above is what TAHTA proposes to carry out, putting together a broad spectrum of consensus and real collaboration among the various organisations operating in the HTA field around the world, basing the work on the following fundamental points:
a) Richer countries spend more on health than poorer ones.
b) In all countries health expenditure rises as the population grows older.
c) Technologies are the main source of change in the procedures of diagnosis and medical therapy as well as assistance, particularly in relation to the older sectors of the population.
d) An increase in the age of the population means a progressive migration from a health service based solely on treatment and assistance systems (hospitals, health services) to prevalently personal health management (home-care e personal-care), relying on the support of remote health centres giving assistance of the help-desk type as well as remote monitoring systems.
e) New technologies, such as IT for the health service, telemedicine and new generation diagnostic instruments, necessary in support of these changes, lead to the need for a preparatory phase of reliable forecasts on the clinical, economic and organisational impact stemming from their introduction.
f) There is the need in all countries for concrete responses to the requests for intervention emerging from the drive for constant technological and organisational renewal and, particularly in disadvantaged countries, the need to assess the technologies available in order to be able to allocate their economic resources in the most appropriate manner enabling them to make informed choices as to where, when and how to implement a particular technology, based on comparative analysis of existing technologies already available on international markets as well as on reliable forecasts as regards emerging technologies.
g) Planning of HTA activity must be a priority condition in consolidating and supporting health investment policies and social development in emerging nations.
h) Technology planning is particularly strategic where developing countries are concerned, countries which need to redesign health services, often needing to introduce technology on a massive scale while keeping costs to a minimum at the same time.
i) The rigorous application of a HTA plan specially adapted to their requirements may lead to significantly different choices in these countries compared to those adopted in countries vaunting consolidated levels of technology.
j) Such action should certainly be considered an element of stability for the countries involved and a working tool for concerted action between these countries and Italy, and not only in terms of a future integration of the different health systems as desired both by the European Union and at local level.
k) The environment most conducive to this activity is necessarily interdisciplinary, involving economists, doctors and engineers; however, at present the interaction between these figures does not receive the support it needs at any level, whether it be local, national or international.
l) A fundamental element of this work on both an ethical and practical level is the up-dating of medical practitioners. It is also an indispensable means to achieving effective participation of the medical class in HTA procedures.
m) The effectiveness of political planning based on HTA results depends on a working partnership being built up between public bodies and private institutions vaunting specific skills and knowledge.
n) There is a need for guidelines to aid in the planning of choices and co-ordinated use of technologies and methodologies available to the various health systems (in terms of hospitals and health services in general) and for personal management of the health services (home-care and personal-care).
The specific tasks to be carried out by TAHTA with the aim of reaching the goals described above will be competently selected by the partners as a group and by the national and international working groups which will be set up to lend support to the project.
A number of actions, in any case, can already be clearly identified:
(a) An internet portal should be set up for HTA, to collect and up-date interested parties on the locations, aims and groupings of all HTA activities taking place around the world, with an adequate search engine enabling even inexpert users to locate information relevant to their needs, with direct access to the specific sites.
(b) The portal must offer direct access to the more important data banks, such as, for example, the ECRI data bank.
(c) The portal must include guidelines for the practical use of information available on the web.
(d) The portal must provide particular resources of help to countries undergoing transition.
(e) The setting up of a European data bank for biomedical technologies is highly desirable, adapting and completing (for example with multilingual support) the data banks already operating in Italy (BDTB and OPT) and in other European countries, creating a single coding system for all of Europe, with transcoding with the American ECRI data bank.
(f) Links with the various Health Ministries and regional Health Offices across Europe, as well as with hospitals, need to be promoted with the aim of achieving integrated networks of activities connected with other centres and other geographical areas of the world.
(g) The possibility of creating a European HTA Centre needs to be explored, a centre which would be linked to other centres operating at international level and regarding certain highly innovative types of technologies.
(h) The activities of the TAHTA project need to concentrate on giving support to countries undergoing transition, i.e. those of Eastern Europe and the Southern Mediterranean area.
(i) The activities of the TAHTA project need to concentrate on new technologies.
(j) Economic, clinical and technical analyses need to be promoted at both national and international level on medical activity conducted through direct and indirect use of technology and its application, along with comparative studies involving industrialised nations and countries undergoing transition.
Why Trieste
Quite apart from its strategic position, Trieste vaunts a position of leadership in Italy and prestige abroad in the management of biomedical technologies and in training in the field of clinical engineering.
Concerted action by the University of Trieste with the local Hospitals and the Research Area of Trieste, along with the Friuli Veneto Giulia Region and the Municipality of Trieste, has in fact led to the carrying out, in the last twenty years in particular, of a series of initiatives in the field of biomedical technology which have been and still are today a point of reference for the management and running of the Italian Health Service and lately, also of the bordering Eastern countries.
To cite some among the numerous activities, the first clinical engineering service in Italy came into being in the 1970s in what was at that time the USL1 in Trieste; in the 80s a Centre for the Assessment of Biomedical Equipment was set up, from which grew the Centre for Research and Study of Biomedical and Health Service Technologies (CRSTBS) and later, commissioned by the Ministries of Health and MURST, the Centre for Information and Assessment of Biomedical Equipment (CIVAB) which identified a series of tools for the running of the Italian Health Service, among which figured the National Data Bank of Biomedical Technologies (BDTB) and the Prices and Technologies Observatory (OPT) for the Ministry of Health.
In 1991 the School of Specialisation in Clinical Engineering was founded, and since then it has been training engineers who go on to set up Clinical Engineering Services around Italy and which can count 35 agreements to date with the most prestigious Health Institutes in Italy and abroad.
The first PACS commercial system was set up in 1988 in Europe, and since then a broad-spectrum plan governing IT in the Health Service of the city has been developed by the Bioengineering group of Trieste (GNBTS), based on the DPACS telemedicine plan and on almost three years of experience of capillary computerisation of the Health Service and public management of the entire Friuli Venezia Giulia Region, carried out by Insiel S.p.A., and supported by strong combined action with the Municipality of Trieste and the local Hospitals.
In the field of telemedicine the University set up, along with other partners, the Meditteranean Institute for IT in the Health Service, in Rome, in 1999, (IMTES), while in 2000, along with LUISS University in Roma it inaugurated the International Center for Transitional Studies (ICETS) which deals with economic, legal and IT aspects regarding countries undergoing transition, particularly as regards the Health Services.
Drawing on these numerous activities in the field of biomedical technology the company Italtbs S.p.A was set up in the Research Area of Trieste in 1993, growing rapidly to become today the largest clinical engineering company in Italy and in Europe.
Furthermore, Trieste boasts the highest concentration of Research Institutes in Italy, housed in the Research Area which accounts for circa 60 bodies and high-tech industries, the international centres ICTP (International Center for Theoretical Physics), ISAS (International School for Advanced Studies), ICGEB (International Center for Genetic Engineering and Biotechnology), ICS (International Centre for Science and High Technology), Luce di Sincrotrone Elettra (Sincrotrone S.c.p.A), the majority of which operate, on behalf of the United Nations, in support of third world nations and countries undergoing transition, as well as numerous national centres. |