Finally, it recommends along with very rigorous and integral training programs for clinical investigators, such as the ones of

The Unity of Human Being Health Needs

a Program of Human Health, Development, Medicine, and Behaviour Projects, to Integrate with the Human Genome Project

(Informal First Draft 10/04/00 for Scientific Meditation)

Rodolfo J. Stusser, MD

Clinical Research Center / Plaza Community Polyclinic

This idea of a global research program for global health has been written for the ACHR of WHO, STRATEC of GFHR, COHRED, WB, CIOMS, and INCLEN, to contribute to the strengthening of a global scientific approach, as a premise for the World Health Research for Development Forecast, Policy & Program 2001-2010, in their meetings around the ICHRD on October 10-13, 2000.

To write this paper, a selection of the main medical & health scientific literature during the last decade, searching Medline CDs, Current Contents, & PubMed Internet database, has been carefully studied. Main reports of the WHO, GFHR, COHRED, WB, of the Worldwide Consultation Process, & the Discussion Paper for the IC2000, has been studied as well.

In a certain way it is a late response to the challenge stated in “The Goals of Medicine” Project Report, which kindly sent me Professor M. Manciaux and Dr. B. Mansourian, in August 1997, when I sent Dr. H. Nakajima the first three research & research training projects of my Integration Science Program.

1. Background, Hypothesis and Objective

In 1996, a crucial International Project “The Goals of Medicine. Setting New Priorities” was finished by the Hastings Centre & the WHO with 13 developed & developing countries. A broad spectrum of priorities for Medicine long-term progress was established. One of them, was to carry out imperatively reforms in medical research, although always preserving all the freedoms to research [1].

The first research reform, in brief, stated to use much more both dichotomised medical research paradigms, not only one of them (i.e. biomedical & bio-psychosocial, disease & health). Since 1994, an international project on a “Unified Theory", which deals with this reform, has been in preparation [2 ].

The second research reform, in a few words, affirmed the need to strengthen basic social sciences research in clinical medicine & public health, as pertinent and equivalent to the basic Human Genome Project. In 1997, an international project on a “Unified Methodology” dealing with it was written [3].

In regards to both reforms, the positive forces of the world could fulfil better with the criticised but still advanced WHO definition of health, adopted in 1948 to improve health at the individual, population, national, & world levels; if of its content: “Health is a state of complete physical, mental, & social well-being, and not merely the absence of disease or infirmity” [1], the mental well-being, and specially the social well-being, would not be more minimised or even sometimes unknown.

Unfortunately, WHO, working for 52 years throughout the world with a health definition of so broad and integrating social scope, has not been able to balance yet the specific weights of the biological & disease paradigms of medicine & public health, because coincidently they have been reaffirmed more than ever in that same period of time, because of the parallel explosion of high-technology to handle material physical, chemical, & biological scientific problems, after the successful Manhattan Project.

This situation has impacted and enhanced the prevailing biomedical model of the world health policy and health care system, which continues demanding much more research to cure acute and chronic diseases, than to promote in the individual & population, an optimum health in the rich countries, and a good or at least minimum health in the poor ones. Fortunately, the demand of research for prevention & control of acute & chronic diseases, have been less critical than the one for health promotion.

Nevertheless, in the last 40 years was born and growing slow and quietly, with the development of powerful computers, and informational networks among them, a new kind of high-technology to handle the informational and communicational scientific problems. The result of this early ARPAnet project is Internet. It was quickly used to carry out in the 90ies the successful Human Genome Project. However, Internet has never been used in all its potentialities yet for basic integrative social projects.

Today are accepted two main theories about health. The biostatistical theory defines health as a normal functioning of the individual without interference of disease, and calculated statistically with respect to age and sex groups. The holistic and welfare theory defines health as a minimal happiness felt when the vital goals of the individual are achieved by second-order abilities [4]. However, they have not been integrated yet in one and operationalised to measure both cardinal biological and social dimensions.

The hypothesis here, is that there are some disequilibriums affecting the integrity of the scientific knowledge & methodology of medicine & public health research progress, in regards to the unity of human being health [2,3,5]. These gaps only can be found when are analysed all the evidences that reflect the effects of the social & fundamental known forces of the logic of progress in medical & health sciences. They could be understood and taken into account for the global health research forecast.

First, a long-term logical and historical analysis, and prediction of biological health, measuring healthy life years without disease & disability by age, sex, and areas, could be considered only as partial evidence. Whole evidence needs to consider also the analysis of psychosocial health, measuring in some way unknown yet, the minimal wellness felt by the individuals & populations when their vital goals are achieved. Nevertheless, whole evidence is still much more than clinical & public health indexes from data continually registered or sporadically estimated by epidemiological surveys.

Second, complete evidence also includes the gap found among the very powerful progress of many differentiating programs in research laboratories, producing new basic biological models & methods on disease in regards to health, and technological means for patient-care through the pharmaceuticals & devices industrial laboratories, with their corresponding applied clinical & population trials’ results, in relation with the very weak progress of few differentiating and integrative programs for new psychosocial patterns & tools from basic & applied psychosocial research on both disease & health.

Third, whole evidence also includes the situation that there are very few integrated programs with results & methods for basic, clinical & health research. Clinical Epidemiology program promoted by INCLEN in the last decades is a two branch-example centred in disease. There is not even one integrated research program yet being carried out for the outcomes & means about disease and health by the three main basic & applied branches of differentiating programs. Conjoined endeavours through global international projects in differentiation and integration programs should continue, although in all main research programs of medical & health sciences to enhance more their progress in the future.

The objective of this paper is to suggest and ground the idea of a complementary program of four global basic integrative social research projects: Human Health, Human Development, Human Medicine, and Human Behaviour Projects, to integrate their results & methods according to their hierarchical order, with the ones of the Human Genome & Human Brain Projects, and other biological research projects to come by.

In this presentation of ideas for a Human Development Project & a Human Behaviour Project, it will be put more emphasis than for a Human Health Project & a Human Medicine Project, because the latter have been suggested in a paper developed further for the WHO ACHR and RPS in 1997 [3].

http://www.fortunecity.com/skyscraper/systems/1000/artwho9.html

2. The Design of a Global Basic Project on Human Health

For more than fifty years, a basic research project as a "Human Health Project” has been lacking in public health research in a worldwide scale. It has been much used the biostatistical theory of health and less or practically not used its holistic or welfare theory [4]. If these two definitions would be in someway integrated and operationalised to measure health, this would help much more the development of a healthy individual & population, and at the same time, of a healthy world.

It has been greatly developed an epidemiology of disease, arriving in the last decades to even a genetic, pharmacological, environmental, and molecular epidemiology. However, it has been stagnated the project of an epidemiology of health [6]. Why not? If an “epidemic” of health, would be the most wonderful event that could face and even promote a medical and public health institution…

If the etymological origin of term epidemiology does not help, then it could be created and developed another medical & public health sciences of health, as salutology [7], to foster the accomplishment of the transition from a health policy & health care subsystem for the sick individual, only, to other integrated for both the sick and the healthy individuals at the same time.

Very complex scientific problems that we do not hardly know even how to begin to state them yet, as “Human Healthy Life”, “Human Healthy Environment”, “Causes of a Healthy Life”, “Means to Promote a Healthy Life & Environment”, “Health Care of the Healthy Individual & Population”, a real “Health Diagnosis & Health Promotion Program” using categories of health with positive ethical values, are still there waiting for being intensively investigated in such a basic project like that [3].

It has being more studied in the last decades what it is known as quality of life to complement the measurement of levels of life, mainly as is used in the health care settings. It is a very descriptive concept simpler than health, but important too, because survival & longevity without both of them are not worthwhile. Its use is much easier than to face the improvement of the very complex system of health related concepts, beginning by the health one, because its other concepts: disease, illness, malady, lesion, injury, disability, handicap, have been much more well studied, defined and classified.

According with the great effects of the powerful biomedical and disease paradigms, arresting the enormous potentiality of the concept of health defined by the WHO, it is known that in these 52 years the WHO has been able to promote the last four of the ten revisions of the international classifications of causes of death, disease, lesions & injuries, allowing the statistical handling of the states seen by forensic and other specialists in hospitals, and even some classifications of functioning, disabilities and handicaps, seen by the physiotherapists and other specialists in hospitals too.

Around the health & illness concepts, the WONCA making a creative effort has adapted the ICD algorithm to different health problems & illnesses, more seen by the general practitioner, family physician, & other health care professionals in the primary care at their communities. The WHO ICD tenth revision has joined together the diseases & related health problems in only one classification, but health states categories with positive values to reflect a dynamic continuum of care do not exist yet.

It could be developed a satisfactory complete and continuum “International Statistical Health Classification of Health States”, beginning from something like optimum, good or acceptable health categories with positive ethical values, through non illness & non disease suffering, going to other categories like unacceptable, bad or terrible health, or ranking the health states, according to the phases of the individual life cycle and sex , within other psychological & socio-demographical variables too [3].

In the meanwhile, as a consequence of this, there are not also in use direct categories of truly health to measure health in the individual yet. Health is still measured in populations, countries, regions, and world, using indirect indexes of increasing sophistication [3], about the whole set of negative values health related concepts in the framework of demographical concepts and indexes.

In the last half past century, there have been used first to measure health, the rates of general or specific infantile mortality, proportional mortality of less than 5 years or more than 49 years, and life expectancy at birth or one year, within many others [8,9,10]. All of them only measuring demographic lengthen of biological life & postponement of premature death, old restricted main goal of medicine [1].

In the last decade, it has been made the greatest efforts using different measures. From the burden of disease with disability-adjusted life years (DALYs), quality-adjusted life years (QALYs), healthy life years (HEALYs), to the disability-adjusted life expectancy (DALE) level and distribution, and health-adjusted life expectancy (HALE), and the index of equality of child survival [11,12,13]. The last positive but still indirect measures, continue leaving outside the more, less or none mental and sociological welfare of individual & populations, no related with the suffering by disease & disability.

In spite of the fact that these single and compound indexes have been validated since the 50ies, with the most robust statistical tools as discriminant analysis [14], within others, the lack in measuring the mental & sociological dimensions of health, has led to a biased estimation of the health of the rich & of the poor countries too, much more when are applied within their specific social structures.

These last pure biological health measures, have led recently to important contradictory results and interpretations, in logical comparative analyses between international levels of health and of growth and development in a paper about Health in Development [15]. The main bias of these results has probably consisted in excessive confidence in the scarce possibilities of these algorithms used to measure integral human being health, although never should be forgotten the high dispersion of the health primary data accuracy among poor countries.

Good health, good quality of life, and high survival and longevity are not strictly human being goals, although are goals of the health policy and health care systems. They are really human means as well as good education, good culture, and high income, to achieve the vital biosocial goals of each individual aware or unaware of his /her specific life plan.

Theoretically, those biostatistical indexes could approach better the health of the poorest countries than of the richest ones, because in the latter generally the levels of welfare are higher and more distributed than in the former. The lack of control in the analysis of the confounding variables never measured by any index yet, as the psychosocial functioning and welfare of individuals, populations, and society, put the rest.

Between the scientific problems of the health of individual and of the population, there is the one of the health of the family, the most important structural cell or unit of society. This scientific problem could be also studied in a Human Health Project, as well as the health of the community, a more important unit sociologically than the demographical population unit [3].

Both family health and community health would have required many more special reflections in this paper, but there is not enough time, and there are some meditations already stated about them, in a paper since 1995 about a project on new research spaces for family medicine [16].

3. The Design of a Global Basic Project on Human Development

All the programs concerning tropical medicine & health, including: individual hygiene, environmental hygiene, infectious diseases, reproductive risk, family planning, maternal-infantile health, and child health & nutrition, still need many more global basic and applied biological research projects to be successful. Nevertheless, it would be a mistake to be unaware that they also need as a complement, many basic (and in consequence applied) social sciences research projects for their success.

To begin to balance and integrate the biological & disease paradigms, developing much more the social & health paradigms too, it is necessary to design an international collaborative global Human Development Project, to carry out social basic research intensively in at least five, ten or fifteen years.

The project first premise is that a sustainable development of the human life and health standards in the poor & poorest countries, is impossible to achieve in these moments with the most advanced biomedical knowledge, vaccines, products, diagnostics, devices, drugs, and sanitary programs against the main diseases, alone, without a parallel integral sustainable development.

The World Commission on Environment & Development suggests that development is sustainable where it "meets the needs of the present without compromising the ability of future generations to meet their own needs." It involves the simultaneous pursuit of economic prosperity, environmental quality & social equity. Companies aiming for sustainability need to perform not against a single, financial bottom line but against the triple bottom line [17].

Its second premise is that the studies, programs, and experiences accumulated up-to-date to improve the sustainable development of health, isolated of the ones to improve the economic & social sustainable development, have not been successful enough, and need a complete revision, as well as the design of new studies focusing an integral sustainable development including the immediate guarantee of good or at least minimum levels of health.

Why do the poorest countries have not received the benefits of the 20-century Health Scientific Revolution yet? The WHO Director-General Dr. Gro Harlem Brundtland has asked [11,12]

Why do the poorest countries, for instance: Mozambique, Tanzania, Nepal, Bangladesh, Haiti, and Nicaragua, in the last 50 years, could not organise and develop integrally their countries with the high levels of welfare, living, education, health, and science as the richest countries, for example: Switzerland, Norway, Denmark, and even Japan, having this been destroyed by two World Wars?

The statement in the Ottawa Charter for Health Promotion said: "The fundamental conditions and resources for health are peace, shelter, education, food, income, a stable eco-system, sustainable resources, social justice & equity. Improvement in health requires a secure foundation in these basic prerequisites” [18].

Of these prerequisites, housing, food, income, and sustainable resources, directly depend from the efficiency of the productive infrastructure of the country. However, peace, education, a stable eco-system, social justice & equity, however, which depend directly of the ideologies & institutions of the superstructure, in the last instance also depend from the same economical basis, and cannot survive & progress without it previous development.

It is vital to be aware that all the history of humanity up-to-date has shown that a natural economic growth of the infrastructure of a country, autochthonous or assisted, is a premise to finance a successful social, educational, sanitary & scientific progress in it. All advances in the superstructure temporary subsidised from outside, only originate at last an imbalance, an unsustainable development, and even an underdevelopment.

The UN agencies, IMF, WB, other banks, WBCSD with 140 companies, dozens of development agencies (NGO & GO), BMGF, RF and dozens of philanthropic foundations, assisting the integral development of the poorest countries, have helped very much, but is still needed much more aid to achieve minimum levels of growth in them. The huge difficulties of the inhabitants of the poorest societies to take advantage of this assistance could be taken into account as a basic scientific social problem of human development, which needs much more research to foster a sustainable development.

It could be studied all the economical, social & behavioural causes of unsustainable development in the societies of the poorest & poor countries from a logical & historical perspective. However, it should not stay in descriptions and suggestion of hypotheses to guide the social “experiments”. It should also make previously comparative studies with the successful progress achieved by the societies of the richest & rich countries in the five past centuries, although more in the last century, to obtain more founded explanations & predictions, before experimenting.

It is a truth that today with the so urgent health problems as TB, malaria, & AIDS, the WHO, COHRED, GFHR, CIOMS, other agencies, networks, partnerships & initiatives, vaccine & drug industries, and other donors, cannot wait for the achievement of a suitable economical development in more than a hundred countries. They must continue focusing its technical and funding capacity in health system reforms & performance, health policy & system research, and classical biomedical & disease centred research, trying to address much more of the latter to the health needs of the poor & poorest countries.

Health standards improvement is not only part of the social but also of the economical development, and increasing health, the poor countries can enhance their advances [15]. Hence, health research can play a central place in the development agenda [11,12,13,19]. However, focussing the fight against the diseases of the poverty, health research needs to do much more basic social research. There is a complex scientific problem of unsustainable progress of a social nature in those countries that cannot be unknown, because is the most general obstacle to foster the health in their populations.

A very important Initiative on “Health and Societies” (first Social Organisation) suggested by the GFHR in 1997 should receive attention and funding, because it is very far of been abstract & academic, and could give useful results to help develop the societies and health systems of the poor countries [19]. A WHO Supercourse in the Internet on “Health, Environment and Sustainable Development”, touching Lectures on “Poverty and Health” and “Sustainable Development”, should be reprogrammed again.

Nowadays, there is a great need for a global basic research “Human Development Project”, to be able to achieve at least a satisfactory or even good level of integral development, including health. This would study with international multidisciplinary teams, the geographical, archaeological, ecological, anthropological, psychological, behavioural, ethnical, cultural, religious, juridical, ethical, aesthetic, demographical, economical, sociological, political, organisational, and communicational problems of the poorest societies, and over the basis of scientific results, propose the solutions and take the decisions.

The problem of giving up the globalised poverty throughout the poor countries of Africa, Asia, Oceania, Latin America & the Caribbean, must continue as a very practical problem faced with infinite expert analyses, decisions, programs, and actions. Even so, only by that way, it could be discussed 100 years more by the World Summits, but not solved. If their deep economical but also social causes and how to eliminate them, and if the own responsibilities of the countries are not very clear for their people, and if the help of the donors is not well used, those countries will continue for ever with their people in the misery, homeless, stacking, starvation, ignorance, ill health, and emigrating to the developed countries.

The economical & social experiences in the 20-century have given enough proofs that the globalised western model of organisation of economy, democratic society, and peoples way of life and health care, in two words, western civilisation, is the very accepted by about 180 countries in all regions of the world as the gold standard for progress, due to its great strengthens for economic prosperity, in spite of the great weaknesses it still has for environment quality & social equity --which must be more studied.

If an underdeveloped country belongs basically to the western civilisation, and is able to evaluate, accept, and adapt the best features of the western model, together with the best features of its autochthonous native civilisation, idiosyncrasy, and identity, the possibilities to have a sustainable development would be the best and quickest, in dependence of the seriousness of the efforts to be done.

The possibilities to obtain sustainable development with this same integrating algorithm in other cases are as follows: They wood be good and quick, if the country belongs to the eastern or oriental civilization, in function of the greatest efforts that could be done, and they would be real, but bad and slow, if it belongs to a very primitive culture not civilised yet, even doing the supreme efforts.

The most difficult case would be, if an underdeveloped country, would like to be considered and helped by the western rich countries exclusively in the own way that it wants for the absolute maintenance of a non-western model. If it is a very primitive culture, it would not receive enough help and this could have fateful consequences for the survival of its people, and even of the country. If it has a middle or high degree of development, it could arrest it more or even could go back to former levels.

Not only it could be studied more in depth the causes of unsustainable development of the last decades of the poorest countries, summarising them by region and world with cross sectional and cohort methods. It could also be investigated them in a broader “World Development Comparative Study”, analysing the positive experience of the Northern countries in the last 500 years and first 50 of the 20-century, when they had lower levels of development and higher levels of poverty & ill health too.

Within these studies, it will be very important the comparative studies to make by the different regions of the South with the different effects produced by the European metropolis. For instance, in America: Why and how after been discovered the New World, the British & French colonisation of North America produced finally two of the seven richest & wholesome G7 countries of the world: United States of America & Canada, where prevail “poor” minorities, while the Spanish & Portuguese colonization of Latin America & Caribbean produced only underdeveloped countries prevailing “Poor” Majorities?

Finally, it could be studied the nature of the interactions between the poorest & richest societies in the past, the present, and the future, in the sense to promote a maximum assistance of the poor, but with the minimum lost of money and time. All these studies would be made by international teams composed by social scientists of the poor & rich countries, with the most advanced methods and means of the broadest scope of modern social sciences, and communication high technologies of today.

In a short-term, the basic genome, brain, and other biological global research projects that will be designed and carried out by the Northern countries, by the moment could have as complement and counterpart in the Southern countries basic social global research projects about Why and how to promote in the South an adequate and integral sustainable economical development and healthy population growth? This would be not only necessary for global science, but also for global fairness.

It is possible that with the results of a Human Behaviour Project, the results about the genome sequence of each disease microorganism as malaria, TB, AIDS, and pneumonia to pneumoccoco and other drug-resistant microorganisms, could be integrated with the results about the "memome “ sequence of each social ill as misery, homeless, stacking, hunger, ignorance, and unhealthy, and both biological & social knowledge & methods could be better and quicker developed to control together effectively these ten “epidemics”.

With the programmed partial and final scientific results in the hands of the governing team of this project, it could be proposed to the UN, NGO, GO, and world private sector, the required reports and suggestion of action programs to enhance scientifically the integral sustainable development in the poor countries, including health, with the help in a first place, of their own native leaders and societies, in a second, of these international organisations, and in third, of the donors of the rich countries.

4. The Design of a Global Basic Project on Human Medicine

Clinical Medicine has to be well prepared to receive the beneficial impact of the very important results of the Human Genome, Human Brain, and other global basic biological projects to come by. A Human Medicine Project could be designed, with a Clinical Medicine Interface Subproject to rigorously translate and validate those biological results to practice, as well as the ones that could come from a Human Health, Human Development, Human Behaviour, and other global basic psychosocial projects.

In this first subproject could interact the well-established Clinical Epidemiology Network of INCLEN with its relevant line of Evidence-based Medicine, together with another very needed international network of Clinical Medicine scientists that has to be built. This network of clinical scientists has to take on the scientific and ethical responsibilities for the clinical sense, content, and implications of the applied research, and with the feedback and orientation of the research biological & social laboratories & scientists.

Nevertheless, a Human Medicine Project could also have a Basic Clinical Medicine Subproject to produce basic results for the autochthonous program, organisation, and strengthen of its own scientific goals and progress as very important set of sciences.

The following paragraphs belong to a revised summary of the clinical medicine basic research issues of a paper made for the WHO ACHR & RPS in 1997 [3].

Why these two basic subprojects? In the last 50 years, clinical medicine research has lost the direction of medical research, and even of the clinical research per se. It has been remained only as an interface sort of applied research, with lack of man wholeness & healthfulness content, which outputs only second hand knowledge extension & technology translation to the clinical practice in hospitals & communities, generated in the research laboratories.

To this crisis in its internal logic of progress has contributed far beyond external factors, the stress in the thought that medicine is only a non-classical science of particulars. This has aborted the enormous heuristic potential of the clinical researcher and the studious practitioner to generate new scientific hypotheses not only in diagnosis and therapy, but also in aetiology, pathogeny, prevention and rehabilitation.

Clinical judgment has solely stayed and is being perceived as a simple practical application of the hypothetical-deductive scientific method with the aid of probabilities to patient care, but without any possibility to formulate at least as primitively as before, hypothesis and law-like generalizations to clinical medicine as also a science of generals [20]. To solve these situations, along with the ideas of the individualised care of each patient, new integrative ideas about the achievement of general knowledge have to be developed too.

In this sense a "Human Medicine Project", could fulfil some essential needs of basic knowledge and methods in the hospital and community, with at least the following subprojects: "Integration of Alternative Medicine with Scientific Medicine" (Primitive, Oriental, Eastern, and Western Medicine), "Conception of General and Special Clinical and Surgical Medicine Self Research Spaces", "Creation of Family Medicine New Research Spaces".

It could take very hard work to unify four of the main dichotomised medical research paradigms: humanism-science, body-mind, biomedical-biopsychosocial, and disease-health. However, simultaneously, the critical mass of clinical investigators has to be increased and better prepared than ever. Working on the flourishing of the clinical judgment, as scientific discovery method of generalities again, could be the most powerful way to attract younger generalist & specialist physicians, giving them a much better scientific training concerning both clinical & surgical research and practice.

Nevertheless, these last efforts will not be enough to satisfy the present and future needs of national, regional, and international clinical research, education and care worldwide. This is because, laboratory and sanitary researchers cannot direct and make the indispensable research of the dormant huge mass of clinicians & surgeons to personally solve health problems of the entire individual: unattainable top frontier of the laboratory research and essential operational unit and last objective of public health research.

There exists also a great potential for clinical research within nurses and other health professionals of the world, because almost all of them work in clinics and could contribute even more with research outcomes in regards to improving whole clinical care too. Therefore, it is very necessary to make also some international clinical and surgical research projects as complex as the genome project, but that will probably not require so much high-cost high-technology. Internet First & Second Generation is waiting to be applied as a powerful low-cost high-technology, specially using the very high relational potentiality of its main HTML language, and subsystems [21,22].

Clinical & surgical researchers and their educators must carefully study the experiences of robust scientific training in last decades of laboratory & sanitary researchers. For instance, this could be achieve visiting & studying the training programs for basic laboratory researchers applied in the US National Cancer Institute, Oxford Institute for Molecular Medicine, and so forth, and the training for sanitary researchers in the John Hopkins School of Public Health, and London School of Hygiene and Tropical Medicine, and so on.

For some decades, both the US Robert Wood Johnson Foundation in the Yale University School of Medicine and other US schools, and the Rockefeller Foundation in some medical schools at home and abroad (like in China since 1979), have been strengthening clinical research capacity respectively, with programs to prepare good clinical specialists of the most orthodox class & clinical epidemiologists to make better clinical trials, respectively.

However, due to the previous analysis of clinical and surgical research weaknesses, the new model of training proposed has to exceed these important efforts, and be more powerful in order to approach a broader spectrum of ortho-research through its own initiative. Clinical research training has to receive more than the hypothetical-deductive, Gaussian, Bayesian, and non parametric statistics, computing, artificial intelligence, decision making, and cost-effectiveness methods, as well as human experimentation by computer simulation, along with clinical trials meta-research and its ethics.

A nucleus for the beginning of this work could be a unified methodological approach research education course program developed since 1995 [23]. They ought to receive mainly two handbooks: One of a unified medical & health research methodology, and another about a broad clinical research methodology, in a research training of one to two or more years to obtain with a thesis a Master in Clinical Science (MCS) or a Ph.D. degree, before, beginning or after the generalist or specialist training.

It must also include mathematics, genetics, anthropology, psychology, sociology, social epidemiology, full uses of Internet WWW and E-mail for clinical research, education and practice, and specially philosophy of medicine, including ethics, ontology, and epistemology. For nurses and other health professionals, the program could be modified attending to their specific profiles and requirements.

An international pilot school or institute, could be established somewhere within some institution, under the direction and coordination of the World Health Organization, with funds from different international sources. It could be aimed to research and elaborate didactic materials for postgraduate education in this new concept of whole medical & health research process, including the clinic, laboratory & health system; guided by a unified methodological system of scientific research, to rescue and strengthen the complete internal logic of progress of medical & health research.

The programs of courses, workshops and conferences, would be very important not only to be taught and studied by clinical & surgical researchers, but also by sanitary & laboratory biological and social scientists, as well as by health research policy makers & medical research industrial managers and economists worldwide.

This school or institute could be the head coordination centre in the country selected, carrying out clinical medicine & public health jumbo projects. Its subprojects could be coordinated with different peripheral centres in other countries. Later, previous or simultaneously with this experience, it is also possible to set inside or outside of the above institution, another international pilot clinical ortho- and meta-investigation school or centre, to begin to research, elaborate didactic materials, and prepare clinical and surgical researchers with a more solid background, creative skills, and a broader scope than the one that the trialists have today, in order to develop more the clinical medicine science.

The analysis of the results obtained with this trans-methodological research model, beginning with the postgraduate programs, should be a guide of how to introduce it into the undergraduate curriculum of medical, nursing and other health professional students. International exchange through Internet and new communication technologies of enough scientific methodological information without high-cost technologies could solve many communication problems that would have made such projects impossible to be carried out in the past.

The practical application of this unified methodological approach for a medium and long-term, along with a greater use of the present and future separated research methodologies, from the student, scientist, physician, nurse, sanitarian, and other health professionals, up to the medical organizations of centre, basic, clinical and industrial laboratories, as well as university, nation, region and world, might become very significant.

5. The Design of a Global Basic Project on Human Behaviour

The main premise of this project is again that health promotion, prevention and control of main diseases & biological risks in the poor countries, will not be possible to reach now, even with the most advanced biomedical & bio-health knowledge & technology in all kind of health programs, if in parallel many studies of their ill-health related lifestyles & behaviours are not started, and many psychosocial programs on lifestyle & behaviour change of each individual are not carried out.

The following preliminary ideas for a Human Behaviour Project are grounded on the basis of a nuclear structure composed by the classical and more recent basic papers of Prochasca and DiClemente theory of behaviour change, and of Hall experiences changing lifestyles, both in chronic diseases [24-28]. They are adapted to the individual that lives in the chronic circle of poverty with all kind of sufferings due to disease, illness, grief, and even for the ill feeling of being living in an underdevelopment process without hope of solution.

Around the action of the biological causes of human disease & health given by the own individual interacting with his/her environment, it cannot be forgotten the continuous action of also behavioural causes, as expressions of the genes & the “memes” too. These behavioural causes are generally considered as indirect or mediate risk or protective factors of the most direct & immediate biological factors, although they have been also considered as direct factors mainly in some mental diseases.

The study of the ill-health or non-healthy related behaviours study began in the first half of the 20-century. Their control with counsels by clinicians & in public health campaigns, began 50 and 35 years ago, respectively, growing inside the biomedical programs of chronic diseases in the richest countries. However, these ill-health related behaviours could also be tested into the biomedical programs of the acute & maternal-infantile diseases of the poor countries, to eradicate or minimise them too.

There is a great need for much more basic social research projects, to go in depth in the theories and models explaining the human behaviour in general, and the behaviour ill-health related of the individuals, and in the methods and means of behaviour change, not only in the more civilised populations of the developed countries, but also in the less civilised and even yet uncivilised populations of the underdeveloped countries.

In the one hand, the change of the non-healthy behaviours will enhance much more the great progress achieved in the 80ies, which decreased in the 90ies, in regards to the prevention, treatment, and rehabilitation of the chronic diseases & injuries that have been growing in the last 50 years in epidemic proportions in the middle-aged & aged populations of the rich and many poor countries too.

In the other hand, it will allow to begin the prevention and change of the non-healthy behaviours also that favour the survival of eradicable or controllable infectious diseases, explosive overpopulation, unsafe sex and motherhood, unsafe child birth and growth, hostility, violence and warrior spirit, in the populations at all the levels of risk of the poorest and even less poor underdeveloped countries.

Why do we behave the way we do? During the 1970s and 1980s, Prochaska & DiClemente developed a theory of behaviour change to explain, predict, and change multiple human behaviours. Much has been done educating in developed countries since 1983, with their multi-stages of change, created for smoking cessation. This transtheoretical (TTR) model of change was more developed in 1992 with Norcross. It is an alternative to the traditional confrontational models of "breaking through denial."

The stages of the model are: pre-contemplation, contemplation, preparation, action, maintenance, and finishing. Programs matched to each stage of change can produce unprecedented participation and impact rates, different to the clinical and public health action programs proved up-today.

The model has also been used promoting other health behaviours as exercising regularly, seatbelt use, avoidance of high fat food, eating a high-fiber diet with vegetables & fruits, attempting to lose weight, avoiding sun exposure, sunscreen use, attempting to reduce stress, conducting cancer self-exams, stopping drinking, condom & other contraceptive use in adolescents and adults, HIV risk reduction in injection drug users and in patients with haemophilia, leaving addictions and chemical dependences.

There is a huge potential of application of this and other theories and models of health-related behaviour change such as: the health belief model (Rosenstock et al 1988), the elaboration likelihood model (Petty & Cacioppo, 1986b), the theory of reasoned action (Fishbein & Ajzen 1985), the theory of planned behaviour (Ajzen 1985), to the health education elements to foster a more health-related lifestyle. If results with these methods continue to be replicated, and basic social research is increased, health promotion programs will be able to produce unprecedented impacts on entire at-risk populations.

Interactive technologies for health behaviour change have the potential to be to behaviour medicine what pharmaceuticals are to conventional medicines: the most cost effective method for delivering the maximum science to entire populations for major problems in user friendly ways but with no known side effects. Expert systems accessed though Internet will develop much more the behaviour schools and clinics than any other system in the future.

At the personal level it could be considered the existence of five determinants to health status: 1. How we choose to live our lives, risk & protective factors, ill & good health behaviours, and family history; 2. The degree to which we are surrounded by loving support or not; 3. The environment within we live; 4. The ability we have to meet financial requirements for daily life; and 5. Access to health care.

The first two are very important and contribute to control and prevent chronic diseases such as heart, diabetes, pulmonary, and cancer, because they involve personal choice. The ability to manage lifestyle and behaviour is an internally driven process. Understanding the components, which lead to wellness, examining attitudes and values, self-efficacy, openness and empowerment are the beginnings.

Research on cognitive factors and motivational readiness for health-related quality of life, and cognitions about self-perceived quality of life, could give findings suggesting the best cognitive-motivational messages designed to emphasize quality of life benefits associated with the health-related behaviours, and useful intervention strategies for people who are less motivationally ready to change.

All the health programs concerning tropical medicine & health, including individual and environmental hygiene, infectious diseases, reproductive risk, family planning, maternal-infantile health, premature & low-weight born, child health & nutrition, children & women protection from violence, still need many more basic biological research projects. Nevertheless, it would be another mistake to be unaware that they need very much of a basic behavioural research projects to be successful.

In the underdeveloped countries, working on the determinants of health status 1, 3, 4 & 5 would be very important for the success of the anterior health programs. The management of the latter are primarily passive reactive process for patients and practitioners, and many more proactive approaches to these diseases and problems need to complement the classic style of the health care system.

These methods to change minds and behaviours ill-related are very powerful instruments. Therefore, they should be well studied ethically to guarantee that they will be used only and always in a process with all the liberties & rights. In this process, the individual must not feel attacked, or even that had lost any degree of his freedom interacting with practitioners & institutions, to choose whatever is better for him in relation to his lifestyle & health, but knowing what is better to choose by himself [29].

In this sense, in most underdeveloped countries the management of the diseases of the poverty, needs much more basic social research than in the developed countries. It happens that the poor peoples due to their nature with scarce resources are more difficult to move from the pre-contemplation and contemplation stages to the action stage of behaviour change. With them, the application of the TTR model will be more complex, without thinking in the action, maintenance and finishing stages.

In the poor populations there is the greatest resistance to the sanitary education in the classic passive way. They do not follow well the preventive and therapeutic measures with medicines, vaccines, and very specially changing their unhygienic ways of living to a more hygienic one, even if you move them to live into a luxurious mansion. These models could be adapted and further developed for them.

This is because they could have received more, less or none instruction in the schools, but they often suffered from a lack of good politeness, education, culture, traditions, and customs, according to the western or oriental civilisation, and many rejected some of them with hostility, because they remembered the way of living of the peoples of the old metropolis that colonised or neo-colonised their country and forefather.

The most important steps to behaviour change process are helping the individual to identify personal abilities, and leading them into a successful own decision making process. However, these educational experiences have to be adapted from the developed countries, used and advanced also in the underdeveloped countries with a broader scope and manner toward a more civiliser function too.

In the one hand, it could be studied much more in the richest countries the non-healthy behaviours of the individual, and the new proactive approaches of behaviour change for chronic diseases management complementing the passive-reactive specific protection and treatment of acute diseases management, and substituting the traditional confrontational models of “breaking through denial”.

In the other hand, it could be started similar studies in the poorest countries of the ill-health related behaviours of the individuals, and the adaptation of the proactive approaches to complement the classical health care system measures of passive-reactive specific protection and treatment of acute and maternal-infantile diseases, lesions and injuries, and developing new proactive approaches too.

The disease alleviation or cure does not need a high cultural and educational background, because the individual perceives the suffering, and is aware of the ill or harm. However, all the health promotion, as well as the protection, and early diagnosis stages of disease prevention in which disease has not begun or is not perceived yet, need of that important background.

It is very necessary the use of all the methods achieved by science to be able to change the mind and the behaviour of the poor individual, to eradicate the acute and maternal-infantile diseases, lesions and injuries of the poor countries now. This is due to the fact that most of those diseases, except the autochthonous ones, were eradicated more than 50 years ago in the richest countries, only with the passive-reactive protection and treatment, because their populations were then much more civilised than the poor countries now.

The comparative studies in ill-related behaviours and responses to different models of change behaviour between the rich & poor individuals in the richest countries could be continued. Comparisons in this same sense of the rich and the poor individuals in their own poor countries, and of the poor individuals of the rich and poor countries could be started as well.

The studies in the poor countries of the process by the one the individual became lazy and immersed progressively in the vicious circle of the poverty with misery, homeless, stacking, starvation, ignorance, and unhealthy, and how the individual could respond with a positive behaviour change to give up his/her laziness could be started. These studies could be made by age, sex, ethnic groups, geographic zones, and other socio-demographic data too.

Other studies could be made on uncivilised individuals of very primitive cultures, who are poorest with many ill-health related behaviours according to the western patterns, but who could feel richest with much wellness by their native beliefs, and, if it is fair & ethical to induce them to change their lifestyle & behaviour, against their willingness, because they could be focus of spread of biological & social plagues.

All these studies could be made by international teams composed by social scientists of the underdeveloped and developed countries, with the most advanced methods and means of the broadest scope of all modern social sciences, and communication high technologies of today.

With the programmed partial and final scientific results in the hands of the governing team of this project, it could be proposed to the WHO, COHRED, GFHR, CIOMS, other UN agencies, NGO, GO, and world private sector, the required reports and suggestion of action programs to enhance the improvement of the levels of ill-health related lifestyle and behaviours in the poor countries.

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