Summary Research Education Program of an Advanced Course in:

"Medical Scientific Research, Intervention & Development at the Clinic, Health System and Laboratory. A Unified Methodological Approach"

Rodolfo J. Stüsser, M.D.

Professor of Havana University, Researcher of Clinical Epidemiology & Biostatistics Division of the Clinical Research Centre, 34 # 4501 / 45-47, Playa, Havana-13, Cuba.

December 2, 1998

FOUNDATION

Medical scientific research is passing through a worldwide progressive crisis, specially in the last two decades. Its effectiveness has been diminished to achieve the humanistic goals of medicine. The impact of its outcomes on the health of the person, the family and the society has remained stationary. The health research costs along the expenditures of health care have been multiplied. The clinical ortho-investigation of high-quality, guided by internal forces of the clinical knowledge, originated-in-the-patient and investigator-driven, has been discouraged in the physician generalist as well as in the specialist.

At the beginning of the second half of this century, the leading external force of the clinical progress has become the development of basic knowledge by the biomedical models, along with the advancement of new means for medical and health care by the technological development of pharmaceutical, medical-devices and specially biomedical procedures in the research laboratories. Also, the improvement of better public health's indexes of disease, death and survival, as well as of expenditures and efficiency, have been another prominent external force of the clinical progress.

The clinical meta-investigation evaluating the outputs of the research laboratory, guided or not by the public health indexes, is being considered currently as the most rigorous clinical research, because it is an extension of the laboratory research. Nevertheless, without clinical ortho-investigation are lost the skills necessary to make good meta-investigation, and very important too, is delayed the achievement of the solutions of the more biopsychosocial health problems of the whole person and his family and community.

This course program calls to confront medical research challenges with much more than integration of the qualitative with the quantitative methods of medical research. It exhorts essentially to link the research and intervention (R&I) with the research and development (R&D) of all medical research objects and sites, as well as the empirical and quantitative methods of research with the rational and qualitative ones, to make medical scientific research enterprise more integral and balanced. Thus, conceives research on the person and family, at the house, clinical office or ward, as well as on the community, population, health system and service, at the health zone or center, and on the medical model and technology, at the basic and industrial laboratory, as related fields and moments within a unique creative process to solve scientific problems, which must integrate multilaterally their methodologies to achieve more efficacy than when they are used separately.

A requirement exists of a unified methodology of vertical and horizontal R&I and R&D, to fill the spaces of the medical science's disciplinary matrix, improving the theoretical and practical efficacy of medical science. The rapprochement across the methodologies shall allow establishing later scientific methodological principles of whole medicine. Linking explicitly, the ignored, theoretical and interpretative methods along with the factual , low & high-technological procedures, is one suggestion. Thus, besides the use of the hypothetical-deductive method, it argues the utilization of an axiomatic-like method too.

Another proposal, is that clinical judgment --central algorithm of clinical daily practice-- has to reflourish as a creative or heuristic method, to also generate new scientific hypotheses to be verified by own clinical and surgical studies, as well as by laboratory and sanitary investigations too. Thus, it should provide a powerful tool to attract more and train better young generalist and specialist physicians, nurses and other health professionals to a new high-rigor clinical ortho-research on the person and the family.

The endeavors are addressed to all the levels of research from the student, the physician, the nurse and other health professionals, until the medical organizations of center, medical basic or industrial laboratory, scientific school, university and province, and even the nation or region of the world. This integral medical research program of training, has to be complemented with clinical ortho-investigation programs of training, including Masters and Ph.D. in Clinical Sciences. Finally, it recommends other epidemiological and public health international projects regarding the integration of them hierarchically with the genome, brain, and other basic projects, through a clinical medicine one.

OBJECTIVES

The purpose of this preliminary course program is to give a new coherent, comprehensive and unique methodology to conceive, educate and make medical scientific research, particularly clinical research, more creative and fruitful with lower expenditures, strengthening its internal logic of scientific progress.

It will be achieved giving through a broad, theoretical and ambitious approach at a high scientific level of abstraction, the theoretical and practical components of the medical scientific research process on the person and family, and the home, clinic, laboratory, community and population, as well as their more intimate interrelations, addressing them to the following aims:

First, to define the principles of the philosophy, ethic, anthropology, ontology, epistemology, logic, history and methodology of the medical scientific creative thinking of the new good idea --being this a hypothetical discovery, invention, innovation of knowledge, technology or product--, and the methodological precepts of the successive validation of its objective and true nature with the correspondent scientific skills.

Second, to delimit the credibility of the scientific care of the patient and its results with good medical practices, and good technologies, statistics, computers, networks at all research levels, from the forecast, policy, program until the project, report, patent and article of the research results, as well as their quick insertion improving that practices, evaluating the impact on the health of the person, society and economy.

 

THEMES AND PARTS

This preliminary postgraduate research education program could be taught in English and/or Spanish language within a period between 40 and 320 hours (1-8 weeks), with any character: short or large workshop, academic course or tutorial, from 1 to 50 professionals, at a more practical or theoretical level, of part or all the themes, according to the interests of the audience about the nature of the themes in anyplace. It would be illustrated with instances of the literature of developed and underdeveloped countries and from the audience and professor experiences. It would require at least one personal computer well equipped with modem, multimedia, projector, datashow or videobin, standard software, scanner-photocopier-laser printer, full Internet facilities (WWW and E-mail), and SPSS, EGRET or BMDP, softwares. The list of principal themes would be as follows:

THEMES:

A. Introduction:

1. Goals & means of medicine & medical science. Scientific knowledge & methodology of the R&I and R&D, basic, applied & participatory in the eve of the 21th-century. Human interests, values, feelings & objectives; social-historic & ethic-epistemologic, contexts. Empirism & rationalism in medical research.

B. Most Qualitative Ways and Methods of Medical Scientific Progress:

2. Philosophic, ethic, anthropologic, ontologic, epistemologic, axiologic, historic & logic precedents of the R&I and R&D. Medical methodological foundations: unity of concepts, methods and problems.

3. Ideas come first, experiments come later. Innovative and unorthodox ideas, unconventional methods. The research ethics concerning patient, and humanity. To venture in new territories, and ask creative questions.

4. The "inertia" of scientific thought, and scientific "herd" instinct. The peer review applying for research grants, and positions; peer review submitting results to meetings committees, and to journal editorial boards.

5. External leading forces of clinical research: Basic models-oriented, technology-oriented and index-driven. Internal prominent forces of medical and clinical research: Patient-oriented and investigator-driven.

6. Modern methodologies of science or logics of discovery: Hempelian inductivism, Duhemian conventionalism, Popperian hypotheses falsification, Kuhnian paradigms, Lakatosian research programs.

7. Forecast, policy, program & coordination of the medical R&I and R&D. The project, grant, report, article & patent of the outcomes, & the evaluations of data and theory, publications-applications & practical impact.

8. Medical methodology of R&I and R&D. Tendencies & ways of thinking & knowing, models & methods of hypothesis formulation, factual validation, theory acceptation & formation. Methaphyiscs and dialectics.

9. Medical scientific thinking trends: static disease-oriented, survival, dynamic illness & health-oriented, life quality; biomedical, biopsychosocial, black & Chinese boxes, & infomedical models in hypothesis building.

10. Medical scientific thinking ways: analytical-reductive, synthetical-integrative, holism; analogic, statistical, linear & reticulate or nonlinear, mathematical & computer simulation & representation of hypotheses models.

11. General scientific methods & relations: hypothetical-deductive, axiomatic, structural-functional, determinist-probabilistic, hermeneutic; empiric-observation-measuring, survey-assay, qualitative-quantitative.

12. Good heuristic clinical judgment (creative) with low and/or high technology of R&I and R&D; good algorithmic clinical judgment (current), based in the evidence of the R&I, to handle facts scientifically.

13. Direct observation, in-depth interviewing, systematic accumulation of written & published data, content-analysis --preliminary critical activity for formulating hypotheses & interpreting hypotheses testing.

14. Thought, design and project of the medical R&I and R&D. Ideabases, data form & databases. Results analysis, interpretation & report. Medical high & low technological and non technological development.

C. Most Quantitative Ways and Methods of Medical Scientific Progress:

15. Discovering, understanding & discriminating the dependent & independent variables in the cause-effect web in medical research of linear & nonlinear (chaotic) relations in any health problem object of study.

16. Phenomena measuring methods of hard variables, biophysics-chemical (genetics & environmental) with high technologies, and of soft variables with higher psychosocial techniques of R&I and R&D.

17. Reducible systematic errors of observation, measuring, clinical judgment, survey & assay (methodologic & logic). Control of statistical errors a y ß in auxiliary hypotheses testing (random sampling & assignment).

18. Computer aid to the R&I and R&D: 3W, infobases & E-mail by Internet, processors and bases, statistical packages, coupled technology, artificial intelligence (diagnosis-therapy; new medical scientific hypotheses).

19. Maintenance, recovering & promoting health in persons. Comforting, relieving, curing & preventing: suffering, illness & disease. Disease subclinical & clinical progression-stabilization-regression process.

20. Diagnostic & prognostic surveys and assays of diseases & health, of clinics, laboratories, communities & populations. Generation & proving a new test, marker or system of them & their requirements.

21. Therapeutic & rehabilitation surveys and assays of diseases & disabilities, of clinics, laboratories, communities & populations. Creation & experimenting a new drug, instrument or protocol & their requisites.

22. Etiologic, pathogenic & healthgenic surveys and assays of diseases & health, of clinics, laboratories, communities & populations. Genesis & testing a new cause, factor, pathogeny, healthgeny & their demands.

23. Health promotion and diseases protection surveys and assays, of clinics, laboratories, communities & populations. Birth & verifying of a new promoter or protective measure or program & their demands.

24. Health & medical services surveys and assays, of clinics, laboratories, communities & populations. Beginning & experiment of a new service structure, model of care or program of actions & their requisites.

25. Metascientific unified analysis retrospective and prospective of evidence of surveys and assays, and of the structure, dynamic and synthesis of the medical & health problems, hypotheses, law-like and theories.

C. Complementary Ways and Hybrid Methods of Medical Scientific Progress:

26. Complex induction of unifying principles to assist the formulation of medical and health integral hypotheses, through unorthodox ways of inference from the principles and accepted partial theories and data.

27. The need of the isolated methodological approach to research education in medical and health sciences, complemented with the unified approach to clinical, health and laboratory scientific research methodologies.

D. Epilogue:

28. Confronting the ethic, cognitive & axiologic crisis and challenges of the present medical sciences' R&I and R&D progress, and of its methodological system. Integration of scientific networks and programs of medical care, education, and R&I and R&D projects in all the medical scientific research fields.

Foundation Papers:

-Stüsser RJ. Human health: Medical scientific principles to increase it. Under revision in WHO.

-Stüsser RJ. Unified approach to medical scientific research methodologies. Under revision in WHO.

E-mails:
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