(A SCIENTIFIC CALCULATOR will be needed for the examination)

 

1. Science and the scientific method

Kerlinger FN. Investigación del comportamiento. Ed. McGraw Hill Interamericana. Second edition. 1989 pp.5-29.

Jenicek Mirlos, Cléroux Robert. Epidemiología Principios-Técnicas-Aplicaciones. Editorial Salvat, 1987. Chap.1.

2. The research outline

Hulley SR and Cummings SR. Designing Clinical Research. Williams & Wilkins. First Edition Baltimore, 1988. Chaps. 1 and 17.

3. The research problem: generating a research question

4. Hypotheses

5. Objectives

Hulley SR and Cummings SR. Designing Clinical Research. Williams & Wilkins. First edition Baltimore, 1988. Chap. 2.

The research problem. In: Stein F, ed. Anatomy of clinical research. Slack Inc.,USA 1989:135-149

6. Selection of the study population

Hulley SR and Cummings SR. Designing Clinical Research. Williams & Wilkins. First edition Baltimore, 1988. Chap. 3.

Elwood JM. Causal Relationships in Medicine. Oxford Medical Publications, 1988. Chap. 4.

7. Measure Planning: consistency and validity

Hulley SR and Cummings SR. Designing Clinical Research. Williams & Wilkins. First edition Baltimore, 1988. Chap. 4.

Feinstein AR. Clinical epidemiology. The architecture of clinical research. WB Saudres Co. USA. 1985. chap. 6.

Hennekens CH, Mayrent SL. Epidemiology in Medicine. Editorial: Little, Brown and Company. Boston/Toronto. 1987. chap. 4.

8. Normality

Feinstein AR., ed. Clinical Epidemiology. WB Saunders Co. USA 1985. chap. 28.

Fletcher RA et al. Clinical Epidemiology. Editorial: Williams & Wilkins, 2nd edition, Baltimore/London, 1992. Chap. 2.

9. Structure of clinical research

Feinstein AR. Clinical Epidemiology. The architecture of clinical research. Sauders Co. WB, 1985. Philadelphia PA USA. Chap 2.

Dawson-Sauders B, Trapp RG, eds. Basic and clinical biostatistics. Appleton &Lange USA, 1990. Chap. 2,

10. Observational designs: I cohort studies

Hulley SR and Cummings SR. Designing Clinical Research. Williams & Wilkins. First edition Baltimore, 1988. Chap. 7.

Hennekens CH, Mayrent SL. Epidemiology in Medicine. Editorial: Little, Brown and Company. Boston/Toronto. 1987. Chap. 7

11. Observational designs: II Transversal studies, case studies and controls

Hulley SR and Cummings SR. Designing Clinical Research. Williams & Wilkins. First edition Baltimore, 1988. Chap. 8.

Feinstein AR. Clinical epidemiology. The architecture of clinical research. WB Saudersco. USA 1985. chap. 18 y 23.

Schlesselman JJ. Case- Control Studies. Oxford University Press, 1982. pp 27-68.

12. Observational designs: III Validation of diagnostic tests

Hulley SR and Cummings SR. Designing Clinical Research. Williams & Wilkins. First edition Baltimore, 1988. Chap. 12.

Feinstein AR. Clinical epidemiology. The architecture of clinical research. WB Sauders Co. USA. 1985. chap. 25.

Fletcher RA et al. Clinical Epidemiology. Editorial: Williams & Wilkins, 2nd edition, Baltimore/London, 1992. Chap. 3.

13. Strengthening causal inference in observational studies

Hulley SR and Cummings SR. Designing Clinical Research. Williams & Wilkins. First edition Baltimore, 1988. Chap. 9.

Feinstein AR. Clinical epidemiology. The architecture of clinical research. WB Sauders. Co.. USA 1985. chap 4.

Fletcher RA et al. Clinical Epidemiology. Editorial: Williams & Wilkins, 2nd edition, Baltimore/London, 1992.

Jenicek Mirlos, Cléroux Robert. Epidemiología Principios-Técnicas-Aplicaciones. Editorial Salvat, 1987. Chap. 6.

14. Experimental designs: experiments

Hulley SR and Cummings SR. Designing Clinical Research. Williams & Wilkins. First edition Baltimore, 1988. Chaps. 10 and 11.

Feinstein AR. Clinical epidemiology. The architecture of clinical research. WB Sauders Co. USA. 1985. chap 29.

15. Use of secondary data bases: the clinical file as a source of information

Hulley SR and Cummings SR. Designing Clinical Research. Williams & Wilkins. First edition Baltimore, 1988. 13.

16. Estimating sample size: the hypothesis and its principles

Hulley SR and Cummings SR. Designing Clinical Research. Williams & Wilkins. First edition Baltimore, 1988. Chaps. 5 and 6.

17. Ethical aspects in research

Hulley SR and Cummings SR. Designing Clinical Research. Williams & Wilkins. First edition Baltimore, 1988. Chap. 14.

Braddock CH. Advancing the cause of informed consent: Moving from disclosure to understanding. Am J Med 1998;105:354-355

18. Questionnaires and data collection forms

Hulley SR and Cummings SR. Designing Clinical Research. Williams & Wilkins. First edition Baltimore, 1988. Chap. 15.

Feinstein AR. Clinimetrics. Yale University Press. 1987. Chap. 3.

19. Planning for data management and analysis

Hulley SR and Cummings SR. Designing Clinical Research. Williams & Wilkins. First edition Baltimore, 1988. Chap. 16.

Greenberg RS. Medical Epidemiology. First edition. 1992. chaps. 7,8 and 9.

20. Organization of data collection: pilot study, quality control and protocol review

Hulley SR and Cummings SR. Designing Clinical Research. Williams & Wilkins. First edition Baltimore, 1988. Chap. 17.

21. Multicenter, community and international studies

Hulley SR and Cummings SR. Designing Clinical Research. Williams & Wilkins. First edition Baltimore, 1988. Chap. 18.

22. Writing up proposals and research project financing

Hulley SR and Cummings SR. Designing Clinical Research. Williams & Wilkins. First edition Baltimore, 1988. Chap. 19.

23. Design of clinical and basic studies

Portney LG, Watkins MP. Foundations of clinical research: applications to practice. Appleton and Lange. Second edition. 2000. Chaps. 10 and 11.

24. Clinical course and prognostic studies

Fletcher RA et al. Clinical Epidemiology. Editorial: Williams & Wilkins, 2nd edition, Baltimore/London, 1992. Chap. 6.

Feinstein AR. Clinical epidemiology. The architecture of clinical research. WB Sauders Co. USA. 1985. chap. 3.

Methods, models and measures of health-related quality of life. In: Drotar Dennis, ed. Measuring health-related quality of life in children and adolescents. Lawrence Erlbaum Associates, Publishers. London. 1998:39-52

25. Systematic reviews and meta-analysis

Egger M, Smith GD, Altman DG. Systematic Reviews in health care. BMJ Books 2001: 23-68

Overview of the methods. In: Petitti DB, ed. Meta-analysis, decision analysis and cost-effectiveness analysis. Oxford University Press USA 1994:15-34

Advanced issues in meta-analyisis. In: Petitti dB, ed. Meta-analysis, decision analysis and cost-effectiveness analysis. Oxford University Press USA 1994: 70-154.