Clinical Epidemiology
Code
5106
Academic unit
Escola Nacional de Saúde Pública
Department
Saúde Pública e Comunidade
Credits
3.0
Teacher in charge
Pedro Manuel Vargues Aguiar
Total hours
24
Teaching language
Português
Objectives
Identify different phases of a clinical study.
Know how to validate a diagnostic test.
To plan, analyze and make interpretation of the results of a clinical study.
To define a clinical sample size.
Subject matter
Clinical epidemiology in the context of general epidemiology.
Clinical trial phases I, II, III, IV.
Superiority versus non-inferiority clinical trials.
Diagnostic tests: sensitivity, specificity, predictive values and ROC curves.
Stratified analyses and logistic regression; confounding and effect modification.
Kaplan-Meier survival analysis and Cox regression.
Determination of the sample size in a clinical study.
Case studies of clinical epidemiology.
Bibliography
Aguiar P (2007). Guia Prático Climepsi de Estatística em Investigação Epidemiológica. Lisboa: Climepsi Editores.
Fletcher, R., Fletcher, W., (2005). Clinical epidemiology: the essencials. Baltimore: Lippincott Williams & Wilkins.
Oliveira AG (2009). Bioestatistica, Epidemiologia e Investigação – Teoria e Aplicações. Lisboa: Lidel.
Pocock,S.J.(1983). Clinical Trials: a practical approach. Chichester: John Wiley & Sons.
Rothman K. Greenland S. Lash T.L. (2008) Modern Epidemiology 3rd ed. Philadelphia, PA. Lippincot Williams & Wilkins.
Teaching method
Theoretical sessions with slides presentation.
Discussion of published papers on clinical epidemiology.
Case study of clinical epidemiology made in Portugal.
Data analysis with SPSS and OpenEpi.