Learning objectives
acquire the basic skills in order to understand the methodology of clinical research; how to participate in a clinical study; critically read the scientific literature relating to epidemiological studies.
Prerequisites
Course unit content
Basic concepts of epidemiology; observation methods; validity and accuracy; random and systematic error; investigation directionality.
Types of epidemiological investigation: concept of manipulation and randomization. Observational, semi-experimental and experimental studies.
Observational studies: environmental, genetic and molecular epidemiology. Descriptive and analytical studies: main features, advantages and disadvantages. Types of analytical study: cross-sectional, case-control and cohort study; limits and potential. Semi-experimental investigations: studies with internal or external comparison, laboratory and clinical studies, health policy interventions. Advantages and limitations. Experimental investigations: clinical trials. Theoretical effectiveness (effectiveness) and practice (effectiveness), evaluation criteria (endpoints). Treatment concepts and placebos (controlled and uncontrolled studies), blinding. Phases of the trial: main differences between phase I, II, III and IV studies. Types of systematic biases and bias reduction techniques; effect modification, interaction. General characteristics of the clinical study: design, sample size, protocol; the methodology for drafting clinical study protocols. The statistical significance and the power of the study; efficacy measures in epidemiology.
Full programme
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Bibliography
Fondamenti di ricerca infermieristica Polit; Beck. Mc Graw Hill
Costantini W., Calistri D. – OSTETRICA – libro 2. Piccin
Evidence-based clinical practice. La pratica clinico-assistenziale basata su prove di efficacia Chiari P. Mc Graw Hill
Teaching methods
The course will be carried out through face-to-face lectures (classroom) and work in
small groups. The material will be available on the Elly platform
Assessment methods and criteria
The evaluation takes place through an oral exam with a score expressed in thirtieths or, alternatively, at the discretion of the teacher, through a multiple choice test. In case of problems, a teleconference platform can be used.
Other information
