Teaching code

4S000326

Credits

4

Coordinator

Gian Luca Salvagno

Language

Italian

Moodle Seminars 0

The teaching is organized as follows:

Learning outcomes

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MM: EPIDEMIOLOGIA CLINICA E SPERIMENTALE
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The course aims to provide skills in epidemiology and biostatistics that enable to assess the frequency of diseases in human populations and the associated risk factors.
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MM: VALUTAZIONE E CONTROLLO DELLA QUALITA' DEI SERVIZI DIAGNOSTICI
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The course allows the student to acquire basic notions regarding the evaluation of quality control processes in diagnostic services. The course provides the student with the cognitive and methodological tools necessary for the verifi-cation of technical-analytical processes, especially in the management of the pre-analytical, analytical and post-analytical phases. In particular, attention will be paid to the meaning of validation and verification of a analytical methods in clinical biochemistry, implementation of analytical goals and objectives for a continuous im-provement of the diagnostic service offered. The course allows the student to understand the meaning of: - Standard Operating Procedure (SOP), - Validation and verification of a clinical biochemical methods. -Procedure for implementation and maintenance of a Certification System according to the ISO 9001 standard - Accreditation of clinical laboratories, according to ISO Standard 15189 - knowledge of CLSI documents (Clinical and Laboratory Standard Institute) - definition of an indicator for monitoring the performance of pre-analytical, analytical and post-analytical procedures.

Program

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MM: EPIDEMIOLOGIA CLINICA E SPERIMENTALE
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The course is structured in frontal lectures (20 h). - Introduction to epidemiology - The objects of epidemiological research (outcome, outcome parameter, determinant) - Measures of disease frequency (incidence rate, cumulative incidence, prevalence) - Measures of association (attributable risk, relative risk, Odds ratio) - Epidemiological study design (cross-sectional, case-control, cohort, experimental) - The causal interpretation of an empirical association (models of causality, random error, bias, confounding) - Effect modification - Prevention, screening and diagnostic tests (indicators of validity and agreement between measurement methods) - Normal distribution - Sampling - Statistical inference (test of significance and confidence interval) for quantitative variables - Regression analysis and correlation
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MM: VALUTAZIONE E CONTROLLO DELLA QUALITA' DEI SERVIZI DIAGNOSTICI
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Objectives of the course At the end of the course the student will be able to: • Use the own methodologies of clinical biochemistry for the Verification and Validation of Analytical methods • Implement the Standard Operating Procedures (SOP) for pre-analytical, analytical and post-analytical activities • Implement and evaluate an Internal Quality Control System for analytical systems (CQI) and exter-nal Quality Assessment (VEQ) • Follow the methodologies used in diagnostic services for accreditation and certification procedures.

Bibliography

Examination Methods

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MM: EPIDEMIOLOGIA CLINICA E SPERIMENTALE
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The exam consists of a written test with multiple-choice questions and exercises. The final evaluation is expressed in thirtieths.
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MM: VALUTAZIONE E CONTROLLO DELLA QUALITA' DEI SERVIZI DIAGNOSTICI
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The assessment of the learning outcomes includes a written and oral test. Written exam, with some open questions and multiple choice tests. This test consists of an interview aimed at ascertaining the knowledge of the topics in the program and the analytical and argumentative capacity.