Bachelor's degree in Biomedical Laboratory Techniques (to qualify as a biomedical laboratory worker) (Verona)

Methodologies for an evidence-based professional practice (2015/2016)

Course code
4S000326
Credits
4
Coordinator
Maria Elisabetta Zanolin

Teaching is organised as follows:
Unit Credits Academic sector Period Academic staff
EPIDEMIOLOGIA CLINICA E SPERIMENTALE 2 MED/01-MEDICAL STATISTICS lez 3 anno 1 semestre TLB Maria Elisabetta Zanolin
VALUTAZIONE E CONTROLLO DELLA QUALITA' DEI SERVIZI DIAGNOSTICI 2 BIO/12-CLINICAL BIOCHEMISTRY AND MOLECULAR BIOLOGY lez 3 anno 1 semestre TLB Gian Luca Salvagno

Learning outcomes

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MM: EPIDEMIOLOGIA CLINICA E SPERIMENTALE
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The course aims to introduce the basic theoretical tools of Quantitative Medicine. The course points to prepare students to: - describe, interpret and communicate appropriately the information gathered on a collective of patients (or other experimental units); - assess the reliability of the measurements in the biomedical field, in terms of sensitivity, specificity, accuracy and precision; - generalize the observations collected on a limited number of subjects to the population of origin using elementary inferential techniques - read critically the articles of the biomedical area
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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.

Syllabus

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MM: EPIDEMIOLOGIA CLINICA E SPERIMENTALE
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Introduction: The purpose of the statistics in medicine. Descriptive statistics 1) The measurement process and the different types of measurement scales 2) The statistical variables and their representation by means of frequency distributions: tables with one or two variables. 3) Graphical representation of a frequency distribution 4) Measures of position (mean, median, mode, percentiles, weighted average) 5) Measures of dispersion (range, interquartile deviation, deviation, variance, standard deviation, coefficient of variation) Probability 1) Definitions of probability: classical, frequentist, subjectivist 2) The rules of calculation of probability: addition and product rule 3) Independent and conditional probability 4) The sensitivity and specificity of a diagnostic tool 5) ROC curves 6) Bayes theorem and its applications to differential diagnosis 7) Random variables 8) Normal Distribution 9) Population and sample. Introduction to the sampling theory 10) The sampling distribution of an estimator (sample mean) Inferential Statistics 1) Point and interval estimates: confidence interval 2) The logic of hypothesis testing: the null and the alternative hypothesis; first and second type error; the power of a test 3) Comparison of a sample mean with a population mean: z-test and t-test 4) Comparison of two sample means: t-test for unpaired data and for paired data 5) Chi-square test 6) Correlation and regression
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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.

Assessment methods and criteria

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MM: EPIDEMIOLOGIA CLINICA E SPERIMENTALE
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The exam is written and consists of multiple choice tests and exercises. The answers provided in the examination will be discussed with the student.
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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.

Reference books
Author Title Publisher Year ISBN Note
Jekel JF, Katz DL, Elmore JG, Wild DMG Epidemiologia, Biostatistica e Medicina Preventiva Elsevier-Masson 2009
Verlato G, Zanolin ME Esercizi di Statistica Medica, Informatica ed Epidemiologia Libreria Cortina Editrice, Verona 2000
Carl A. Burtis Edward R. Ashwood, David E. Bruns Tietz Textbook of Clinical Chemistry and Molecular Diagnostics (Edizione 5) Elsevier 2011




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