Biostatistics and Clinical Epidemiology

A.Y. 2023/2024
3
Max ECTS
36
Overall hours
SSD
MED/01
Language
Italian
Learning objectives
The aim of the course is to develop knowledge and skills related to the concept of probability, to deal with situations of decision-making uncertainty, to descriptive and inferential statistical methods, necessary to address the problem of biological variability, to aspects relating to critical judgment on the quality of studies published in scientific literature, from which to extract evidence for clinical decisions in the practice of Evidence Based Medicine (EBM).
The student will learn to deal with outcomes of stochastic experiments in terms of probability, having clarified the concepts of the event universe, elementary event and compound event, conditional event, applying the sum and product rules and the Bayes theorem to derive the probability a rear. He will also learn to use the concept of random variable, in the various probability distribution models useful for statistical inference (Gaussian, binomial, poissonian, hypergeometric, Student's t, chi-square model) and to interpret the values of the estimators, calculated on data samples, to make a correct inference, as regards the corresponding parameters of the population.
The student will also learn to recognize the different types of study used in epidemiological-clinical research (observational and experimental studies, cross-sectional and longitudinal studies, cohort and case-control studies), to assess their quality (confounding bias, in observational studies, information bias in experimental studies) and to extract information useful for clinical decision (accuracy measurements from diagnostic studies, estimates of association between exposure and disease from etiological and prognostic studies, measures of efficacy and therapeutic safety from comparative therapy studies).
The student will acquire the skills necessary to set up a database on a spreadsheet and proceed to the calculation of the necessary descriptive and inferential statistics (comparison of averages, simple linear regression analysis, comparison of proportions, analysis of simple and multiple contingency tables, adjustment techniques for confounding, calculation of confidence intervals).
Expected learning outcomes
The student will be able to read a scientific publication at the end, correctly interpreting the various sections of which it is composed: introduction, for the completeness and quality of the premise of the study, for its rationale and objectives; the materials and methods, for the eligibility and exclusion criteria that serve to define the target population, for the definition of the variables detected and considered in various ways in the study, for the appropriateness of the statistical analysis methods; the results, for the critical reading of tables and indexes to be interpreted in their practical meaning and for their correct interpretation for the purposes of application to the clinic; the discussion, due to the different possible interpretations of the results, with particular attention to the weak aspects of the study.
Single course

This course cannot be attended as a single course. Please check our list of single courses to find the ones available for enrolment.

Course syllabus and organization

Single session

Responsible
Course syllabus
Premise
Short historical overview of quantitative methods in medicine
Role of medical statistics in clinical practice.
Types of studies.
Introduction to Evidence Based Medicine
Introduction to Health Technology Assessment

The variability of biological phenomena
Measurement scales
Sources of variability
Variability within and between subjects
Measurement errors
Accuracy and precision

Elements of descriptive statistics
Graphical representations
Measures of location and dispersion
Measures of correlation
Data transformations and empirical distributions.

Diagnostic and screening tests
The diagnostic test with dichotomous response vs more categories.
Properties of a test and informative contribution in medical decision
Sensitivity and specificity, positive predictive value (PPV) and negative (NPV).
Odds and likelihood ratios for the calculation of PPV and NPV.
The Fagan nomogram and its practical application in the evaluation of a diagnostic test

Statistical inference 1: parameter estimation in statistical models
Sample variability and sampling distributions.
Empirical sample proportions.
The concept of estimation of the parameters of a probability model .
Intuitive introduction to the results of the central limit theorem
Empirical derivation of the Gaussian distribution
Point estimates and standard errors.
Confidence intervals.

Study of the association between risk factors and disease.
Probability and risk of a disease
Measures of prevalence and incidence.
Relative risk and odds ratio between exposed and not exposed to a risk factor.
Measures in cohort and case-control studies

Statistical Inference 2: Test of statistical hypotheses.
Application of the statistical test for comparison between groups with different treatment.
The statistical significance
The power of a statistical test
Comparison between statistical significance and clinical relevance.


Assesement of a medical intervention.
Etical issues in observational and experimental studies
Clinical trials of phase I, II and III
Target population and inclusion criteria.
Random assignment to treatment.
Measures of effectiveness of treatments
Confounding and interaction (treatment response)
Prerequisites for admission
Preliminary knowledge of the Medical Statistics module of the First Year Biology and Genetics course is required. Passing this exam is a prerequisite
Teaching methods
The teaching methods consider lectures, exercises, seminars and non-formal teaching activities in small groups oriented to the acquisition of practical skills integrated with the professionalizing teaching module.
The preparation of documents and / or research with the use of telematic supports is also considered

In detail:
- Frontal lessons supported by slides.
- Group exercises
- Professional training activity (optional) carried out on PC with open source software R. Bibliographic research methods on portals and certified search engines for medicine.
to learn how to correctly apply descriptive and interpretative models to small sets of real data, to critically use diagnostic tests, through the application of the concepts of norm and probability in medicine, and finally to evaluate the results of a clinical study, also through the critical analysis of the medical literature.
Teaching Resources
A specific text is not indicated but some possible reference texts

M. Pagano e K. Gauvreau. Biostatistica (2ª edizione)
Editore: Idelson-Gnocchi 2003

M. Bland. Statistica medica (Idee & strumenti)
Editore: Apogeo 2009

JF. Jekel, DL. Katz, JG. Elmore, DMG. Wild. Epidemiologia Biostatistica e Medicina Preventiva (3ª edizione)
Editore: Masson 2009

Statistica medica: intervalli di confidenza nella ricerca biomedica / D. G. Altman ... [et al.] ; edizione italiana a cura di F. Cavallo. - 2. ed.-Torino : Minerva medica, 2004. - , 238 p..

La medicina basata sulle evidenze scientifiche: come praticare e insegnare l'EBM / D. L. Sackett °et al. - 2. ed. riv. e ampliata, ed. italiana / a cura di Marco Bobbio. - Torino : Centro scientifico, °2002. - XVI, 248 p.

The course slides and additional materials presented in class are available on the Ariel teaching website
Assessment methods and Criteria
The exam includes a written test divided into two parts of 1) Statistics and 2) Evidence Assessment organized as follows:
1) problem solving (simple calculation exercises related to the topics covered in each module of the course);
2) interpretation of the results reported in the scientific papers (critical reading of what is reported in the abstract of the scientific articles in English).
The oral examination takes place at the sole discretion of the teaching team, it consists in the discussion of the answers provided by the student in the preliminary test and of 3 or 4 questions on the entire program.
However, the Students can propose an additional assessment linked to an original optional study on the topics of the teaching course.
The Students, equipped with a suitable calculator as an aid to the solution of the proposed exercises, can freely consult any paper material they deem appropriate for carrying out the exam.
The exam test results are communicated via the teaching team on MS Teams.
MED/01 - MEDICAL STATISTICS - University credits: 3
Lessons: 24 hours
: 12 hours
Professor(s)
Reception:
On appointment (email)