67833 - Multidisciplinary Seminar for Specific Studies

Learning outcomes

At the end of Module 1, the student will have acquired the skills necessary for a critical understanding of the rationale, design, and conduct of clinical trials.
At the end of Module 2, the student will have gained knowledge of the technical and analytical procedures related to specific biological samples (tears, aqueous and vitreous humor, saliva, synovial fluid, cerebrospinal fluid, sweat, and hair), with particular emphasis on the use of Point-of-Care Testing (POCT) technologies.

The seminar supports SDG 3 (Good Health and Well-Being) by enhancing diagnostic and research skills related to non-invasive sampling and Point-of-Care Testing in district medicine. It promotes SDG 4 (Quality Education) through interdisciplinary and up-to-date technical training for biomedical laboratory professionals. Furthermore, it aligns with SDG 9 (Industry, Innovation and Infrastructure) by addressing technological innovation in analytical methodologies and supporting decentralized healthcare systems.

Course contents

The seminar is structured into two modules, both delivered by the same teacher, for a total of 40 hours. The overall objective is to provide students with integrated theoretical and practical training in clinical research methodology and in the application of advanced analytical technologies in District Medicine.

Module 1 focuses on the fundamentals of research methodology, with particular emphasis on clinical research. Students will acquire skills for a critical understanding of research logic, study design principles, types of experimental designs, and the conduct of clinical studies in accordance with Good Clinical Practice (GCP). The module also introduces structured analysis of scientific literature, including practical exercises based on selected articles.

Module 2 is dedicated to micro-sampling and analytical microtechniques applied to biological fluids contiguous to the target organ, in the context of so-called District Medicine. Students will explore the biochemical characteristics, sampling techniques, and analytical procedures related to minimal biological samples such as tears, aqueous humor, vitreous humor, saliva, synovial fluid, cerebrospinal fluid, sweat, and hair. Special attention is given to the use of Point-of-Care Testing (POCT) technologies and their integration into clinical practice, including decentralized or outpatient settings. The module also promotes a critical approach to data interpretation based on the principles of Evidence-Based Laboratory Medicine (EBLM).

Summary of Seminar Topics:

Module 1 – Research Methodology (24 hours)

Introduction to research methodology: science and the scientific method

Phases of scientific research and formulation of the clinical research question

Literature review: databases and bibliographic search strategies

Clinical research architecture: study design types

Definition of study objectives, target population, sample size, endpoints, and database creation

Experimental research: drug development phases and randomized controlled trials

Ethical aspects of research: the role of Ethics Committees

The clinical protocol, Good Clinical Practice (GCP), study conduct, and regulatory authorities

Structure and critical reading of scientific articles

Module 2 – Micro-sampling and Analysis of Biological Fluids (16 hours)

Basic anatomy, physiology, and biochemistry of: tears, aqueous and vitreous humor, saliva, synovial fluid, cerebrospinal fluid, sweat, hair

Sampling methodologies, analytical techniques, and interpretation of results

Evidence-Based Laboratory Medicine (EBLM): diagnostic appropriateness of tests in relation to specific diseases

Fundamentals of District Medicine and applications of Point-of-Care Testing technologies

 

Readings/Bibliography

A selection of the teaching materials presented during the lectures will be made available to students on the course’s Virtual Learning Platform.
In addition, students will be encouraged to consult open access resources available on the following websites:

Cochrane Library
International database of evidence-based systematic reviews.
Link: https://www.cochranelibrary.com/

PRISMA Statement – Preferred Reporting Items for Systematic Reviews and Meta-Analyses
Official guidelines for the reporting of systematic reviews.
Link: http://www.prisma-statement.org/

STARD – Standards for Reporting Diagnostic Accuracy Studies
International standards for transparent reporting of diagnostic accuracy studies.
Link: https://www.equator-network.org/reporting-guidelines/stard/

AGREE II – Appraisal of Guidelines for Research & Evaluation
Tool for assessing the methodological quality of clinical practice guidelines.
Link: https://www.agreetrust.org/

GIMBE – Evidence-Based Practice and historical educational resources
Italian website offering introductory materials on clinical research methodology.
Link: http://www.gimbe.org/

Evidence.it – Archive of methodological tools and historical articles
Collection of documents and checklists related to Evidence-Based Medicine methodology.
Link: http://www.evidence.it/elencoarticoli/209/it

Teaching methods

Frontal teaching with practical examples. Team work.

Assessment methods

Short talk given on a topic chosen by the student. Test with multiple choice quiz on topics from the program.

Teaching tools

Video projector, PC, mobile app for interactive teaching.

Office hours

See the website of Piera Versura