Learning objectives and expected results The students will learn to: - define, explain and apply the basic terminology and principles specific to clinical epidemiology - characterize the different epidemiological study designs for the clinical research - differentiate between the different domains of clinical epidemiological research (diagnosis, prognosis, etiology, prevention, treatment) - evaluation epidemiological evidences - construct a clinical research question that includes outcome, determinants and domain - critically read clinical research protocols or reports.
By the end of the course, students should be able to: - Critically read current clinical research papers, by comparing their actual contents to those they should report (e.g. study design, epidemiological measures, quality of evidence), using the medical knowledge they have acquired in past study, as well as their notions of medical statistics and study design. - Define a clinical research question and list the main steps necessary to write a research protocol for a clinical research study. - Apply concepts and principles of outbreak disease investigations
Course Prerequisites
The students should have attended the first Epidemiology and medical statistics modules (delivered during the first year of the Harvey Medicine curriculum) or, as an alternative, the students should review study design and measures of occurrence and association for the observational studies.
Teaching Methods
The theoretical coverage of all topics (by lectures) will always be supplemented by substantial practical applications. The discussion sessions will entail the use of real epidemiological data, and will be performed using research articles, public data and ad hoc exercises under the teacher’s supervision. Examples of diseases discussed in the other modules of disease control and eradication will be used.
Assessment Methods
A closed book, written examination including multiple choice and short answers items will be based on interpretation of case studies. Duration: 90 minutes.
Texts
Suggested course textbooks Modern Epidemiology, 4rd Edition. 2021. Lash, WanderWeele Haneuse, Rothman, KJ. Walters Kluwer. Methods of Clinical Epidemiology. 2016. Doi S and Willims GM. Springer Clinical Epidemiology: How to do Clinical Practice Research. 3rd Edition. 2005. Haynes RB, Sackett DL, Guyatt GH, Tugwell P. Lippincott Williams & Wilkins. Gordis Epidemiology. Sixth Edition. 2019. Celentano DD and Szklo M. Elsevier Health Sciences Division.
Contents
This course will review the epidemiological study designs and measures for the clinical research, discuss the evidence-based approach to optimize diagnosis, treatment and prevention, present some methods for rating scientific evidence quality. A special focus will be dedicated to what is a good clinical research question and the guidelines for writing a clinical research protocol, in order to really answer clinical questions.
Topics: - study designs and epidemiological measures - clinical research domains - the clinical research question (including outcome, determinants and domain, PICO framework) - rate scientific evidence quality - the research protocol - Review of current clinical research papers