THEMATIC PLAN OF CLASSES IN THE DISCIPLINE "METHODOLOGY OF EVIDENCE-BASED MEDICINE". IV COURSE. 2022-2023 academic year

Class number

The topic of practical classes

Duration (hours)

1

Evidence-based medicine as a science. Basic concepts.

Evidence-based medicine: basic concepts, main principles, tasks. The concept of "evidence in evidence-based medicine". Stages of development of evidence-based medicine.

2

2

Evidence-based approach in medicine.

Development of evidence-based medicine in the world. Prerequisites for the emergence of evidence-based medicine. Formation of evidence-based medicine in the modern development of society. Achievements, criticism, technologies, practical implementation of the principles of evidence-based medicine.

2

3

Clinical epidemiology in the structure of medical sciences.

Clinical epidemiology as a methodological basis of evidence-based medicine, definition of the concept. The relationship of evidence-based medicine with clinical epidemiology and biological statistics. The concept of "social epidemiology".

2

4

Design of epidemiological studies.

Continuous epidemiological studies. Sample studies. Representativeness of the sample. The method of directed selection. Descriptive, analytical, experimental research. Routine and scientific research. Simultaneous and dynamic research. Retrospective and prospective research.

2

5

Design of clinical trials.

Randomized, controlled (clinical trials), cohort, single-case studies, case-control studies, case reports, randomized double-blinded placebo-controlled studies. Randomization. Stratification method. Placebo. Criteria for inclusion and exclusion from the study.

2

6

Evidence value of different types of studies.

Determination of the level of significance of evidence. The concept of statistical reliability and clinical significance of clinical trial results. Criteria for the effectiveness and safety of treatments. International standards GLP, GCP, GSP. Characteristics of relative and absolute indicators of treatment effect. The concept of point size of treatment effectiveness and its confidence interval.

2

7

Medical and ethical problems of the clinical trial process.

Rules of research ethics. Ethical standards, ethical considerations in the research process. International guidelines for ethical review of research. The role and rights of patients in clinical trials. Informed consent of the patient.

2

8

Information support of evidence-based medicine.

Sources of medical information. Advantages and disadvantages of different sources of information. Structure and content of scientific publication. The main sections of scientific publication. Analysis of articles and their critical evaluation. Systematic reviews: concept, structure. Meta-analysis: definition, purpose, objectives. Planning and main stages of meta-analysis. The concept of clinical guidelines. Protocols of patient management.

2

9

Computer resources of evidence-based medicine.

Characteristics of medical electronic database - CochraneLibrary. Characteristics of medical electronic databases - MEDLINE, BestEvidence, UpToDate, ClinicalEvidence. Stages of creating information messages in evidence-based medicine databases.

2

10

Structured clinical question: main components.

The main components, requirements, advantages of a structured clinical question. Formulation of a clinical problem using the PICO principle. Components of PICO: patient, intervention, comparison, outcome. Matrix for formulating a clinical question. Criteria for evaluating the results.

2

11

Methodology of critical evaluation and implementation of evidence in medical practice.

Analysis of articles and their critical evaluation. Characteristics of a review article. Opportunities and limitations of systematic reviews. Planning and main stages of meta-analysis, presentation of results. Levels of evidence for medical interventions in evidence-based clinical guidelines.

2

12

Evidence-based screening.

The main types of screening programs and screening criteria. Advantages and disadvantages of screening. Factors that distort and complicate the evaluation of the effectiveness of screening programs. The main differences between "screening" and "early diagnosis".

2

13

Evidence-based preventive medicine.

Definition of the concept of "health". The concept of "disease burden". Leading factors that affect the health of the population. Indicators of population health. Integral indicators of the WHO population assessment system. Health groups. Global and National Strategy for the Control of Dangerous Infectious Diseases. Methodology of preventive counseling.

2

14

The concept of risk factors.

Risk factors, risk calculation methodology. Absolute, additional risk. Relative risk. Additional population risk. Additional share of population risk. Chance. The ratio of the odds.

2

15

Evidence-based medicine and quality of medical care.

The concept of three "E". Qualification level of medical personnel. Standardization of medical practice. Basic management decisions. Stages of reforming the system of quality assurance of medical care.

2

16

Evidence-based medicine and marketing.

Application of the principles of evidence-based medicine in the standardization of medical care and implementation of the formulary system in health care in the world and in Ukraine. Evidence-based medicine as a means of promoting medicines. Signs of incorrect advertising of medicines. Unfair competition. Information that misleads the consumer. Surrogate endpoints. Development of the National Medicinal (Pharmaceutical) Policy.

2

17

Principles of medical audit.

Medical audit: definition, purpose, principles. Planning and practice of medical audit. Audit of the effectiveness of medical care. Analysis of errors.

2

18

Final module control: assessment of practical training, theoretical training

2