3. Program of Academic discipline

MODULE 1.

BIOSTATISTICS

Content module 1

INTRODUCTION INTO BIOSTATISTICS. EPIDEMIOLOGICAL RESEARCHES AND THEIR ANALYSIS.

SPECIFIC OBJECTIVES:

• know the definition of biostatistics as a discipline and its role in the system of evidence-based medicine;

• master the theoretical and methodological foundations of biostatistics;

• master the basic organizational elements of statistical analysis, it is methodical and practical aspects;

• master the basic approaches and indicators to characterize the statistical evaluation of data sets and dynamics;

• be able to assess and analyze statistical data and statistical parameters totalities .

TOPIC 1. METHODOLOGICAL FOUNDATIONS OF STATISTICAL RESEARCHES IN HEALTH CARE SYSTEM.

Theory and concepts of statistical observation stages of its implementation. Methodological foundations, forms and methods of statistical observation and data collection. The accuracy of the observations. Using different measurement scales: absolute, ordinal, interval, relations.

Sources of statistical information. Types of statistics, statistical reporting, sample surveys.

Marketing and public opinion polls, the types of questions in the survey, the problem of surveys in health care.

Types of sample surveys, the concept of randomization and stratification, the design of clinical researches.

Grouping of statistical data, methods, meaning. Types of groupings , the principles of statistical groupings and classifications. Comparability of statistical groupings. The concept of multidimensional classification.

Statistical tables, their characteristics, types and rules of construction.

Methodological foundations of reading and analysis of tables.

The concept of non-numeric data qualitative features.

TOPIC 2. RELATIVE VALUES (STATISTICAL COEFFICIENTS). GRAPHICAL ANALYSIS METHODS.

The concept of statistical indicators, their types, forms of representation.

Absolute data relative values, their practical importance.

Types of relative values method of their calculation and methodical basis of the application for data analysis.

The concept and types of structures of biomedical data, structural changes, especially their analysis.

Graphical methods for data analysis. Types of schedules, rules of their construction.

TOPIC 3. RISK FACTORS. METHOD OF CALCULATION AND RISK ASSESSMENT.

The concept of risk factors. Risk indicators, methods of calculation and analysis. Absolute, additional risk. Relative risk, the additional population risks. The odds ratio.

Practical use of risk assessment methodology.

TOPIC 4. METHOD OF STANDARDIZATION.

Problems of comparison of statistical indicators.

Types of methods of standardization, characteristic, evaluation of the results.

TOPIC 5. DYNAMIC LINES AND THEIR ANALYSIS.

Type of dynamic lines. Basic rules for the construction and analysis of dynamic lines in the study of the dynamics of biomedical phenomena.

The main indicators of dynamic lines analysis.

Basic techniques for handling dynamic lines for determining the trend.

The study and measurement of seasonal variations in dynamic lines.

Comparability of dynamic lines.

Interpolation and extrapolation of dynamic lines.

The prediction based on extrapolation of dynamic lines.

Content module 2.

ANALYTICAL STATISTICS.

SPECIFIC OBJECTIVES:

• obtain skills and abilities formation of statistical hypotheses;

• be able to analyze and evaluate statistical models for their main characteristics, indicators.

• master the methodical basics and the main criteria for selecting of adequate methods of analysis for testing statistical hypotheses;

• obtain practical knowledge and skills using applied biostatistics methods for data analysis;

• master the theoretical and methodological foundations of statistical analysis of the results of their assessment and description in order to develop reasonable conclusions.

TOPIC 6. Characteristic and analysis of statistical data. Averages and variation indexes.

Average values in clinical and epidemiological studies, their types, practical importance, methods of calculation.

Concept of variation and its significance. The variability of the parameters of a totality, methods of evaluation. Absolute numbers of variation, standard deviation, their assessment. Ratios variation: coefficients of variation and determination.

Measures of variation, concept of the laws of distribution, types, characteristics.

TOPIC 7. Parametrical methods of estimation and analysis of statistical hypotheses.

Selective observation as a source of statistical information.

Zero and alternative hypotheses.

The errors of the first and second kind. Significant statistical criteria.

The average error and the average relative size, confidence interval.

Estimation of the probability difference: Student test , method of calculation , its evaluation, the use of common errors .

Theme 8. Nonparametric methods of estimation and analysis of statistical hypotheses.

Justification of the use cases nonparametric methods to assess their value.

Types of comparable totalities and their characteristics.

Analysis and evaluation of related collections criterion marks Wilcoxon.

Testing of statistical hypotheses for independent samples, the Kolmogorov- Smirnov test, Yait, serial.

Xi- square criterion, its assessment and practice application.

SUBJECT 9. Analysis of correlation between statistical indexes of population..

Studying the link between quantitative variables. Correlation , types of correlation coefficients .

The coefficient of linear correlation, its estimation, characteristic.

Non-parametric estimation methods of communication - rank correlation coefficient.

Regression analysis, regression coefficient, regression equation. Using regression analysis for prediction.

4. The structure academic discipline

Content Modules and Themes	Hours
	Full-time
	all	including
		Lect.	Pract.		Labs	Indiv.		Self-study
1	2	3	4		5	6		7
Module 1. Biostatistics
Content module 1. *Introduction to Biostatistics. Epidemiologic research and its analysis.*
Theme 1. Concept and role of Biostatistics as the basic component of the system of evidence-based medicine, history of development and value for health care.	3	2					1
Theme 2. Epidemiological studies in health care, their description and analysis. Fundamentals of Biostatistics, its importance in the practice of public health.	3	2					1
Theme 3. Methodological basis of statistical studies in the organization of health care.	4			3			1
Theme 4. Clinical epidemiology. Modern principles and rules of conducting clinical research. Concept of null hypothesis, principles of randomization and stratification in medical research.	3	2					1
Theme 5. Relative values (statistical indices). Graphic methods of analysis.	4			3			1
Theme 6. Risk factors, method of risk calculation and assessment.	1						1
Theme 7. Analysis of epidemiologic research indexes, risk estimation.	1						1
Theme 8. Method of standardization.	4			3			1
Theme 9. Series of dynamics and their analysis.	4			3			1
Total for content module1	27	6		12			9
Content module 2. Analytical statistics.
Theme 10. Characteristic and analysis of statistical data. Averages and variation indexes.	3			2			1
Theme 11. Parametrical methods of estimation and analysis of statistical hypotheses.	2			1			1
Theme 12. Nonparametrical methods of estimation and analysis of statistical hypotheses.	2			1			1
Theme 13. Analysis of correlation between statistical indexes of population.	3			2			1
Theme 14. Types of information, principles of forming of statistical sample (database) for analysis. Generalization of results of statistical research, meta-analysis. Analysis of qualitative parameters, modern approaches to the analysis and estimation of quality of living. Types and characteristics of questionnaires.	3	2					1
Theme 15. Gathering data for epidemiologic and clinical research. Role of official statistics in the analysis of population health, its advantages and disadvantages. European database “Health for all”. Statistical research software.	3	2					1
Total for content module 2	16	4		6			6
Preparation for the final evaluation on module 1.	2						2
Course Paper – not applicable	-			-			-
Total hours	45	10		18			17

5. Themes of Lectures

No	Themes of lectures	Number of hours
Module 1. Biostatistics
*Content module 1. Introduction to Biostatistics. Epidemiologic research and its analysis.*
1	Concept and role of Biostatistics as the basic component of the system of evidence-based medicine, history of development and value for health care.	2
2	Clinical epidemiology. Modern principles and rules of conducting clinical research. Concept of null hypothesis, principles of randomization and stratification in medical research.	2
*Content module 2. Analytical statistics.*
3	Types of information, principles of forming of statistical sample (database) for analysis. Generalization of results of statistical research, meta-analysis. Analysis of qualitative parameters, modern approaches to the analysis and estimation of quality of living. Types and characteristics of questionnaires.	2
4	Basics of biostatistics, its values in practice of health care.	2
5	Gathering data for epidemiologic and clinical research. Role of official statistics in the analysis of population health, its advantages and disadvantages. European database “Health for all”. Statistical research software.	2
Total		10

6. Themes of Seminar Classes - not applicable

7. Themes of Practical Classes

No	Theme		Number of hours
Module 1. Biostatistics
*Content module 1. Introduction to Biostatistics. Epidemiological research and its analysis.*
1.		Biostatistics and its value for estimation of population health and activity of health care institutions. Organization of statistical research in the system of health care. Relative values.	6
2.		Series of dynamics and their analysis. Direct method of index standardization. Graphic methods of analysis.	6
*Content module 2. Analytical statistics*
3.		Characteristic and analysis of statistical data. Averages and variation indexes. Parametrical and nonparametric methods of estimation and analysis of statistical hypotheses. Analysis of correlation between indexes of statistical samples.	6
Total			18

8. Themes of Labs – not applicable

9. Self-Study

No	Theme	Number of hours
Module 1. Biostatistics
*Content module 1. Introduction to Biostatistics. Epidemiological research and its analysis.*
1.	Concept and role of Biostatistics as the basic component of the system of evidence-based medicine, history of development and value for health care.	1
2.	Epidemiological studies in health care, their description and analysis. Fundamentals of Biostatistics, its importance in the practice of public health.	1
3.	Methodological basis of statistical studies in the organization of health care.	1
4.	Clinical epidemiology. Modern principles and rules of conducting clinical research. Concept of null hypothesis, principles of randomization and stratification in medical research.	1
5.	Relative values (statistical indices). Graphic methods of analysis.	1
6.	Risk factors, method of risk calculation and assessment.	1
7.	Analysis of epidemiologic research indexes, risk estimation.	1
8.	Method of standardization.	1
9.	Series of dynamics and their analysis.	1
*Content module 2. Analytical statistics*
10.	Characteristic and analysis of statistical data. Averages and variation indexes.	1
11.	Parametrical methods of estimation and analysis of statistical hypotheses.	1
12.	Nonparametrical methods of estimation and analysis of statistical hypotheses.	1
13.	Analysis of correlation between statistical indexes of population.	1
14.	Types of information, principles of forming of statistical sample (database) for analysis. Generalization of results of statistical research, meta-analysis. Analysis of qualitative parameters, modern approaches to the analysis and estimation of quality of living. Types and characteristics of questionnaires.	1
15.	Gathering data for epidemiologic and clinical research. Role of official statistics in the analysis of population health, its advantages and disadvantages. European database “Health for all”. Statistical research software.	1
Preparation for the final evaluation on module 1.		2
Total		17

10. Individual work - not applicable

11. Teaching Methods

According to sources of knowledge, the following teaching methods are used: word – narration, explanation, lecture, briefing, visual – demonstration, illustration, practical – practical work tasks.

According to the nature of the logic of knowledge, the following methods are used: analytical, synthetic, analytical-synthetic, inductive, deductive.

In terms of individual mental activity, the following methods are used: problematic, exploration, research.

12. Methods of Evaluation

Forms of Testing and Evaluation

In evaluation of students' knowledge, standardized methods of evaluation are primarily used: test (oral, written, computer-based), structured written work, structured monitoring of practical skills.

Subject grade is defined as the module grade according to the course structure.

Assessment for the module is the sum of daily grades and evaluation of the final module test and based on 200-point system.

Forms of evaluation

Daily evaluation is performed each class for specific topics. At all classes, objective evaluation of theoretical knowledge and practical skills is done.

Forms of daily evaluation:

Theoretical knowledge – tests, computer-based tests, individual surveys, interviews, written work.

Practical skills – independent individual tasks and the ability to draw conclusions on their own ability to perform certain transactions, writing schemes and algorithms. Final test is based on theoretical knowledge, practical skills and abilities.

Final test of the module takes place at the end of study of the relevant content modules in the form of a test and is considered passed if the student scored at least 50 points.

Forms of final test:

Theoretical knowledge – a system of questions for written and computer-based testing.

Practical skills and ability – using basic methods of medical statistics in conducting and evaluating biomedical researches taking into account the main provisions of evidence-based medicine, a comprehensive assessment of health in relation to social and environmental factors in determined area.

13. Distribution of points received by students

Maximum number of points assigned to students in mastering the module (test credits) – 200, including daily scores – 120 points, results of final module test – 80 points.

Evaluation of daily training:

At each stage of a practical class (practical, seminar, written test) students are assigned rating in the 12-point scale. Then arithmetic mean of the three evaluations is derived and noted in the register.

For each phase of the practical part of a class, students get points as follows:

1. At the beginning of the practical part, students must qualify for practical work (they must know the process of practical work, etc.). For this stage students can get a maximum of 2 points.

2. Practical work is monitored by the teacher and assessed at the end. Students can get a maximum of 4 points for this type of work.

3. Defense of practical work. At this stage, students can receive a maximum of 6 points.

At the end of practical part, the teacher calculated the mean of the scores for each part of the class and notes it down for each student.

DISTRIBUTION OF POINTS RECEIVED BY STUDENTS

No	Module No 1 (daily test)	Grade
1	Content Module 1
	Class 1	12
	Class 2	12
2	Content Module 2
	Class 3	12
	Average score for the class is converted into the assessment scale	120 points
Final test for Module No 1		80
Total points for Module 1		200

The minimum grade point average that qualifies a student to take final module test – 4 points.

The maximum points that can be earned by a student during module is 120 points.

Final module test:

Final module test is taken at the end of a module. Students who have completed all work stipulated by the curriculum and whose score for the module reached the minimum, qualify for the final test.

The final evaluation should be standardized and include testing in theoretical and practical training. Specific forms of evaluation for the Biostatistics are stated in the syllabus.

The maximum of final test points is 80.

The final module test is passed if a student scores at least 50 points.

Grades for the subject:

Grades for the Biostatistics are received only by students who have completed all modules in the discipline.

The number of points that a student earns for the discipline is defined as the average of points for the modules of the discipline and for the final test of Module 1.

Objectivity of assessment of students must be checked by statistical methods (correlation between the current progress and results of the final module test).

Conversion of points for Biostatistics into grades according to the ECTS scale and 4-point scale (traditional)

Number of points that a student gets for a discipline is converted into the ECTS scale as follows:

ECTS scale	Statistical index
A	Top 10% of students
B	Next 25% of students
C	Next 30% of students
D	Next 25% of students
E	Last 10% of students

Percentage of students is determined out of students of the same year of study within the same specialty.

Number of points for a discipline earned by a student is converted into 4-point scale as follows:

ECTS scale	4-point scale
A	"5"
B, C	"4"
D, E	"3"
FX, F	"2"

FX and F ("2") score for a discipline is assigned to a student who has not passed at least one module of the discipline.

FX ("2") score is assigned to students who earned the minimum number of points for daily academics, but have not passed the final module test. They have the right to repeat the final module test up to 2 times during winter break or in two (additional) weeks after the end of the spring semester schedule approved by the Rector.

Students who received an F score after completing the course (have not completed the program of at least one module or have not earned the minimum number of points in the current module) must undergo re-training according to the individual curriculum.

Grading scale: national and ECTS

Total points for all kinds of learning activities	ECTS score	Evaluation on the national scale
Total points for all kinds of learning activities	ECTS score	for examination, course project, practice	for credit
	A	excellent	passed
	B	good
	C	good
	D	satisfactory
	E	satisfactory
	FX	failed, allowed to re-take	failed, allowed to re-take
	F	failed, with mandatory re-training	failed, with mandatory re-training

14. Methodological Support

1. Materials for the practical classes

2. Materials for the lectures.

3. Presentations of lectures.

4. Guides for practical classes.

5. Tasks for self-study and individual work of students.

6. Tests for the final evaluation.

7. Tests for daily evaluation.

8. Variants of theoretical questions for self-study.

15. Suggested Reading

Basic

1. Holyachenko, A. Shulhai, O. Nykytyuk. Social medicine and health protection organizations. – Ternopil, “Ukrmedknyga”, 2004. – 171 p.

2. A. Indrayan. Medical Biostatistics, Third Edition. – Chapman & Hall/CRC Press, 2012. – 1008 p.

3. Fundamentals of Biostatistics (7th Edition). – English, 2010. – 891 p.

4. Michael J. Campbell, David Machin, Stephen J. Walters. Medical Statistics: A Textbook for the Health Sciences, 4th Edition. – Paperback, 2006. – 344 p.

5. Frank Emmert-Streib and Matthias Dehmer. Medical Biostatistics for Complex Diseases". – Wiley-Blackwell, 2010. – 412 p.

6. Michael R. Chernick. The Essentials of Biostatistics for Physicians, Nurses, and Clinicians. – Wiley, 2011. – 538 p.

Additional

1. Shein-Chung Chow. Controversial Statistical Issues in Clinical Trials (Chapman & Hall/CRC Biostatistics Series). – Chapman and Hall/CRC, 2011. – 611 p.

2. Peter Armitage, Theodore Colton. Encyclopedia of Biostatistics: 8-Volume. –John Wiley & Sons, 2005. – 6100 p.

3. Gerald van Belle, Patrick J. Heagerty. Biostatistics: A Methodology for the Health Sciences (Wiley Series in Probability and Statistics). –Wiley-Interscience; 2 edition, English, 2004. – 888 p.

4. Riccardo Rizzo. Computational Intelligence Methods for Bioinformatics and Biostatistics: 7th International Meeting. – Palermo, Italy, CIBIB, 2011. 301 p.

5. Robert C. Elston, William Johnson. Basic Biostatistics for Geneticists and Epidemiologists: A Practical Approach. – Wiley, 2008. – 384 p.

6. Steve Selvin. Survival Analysis for Epidemiologic and Medical Research (Practical Guides to Biostatistics and Epidemiology) – Cambridge University Press, 2008. – 296 p.

16. Information Resources

1. B. Burt Gerstman. Basic Biostatistics: Statistics for Public Health Practice. ‒ Jones & Bartlett Learning, 2008. – 557 p.

2. Bernard A. Rosner. Fundamentals of Biostatistics. - Cengage Learning, 2006. – 868 p.

3. Practical classes materials.

4. Lecture materials.

Name of indicators	Branch of knowledge, direction of training, educational qualification level	Characteristics of the discipline
Name of indicators		full-time education
Number of credits – 1,5	field of knowledge ____1201 Medicine___ (code and name)	Normative
Number of credits – 1,5		Normative
Modules – 1	Specialty: 7.12010001 "General Medicine"	Year of study
Content Modules– 2		4-th
		Term
Total number of hours – 45		7-th
Total number of hours – 45		Lectures
Weekly hours for the full-time study: auditorium hours – 1,4 Individual work of students – 0,85	Educational qualification level: specialist	10 hours
		Practical classes
		18 hours
		Laboratory classes
		–
		Individual work
		17 hours
		Individual tasks:
		–
		Type of evaluation:
		Test control module

On Biostatistics

Syllabus on biostatistics for students

Preparation for the final evaluation on module 1.

Course Paper – not applicable

Total hours