No.

Themes

Educational Objectives (required concepts & skills)

To validate this course, students should be able to:

1

Introduction. Importance of Medical Research Methodology. Variability.

Motivate and explain the need to study and understand the proper design and implementation of medical studies, as well as the rules of medical writing and proper dissemination of research results, in their future positions as research “producers” (graduation thesis researcher)  and research “consumers” (medical practitioners). Define medical information, medical data and its processing (medical informatics). Define biological variability and medical variables. Classify medical variables by type. Exemplify the types of medical variables. Recognize the types of medical variables in specific cases. Explain ways of collecting accurate medical information and coding it as medical data. Explain correct ways of presenting and measuring medical data (measurement scales) and their interpretation as medical information. Collect and encode medical information correctly (transforms information to data properly). Correctly present medical data (reconstruct information from data properly).

2

Sequences (phases) of medical research.

Bibliographic documentation.

Explain the sequences (stages/phases) of medical research. Explain the utility of bibliographic documentation in medical research and medical practice. Explain the stages of research in which bibliographic documentation is necessary. Exemplify commonly used bibliographic medical databases. Define and applies bibliographic search strategies using the PICO technique for specific situations. Use the computer for bibliographic documentation: applies bibliographic search strategies using the PICO technique in PubMed (MEDLINE). Formulate appropriate research questions. Associate correct hypotheses to relevant research questions. Applies search strategies to identify medical sources in the UMF Cluj Library. Choose relevant literature for specific research questions. List the components of a bibliographic catalog. Create a correct bibliographic catalog in electronic format on a given research question. Explain the utility of references in research. Explain and applies the Vancouver referencing system for different types of medical text (original article, book, etc.). Correctly write various types of references according to Vancouver system.

3

Sequences (phases) of medical research. The research protocol. Study variables. Types of research. Research Team.

Formulate the sequences (phases) of a medical study. Names and explains the composing parts of a medical research protocol /plan. Identify the components of the research protocol for specific research scenarios. Name and explain the types of data collection in medical studies. Name and explain the kinds of sampling (probabilistic and non-probabilistic) in medical studies. Formulate the goal and objectives for specific research scenarios. Formulate hypotheses for specific research scenarios. Correctly recognize the domain of clinical research. Recognizes and classifies medical studies by type (depending on the objectives and expected results). Correctly define the target population and accessible population of a medical study. Correctly formulate inclusion and exclusion criteria for a study sample in a given research scenario. Correctly identify the type of data collection for a given research scenario. List the methods for describing different types of variables in specific medical studies (through tables, graphs and descriptive statistics). Correctly apply methods for describing different types of variables in specific medical studies using statistical software (tables, graphs and descriptive statistics). Explain the meaning of descriptive results of concrete medical studies (tables, graphs and descriptive statistics). List correct methods of data analysis for different variable types in concrete medical studies (statistical tests, correlation, regression models, statistical and medical indicators). Apply correct methods of data analysis for different variable types in concrete medical studies using statistical software (statistical tests, correlation, regression models, statistical and medical indicators). Explain the meaning of specific analytical results of medical studies (tests, correlation, regression models, statistical and medical indicators).

4

Descriptive studies.

Studies evaluating prognostic factors of diseases.

Explain descriptive studies as sources of new hypotheses. Explains descriptive research questions, as opposed to analytic research questions.

Define the assessment (evaluation) studies of prognostic factors (involved in different pathologies). Explain different types of evaluation studies of prognostic factors. Explain the methodology of evaluation studies of prognostic factors. Construct contingency tables based on data from specific research scenarios of prognostic factors, or based on data files. Test the existence of links between prognostic factors and diseases. Calculate medical/health indicators to quantify the importance of links between prognostic factors and illnesses. Evaluates the existence of a causal link between the presence of prognostic factors and the development of diseases of interest. Choose and justifies suitable medical indicators for quantifying the relationship between prognostic factors and diseases. Statistically interpret medical indicators used to quantify the relationship between prognostic factors and diseases (point estimates and their 95% confidence intervals). Clinically interpret medical indicators used to quantify the relationship between prognostic factors and diseases (point estimates and their 95% confidence intervals). Assess the precision and clinical importance of these results. Discriminate between precision and accuracy / validity of results.

5

Studies evaluating diagnostic methods / tests.

Define assessment studies of diagnostic tests. Explain the four phases in the evaluation of diagnostic tests. Explain the methodology for studies evaluating diagnostic tests. Construct contingency tables based on data from specific research scenarios of diagnostic tests, or based on data files. Test the existence of links between the results of compared diagnostic tests. Calculate medical indicators to quantify the qualities of diagnostic tests. Choose and justifies suitable medical indicators for measuring the qualities of diagnostic tests (screening /confirmation). Statistically interpret medical indicators used to quantify the qualities of diagnostic tests (point estimates and their 95% confidence intervals). Clinically interpret medical indicators used to quantify the qualities of diagnostic tests (point estimates and their 95% confidence intervals).  Assess the precision and clinical importance of these results. Discriminate between precision and accuracy / validity of results.

6

Studies evaluating therapeutic approaches / treatment options.

Define assessment studies of treatment options. Explains different approaches in the evaluation of treatment options. Explain possible methodological approaches of experimental evaluation studies of therapeutic approaches (types of Clinical trials, Phases I, II, III, IV). Construct contingency tables based on data from specific research scenarios of clinical trials, or based on data files. Test the existence of links between the assessed therapeutic factors and the experimental events defined in the study; assessing the existence of a causal link between them. Calculate medical indicators to quantify therapeutic efficacy/safety. Choose and justifies suitable medical indicators for measuring therapeutic efficacy/safety. Statistically interpret medical indicators used to quantify therapeutic efficacy/safety (point estimates and their 95% confidence intervals). Clinically interpret medical indicators used to quantify therapeutic efficacy/safety (point estimates and their 95% confidence intervals).  Assesses the precision and clinical importance of these results. Discriminate between precision and accuracy / validity of results.

7

Survival analysis studies

Define survival studies (time to event studies). Explain the main characteristics of survival variables. Explain the methodology of survival studies. Test the existence of links between prognostic factors and time/probability of survival. Calculate medical indicators to quantify the importance of links between prognostic factors and time/probability of survival. Choose and justify suitable medical indicators used to quantify the importance of links between prognostic factors and time/probability of survival. Statistically interpret medical indicators used to quantify the importance of links between prognostic factors and time/probability of survival (point estimates and their 95% confidence intervals). Clinically interpret medical indicators used to quantify the importance of links between prognostic factors and time/probability of survival (point estimates and their 95% confidence intervals). Assess the precision and clinical importance of these results. Discriminate between precision and accuracy / validity of results.

8

Validity of the study. Evidence cutting errors in medical studies

The student:

Defines random errors. Defines systematic errors (bias). Defines and exemplifies confounders. Classifies and defines the main types of selection bias.  Explains methods that can be used to prevent / reduce / control selection bias. Classifies and defines the main types of observation / information bias.  Explains methods that can be used to prevent / reduce / control observation / information bias.

Classifies and defines the main types of analysis bias.  Explains methods that can be used to prevent / reduce / control analysis bias. Explains methods that can be used to prevent / reduce / control confounders. Explains and distinguishes between precision and accuracy of research results. Explains and distinguishes between validity and relevance of research results. Recognizes different types of bias in specific scenarios of medical studies. Explains the influence of different types of bias on study results in specific scenarios of medical studies. Recognizes confounders in specific scenarios of medical studies. Explains the influence of confounders on study results in specific scenarios of medical studies.

9

Evidence-based medicine (EBM)

Defines evidence-based medicine (EBM) and evidence-based research. Classifies types of studies in the hierarchy of evidence for the diagnostic, prognostic, prophylactic, therapeutic domains of research. Explains the criteria for assessing the validity of studies in the diagnostic, prognostic, prophylactic, therapeutic domains. Explains the relevance of study results in medical practice and medical research. Critically appraises evidence from literature on concrete examples of medical studies (risk or protective factors, diagnostic tests, therapeutic approaches). Critically appraises evidence from systematic reviews on concrete examples. Ranks literature search results (from PubMed) by the type of studies, according to the hierarchy evidence for each domain of clinical research: prognostic, diagnostic, therapy. Explains in medical terms (for peers) and critically assesses scientific results found in literature. Explains in lay terms (for patients) scientific results found in literature.

10

Meta-analysis

Defines the systematic review and meta-analysis. Explains the methodology for a systematic review with or without meta-analysis. Explains the problem of effect size. Explains the forest plot. Decides and justifies suitable indicators for meta-analysis of different types of tracked results (dichotomous, quantitative, survival). Statistically interprets a forest plot diagram (point estimate and 95% confidence interval). Clinically interprets the results of a meta-analysis (point estimate and 95% confidence interval). Evaluates the precision and validity of results of a meta-analysis.

11

Choosing statistical methods

Defines statistical tests. Explains point estimates and confidence intervals. Explains the benefits offered by confidence intervals over the results of statistical tests. Names the factors which determine the choice of statistical methods. Formulates the null and alternative hypotheses of a statistical test for specific scenarios of medical research. Identifies appropriate statistical methods to compare independent groups in specific situations of medical research. Identifies appropriate statistical methods for comparisons of dependent (paired) groups in specific situations of medical research. Identifies appropriate statistical methods to assess the relationship between two or more variables for specific situations of medical research.

12

Medical writing and communicating research results

Lists and describes the main types of medical scientific publications. Lists and explains the objectives and qualities of scientific medical writing. Lists and explains the principles of medical scientific writing. Describes the structure and chapters of a graduation thesis in medicine. Indicates and explains the content for each chapter of a graduation thesis in medicine. Describes the structure and chapters of an original research article in medicine. Indicates and explains the content for each chapter of an original research article in medicine. Explains the structure, content and drafting rules of an oral communication in support of medical research (article or graduation thesis). Explains the structure, content and drafting rules of a poster presentation. Explains and discusses the ethical principles governing scientific medical writing. Critically appraises in terms of structure and content an article or article fragment offered for reading and critical evaluation. Chooses the appropriate type of graphics for presentation of results according to the type and nature of the distribution of the data (pie charts, column charts, box and whiskers, histograms, scatter, Kaplan-Meier survival curves). Explains and applies the rules of correct scientific writing of research results in the form of text, tables and graphs. Produces the slides for an oral presentation of an article or thesis according to the rules of scientific medical writing.

13

Research Ethics

Lists important phases in the historical evolution of medical research ethics. Lists important declarations of ethical standards in medical research. Lists the composition and duties of a medical research ethics committee (REC). Lists the ethical principles that govern medical research. Explains and discusses the ethical principles that govern medical research. Lists and explains the kinds of fraud and misconduct in medical research and publication. Lists regulatory bodies in medical research and publication ethics and their specific tasks. Identifies and explains the need to apply ethical principles in the context of different types of concrete medical studies. Specifies procedures for applying ethical principles in the context of concrete medical research projects.

14

Regression analysis and modelling in medical research

Defines modeling and simulation in research and explains their purpose. Exemplifies models in various fields of medical research. Evaluates correlation between quantitative variables using correlation coefficients and scatter charts. Explains and interprets models by simple and multiple linear and logistic regressions.