Ateneo - UPO

Scientific articles and teaching materials provided in class and available on the DIR platform

Knowledge of the distinctive features of randomized controlled clinical trials and meta-analyses, of the statistical methods for data analysis, and of the methods for evaluating diagnostic test performance. Understanding of the results reported in scientific articles concerning the topics covered in class.

For the EBM and Statistics for EBM modules, a qualifying exam ("esonero") is scheduled in June and July, approximately one week before the Medical Pathology III exam, and subsequently one in September and one in January. In September and January, two exam sessions of Medical Pathology III are scheduled; however, the qualifying exam will be held only once and will be valid for both sessions. The grade obtained will remain valid for all subsequent exam sessions. It will not be possible to take the oral exam of Medical Pathology III without having passed the qualifying exam.
The EBM exam consists of a written test with 2 open questions on the group project. The questions concern the methods, tools used, and results of the group project.
The Statistics for EBM exam consists of 5 multiple-choice questions on the evaluation of diagnostic test performance, and 2 open questions requiring comments on the results reported in a meta-analysis and in one of the trials identified by the instructor and made available on DIR at the end of the course. Specifically, a figure or table from a trial and a meta-analysis (selected from those proposed) will be provided, and students will be asked to comment on the reported results.
The instructors will assign a single grade based on the integrated results of the two modules. A passing grade will be achieved if the student demonstrates a correct, even if essential, understanding of the key concepts (methods and tools of EBM used in the group project; basic interpretation of statistical parameters and of trial/meta-analysis results for Statistics for EBM), without major conceptual errors. Excellence will be achieved if the student demonstrates complete and critical mastery of the tools and methods, the ability to conduct in-depth analysis of the results and their clinical implications, and rigorous and precise use of technical and scientific terminology.

Randomized Controlled Trials (RCTs): study design, randomization methods, analysis approaches (intention-to-treat, per-protocol, as-treated), study objectives (superiority, non-inferiority, and equivalence trials), bias (selection, performance, detection, and attrition bias) and methods to avoid them. Frequency measures for the occurrence of dichotomous outcomes (risk, incidence, and prevalence), measures of association and impact, tests for comparing means, survival analysis (Kaplan-Meier method for risk estimation, survival curves, log-rank test, Cox proportional hazards model).
Meta-analysis: defining the research question, defining the literature search strategy, defining inclusion and exclusion criteria, quality assessment of included studies (RoB2 scale for RCTs), data extraction and analysis (calculation of fixed-effect and random-effects meta-analytic estimates and assessment of heterogeneity between studies, Cochrane's Q test, I² index), assessment of sources of variability and robustness of results (subgroup/stratified analysis to identify sources of heterogeneity, influence analysis, publication bias). Overview of network meta-analysis.
Evaluation of diagnostic test performance: definitions of sensitivity, specificity, positive and negative predictive value, accuracy and confidence intervals, serial testing, parallel testing, ROC curve, criteria for determining the optimal cut-off, area under the curve (AUC).

Knowledge: By the end of the course, students will be familiar with the main characteristics of randomized controlled trials and meta-analyses, the main analysis and sensitivity analysis methods, as well as the main techniques for evaluating the performance of diagnostic tests with dichotomous and continuous outcomes.
Competence: By the end of the course, students will be able to interpret the results of scientific articles related to randomized controlled trials/meta-analyses based on the data reported in tables and figures. They will also be able to assess whether a diagnostic test is adequate for identifying a given condition.
Transversal skills: By the end of the course, students will be able to critically read a scientific article and draw conclusions regarding the potential treatment of future patients based on the evidence of efficacy available in the scientific literature.