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 EBM and Statistics for EBM modules, a preliminary test (exemption) is scheduled for June and July—approximately one week before the Medical Pathology III exam—followed by one session in September and one session in January. Although there are two exam dates for Medical Pathology III in both September and January, the preliminary test is a
single event valid for both dates within the session. The grade obtained remains valid for all subsequent exam sessions. Students cannot take the Medical Pathology III exam without first passing the EBM/Stat for EBM preliminary test.
The EBM exam consists of a written test featuring two open-ended questions based on the group project. These questions cover the methods, tools used, and results of the group work.
The Statistics for EBM exam consists of five multiple-choice questions regarding the performance evaluation of diagnostic tests, and two open-ended questions requiring comment and interpretation on results from a meta-analysis and a trial (selected and made available on the DIR platform at the end of the course). Specifically, students will be provided with a figure or table from one trial and one meta-analysis and asked to comment on the reported results.
It will be determined a single grade based on the combined results of the two modules. A passing grade is achieved if the student demonstrates a correct—albeit fundamental—understanding of key concepts (EBM methods and tools used in the group project; basic interpretation of statistical parameters and results from trials/meta-analyses for the statistics module) without serious conceptual errors. Excellence is achieved if the student demonstrates complete, critical mastery of the tools and methods, the ability to
conduct an in-depth analysis of results and their clinical implications, and a rigorous, 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.