Clinical Research Fundamentals

Recommended Prerequisites

Not applicable.

Teaching Methods

This course offers theoretical-practical classes during which basic concepts necessary for the development of clinical research projects are presented. Simultaneously, the student has the opportunity to participate in the analysis and discussion of specific cases of clinical research.

Assessment: Midterm exam – 30%; Test – 30%; Problem solving report: 40%.

Learning Outcomes

The objective of this Course is to provide students with basic concepts and competencies required to understand the specificities, fundamentals and dynamics of the clinical research process. The course will tackle two main areas: 1) Systematic Review and Meta-analyses and 2) Observational Research - Methods and Analyses.

Work Placement(s)

No

Syllabus

Systematic Review, Fundamentals, The Cochrane Collaboration

PICO approach

Preparing a protocol of a systematic review

Searching the literature (I): PubMed

Searching the literature (II): Embase, and others

Bibliographic management. Selection of Studies

Collection & synthesis: Data collection forms. Evidence tables

Meta-analysis. Principles.

Meta-analysis and meta-regression. Examples with Stata

How to write an article on a systematic review

Critical appraisal of systematic reviews

Fundamentals of observational research

Research question

Preparing the protocol of an observational study

Basic designs

Selection of subjects

Measures and variables in observational designs

Analysis plan

Analysis of case control studies

Analysis of longitudinal studies

How to write an article on an observational study

Critical appraisal of observational studies.

Head Lecturer(s)

José António Pereira Silva

Assessment Methods

Assessment
Frequency: 30.0%
Mini Tests: 30.0%
Resolution Problems: 40.0%

Bibliography

_Higgins, J.P.T., Thomas, J., Chandler, J., Cumpston, M., Li, T., Page, M.J., & Welch, V. A. (editors) (2021). Cochrane

Handbook for Systematic Reviews of Interventions version 6.2. (updated February 2021). Cochrane, 2021.

www.training.cochrane.org/handbook.

_Santos, E.J., & Cunha, M. (2021). Revisão sistemática da literatura com meta-análise: Um guia prático para iniciantes.

Edicioes esgotadas.

_Greenhalgh T (2019). How to Read a Paper: The Basics of Evidence-based Medicine and Healthcare, 6th Edition. Willey-

Blackwell. Oxford ISBN 978-1-119-48474-5

_Apóstolo, J. (2017). Síntese da evidência no contexto da translação da ciência. Coimbra, Portugal: ESEnfC

_Hulley, S.B., Cummings, S.R., Browner, W.S., Grady, D.G., & Newman, T.B. (2013). Designing Clinical Research.

Philadelphia: Lippincott Williams & Wilkins.