10 September - 26 October 2018

Lectures, tutorials and practicals are planned on Fridays.


This module will focus on experimental research in human beings outside the laboratory.

Course coordinator

Carolien Bastiaenen, PhD, Department of Epidemiology
T: +31 (0)43-3882195




Regular master’s fee or €1460 (non-master student)


EPI4922 - Intervention Research in Health Care

The umbrella term ‘intervention study’ refers to those study designs in which one or more independent variables are manipulated by the investigator, whereas the other independent variables are kept constant or controlled at the same time. This ‘experimental’ approach is regarded the most powerful study design for discovering causal relationships and can be the sturdiest ways of doing research, however, has many ethical and design issues to be taken into account. This module will focus on experimental research in human beings outside the laboratory. ‘Clinical trial’ is a common name to indicate this type of experiments especially as it is often used to assess the efficacy and effectiveness of a new treatment for patients.

A well designed, methodologically sound RCT evaluating an intervention can provide strong evidence of a cause-effect relation if one exists. These studies are often used to chance practice and taken up in guidelines, being the ultimate goal of research on therapeutic effectiveness. On the other hand, poorly designed studies are dangerous because of their potential to influence practice based on flawed methodology. Students will learn how to assess quality of different study designs (parallel group design, cross-over design, non-inferiority and n-of-1 designs).

As there are many potential errors associated with health services research, this module will focus on various key features of RCT design, with particular emphasis on design, validity and data-analysis.

There are various aspects to remember when constructing an RCT and many of the issues involved will be discussed in lectures, through practical and discussion groups: design options, issues in good clinical practice such as informed consent, blinding, issues in multicenter trials, power calculation and randomization, missing values and data-analyses in general. Furthermore, participants will learn to assess the publications of clinical trials.

The module is a 8 week course (one day a week; Friday), which is open for external participants as well (e.g., PhD students). The module ends with an open-ended questions exam.