Studiegids

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Clinical Research in Practice

Vak 2018-2019

Admission requirements

The student:
* Knows relevant research methodologies.
* Understands (dis)advantage of different study designs.
* Applies concepts, based on examples of studies, and formulate the results as well as the assumptions upon which results and evaluations are based.
* Is able to advise a (in retrospective or pro perspective) study design.
* Is able to align methodology to research question and context after having critically evaluated conducted studies.
* Is able to critically assess statistical methodology in clinical application.

Description

Period: 24 September 2018 - 19 October 2018

In previous courses on epidemiology, data management, or (bio)statistics, you may have studied these subjects more or less as – stand alone – disciplines.
In practice however, research is only possible through strong interdisciplinary collaboration. This means that researchers must be able to combine and exploit knowledge across disciplines when formulating research questions based on a clinical problem, discussing and evaluating appropriate study designs, proposing the data collection and storage procedures and discussing the epidemiological and statistical analysis procedures which are appropriate. For these reasons, we will discuss in this course the practical problem of scientific research design and methods. We will start the course with the discussion of a real-life example in clinical scientific research. From this discussion,we will evaluate through a joint discussion which problems may be encountered when carrying out research and what the appropriate options are for study design and analysis. The focus of the course is thus on the interdisciplinary aspects of applied research and how epidemiology, data management and (bio)statistics work together to help us solve practical research questions.

Course objectives

• You are able to design a study based on a clinical scientific problem, and understand the connection between epidemiological methodology, database design and management and concepts of statistical data analysis of clinical research questions.
• You are able to discuss and evaluate the concepts and methods based on specific and precisely defined questions in clinical scientific research.
• You can apply Directed Acyclic Graphs in the critical appraisals of study designs and for the causal interpretation of research findings.
• You recognize the limitations of using crude epidemiological concepts such as relative risk and odds ratio, and know how to adjust these using statistical methods such as logistic regression and survival analysis.
• You are able to apply these concepts, and formulate the results as well as the assumptions upon which results and evaluations are based.
• You are able to apply these principles to your own study protocol.

Timetable

All course and group schedules are published on our LUMC scheduling website or on the LUMC scheduling app.

Mode of instruction

Lectures, workgroups, (computer) practical sessions, self study exercises.

Assessment method

Summative assessment:
* Written test (open book) with open questions

The exam dates can be found on the schedule website.

Blackboard

Blackboard will be used during this course.

Reading list

An up-to-date working version of tThe programme SPSS has to be acquired from Surfspot: https://www.surfspot.nl/software.html.
The following is a list of English text books which are suitable for study. The course book contains an extended list of Dutch course texts as well, which may be used by students instead of the texts below.

• Epidemiology. An introduction. K.J. Rothman. 2002, New York, Oxford University Press, ISBN 0-19-513554-7 (Alternative English book)
• Epidemiology, beyond the basics. M. Szklo, F.J. Nieto. 2004, Sudbury Massachusetts, Jones and Bartlett Publishers, ISBN 0-7637-4722-X (for optional further reading)
• Medical Statistics at a Glance. Aviva Petrie and Caroline Sabin, Blackwell Science, 200

Registration

Registration for FOS courses, H2W, Scientific Conduct, How to start, Course on Animal Science , and CRiP and Adv concepts courses takes place in lottery rounds in the beginning of July. After the lottery rounds: if you want to register for a course you are kindly asked to contact the student administration at masterbw-courses@lumc.nl.

Contact

masterbms-courses@lumc.nl