Course catalogue doctoral education - VT24

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Title Study design in clinical research
Course number 1794
Programme 0-Not part of doctoral programme
Language English
Credits 4.0
Date 2014-03-03 -- 2014-03-21
Responsible KI department Department of Molecular Medicine and Surgery
Specific entry requirements
Intended learning outcomes After completion of the course the students should be able to:
1) Independently plan and produce a study protocol including a thorough methodological evaluation and choice of appropriate study design.
2) Critically reflect on other students individual project work in a scientifically constructive way.
3) Interpret and critically evaluate scientific studies relevant to the course content.

Contents of the course The course is designed for PhD-students, in particular those who are at an early stage of their research education, and those with an interest in conducting clinical research. The content of the course is as follows: 1) Basic terms in epidemiology and clinical study design, 2) Measures of disease occurrence and incidence, causality, 3) Observational studies- cohort and case-control studies, 4) Systematic and random errors, 5) Experimental studies, randomised clinical trials, 6) Quality of life in clinical research, 7) Examination and course evaluation. Throughout the course, the students will work on an individual project (examination 1) for peer-review (examination 2). Further, students will critically review and discuss relevant scientific articles (examination 3).
Teaching and learning activities Lectures, seminars, individual article review, group discussions and homework tasks will be used. The course focuses on active learning, i.e. putting knowledge into practice and critically reflecting upon the knowledge, rather than memorising facts. Therefore, much of the focus of the course is on the individual project where students are required to develop a full study protocol including several important aspects covered in the lectures, article reviews and group discussions. Students will also peer-review eachothers projects and this will form the basis for the final examination seminar.
Compulsory elements Compulsory attendance includes the scheduled lectures and seminars. Absence will need to be replaced by individual assignments following discussion with the course co-ordinator, e.g. article reviews, with written or oral follow-up.
Examination To pass the course the student must actively participate in the course and pass the examinations: 1) Individual project work: To develop a written comprehensive yet concise study protocol including several important aspects study design as discussed during the course; 2) Peer-review of other students projects followed by oral presentation own project and opposition of other students projects during the group examination; 3) Critically review scientific articles relevant to the course content and participate actively in the seminars.
Literature and other teaching material Mandatory: Kenneth J Rothman ""Epidemiology -an introduction"" (2012) Oxford University Press, USA.
Scientific articles (handed out during course).
Number of students 20 - 25
Selection of students Preference will be given to students early on in their PhD education, who have a clinical research focus, and where the benefits of this course will be greatest. Date of registration as a PhD student, suitability of PhD project, and the motivation to attend the course given will be used in the selection process.
More information The course will take place during a 3-week period, at Eugeniahemmet, Karolinska University Hospital, Solna. The majority of lectures and seminars are scheduled during the first week. There is one mandatory seminar during the second week. The oral exam will take place at the end of the third week. Between lectures and seminars, the students are expected to work on their individual projects which will be examined at the end of the course. As the course entails 4 HEC, it requires 2,5 weeks of full-time work. Lecturers are researchers active in the unit of Upper Gastrointestinal Research, directed by Professor Jesper Lagergren. The course is targeted at PhD students with an interest in clinical epidemiological research. The course focuses on observational clinical research and clinical trials. Scientific articles included focus on gastroenterological and surgical research but the main focus remains on the advantages and disadvantages of different study designs. Emphasis is on the application of knowledge gained during the course to the student's own research and planned studies.
Additional course leader
Latest course evaluation Course evaluation report
Course responsible Nele Brusselaers
Department of Microbiology, Tumor and Cell Biology
0761516212
nele.brusselaers@ki.se

CTMR - Nobelsvag 16 - KISolna

17177
Stockholm
Contact person Ulrika Eriksson
Institutionen för molekylär medicin och kirurgi
08-517 709 58
Ulrika.Eriksson.3@ki.se