Syllabus database for doctoral courses

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SYLLABI FOR DOCTORAL COURSES

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Swedish title Studiedesign vid klinisk forskning
English title Study Design in Clinical Research
Course number 2980
Credits 3.0
Responsible KI department Institutionen för molekylär medicin och kirurgi
Specific entry requirements
Grading Passed /Not passed
Established by The Committee for Doctoral Education
Established 2023-02-22
Purpose of the course The purpose of the course is to present an overview over study designs employed in clinical research, to explain why and how to write a study protocol, and to critically reflect on protocols’ content.
The course is ideal for doctoral students that are going to conduct clinical research.
Intended learning outcomes At the end 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 1) Basic terms in epidemiology and clinical study design; 2) Measures of disease occurrence; 3) Observational studies, including cohort and case-control studies; 4) Systematic and random errors; 5) Experimental studies, including randomised clinical trials; 6) Quality of life in clinical research; 7) Screening and diagnosis in relation to clinical research. Throughout the course the students will work on an individual project (examination 1) for peer-review (examination 2) and the students will critically review and discuss relevant scientific articles (examination 3).
Teaching and learning activities Lectures, individual article review, group discussions, and homework tasks. 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 peer-review each other's projects during the examination.
Compulsory elements Compulsory attendance includes the scheduled lectures and seminars all held during the first week of the course. 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 1) Individual project work: Develop a written comprehensive yet concise study protocol including several important aspects of study design discussed during the course; 2) Peer-review of other students' projects followed by oral presentation of their project and opposition of other students projects during the group examination; 3) Critically review scientific articles relevant to the course content and participate actively to the discussions. To pass the course the student should show that all intended learning outcomes have been reached.
Literature and other teaching material Mandatory:
Kenneth J Rothman ""Epidemiology -an introduction"" (2012) Oxford University Press, USA.
Scientific articles (handed out during course).

Recommended:
Fayers PM, Machin D. Quality of life: the assessment, analysis and reporting of patient-reported outcomes. John Wiley & Sons; 2015 Nov 23.
Course responsible Giola Santoni
Institutionen för molekylär medicin och kirurgi


giola.santoni@ki.se

Contact person Kalle Mälberg
Institutionen för molekylär medicin och kirurgi


kalle.malberg@ki.se