| Title: |
Experimental Epidemiology (online) |
| Keywords: |
Statistics (incl.. risk assessment)
Research method
Quantitative methods
Planning and programming (incl.. budgeting and evaluation)
Epidemiology
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| Country: |
Norway
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| Institution: |
Norway - Centre for International Health, Universitetet i Bergen
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| Course coordinator: |
Thorkild Tylleskär
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| Date start: |
2021-02-01 |
| Date end: |
2021-02-26 |
| About duration and dates: |
4 weeks in total: 1-week self-study: 2021-02-01 to 2021-02-07 3-weeks interactive course: 2021-02-08 to 2021-02-26 |
| Classification: |
advanced optional
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| Mode of delivery: |
Distance-based
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| ECTS credit points: |
5 ECTS credits
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SIT:
1+3 weeks, 150 hours:
Self-study week:
• Video-based instructions to the course, successful log-on to learning platform and self-presentation on the platform, successful download of course literature and statistical software, video-based basic introduction to statistical software and pre-reading of introductory material: 20 hours
3 weeks online teaching (130 hours) including:
• Asynchronous studies of web-based lectures (videos, annotated PowerPoint presentations and exercises/quizzes): 50 hours
• Synchronous, moderated web-based sessions including Q&A using chat and plenum discussions and group work using breakout rooms: 20 hours
• Online group work: 20 hours
• Individual studies and reading during the course: 40 hours |
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| Language: |
English
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Description:
At the end of the module the student should be able to:
• Demonstrate understanding of the principles of clinical and field trials,
• Plan clinical and field trails in accordance with the EU Directive 2001/20/EC on Good Clinical Practice and the highest ethical principles, including those reflected in Article 6 of the Treaty on the European Union, in the Charter of Fundamental Rights of the European Union and the Council of Europa’s Convention on Human Rights and Biomedicine
• Assess and select relevant designs for clinical/field trials,
• For both individually and community-randomized trials, conduct:
- sample size estimations
- random allocation
- blinding/masking
• Analyse clinical and field trial data-sets, also from community-randomised trials |
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Assessment Procedures:
Mandatory participation in group work prior to exam.
A 2-hour written exam online, consisting of short questions and problem-solving questions and calculations (60% of the grade). In addition, an oral zoom-based face-to-face exam of 20 minutes (40% of the grade).
The oral assessment makes it possible to ensure that the student presents his/hers knowledge.
ECTS Grading scale: A-F (F=fail)
If the student fails the exam, he/she can resit for exam in the same semester. If the student fails a second time, he/she will be advised to participate in the course one more time in the next year and have a new exam afterwards |
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Content:
This course addresses critical methodological aspects of clinical and field trials and a special effort is made to address trials that will measure the impact of relevant interventions against poverty related diseases in low-resource settings.
The lectures in the course cover the following: General principles of field trials, literature review: what & how to read, randomisation & blinding, review of basic statistics (Mean, SD, SE, 95%CI), proportions, 2 x 2 tables, trial size for adequate precision and power, cluster design, data management and study implementation, interaction & confounding, effect measures (risk ratio, rate ratio, difference in means), relative risk reduction, measurement: validity & reproducibility, analysis plan, data exploration, baseline comparison, main effects, analysis of community-based studies, hypothesis tests & precision of effect, analysis of repeated outcomes, data collection (questionnaire design, field organisation, training & standardisation) & quality control, good clinical practice (GCP), interpretation of negative trials and ethical aspects of clinical trials in low-income countries.
The group work covers a) the analysis of a published trial, b) the development of proposal and protocol, the structure of baseline and main effect tables, randomisation & blinding.
The computer laboratory exercises include generating random numbers, calculating trial size, importing files, data exploration, baseline comparisons, main effects, adjustment for confounding, adjustment for confounding, sub-group analysis and interaction. |
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Methods:
Self-study week: video-based instructions to the course, successful log-on to learning platform and self-presentation on the platform, successful download of course literature and statistical software, video-based basic introduction to statistical software and pre-reading of introductory material: 20 hours
Interactive part of the course: Daily sessions for 2.5 weeks, 2 days reading for exam and 1 day for the exam. Each day has a mixture of asynchronous online lectures (videos and annotated PowerPoint presentations and synchronous moderated sessions including group work and computer exercise sessions). The course includes group work on specific topics as well as literature review
All course material is available on the University’s learning platform called “Mitt UiB”, a Canvas-based platform |
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Prerequisites:
Students admitted to a Master’s degree Programme may join this course (e.g. tropEd Europe network)
Proficiency in English at a level corresponding to TOEFL score of at least 550 points paper-based or 213 points computer-based, or an equivalent approved test
Completed a course in Basic introduction to Methods in Global Health Research |
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Attendance:
Minimum number of students: 10, maximum number of students: 50 (max number of tropEd students: 20) |
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Selection:
The selection will be based on documented skills in epidemiology and biostatistics.
Priority:
Master students in Global Health enrolled at the University of Bergen and Master students from institutions within tropEd will be registered before others. |
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Scholarships:
None available from the University of Bergen |
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Major changes since initial accreditation:
This is an online course with the same content as the previously accredited course Experimental epidemiology, but has not been run yet |
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tropEd accreditation:
This is a new course – online version -, but has the same content as an on campus course which was:
Accredited in Copenhagen 2003, Re-accreditation in Edinburgh, September 2004. Re-accreditation in London, September 2009 and in October 2011. Re-accredited in January 2017. This accreditation is valid until October 2022 |
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Remarks:
Course literature:
Peter G. Smith, Richard H. Morrow, and David A. Ross (Eds),
Field Trials of Health Interventions – A Toolbox,
Oxford University Press, Oxford, 3rd Ed, 2015.
Freely downloadable from:
http://ieaweb.org/wp-content/uploads/2015/07/Field-trials-of-health-interventions-a-toolbox-with-full-hyperlinks-July-15.pdf
or
http://www.oapen.org/download?type=document&docid=569923
2. ICH harmonised tripartite guideline: Guideline for good clinical practice E6. Downloadable from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2__Step_4_2016_1109.pdf
3. WHO. Handbook for guideline development. 2nd ed. WHO 2014. Downloadable from: http://apps.who.int/iris/bitstream/10665/75146/1/9789241548441_eng.pdf?ua=1
4. Welch, V. A., et al. (2017). "CONSORT-Equity 2017 extension and elaboration for better reporting of health equity in randomised trials." BMJ 359: j5085. Downloadable from:
https://www.bmj.com/content/359/bmj.j5085 |
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| Email Address: |
Linda.Forshaw@uib.no |
| Date Of Record Creation: |
2012-01-13 01:19:11 (W3C-DTF) |
| Date Of Record Release: |
2014-10-10 09:26:39 (W3C-DTF) |
| Date Record Checked: |
2020-11-04 (W3C-DTF) |
| Date Last Modified: |
2020-11-23 13:15:41 (W3C-DTF) |
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