Writing a Research Protocol
Full course description
Students will learn how to write a research proposal for their thesis topic in Epidemiology. The main activity is to write their proposal supported by active discussions of different sections of their protocol by peers and teaching staff. These activities will additionally be supported by lectures. Three lectures will elaborate on each of the sections of the protocol: 1) the background leading up to the main aim of the study, the specific research questions and hypotheses, 2) the study design, and 3) and the statistics and power calculations. There will also be a working lecture on power and sample size calculation during which students will compute the required sample size or the power of the study. In addition, there is a lecture at the beginning of the module on scientific writing in English which will be provided by the language centre. In addition, there will be a lecture on how to make a scientific poster and a question hour. The module runs in parallel to the module on “Systematic Literature Review and Meta-analysis”, during which students start learning how to critically and systematically assess literature. Throughout the module attention will be given to research ethics and research integrity. Last but not least, students will learn how to make a time-line, which they will use on a weekly basis during their entire internship period. At the end of the module each participant will present and defend his/her research protocol through a poster presentation during a plenary session in front of a ‘review committee’ consisting of peer students and staff members from the Department of Epidemiology.
Knowledge and understanding
- Knowledge of and insight into the basic outline of an epidemiological research protocol
- Knowledge of and insight into the requirements regarding the various components of a scientific research protocol (e.g., title of the research project, abstract, background, aim of the study, research question(s), hypotheses, study design, choice of study population including in- and exclusion criteria, describing measurement instruments for main outcome variables, determinants / interventions, confounders and effect modifiers, sources of bias, proposed statistical analyses, power calculations, ethical considerations, timeline, bibliographic references, and a statistical analysis plan)
- Knowledge of the guidelines for writing a research protocol
Applying knowledge and understanding
- Ability to write an epidemiological research proposal independently in scientific English
- Ability to review and assess the quality of research protocols written by others
- Ability to form a balanced judgment on the quality and relevance of research proposals in the field of epidemiology ("responsible epidemiological research practice"), also in a comparative sense.
- Ability to communicate with experts and non-experts, both by means of written report / comment and oral presentation on the contents, the strengths and the weaknesses of (epidemiological) research proposals, conceived by him- or herself or by other investigators.
- Ability to proceed to a higher level of scientific writing, for instance writing a proposal for a larger and more complex research project, or writing skills which can be applied during the writing of the thesis in the form of a scientific article.
- Skills to present and defend the final version of a study protocol in front of a scientific committee.
- Polit DF, Beck CT. Nursing research; principles and methods; 7th ed. Part 6: Communicating research. Chapter 25: Writing a research proposal; pp. 629-650. Philadelphia: Lippincott Williams Wilkins, 2004. - Dos Santos Silva I. Cancer Epidemiology: Principles and Methods. Lyon: IARC publications, 1999. Ch18: Designing, planning and conducting epidemiological research. http://publications.iarc.fr/Non-Series-Publications/Other-Non-Series-Publications/Cancer-Epidemiology-Principles-And-Methods-1999 - Written series of 12 one-pagers on effective writing and publishing scientific papers by Daniel Kotz and Jochen Cals in the Journal of Clinical Epidemiology. Available online: http://www.scientificwritingtips.com/ - Webb P, Bain C. Essential epidemiology; An introduction for students and health professionals. Cambridge: Cambridge University Press, 2016. - Bouter LM, Zielhuis GA, Zeegers MP. Textbook of Epidemiology. Houten: Bohn Stafleu van Loghum, 2018. - Campbell JD. Formulating the research question. Dept. Family and Community Medicine, University of Missouri, 2004. Available online: https://www.atsu.edu/research/pdfs/campbell_syllabus.pdf - Creswell JW. Research design. Los Angeles: Sage, 2009; Ch7: Research Questions and Hypothesis. Available online: https://www.sagepub.com/sites/default/files/upm-binaries/22782_Chapter_7.pdf - Haynes RB (2006). Forming research questions. Journal of Clinical Epidemiology 59, 881-886. Available online: https://www.jclinepi.com/article/S0895-4356(06)00233-2/abstract. - Friedman LM, Furberg CD, DeMets DL. Fundamentals of clinical trials; 5th ed. New York: Springer, 2015. - De Vet HCW, Terwee CB, Mokkink LB, Knol DL. Measurement in medicine. Cambridge: Cambridge University Press, 2011. - Higgins JPT, Green S, eds. Cochrane Handbook for Systematic Reviews of Interventions (formerly: Cochrane Reviewers' Handbook). Cochrane Book Series. New York: John Wiley & Sons, 2008 (version 5.0.2, updated September 2009). Free on-line version available on Cochrane Collaboration website: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from: https://handbook-5-1.cochrane.org/ - Centre for Reviews and Dissemination. Systematic reviews; CRD's guidance for undertaking reviews in health care. York, University of York, Centre for Reviews and Dissemination, 2009. This complete and thorough guide for undertaking reviews in health care can be consulted online or a free copy in PDF format can be downloaded from CRD's website: http://www.york.ac.uk/inst/crd/index_guidance.htm - Szklo M, Nieto FJ. Epidemiology: beyond the basics; 3rd ed. Burlington: Jones and Bartlett Learning, 2014. - Kelsey JL, Whittemore AS, Evans AS, Thompson WD. Methods in observational epidemiology; 2nd ed. New York: Oxford University Press, 1996. - Rothman KJ, Greenland S. Modern epidemiology; 3rd ed. Philadelphia: Lippincott Williams & Wilkins, 2008. - Detels R, Gulliford M, Abdool Karim Q, Chuan Tan C. Oxford Textbook of Global Public Health; 6th ed. Oxford: Oxford University Press, 2015. The latest, 6th edition of The Oxford Textbook of (Global) Public Health is freely available and downloadable with UM account: http://oxfordmedicine.com/view/10.1093/med/9780199661756.001.0001/med-9780199661756 - Giesecke J. Modern infectious diseases epidemiology; 2nd edition. Oxford: Hodder Arnold, 2001. - Boffetta P, Boccia S, La Vecchia C. A quick guide to cancer epidemiology. Springer Briefs in Cancer Research. New York: Springer, 2014. - Khoury MH. Genetic epidemiology. In Rothman KJ, Greenland S, eds. Modern epidemiology; 3rd ed; Section IV: Special topics, Chapter 28. Philadelphia: Lippincott Williams & Wilkins, 2008. - Field A (2013). Discovering statistics using SPSS for Windows; 4rd ed. London: Sage. - Field A. Miles J., Field Z. Discovering statistics using R; London: Sage Publications Ltd, 2012. - Streiner DL, Norman GR, Cairney J. Health measurement scales; a practical guide to their development and use; 5th ed. New York: Oxford University Press, 2014.