About this course

This course provides an introduction to designing and evaluating epidemiological studies. Students learn how to develop a study protocol for either a randomized controlled trial or an observational study, and how to critically assess study designs used in scientific research. The course covers core epidemiological measures, basic causal thinking, and the specification of aims and estimands. Students are introduced to common observational study designs as well as randomized trials, and diagnostic test evaluations.

Key topics include identifying major sources of bias, understanding sampling strategies, performing simple power and sample size calculations, and evaluating data quality. Students also learn how to plan data collection (including questionnaires), plan the stucture of datasets, and outline a target trial and its observational emulation. Directed acyclic graphs (DAGs) are used to describe causal assumptions and guide adjustment strategies. The counterfactual framework and assumptions required for causal effect estimation is introduced.

Learning outcome

The overall learning objectives for this course are to enable students to develop a sound protocol for their own randomized controlled trial or observational study, and to critically evaluate the study design of studies reported in scientific publications. This entails learning to:

  • Estimate and interpret measures of disease occurrence and measures of association.
  • Describe and apply approaches to studying causality, including the counterfactual framework.
  • Formulate well-defined aims for epidemiological studies.
  • Specify estimands and target estimates that address the study aims.
  • Describe the characteristics of randomized controlled trials, evaluations of measurements and diagnostic tests, and observational study designs—including prevalence surveys, cohort studies, case‑cohort and case‑control designs, cross-sectional studies, interrupted time-series designs, and self‑controlled case-series designs.
  • Discuss the strengths and limitations of different study designs and justify the choice of design for one’s own study.
  • Identify sources of bias (selection, information, confounding, immortal time) in both planned studies and published articles.
  • Discuss how sampling strategies influence selection bias and generalizability, and design a reasonable sampling scheme for one’s study.
  • Make simple estimations of statistical power and sample size and discuss when more advanced approaches may be necessary.
  • Propose approaches for evaluating data quality—including the quality of registry and other secondary data—and discuss how data quality affects information bias.
  • Plan well‑structured, analysis‑ready datasets.
  • Plan a questionnaire‑based data collection, including questionnaire development.
  • Specify a target trial (eligibility criteria, time zero, treatment strategies, outcome, follow‑up, causal estimand) and design an observational emulation that aligns with it.
  • Use directed acyclic graphs (DAGs) to articulate causal assumptions, assess identifiability of causal estimands, and determine required data and appropriate adjustment sets.
  • Consider whether the assumptions required for causal effect estimation (exchangeability, positivity, consistency, no unmeasured confounding, no interference) are likely to be satisfied in a planned study.
  • Learning activities

    All topics are introduced through lectures and exercises, and students will additionally study them independently (e.g., by reading papers and textbook chapters). Students must work extensively on writing a study protocol for their own epidemiological study, and teachers provide supervision throughout this process.
  • Syllabus

    Recommended reading:

    Chapters in the textbooks:

    Chapters: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 in Dohoo, Ian Robert, Wayne Martin, and Henrik Stryhn. 2014. Veterinary Epidemiologic Research. 2nd ed. VER Inc. Upei.ca/ver.[EE1] [AN2]

    Chapters: 1, 2, 3, 6, 7, 8 in Hernan, Miguel A., and James M Robins. Causal Inference: What If. 1st ed. Chapman & Hall/CRC. https://www.hsph.harvard.edu/miguelhernan/causal-inference-book/.

    Peer-reviewed scientific papers:

    Birkegård, Anna Camilla, Mette Ely Fertner, Vibeke Frøkjaer Jensen, et al. 2018. "Building the Foundation for Veterinary Register-Based Epidemiology: A Systematic Approach to Data Quality Assessment and Validation." Zoonoses and Public Health 65 (8): 936-46. https://doi.org/10.1111/zph.12513.

    Eriksen, Esben Oestergaard, Simon Smed, Karl Johan Klit, and John Elmerdahl Olsen. 2019. "Factors Influencing Danish Veterinarians’ Choice of Antimicrobials Prescribed for Intestinal Diseases in Weaner Pigs." Veterinary Record 184 (26): 798-798. https://doi.org/10.1136/vr.105004.

    Hernán, Miguel A., and James M. Robins. 2016. "Using Big Data to Emulate a Target Trial When a Randomized Trial Is Not Available: Table 1." American Journal of Epidemiology 183 (8): 758-64. https://doi.org/10.1093/aje/kwv254.

    O’Connor, A.M., J.M. Sargeant, I.R. Dohoo, et al. 2016. "Explanation and Elaboration Document for the STROBE-Vet Statement: Strengthening the Reporting of Observational Studies in Epidemiology-Veterinary Extension." Journal of Veterinary Internal Medicine 30 (6): 1896-928. https://doi.org/10.1111/jvim.14592.

    Pegram, Camilla, Karla Diaz-Ordaz, Dave C. Brodbelt, et al. 2024. "Target Trial Emulation: Does Surgical versus Non-Surgical Management of Cranial Cruciate Ligament Rupture in Dogs Cause Different Outcomes?" Preventive Veterinary Medicine 226 (May): 106165. https://doi.org/10.1016/j.prevetmed.2024.106165.

    Rothman, Kenneth J., and Sander Greenland. 2005. "Causation and Causal Inference in Epidemiology." American Journal of Public Health 95 (S1): S144-50. https://doi.org/10.2105/AJPH.2004.059204.

    Sargeant, Jan M., Annette M. O’Connor, David G. Renter, and Audrey Ruple. 2024. "What Question Are We Trying to Answer? Embracing Causal Inference." Frontiers in Veterinary Science 11 (May): 1402981. https://doi.org/10.3389/fvets.2024.1402981.

    Sargeant, Jan M., Annette M. O’Connor, Sarah C. Totton, and Ellen R. Vriezen. 2022. "Watch Your Language: An Exploration of the Use of Causal Wording in Veterinary Observational Research." Frontiers in Veterinary Science 9. https://www.frontiersin.org/articles/10.3389/fvets.2022.1004801.

    Shmueli, Galit. 2010. "To Explain or to Predict?" Statistical Science 25 (3). https://doi.org/10.1214/10-STS330.

    Wickham, Hadley. 2014. "Tidy Data." Journal of Statistical Software 59 (September): 1-23. https://doi.org/10.18637/jss.v059.i10.

    Suggested further reading

    Stone, D. H. 1993. "Design a Questionnaire." Bmj 307 (6914): 1264-66.

  • Assessment method

    Written exam. The student must submit a study protocol for their own epidemiological study, following the template provided during the course. Students who are not planning to conduct an epidemiological study may submit a fictional protocol. There are no restrictions on permitted aids. Students are encouraged to collaborate with supervisors and colleagues involved in their study, and all contributions to the protocol must be declared in the submitted version. Grading: pass/fail.

    Assignment Grading: Passed / Not Passed
  • About use of AI

  • Mandatory activity

    Three assignments with drafts of parts of the student’s study protocol must be submitted. The student must also provide critical peer feedback on another student’s assignments.
  • Notes

    Deadline for registration: February 1st.

    For administrative questions, contact phd.radgiver.vet@nmbu.no

  • Admission requirements

    Open to PhD candidates at NMBU and other universities. Open to veterinary research track students at NMBU.