How to Structure a Medical Research Protocol
The essential sections of a protocol or synopsis, and what reviewers look for in each.
Research Methodology
How the two most common observational designs differ, what each can tell you, and how to choose between them.
Both designs are observational — the researcher does not assign exposures — but they answer different questions.
Exposure and outcome are measured at the same point in time. They are well suited to estimating prevalence and exploring associations. They are relatively quick and inexpensive, which makes them common in postgraduate theses.
The key limitation: because exposure and outcome are measured together, you usually cannot establish which came first.
Participants are classified by exposure and followed over time to see who develops the outcome. Cohorts can estimate incidence, relative risk and time-to-event outcomes, and establish temporal sequence.
Prospective cohorts need follow-up time and effort to minimise loss to follow-up. Retrospective cohorts use existing records and are faster, but depend on the quality of those records.
Both designs are reported using the STROBE statement. Reviewing the STROBE checklist while planning helps you collect everything you will need to report.
This article is for general educational purposes. Always follow your institution’s guidelines and your guide’s advice.
Our consultants can help you apply these principles to your own study.
The essential sections of a protocol or synopsis, and what reviewers look for in each.
A practical framework for turning a clinical interest into a focused, feasible and defensible thesis question.
What you need before calculating sample size, the common formulas, and how to justify your assumptions.
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