Developing the Protocol

Q: What is the quickest way to develop a protocol?

A: Start with a template, and example of a similar study, and a list of outcomes or conclusions that you want to be able to draw from your study in the end.

One of the most important steps in protocol development is knowing what you want to be able to say about your question when the study is finished. The reason is that the design chosen for the protocol will dictate, to some extent what can be said about the results. Poor planning up front can result in a disastrous end, such as insufficient sample size to demonstrate a significant difference between two things, inability to draw a conclusion for a desired patient population, or the inability to make assumptions or generalizations about your findings.

Components of the Protocol

Components of the protocol communicate to the reader or reviewer what you are planning to study, how you will study it, and why the study is an important contribution to patient care and to the literature. Components of the protocol typically include the abstract (not a necessary component of all protocols), statements addressing the significance or background of the problem, statement of the research question or hypotheses, a methods section that includes study design, sample or patient population, inclusion and exclusion criteria, setting, and a discussion of the tools or instruments to be used, and finally, a preliminary stab a the anticipated statistical analysis. In addition to these components that describe your study, there are also several “required” components that are standard for our institution’s IRB. These components include statements related to patient risk, confidentiality, and patient reimbursement for participation in the study.

Begin by breaking the project into steps and take “small bites”. Work on one “bite” at a time, rather than allowing yourself to become overwhelmed by the whole project.