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Developing a protocol

Pre-specifying your Research Question and Writing a Study Protocol🔗

Note

This section is a work in progress, and will be further developed.

Briefly, pre-specifying your research question and developing a study protocol which outlines your methodology is an important open science principle. There are several benefits to developing a protocol:

  • It reduces "researcher degrees of freedom" and minimises the risk of questionable research practices such as "hypothesising after the results are known" (HARKing) or p-hacking;
  • It increases replicability by explaining the “why” of each analytic decision (whereas study code only tells you the “what”);
  • It allows you to get feedback and identify problems early on in the process, before writing code;
  • It can help set limits on what is to be done;
  • It makes writing the manuscript easier.

Taken together, this can improve both the quality and credibility of your research. Developing a detailed study plan, including figure and table shells, can be particularly helpful when using a federated analytics platform such as OpenSAFELY, as there is less scope for interactively developing these whilst working with the data.

When working with OpenSAFELY, we recommend using this protocol template. It includes many elements common to frequently used reporting checklists (e.g. STROBE, RECORD). You can choose to pre-register your protocol formally on OSF or ENCePP, or informally by uploading "locked" protocol versions to GitHub. You can see examples of protocols we've written for OpenSAFELY studies on most of our public repositories — for example this inhaled corticosteroid (ICS) research repository or this ethnicity research repository.