How I Do It: Writing, Reviewing, and Reading Standard and Pragmatic Clinical Trial Protocol Papers

Randomized controlled trials provide foundational evidence in clinical medicine. However, the quality of evidence generated by clinical trials depends on the quality of their design, conduct, and analysis. A comprehensive protocol is essential for conducting a rigorous, high-quality trial, and publication of the protocol is an important step in transparent trial reporting. Protocol papers summarize key elements of the protocol for a clinical audience. Such papers afford trialists with an opportunity to explain study design choices and provide details about protocol execution that aid in trial interpretation but do not necessarily fit within the main trial manuscript. Consumers of protocol papers should understand the standards for adequate reporting and use a systematic approach to evaluate the planned trial and identify potential threats to its quality. As pragmatic trials have become increasingly common in critical care, their protocols merit special consideration due to unique trial design features that impact trial interpretation, such as embedding trial operations in clinical practice and using electronic health record data. In this perspective, we review components of protocol papers, discuss current reporting guidelines, and highlight key considerations for writing and reading critical care protocol papers, with a specific focus on pragmatic trials.