a detailed plan or set of predefined steps to be followed in a study or project. It outlines the rationale, objectives, and methods to ensure consistency, transparency, and reproducibility. For example, in a systematic review, a protocol describes how studies will be identified, selected, appraised, and how data will be collected and analyzed. In developing a Core Outcome Set (COS), a protocol specifies the procedures and methods to be used at each stage.
Synonyms: Study Plan, Research Plan, Work Plan, COS development plan
Example
In a systematic review of pain management interventions, the protocol specifies the research question, eligibility criteria for studies, databases to be searched, search strategies, data extraction methods, and the statistical techniques for synthesizing results. This protocol is registered in PROSPERO to ensure transparency and reduce the risk of bias.