Standrad Protocolo Items: The SPIRIT statement
The trial protocol provides guidance to individuals conducting the study, serves as the basis for trial registration, and facilitates study appraisal by participants and external reviewers, including research ethics committees/institutional review boards, funders, regulators, journal editors, and systematic reviewers.
However, there is accumulating evidence that many protocols do not fully address important study elements. Incomplete protocol content can impair understanding and implementation of the trial; reduce efficiency of protocol review; and lead to burdensome protocol amendments. This is more evidence in academic trials. In this blog we summarize the SPIRIT statement a powerfull tool to ensure the appropiate content in our study protocol.