The SPIRIT Checklist\u2014lessons from the experience of SPIRIT protocol editors

Abstract

Crystal clear RCT protocols are of paramount importance. The reader needs to easily understand the trial methodology and know what is pre-planned. They need to know there are procedures in place if there are, for instance, protocol breaches and protocol amendments are required, there is loss to follow-up and missing data, and how solicited and spontaneous reported adverse events are dealt with. This plan is important for the trial and for the results that will be published when the data is analysed. After all, individuals have consented to participate in these trials, and their time and their well-being matter. The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) provides guidance to structure RCT protocols and ensures all essential information is included. But sadly, not all trialists follow the guidance, and sometimes, the information is misunderstood. Using experience peer-reviewing for Trials over the last 2 years, we have prepared information to assist authors, peer reviewers, editors, and other current and future SPIRIT protocol editors to use the SPIRIT guidance and understand its importance.