Taking an evidence-based approach comparable to that used in the development of the recently-updated CONSORT statement, an overlapping group of expert trialists recently finalized a new checklist of 33 essential items for trial protocols.
Developed in response to increasing calls for transparency and thoroughness in published protocols, the Standard Protocol Items for Randomized Trials (SPIRIT) guidelines are intended to address the sub-standard reporting of protocols by providing authors with the tools they need to ensure that key methodological, ethical and administrative details are included. The importance of protocol publication is not a new issue. Like prospective trial registration, protocol publication provides a permanent, public record of a clinical trial, helping to reduce the potential for bias due to non-publication of negative or inconclusive results.
Once published, the SPIRIT guidelines will help to improve the quality of trial protocols, allowing readers, systematic reviewers and policy makers to critically evaluate trial results and draw comparisons between what was planned, and what was done.