The EQUATOR Network (Enhancing the QUAlity and Transparency Of health Research) was launched in 2008, seeking to improve the reliability and value of published health research literature by promoting transparent and accurate reporting and wider use of robust reporting guidelines. However, there is still plenty of evidence that key information is commonly missing from published reports of trials.
As part of the EQUATOR project, the SPIRIT Statement (Standard Protocol Items: Recommendations for Interventional Trials) was developed, intended to promote proper trial implementation, reduce avoidable protocol amendments, and facilitate full appraisal of the study’s scientific and ethical considerations.
Trials have made the inclusion of a completed SPIRIT checklist mandatory for the submission of clinical trial protocols to support this aim. Despite this, it can still be difficult to find the specific information readers require, which is often displayed differently between protocols. The SPIRIT statement recommends what should be in a protocol, but not where it should be.
“There is a big problem with journal articles. Readers of published research reports, especially systematic reviewers, struggle to find key details of study methods and often cannot extract the results they seek.” – Professor Doug Altman
In his final Editorial for the journal, the late Professor Doug Altman, Founding Editor of Trials and one of the founding steering group members of the EQUATOR Network, put forward the argument for increased structure in study protocol articles.
He argued that while readability is certainly desirable, readers don’t necessarily want a story they can follow from start to finish; they want all the relevant information where they can easily find it, which requires complete reporting. Supposedly only 10 people read each published journal article on average, and study protocols presumably are even less widely read.
Trials sought to address this problem and, in November 2019, launched a template for a new structured study protocol. Using the SPIRIT checklist as its basis, the template provides a structure for authors to follow where all SPIRIT headings and item identifiers are integrated within the protocol itself. Using the template, authors have no choice but to include every detail required by SPIRIT, all in a format that is easily accessible to readers. Readers benefit from the ability to search by heading or item identifier, which are contained within curly brackets.
“For readers, it means you know what to expect, and where to find it. For authors, it means you don’t need to think about what to report, or where. Follow the structure and your protocol will be a piece of good reporting.” – Professor Shaun Treweek
It was hoped that for those who encounter a structured study protocol as part of a systematic review or in the planning of another trial it will be far simpler to access the specific information they require. As current Editor-in-Chief Professor Shaun Treweek wrote in the launch Editorial, “We are providing information that should be clear, complete and, crucially, easy to navigate”.
Professor Treweek, explains that Trial protocols are functional tools for understanding– “The need for imagination and creativity when it comes to writing protocols ought to be fairly limited; we’re not writing a novel.”
The Structured Study Protocol Template was made downloadable in a semi-editable format from the journal website, and to date (May 2022), over 350 study protocols using the structured study protocol template have been accepted for publication in Trials.
In an anonymous survey sent to members of the Trials Editorial Board about their experiences of handling and reviewing study protocols, we saw that Editors find study protocols structured using the template are faster to review and the SPIRIT items are easier to locate when compared to study protocol submissions reported using the traditional SPIRIT checklist. Additionally, 100% of respondents to the survey would recommend using the template to colleagues, students, or collaborators putting together a study protocol.
Consequently, Trials have found that for study protocols submitted to the journal between January 2020 and December 2021 the average time to a final editor decision for structured protocols is 3 weeks less than for study protocol submissions reported using the traditional SPIRIT checklist.
However, the template is not always used correctly and this can cause problems for Reviewers and Editors. One of the Trials Protocol Editors noted that “The protocol template is only better as a reviewer/editor IF the authors read, understand, and follow the guidance. I recently had a protocol and the authors had not read the guidance and didn’t understand what was expected from the SPIRIT guidance. So they had the wrong or inadequate information under items, looked like already written the protocol and didn’t put specific information under item headings”.
A group of Protocol Editors for Trials have recently highlighted common pitfalls when reporting study protocols in an article published in the journal discussing their experiences of assessing the clarity and comprehensiveness of SPIRIT reporting in study protocol manuscripts.