In this blog for Clinical Trials Day 2022, we reflect on the Trials journal’s draft structured study protocol template since its launch in 2019.
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the ECUADOR 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 strong guidelines in terms of reports. However, there is still lots of evidence that key information is often missing from published trial reports.
As part of the EQUATOR project, the SPIRIT Statement (Standard Protocol Items: Recommendations for Interventional Trials) was developed, intended to promote appropriate trial implementation, reduce avoidable protocol changes, and facilitate a full assessment of the scientific and ethical considerations of the study.
Trials have mandated the inclusion of a completed SPIRIT checklist for the submission of clinical trial protocols in support of this objective. Despite this, it can still be difficult to find the specific information readers need, which is often displayed differently from protocol to protocol. The SPIRIT statement recommends what should be in a protocol, but not where it should be.
“There is a big problem with newspaper articles. Readers of published research reports, especially systematic reviewers, have difficulty finding key details of study methods and often cannot extract the results they seek. – Professor Doug Altman
In its final Editorial for the journal, the late Professor Doug Altman, founding editor of Trials and one of the founding members of the EQUATOR network steering group, put forward the argument for increased structuring of the articles of the study protocol.
He argued that while readability is certainly desirable, readers don’t necessarily want a story they can follow from beginning to end; they want all the relevant information where they can find it easily, which requires comprehensive reporting. so called only 10 people read each published journal article on average, and study protocols are likely read even less.
Trials sought to address this issue and in November 2019 launched a model for a new structured study protocol. Using the SPIRIT checklist as a base, the template provides a structure for authors to follow where all SPIRIT headers and element identifiers are embedded in the protocol itself. When using the template, authors have no choice but to include all of the details required by SPIRIT, all in a format easily accessible to readers. Readers benefit from the ability to search by title or article ID, which are enclosed in braces.
“For readers, that means you know what to expect and where to find it. For authors, this means you don’t have to think about what to report, or where. Follow the structure and your protocol will be a good report. – 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 much easier to access the specific information they need. As Professor Shaun Treweek, current editor, wrote at the launch Editorial“We provide information that should be clear, comprehensive and, above all, 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 should be quite limited; we are not writing a novel.
The structured study protocol template has been made downloadable in a semi-editable format from the journal’s website and, to date (May 2022), over 350 study protocols using the study protocol template structured study have been accepted for publication in Trials.
In an anonymous survey sent to members of the Trials Editorial Board on their experiences processing and reviewing study protocols, we have found that editors find that study protocols structured using the template are faster to review and that SPIRIT items are more easy to locate compared to flagged study protocol submissions using the traditional SPIRIT checklist. In addition, 100% of survey respondents would recommend using the model to their colleagues, students or collaborators to develop a study protocol.
As a result, Trials found that for study protocols submitted to the journal between January 2020 and December 2021, the average time to final editor’s decision for structured protocols is 3 weeks less than for protocol submissions. reported using the traditional SPIRIT checklist.
However, the model is not always used correctly and this can cause problems for reviewers and editors. A die Trials The 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 guidelines and did not understand what was expected of the SPIRIT guidelines, so they had wrong or inadequate information under the items, appeared to have already written the protocol, and did not put specific information under the item headings “.
A group of protocol editors for Trials recently highlighted common pitfalls when reporting study protocols in a article published in the journal to discuss their experiences in assessing the clarity and completeness of SPIRIT reports in study protocol manuscripts.