Proof of concept:
In 2015, we performed the proof of concept on a former version of this tool through a split-manuscript randomised controlled trial (RCT). We evaluated its impact on the completeness of reporting of randomised controlled trials (RCTs). 41 students were randomly allocated to a different real RCT protocol. They had to write six domains of the methods section of the manuscript for the protocol they received over a four-hour period.
For each domain, the tool comprised reminders of the corresponding CONSORT item(s), bullet points detailing all the key elements to be reported, and examples of good reporting. The control intervention consisted of no reminders. The results revealed a large effect of the writing tool on the completeness of reporting. We demonstrated that a writing aid tool can improve the completeness of reporting and that we need to rethink the strategies used to implement CONSORT. The expansion of the tool was recommended to include all CONSORT items and incorporate all extensions.
Later in 2016, we evaluated the impact of a simple web-based tool WebCONSORT (which incorporates the main CONSORT checklist and different CONSORT extensions) on the completeness of reporting of randomised trials published in biomedical journals. WebCONSORT allowed authors to obtain a customized CONSORT checklist and flow diagram specific to their trial design and type of intervention. The study concluded on the need for better education much earlier in the publication process for authors and journal editorial staff on when and how to implement CONSORT and, in particular, CONSORT-related extensions. It may be more effective to focus on a core set of CONSORT items with more detailed information on how to implement each item within the context of a specific trial, the authors concluded.
Content of the tool
The tool includes several personalized templates that considered the different CONSORT reporting recommendations for different study designs, types of interventions and/or types of illnesses. For each of the templates developed, we summarized and combined the reporting recommendations from the main CONSORT statement and its Explanation and Elaboration 2010, the CONSORT Extension to harms, the CONSORT for abstracts and the relevant CONSORT extension/s for specific study design and/or type of intervention (Campbell, et al. 2012, Piaggio, et al. 2012, Boutron, et al. 2017). For instance, if the experimental treatment is a surgical procedure, the bullet points with the key elements that needed to be reported were specific to surgical procedures and the examples of adequate reporting concerned surgical trials.