Quality of manuscript abstracts in phase III clinical trials versus the CONSORT guidelines
Manuscript abstracts are an important source of information for healthcare professionals, who may use the information as a basis for treatment decisions. This is particularly the case when open access articles are not accessible. With this in mind, the EQUATOR network introduced the Consolidated Standards of Reporting Trials (CONSORT) extension statement for abstracts in 2007, which provided a minimum list of elements that should be included in abstracts.
This week, the journal Trials published a study that evaluated the degree of adherence to these recommendations in 174 randomised, controlled, phase III trials in metastatic solid malignancies. According to this analysis (see Table below), the least frequently reported elements of the CONSORT extension were: trial design description (20%), participant allocation method (13%), blinding (24%), trial enrollment status (22%), registration and name of trial (26%) and funding source (18%). The most frequently reported elements were eligibility criteria (98%), study interventions (100%), and primary endpoint (8%).
The authors concluded: “There is poor adherence to the CONSORT recommendations for abstract reporting in publications of randomised cancer clinical trials which could negatively impact clinical decision-making.”.
Table: From Trials 2015, 16:341; http://www.trialsjournal.com/content/16/1/341
Interesting paper, which raises several important issues. First, reliance on the abstract alone for information would be avoided if, as the recent WHO guidelines suggest, authors use open access to maximise accessibility to their research findings. Second, what proportion of failing to include the elements of the CONSORT extension can be attributed to ‘ignorance’ alone – isn’t it more a reflection of word count restrictions, or a combination of both? It would be a challenge indeed to address each aspect of the CONSORT extension with only 150-200 words to work with. Perhaps journals need to relax their word count restrictions in order to help authors meet these important requirements?
In addition to the points raised in the first comment, I have seen instances where some information provided to meet CONSORT requirements (whether in the abstract or the main body of the manuscript) have been edited out during the proof process by the journal. Although this is perhaps unlikely to account for many instances of “missing information” as described in the Trials article, it does raise the point that all stakeholders need to be educated on the importance of CONSORT and other reporting guidelines.