Impact of CONSORT

The CONSORT guideline is the most well-known reporting guideline, the development of which many others are based. It has been listed among the top health research milestones of the 20th century according to the Patient-Centered Outcomes Research Institute (PCORI)(335) and CONSORT 2010 among the top 1% of article-level metrics (views, downloads, citations, social media shares) tracked by PLoS Medicine. Since its original publication in 1996, the main CONSORT publications have been cumulatively cited over 8000 times.

Perhaps the most telling indicator of CONSORT impact is its uptake by journals and subsequent impact on the completeness of reporting of trials. It is currently known to be endorsed by over 600 biomedical journals and endorsed by several prominent editorial organizations including the International Committee of Medical Journal Editors (ICMJE) and the World Association of Medical Editors (WAME). Journal endorsement of CONSORT and other reporting guidelines typically occurs in the form of a supportive statement in a journal’s Instructions to Authors.

A 2012 Cochrane systematic review assessed the effect of journal’s endorsement of CONSORT on the reporting of trials they publish(336)(337). In 50 included studies evaluating the reporting of 16,604 trials, 25/27 CONSORT-related items measured were more completely reported in trials published in endorsing journals than those in non-endorsing journals, five items were significantly better reported (α = 0.01). As an example, how “allocation concealment” was achieved, a defining feature of randomized trials, was reported in 81% more trials published in endorsing versus non-endorsing journals, RR=1.81 (95% CI 1.38 1.84). Similar findings were yielded for many items when comparing trials published in journals before and after CONSORT endorsement. However, upon closer examination, these numbers are not altogether encouraging. Even among endorsing journals, the reporting of key methodological items was still dismal. Allocation concealment, for instance, while significantly better reported in endorsing journals, was reported in only 45% of trials compared to 22% of trials in non-endorsing journals. Many other key features of trials such as reporting the methods of sequence generation and defining the primary outcome were also reported less than 50% of the time in endorsing journals.  The figures below demonstrate differences in the completeness of reporting of CONSORT items a) between trials published in endorsing vs non-endorsing journals, and b) in trials published before and after CONSORT publication.

a) Endorsers vs Non-endorsers

b) Before vs. After endorsement

  • 335.

    Gabriel SE, Normand SL. Getting the methods right--the foundation ofpatient-centered outcomes research. N Engl J Med. 2012 Aug 30;367(9):787-90. doi:10. 1056/NEJMp1207437. Epub 2012 Jul 25.

    PMID: 22830434

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  • 336.

    Turner L, Shamseer L, Altman DG, Schulz KF, Moher D. Does use of the CONSORTStatement impact the completeness of reporting of randomised controlled trialspublished in medical journals? A Cochrane review. Syst Rev. 2012 Nov 29;1:60. doi: 10. 1186/2046-4053-1-60. Review.

    PMID: 23194585

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  • 337.

    Turner L, Shamseer L, Altman DG, Weeks L, Peters J, Kober T, Dias S, SchulzKF, Plint AC, Moher D. Consolidated standards of reporting trials (CONSORT) andthe completeness of reporting of randomised controlled trials (RCTs) published inmedical journals. Cochrane Database Syst Rev. 2012 Nov 14;11:MR000030. doi:10. 1002/14651858. MR000030. pub2. Review.

    PMID: 23152285

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