Identifying areas to improve the quality of reporting in randomized clinical trials published in anesthesiology journals: A study protocol for a series of literature surveys assessing quality of trial registration, adherence to abstract reporting guidelines, adequacy of sample size calculations, and impact of funding source

2016-12-21T21:00:53Z (GMT) by Jeffrey Chow Philip Jones
<p>Background: Randomized clinical trials (RCTs) provide important evidence for clinical decision-making, but low quality design or reporting of these trials may result in a biased or distorted evidence base. Of particular interest are quality of trial registration, adherence to the CONSORT for Abstracts guidelines, accuracy of sample size calculations, and impact of funding source.</p> <p>Methods: This research program will consist of a series of studies assessing these four areas of reporting quality for RCTs published in six general anesthesiology journals. The first study will include RCTs from 2007, 2010, 2013, and 2015; the second and third study will include RCTs from 2010 and 2016; and the fourth study will include RCTs from 2015 and 2016. Comparing both across time and between journals, the first study will determine whether the reported outcomes of published RCTs are the same as the outcomes originally registered in clinical trial registries, the second study will determine the degree of adherence to the CONSORT reporting guidelines for the abstracts of RCTs, the third study will determine whether the quality of sample size calculations has improved, and the fourth study will determine whether industry funding has an effect on the outcomes measured previously. For the first study, the trial registration status will be systematically determined, along with the types of outcome discrepancies observed between the publication and registry entry. For the second study, the number of CONSORT criteria met in the abstract and the number of criteria not met in the abstract but found in the full-text. The third study will only include two-arm, parallel group, superiority RCTs, measuring the number of sample size calculation assumptions reported, the accuracy of those assumptions compared to the actual results, and the post-hoc power. The fourth study will examine the effect of “any industry funding” and “only industry funding” on the outcomes described earlier.</p> <p>Discussion: This series of studies will highlight important issues of reporting quality in anesthesiology RCTs, providing a specialty-specific perspective and updating the literature using the most current RCTs.</p>