Randomised controlled trials, when appropriately designed, conducted and reported,
represent the gold standard in evaluating healthcare interventions. However, randomised
trials can yield biased results if they lack methodological rigour.[1] To assess a trial
accurately, readers of a published report need complete, clear and transparent information
on its methodology and findings. Unfortunately, attempted assessments frequently fail
because authors of many trial reports neglect to provide lucid and complete descriptions of …

Overwhelming evidence shows the quality of reporting of randomised controlled trials
(RCTs) is not optimal. Without transparent reporting, readers cannot judge the reliability and
validity of trial findings nor extract information for systematic reviews. Recent methodological
analyses indicate that inadequate reporting and design are associated with biased
estimates of treatment effects. Such systematic error is seriously damaging to RCTs, which
are considered the gold standard for evaluating interventions because of their ability to …

The CONSORT (Consolidated Standards of Reporting Trials) statement is used worldwide to
improve the reporting of randomized, controlled trials. Schulz and colleagues describe the
latest version, CONSORT 2010, which updates the reporting guideline based on new
methodological evidence and accumulating experience.