Introduction
What is new?
Key findingThe quality of safety reporting in randomized controlled trials (RCTs) published in five major main medical journals is still suboptimal after the publication of the Extension of the Consolidated Standards of Reporting Trials (CONSORT) statement with recommendations for better reporting of harms.
What this adds to what was knownConsiderable evidence suggested that reporting of harms-related data from RCTs is often neglected. This is true even after the publication of the Extension of the CONSORT statement, although there seemed to be an improvement over time. Additionally, a mean score is introduced as an overall measure of adequacy in reporting harms, ranging from 0 to 1. A value of 1 indicates perfect safety reporting, and lower values show poorer quality of harms-related data.
What is the implication and what should change now?Authors should give more attention to writing harms and follow the 10 new recommendations about reporting harms-related issues according to the Extension of the CONSORT statement. This would help to use quantitative objective evidence for harms in performing meta-analyses and making therapeutic decisions.
The Consolidated Standards of Reporting Trials (CONSORT) statement is aimed at standardizing and thereby improving the quality of published reports of randomized controlled trials (RCTs) [1]. In the first version of the CONSORT statement that was published in 1996, there was no item referring to reporting of adverse events [2]. In its revised version, 5 years later, the reporting of safety was first added as an item together with some other important methodological features of RCTs [3]. However, there was still considerable evidence that reporting of harms-related data from RCTs also needed improvement [4], [5], [6], [7]. Therefore, at the end of 2004, an Extension of the CONSORT statement was published that suggested 10 new recommendations with accompanying explanations for the appropriate reporting of harms-related issues [8].
Since the publication of the CONSORT statement, several review articles have investigated its impact on the quality of reports of RCTs [9], [10], [11], [12], [13], [14]. However, these studies showed that the quality of reporting of trials was improved but there was no examination on the safety reporting. Recently, two surveys were published, the one of which investigated the quality of reporting of trial abstracts, where there is only a mention of the proportion of abstracts that describes harms or side effects [15]. The second one evaluated the reporting of adverse events after the dissemination of the Extension for harms of the CONSORT statement, but there was no comparison before the publication of this extended guideline [16]. In the present study, we assessed the impact of the Extension of the CONSORT statement with the 10 new recommendations on the reporting of harms in trial reports published before and after its release. We also sought to understand the settings and predictors that influence the quality in reporting harms and gain insight for improving important deficiencies in this area.