The effect of the CONSORT statement on the amount of “unclear” Risk of Bias reporting in Cochrane Systematic Reviews

Abstract

Background The Consolidated Standards of Reporting Trials (CONSORT) statement aims to improve clarity and consistency of transparency of reporting in Randomized Controlled Trials (RCTs). The Cochrane Risk of Bias (RoB) tool for RCTs helps authors to judge the RoB. as ''low", "high" or "unclear". Objective In this study we aimed to assess whether the implementation and updates of the CONSORT statement influenced the trend of "unclear" RoB scores of RCTs included in Cochrane systematic reviews. Methods All Cochrane reviews published in December to October 2016 were retrieved. The publication year of RCTS included in the reviews were sorted into time frames (�1995, 1996-2000, 2001-2009 and �2010) based on the release-and updates of the CONSORT statement (1996, 2001 and 2010). The association between "unclear" RoB versus "low or high" RoB and the year of publication in different time frames were calculated using a binary logistic regression. Results Data was extracted from 64 Cochrane reviews, with 989 RCTS (6471 items). The logistic regression showed that the odds of RCTs published �2010, compared to �1995 were more likely not to report an "unclear" RoB for the total data (Odds Ratio (OR) 0.69 (95% Confidence interval: 0.59-0.80)), random sequence generation (OR 0.32 (0.22-0.47), allocation concealment (0.64 (0.43-0.95)) and incomplete outcome data (OR 0.60 (0.39-0.91)).

Effects of daily sedation interruption in intensive care unit patients undergoing mechanical ventilation: A meta‐analysis of randomized controlled trials

“…Researchers conducting future RCTs should be aware of the effect of allocation concealment on treatment outcomes. Although unclear reporting of randomization and allocation concealment processes is a common issue in biomedical research, describing the details of the randomization procedure and missing data management is essential because it allows the researchers to examine whether the methodology is sufficiently robust and the results are feasible for clinical practice (Rademaker et al, 2020).…”

A meta-analysis indicating extra-short implants (≤ 6 mm) as an alternative to longer implants (≥ 8 mm) with bone augmentation

“…The Consolidated Standards of Reporting Trials (CONSORT) statement, which was developed in 1996, updated in 2001 and 2010 83 – 86 and endorsed by many biomedical journals, aims to improve clarity and consistency of transparency of reporting in RCTs. There was more possibility for RCTs published after 2010 to have superior performance when evaluated with Cochrane Risk of Bias tool in total 87 . However, the use of the CONSORT statement varies among RCTs since only 20 out of 31 included articles adhere to the CONSORT statement, according to the present systematic review.…”

Clinical trial registration was associated with lower risk of bias compared with non-registered trials among trials included in systematic reviews

“…Although these data are limited to the clinical topic areas covered by the Cochrane MOSS network, prior research has reported similar percentages of high or unclear risk of bias across many different clinical areas. [ 23 , 24 ] It is important to note that risk of bias assessments are driven by two factors – the reporting of methods and the actual methods – and interpretation of unclear or high risk may conflate the two. Another possibility for the high number of unclear and high risk of bias assessments could be the misinterpretation of the first version of the Cochrane Risk of Bias tool.…”