Quality of reporting on randomized controlled trials on recurrent spontaneous abortion in China

Abstract

Background: Despite increasing numbers of RCTs done in China, detailed information on the quality of Chinese RCTs is still missing. The aim of this study was to assess the reporting quality of RSA RCTs and to identify significant predictors of reporting quality. Methods: A literature review was conducted with the aim of identifying published RCTs on RSA conducted in China. In order to rate the report quality, we scored 1 for the item of CONSORT 2010 if it was reported and 0 if it was not stated or unclear. An overall quality score (OQS) with a range of 0-15 and a key methodological index score (MIS) with a range of 0-3 were calculated for each trial. Results: A total of 98 relevant RCTs were included in the final analysis. The median OQS was 7, with a minimum of 1 and maximum of 12. The general level of OQS was not high, especially among 'sample size,' 'baseline data,' 'outcomes and estimation,' and 'ancillary analyses,' all of which had a positive rate of less than 10%. The median MIS was 1 with a minimum of 0 and maximum of 1. 'Allocation concealment,' 'blinding,' and 'intention-to-treat analysis' were mentioned in 1 (1%), 1 (1%) and 69 (70%) of the studies, respectively. In univariate analysis, funding was the only factor associated with an increased OQS. Specifically, the mean OQS increased by approximately 1.52 for manuscripts supported by funding (95% CI: 0.12 - 2.92; p=0.03). With regard to the MIS, no association was found for any variable. Conclusion: RCTs of RSA conducted in China need improvement in order to meet the level of "reporting quality" required by the CONSORT statement.