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

Abstract

BackgroundDespite 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.MethodsA 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.ResultsA 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.ConclusionRCTs of RSA conducted in China need improvement in order to meet the level of “reporting quality” required by the CONSORT statement.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-0665-6) contains supplementary material, which is available to authorized users.

Assessing the quality of reports about randomized controlled trials of scalp acupuncture combined with another treatment for stroke

“…However, due to the challenge of collecting subjects meeting the study criteria within a certain period, it can be difficult to achieve the designed sample size [ 33 , 34 ]. In addition, very small RCTs carry the risk of bias or may be insufficient for measuring a therapeutic benefit [ 29 ]. Therefore, in order to identify a significant difference with high reliability between the intervention and control groups, sample size determination should be the focus of increased attention through consultation with clinical statisticians.…”

“…Each report was independently evaluated by two reviewers (YNY and MYS) in reference to each item’s definition and detailed description in the CONSORT and STRICTA statements, and in cases of disagreement between these reviewers, final scores were determined through agreement with a third reviewer (MRC) (Tables 1 , 2 and 3 ) [ 29 ].…”

Methodological Reporting Quality of Randomized Controlled Trials in 3 Leading Diabetes Journals From 2011 to 2013 Following CONSORT Statement

“…Third, to evaluate the quality of reporting in RCTs quantitatively, we extracted major item instead of all items from the CONSORT 2010 statements. 32 Forth, although the 3 highest impact factor diabetes journals were considered, a number of diabetes related RCTs are published in other nondiabetic or lower impact journals. To some extent, this study reflected the reporting quality of RCTs in a better level of diabetes trials.…”

Assessing the quality of reports about randomized controlled trials of scalp acupuncture treatment for vascular dementia

“…The discussion section items of the CONSORT guideline were excluded, due to the difficulty of objectively evaluating them [26–28]. Each of 17 items in the STRICTA guideline was also scored (range 0–17) (Table 2).…”