Abstract

The Consolidated Standards of Reporting Trials (CONSORT) Statement was published in 1996, and first introduced to China in 2001. Although CONSORT has been widely accepted in high-quality international journals, we still need to have more investigation on how many Chinese journals have adopted the CONSORT Statement, and whether the quality of reporting has improved. A systematic search of the “Instructions to authors” in all Chinese medical journals in China Academic Journals (CAJ) Full-text Database was conducted up to February 2012 and only 7 journals officially listed the requirements of the CONSORT Statement. The research articles about randomized controlled trials (RCTs) published in 2002, 2004, 2006, 2008, and 2010 from journals which had specifically adopted the CONSORT Statement, and from 30 top journals based on the Chinese Science Citation Index (CSCI) 2011 as the control group, were identified. The quality of both cohorts of articles was assessed using the revised CONSORT Checklist and Jadad scale. A total of 1221 Chinese medical journals was identified. Only seven journals stated clearly in the “Instructions to authors” that authors should adopt the CONSORT requirement in the clinical trial paper. None of these journals is among the control group in the CSCI 2011. In the selected years, a total of 171 articles from 7 journals which had adopted CONSORT and 232 articles in the control were identified as including RCT trials. The average scores according to the revised CONSORT Checklist were 29.47 for the CONSORT-adopting journals and 25.57 for the control group; while the average scores based on the Jadad scale were 2.53 for CONSORT-adopting journals and 1.97 for the control group. Few journals among Chinese medical journals have adopted the CONSORT Statement. The overall quality of RCT reports in the 7 journals which have adopted CONSORT was better than those in the top 30 journals which have not adopteded CONSORT. The quality of RCT reports in Chinese journals needs further improvement, and the CONSORT Statement could be a very helpful guideline.

Highlights

  • Background and objectivesScientific backgroundExplanation of rationaleSpecific objectives or hypotheses

  • We firstly conducted a systematic search of the “Instructions to authors” in all Chinese medical journals to identify the journals adopting the Consolidated Standards of Reporting Trials (CONSORT) Statement. We compared these journals’ randomized controlled trials (RCTs) report quality with a control group. Through these process we examined all the medical journals in China to explore how many of them had adopted the CONSORT Statement, how they used it, and the influence of the CONSORT Statement on the quality of papers published in these journals, to analyze the current application status of the CONSORT Statement in China and how to improve the statement’s acceptance in Chinese medical journals

  • Based on the exclusion criteria of this study, 403 articles were selected for further analysis, with 232 articles from the control group, and 171 articles from journals adopting the CONSORT Statement

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Summary

Introduction

Background and objectivesScientific backgroundExplanation of rationaleSpecific objectives or hypotheses. Due to the unsatisfactory situation of randomized controlled trial (RCT) reporting, in 1993, 30 experts met in Ottawa, Canada with the aim of developing a new scale to assess the quality of RCT reports [1]. After merging with another group of experts from Chicago (USA), the Consolidated Standards of Reporting Trials (CONSORT) Statement was first published in 1996 [2]. In an RCT quality evaluation based on the CONSORT 2001 Statement [8], 142 published RCTs from 2004 to 2007 in 5 leading Chinese medical journals were assessed and it was found that only a very small number of CONSORT items was reported clearly in all included trials. Another report, which included 307 RCTs conducted in China and published in 2004, came

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