Abstract

BackgroundThe CONSORT Statement is a reporting guideline for authors when reporting randomized controlled trials (RCTs). It offers a standard way for authors to prepare RCT reports. It has been endorsed by many high-impact medical journals and by international editorial groups. This study was conducted to assess the endorsement of the CONSORT Statement by high-impact medical journals in China by reviewing their instructions for authors.Methodology/Principal FindingsA total of 200 medical journals were selected according to the Chinese Science and Technology Journal Citation Reports, 195 of which publish clinical research papers. Their instructions for authors were reviewed and all texts mentioning the CONSORT Statement or CONSORT extension papers were extracted. Any mention of the Uniform Requirements for Manuscripts Submitted to Biomedical Journals (URM) developed by the International Committee of Medical Journal Editors (ICMJE) or ‘clinical trial registration’ was also extracted. For journals endorsing the CONSORT Statement, their most recently published RCT reports were retrieved and evaluated to assess whether the journals have followed what the CONSORT Statement required. Out of the 195 medical journals publishing clinical research papers, only six (6/195, 3.08%) mentioned ‘CONSORT’ in their instructions for authors; out of the 200 medical journals surveyed, only 14 (14/200, 7.00%) mentioned ‘ICMJE’ or ‘URM’ in their instructions for authors, and another five journals stated in their instructions for authors that clinical trials should have trial registration numbers and that priority would be given to clinical trials which had been registered. Among the 62 RCT reports published in the six journals endorsing the CONSORT Statement, 20 (20/62, 32.26%) contained flow diagrams and only three (3/62, 4.84%) provided trial registration information.Conclusions/SignificanceMedical journals in China endorsing either the CONSORT Statement or the ICMJE's URM constituted a small percentage of the total; all of these journals used ambiguous language regarding what was expected of authors.

Highlights

  • In 1996, in response to concerns about quality of reporting of randomised controlled trials (RCTs), an international group developed the Consolidated Standards of Reporting Trials (CONSORT) Statement [1]

  • One recommended authors of randomized controlled trials (RCTs) to refer to the CONSORT Statement

  • The Chinese Science and Technology Journal Citation Reports (CSTJCR) is the most authoritative citation reports in China, which is released by the Institute of Science and Technical Information of China and updated once a year [13]

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Summary

Introduction

In 1996, in response to concerns about quality of reporting of randomised controlled trials (RCTs), an international group developed the Consolidated Standards of Reporting Trials (CONSORT) Statement [1]. Since the publication of CONSORT, several studies have been conducted to assess the impact of using the CONSORT Statement on improving the reporting of RCTs in medical journal articles [6,7,8] The majority of their results indicated that CONSORT has helped improve the quality of reporting of RCTs and confirm its usefulness. The CONSORT Statement is a reporting guideline for authors when reporting randomized controlled trials (RCTs) It offers a standard way for authors to prepare RCT reports. It has been endorsed by many high-impact medical journals and by international editorial groups. This study was conducted to assess the endorsement of the CONSORT Statement by high-impact medical journals in China by reviewing their instructions for authors

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