A Cross-sectional literature survey showed the reporting quality of multicenter randomized controlled trials should be improved

Xuan Zhang, Wai Ching Lam, Fan Liu, Mengdan Li, Lin Zhang, Weifeng Xiong, Xiaohan Zhou, Ran Tian, Chongya Dong, Chen Yao, David Moher*, Zhaoxiang Bian*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

Objective: To assess the reporting quality of randomized controlled trials (RCTs) with multicenter design, particularly whether necessary information related to multicenter characteristics was adequately reported.

Study Design and Setting: Through a search of 4 international electronic databases, we identified multicenter RCTs published in English from 1975 to 2019. Reporting quality was assessed by the CONSORT (Consolidated Standards of Reporting Trials) checklist (37 items) and by a self-designed multicenter-specific checklist (27 items covering multicenter design, implement and analysis). The scores of trials published in three time periods (1975-1995; 1996-2009; and 2010-2019) were also compared.

Results: A total of 2,844 multicenter RCTs were included. For the CONSORT checklist, the mean (standard deviation) reporting score was 24.1 (5.5), 12 items were assessed as excellent (>90%), 12 items as good (50%-90%), and 13 items as poor (<50%). For the multicenter checklist, the reporting score was 3.9 (2.2), only 3 items were excellent or good, and the remaining 24 items were poor. Time period comparison showed that reporting quality improved over time, especially after the CONSORT 2010 issued.

Conclusion: Although CONSORT appears to have enhanced the reporting quality of multicenter RCTs, further improvement is needed. A “CONSORT extension for multicenter trials” should be developed.

Original languageEnglish
Pages (from-to)250-261
Number of pages12
JournalJournal of Clinical Epidemiology
Volume137
DOIs
Publication statusPublished - Sep 2021

Scopus Subject Areas

  • Epidemiology

User-Defined Keywords

  • CONSORT guideline
  • Extension
  • Heterogeneity
  • Multicenter clinical trials (MCT)
  • Randomized controlled trials (RCTs)
  • Reporting quality

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