TY - JOUR
T1 - A Cross-sectional literature survey showed the reporting quality of multicenter randomized controlled trials should be improved
AU - Zhang, Xuan
AU - Lam, Wai Ching
AU - Liu, Fan
AU - Li, Mengdan
AU - Zhang, Lin
AU - Xiong, Weifeng
AU - Zhou, Xiaohan
AU - Tian, Ran
AU - Dong, Chongya
AU - Yao, Chen
AU - Moher, David
AU - Bian, Zhaoxiang
N1 - Funding Information:
Funding: This work was supported by the EQUATOR China Centre Funding OF Famous Horse Charity Foundation and National Natural Science Foundation of China ( No. 81704198 ). The funders had no role in the design of the study, in the collection, analysis, and interpretation of data, nor in the writing of the manuscript.
Publisher Copyright:
© 2021 The Authors
PY - 2021/9
Y1 - 2021/9
N2 - 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.
AB - 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.
KW - CONSORT guideline
KW - Extension
KW - Heterogeneity
KW - Multicenter clinical trials (MCT)
KW - Randomized controlled trials (RCTs)
KW - Reporting quality
UR - http://www.scopus.com/inward/record.url?scp=85108088227&partnerID=8YFLogxK
U2 - 10.1016/j.jclinepi.2021.05.008
DO - 10.1016/j.jclinepi.2021.05.008
M3 - Journal article
C2 - 34023433
AN - SCOPUS:85108088227
SN - 0895-4356
VL - 137
SP - 250
EP - 261
JO - Journal of Clinical Epidemiology
JF - Journal of Clinical Epidemiology
ER -