A review of adherence and predictors of adherence to the CONSORT Statement in the reporting of tuberculosis vaccine trials
Date
2020-12-16
Journal Title
Journal ISSN
Volume Title
Publisher
MDPI
Abstract
The statement on Consolidated Standards of Reporting Trials (CONSORT) ensures transparency in the reporting of randomized trials. However, it is unclear if the statement has led to improvement in the quality of reporting of tuberculosis (TB) vaccine trials. We explored
the quality of reporting of TB vaccine trials according to the latest version of the CONSORT
statement, released in 2010. We searched PubMed and the Cochrane Central Register of Controlled
Trials in August 2019. We conducted screening, study selection, and data extraction in duplicate;
and resolved differences through discussion. We assessed reporting to be adequate if trials reported
at least 75% of the CONSORT 2010 items. We conducted a trend analysis to assess if there was
improvement in reporting over time. We also used logistic regression to assess factors associated
with adequate reporting. We included 124 trials in the analyses. The mean proportion of adherence
was 67.3% (95% confidence interval 64.4% to 70.1%), with only 46 (37%) trials having adequate
reporting. There was a significant improvement in the quality of reporting over time (p < 0.0001).
Trials published in journals with impact factors between 10 and 20 were more likely to have adequate
reporting (odds ratio 9.4; 95% confidence interval 1.30 to 67.8), compared to lower-impact-factor
journals. Despite advances over time, the reporting of TB vaccine trials is still inadequate and
requires improvement.
Description
CITATION: Ngah, V. D. et al. 2020. A review of adherence and predictors of adherence to the CONSORT Statement in the reporting of tuberculosis vaccine trials. Vaccines, 8(4):770, doi:10.3390/vaccines8040770.
The original publication is available at https://www.mdpi.com
The original publication is available at https://www.mdpi.com
Keywords
Tuberculosis -- Vaccination, Clinical trials -- Reporting, Consolidated Standards of Reporting Trials (CONSORT)
Citation
Ngah, V. D. et al. 2020. A review of adherence and predictors of adherence to the CONSORT Statement in the reporting of tuberculosis vaccine trials. Vaccines, 8(4):770, doi:10.3390/vaccines8040770.