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.
Highlights
Tuberculosis (TB) is a bacterial infectious disease which affects mainly the lungs, and affects other organs
We found that the quality of reporting of TB vaccine trials improved significantly with time
This is in line with several studies that have reported improvement of trial reporting quality over time [20,22,23]
Summary
Tuberculosis (TB) is a bacterial infectious disease which affects mainly the lungs (pulmonary tuberculosis), and affects other organs (extra-pulmonary tuberculosis). The Bacille Calmette-Guerin (BCG) vaccine was the first vaccine for TB [2] and it is still the only licensed vaccine for the prevention of the disease [1] It is efficient in providing immunity against extra-pulmonary TB, its protection against pulmonary TB has been shown to vary considerably among different individuals and it is sometimes ineffective [3,4]. TB is a treatable disease, the Mycobacterium tuberculosis bacteria have become resistant to treatment over the years causing drug-resistant TB, including multidrug-resistant TB and extensively drug-resistant TB [5,6]. This causes a major public health problem and slows down progress made towards control of TB
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