A Review of Adherence and Predictors of Adherence to the CONSORT Statement in the Reporting of Tuberculosis Vaccine Trials

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.

Assessment of the reporting quality of randomized controlled trials related to the pharmacotherapy of COVID-19 based on the CONSORT 2010 checklist: a systematic review

“…The intraclass correlation coefficients for the scoring of inter-observer agreement for the OQS was 0.96. The mean CONSORT adherence rate, 77.4% (95% CI: 69.4%–85.4%), was similar to or higher than that of other RCTs conducted before the COVID-19 pandemic [ 5 , 6 ]. Of the 37 checklist items, 25 were addressed in ≥75% ( Figure1B ).…”

The transparency of reporting 'harms' encountered with the surgically assisted acceleration of orthodontic tooth movement in the published randomized controlled trials: a meta-epidemiological study

“…This result is not surprising, as a low level of HR adherence is well recognized across other fields of dentistry [ 57 , 58 ]. In addition, many studies in the medical field showed that adherence to CONSORT guidelines including the harms item was suboptimal and need to improve [ 59 – 61 ]. However, poor reporting of harm can be explained by some reasons.…”

“…On the contrary, some researchers prefer to focus on the positive aspects of the intervention, so they omit the occurred harms [ 62 ] which may be also one of the reasons for the underreporting of harm. Another reason could be publication bias, where researchers may believe that reporting harms associated with their research may negatively affect the ability to publish their trials, may revoke approval for funding for their research work [ 61 , 62 ], or may affect negatively the widespread of their proposed surgical intervention [ 63 ]. On the other hand, clinical trial participants need to be clearly and adequately informed of both the potential risks and benefits of the proposed intervention [ 64 ].…”

Analysis of the Evidence Underpinning the American Academy of Orthopedic Surgeons Knee Osteoarthritis Clinical Practice Guidelines

“…We considered an RCT to have “adequately” complied with the CONSORT guidelines if ≥75% of CONSORT items were sufficiently met, as done in previously published investigations on CONSORT adherence. 25 Estimated parameters using a population size of 355 RCTs included a hypothesized percentage frequency of 37% for “adequate” adherence to CONSORT reporting (based on data obtained by Ngah et al 25 ), a confidence limit of 5%, and a design factor of 1, which is used in random sampling. Based on these factors, we anticipated a sample size of 179 RCTs.…”